May 12, 2011

II. Rural Areas: Unavailable or Hard-to-Access Strong Pain Medications

Patients who live in remote places are doomed.
—Nurse, District 1, April 16, 2010.

The Story of Konstantin Zvarich

Konstantin, a 67-year-old pensioner from Poltava province in central Ukraine, was in many ways a typical Ukrainian from the countryside. Born in 1943, he grew up amid the hunger and devastation caused by World War II. As a young man, he served in the Soviet army before joining a collective farm, where he worked for 46 years. Konstantin was married, had a daughter, and a grandson.

Konstantin developed problems urinating in January 2009. When the pain became so severe he could no longer pass urine, he went to the local clinic where a doctor diagnosed prostate cancer. Two rounds of surgery provided temporary relief from the pain but were unable to remove all the cancerous cells which soon began to metastasize.

A sudden onset of intense pain in his hands and fingers alerted Konstantin that all was not right. He had further tests which revealed the cancer had spread to his bones, a condition often associated with severe pain. Konstantin told Human Rights Watch:

The pain was so bad that my whole body seemed to break. We would call the ambulance every two to three hours because I could not stand it.[47]

Doctors briefly hospitalized Konstantin and then sent him home with a prescription for tramadol, a weak opioid pain medication. Because few pharmacies in Ukraine stock tramadol—the result of the government’s 2008 decision to treat tramadol essentially like morphine—Konstantin’s relatives had significant difficulty obtaining the medication. When Konstantin was finally able to get tramadol, it turned out to be far too weak to control his excruciating pain. He used all ten ampoules of tramadol—the maximum allowed under Ukrainian law per prescription—in a day without bringing his pain under control.

Konstantin’s daughter, a medical doctor in Kharkiv, a city in eastern Ukraine, advised him to take a variety of over-the-counter pain medications, none of which provided much relief. Although he complained to his doctors of severe pain, Konstantin’s doctors never prescribed morphine. The local clinic did not have the necessary license. (See Chapter III for detail on licensing requirements and procedures.) For four or five months Konstantin suffered ongoing, severe pain. Describing one particular episode, he broke down in tears saying:

It was unbearable. I came home and the pain grabbed me so strongly. It was so bad that I didn’t know what to do with myself. It is so difficult to live like this.[48]

One day in late summer, Konstantin’s pain was so bad that his grandson, who was staying with him in the village, called his mother, telling her that his grandfather was “bouncing of the walls” from pain. The daughter decided she could no longer leave her father in the village and managed to arrange a bed for him at Kharkiv’s hospice. There, Konstantin finally received morphine for his pain. When Human Rights Watch interviewed him in April 2010, he said that his pain was finally under control at the hospice.

Konstantin died in June 2010 at the hospice.

Lack of Narcotics Licenses at Health Clinics and Pharmacies

Tens of thousands of patients with pain across Ukraine’s vast rural areas, where one-third of its population of approximately 46 million people lives, face a similar fate to Konstantin’s every year.

Local health clinics—known asambulatoria and feldshersko-akusherski punkt (FAP)—and even many small hospitals do not have the narcotics licenses necessary to stock and prescribe strong opioid analgesics.[49] Even when patients receive a prescription, few pharmacies in rural areas are licensed to fill prescriptions for opioid medications. Although most of these facilities could apply for a license, Ukraine’s drug regulations require that they have a separate room to store these medications, which is specially equipped to prevent break-ins and theft. The associated cost and lack of spare rooms are the main reasons that few health clinics and small hospitals obtain narcotics licenses.

During its research, Human Rights Watch and local partners visited the main hospitals in five districts in Kharkiv and Rivne provinces, in eastern and western Ukraine respectively. Known as central district hospitals, these are the main health facilities and administrative centers for the public healthcare system in their districts. While all the central district hospitals had narcotics licenses, doctors at each location told us that none of the clinics did. As Table 1 shows, this means that many patients live dozens of kilometers away from health facilities that are authorized to prescribe strong pain medications, even if their own village or town has a health facility. A health official in Rivne province told us that the same was true for all other districts in the province: all 15 central district hospitals have the license but none of the 92 ambulatorias or the 613 FAPs in the province do.

TABLE 1

District

Size[50] (in sq. km)

No. of district hospitals (with license)

No. of ambulatories (with license)

No. of FAPs (with license)

District 1 [51]

467

1 (1)

2 (0)

5 (0)

District 2 [52]

1,149

4 (1)

13 (0)

10 (0)

District 3 [53]

1,011

1 (1)

6 (0)

8 (0)

District 4 [54]

693

1 (1)

4 (0)

33 (0)

District 5 [55]

659

2(1)

6(0)

27(0)

District 6 [56]  

695

1 (1)

43(0)

6(0)

 

A Broken Pain Treatment Delivery System

The lack of licensed health facilities in rural areas means that patients or their relatives have to travel long distances to fill prescriptions for strong pain medications, often on poor roads and infrequent public transport. This already problematic situation is exacerbated by a pain treatment delivery system that does not allow clinics to provide patients and their relatives with a take-home supply of injectable morphine.

In general, doctors do not write prescriptions for strong opioid analgesics for patients to fill at pharmacies. Instead, patients receive morphine from hospital stock. While this has the advantage that patients do not have to pay for their medications, Ukraine’s drug regulations require healthcare workers to administer injectable strong opioid analgesics from hospital stock directly to the patient.[57] In other words, health facilities are not allowed to give the medication to patients or their relatives to take home and administer themselves. Instead, healthcare workers are supposed to visit patients at their homes for every prescribed dose of injectable morphine, often multiple times per day. The regulations do allow self-administration of oral opioid analgesics but none are available in Ukraine due to a lack of effort by the government to offer them through the public healthcare system.

This system is a major barrier to evidence-based pain care in Ukraine’s urban areas and often an insurmountable obstacle in rural areas, where healthcare facilities lack the resources for staff to travel to central district hospitals to pick up strong pain medications and then visit patients at home several times per day. As a result, many patients end up without access to the pain medications they need. Some patients may get pain medications once or twice per day. And only a very few—those who live in districts where doctors are willing to ignore government regulations—might get reasonably effective pain treatment.

In each of the five districts visited for this research, we found that healthcare providers struggled to deliver strong pain medications to patients. Their approaches (Table 2) varied from not providing strong opioid analgesics to patients outside district centers to trying to accommodate them. But even in the best scenario major and unnecessary obstacles remained to evidence-based pain care. In each district, doctors and nurses openly admitted that many patients, particularly those who live outside the district centers, were not getting the care they needed.

TABLE 2

Districts

Approach to delivering pain treatment

Districts 1, 2, 5, 6

Nurses from the central district hospital are responsible for delivering injections with pain medications during the day to patients who live in the district center; ambulances administer the injections during evening hours. Nurses and feldshers from local health clinics are responsible for delivering pain treatment to patients outside the district center. [58] They have to travel to the central district hospital every day to pick up the daily supply of medications for their patients and then visit them at their homes for each injection. Ambulances do not provide pain care outside the district center.

District 3

Ambulances are responsible for delivering strong pain medications to all patients irrespective of where they live and at any time of the day.

District 4

Healthcare workers provide patients or their relatives with a three-day supply of morphine and allow them to administer the medication themselves, in contravention of Ukraine’s drug regulations. Every third day, in return for the empty ampoules, patients or their relatives receive their medications for the next three days. Nurses and feldshers at local health clinics are instructed to check in on patients regularly to ensure that they are using the medications appropriately and are achieving adequate pain control.

In districts 1, 2, 5, and 6, patients living outside the district center often had no access to strong opioid analgesics. The oncologist in district 2 expressed his frustration with the system:

Prescribing is not the issue; it’s delivering the medications. If possible, injections are done daily. If the area is close, the nurse can come every day to pick up morphine. They may come in the car of the FAP or ambulatoria and return the empty ampoules the next day. But not all FAP and ambulatoria have cars or they don’t have money for gas … If people live far away, the reality is that we make do with tramadol [a weak opioid] and dimedrol [an antihistamine]. We try the best we can. It is a tragedy for such patients. I look at them and I want to do something for them but I can’t.[59]

He added there were currently 30 end-stage cancer patients in his district, 20 of whom should have been receiving strong opioid analgesics. Instead, only three were.

The oncologist in district 5 said it was problematic for nurses and feldshers to travel to the central district hospital: “The rural healthcare system is poorly funded so they [nurses and feldshers] talk to the relatives who pay for their travel or bring the feldsher in their own cars.”[60] A nurse in district 1 said that staff at health clinics in her district cannot travel to the central district hospital to pick up morphine due to lack of transportation and time.[61] She took us to the house of a cancer patient who had been prescribed one injection of morphine per day, which was delivered via an ambulance that drove to his house every evening. The patient said he was in significant pain during the day and that “it would be very good to have a second injection. They make me feel so much better.”[62] The nurse said this was unlikely to happen:

If they prescribe an injection during the day, I will have to go to the patient’s home myself. That would mean that when I come to work at 8 a.m. I would pick up the ampoule from the chief nurse and then to walk to the patient’s home because there is no transportation. That takes 30 to 40 minutes. I would do the injection and then have to walk back. So it takes more than an hour to do one injection. That’s why we try not to prescribe during the day.[63]

Poland’s Rural Areas: A Different Story

In Poland, morphine and other strong opioid analgesics are readily available in rural areas. Oral morphine is included in Poland’s essential medicines list, and pharmacies and health clinics are required to stock them. Although pharmacies may apply for a waiver to this rule—and quite a few do for opioid medications—there is a dense network of pharmacies with narcotics licenses throughout the country.

When a pharmacy does not have opioids in stock, it can request them from a wholesaler and generally receive new supply within half a day. Opioid medications are provided free of charge at pharmacies. Doctors can prescribe a 30-day supply of oral morphine per prescription. The prescription can be filled at any pharmacy that has a narcotics license.

Human Rights Watch interview with Dr. Tomasz Dzierzanowski, palliative care physician

Most patients in the district, she said, receive just one injection of morphine per day at most, leaving them in pain for most of the day. The nurse noted that occasionally patients get a second injection. She could remember only one patient in her eight years at the hospital who received three injections of morphine per day.[64]

Asked if they ever simply gave ampoules, small glass vials that contain morphine, to patients or their relatives to take home, healthcare workers in districts 1 and 2 said that they never did because of the strict control over these medications. The nurse in district 1 said: “The chief nurse [who is responsible for keeping records] is very strict with narcotic drugs. She has to protect herself because there can be an inspection anytime and if ampoules are missing she is in trouble.” [65] The oncologist in district 5 said that she and her colleagues sometimes provide patients from villages with a two or three-day supply. [66]

In district 3, where ambulances deliver pain medications to all patients, access to pain medications is significantly better. However, the ambulance service is not able to visit patients every four hours, so most receive two doses of morphine per day. [67] The chief doctor noted that poor weather—much of Ukraine sees significant snowfall in winter—can undermine the delivery of pain medications. He recalled difficulties during the winter of 2010 when major snowfall made many roads inaccessible:

If there is no road [accessible] we drive to the farthest point and then go on foot. But in some cases, getting to the village—not to speak of the house—was impossible this winter. We would contact the road service … We had three patients in [rural villages] and asked if they could at least open up the roads there. So we didn’t leave them without help. Of course we couldn’t stick to the timing of the injections.[68]

In district 4, healthcare workers violate Ukraine’s drug regulations—and potentially expose themselves to disciplinary and criminal sanctions—to improve patients’ accessibility to strong opioid analgesics. Here, patients and their relatives are responsible for obtaining pain medications from the central district hospital themselves. This gives them the option of getting more doses of the pain medications, and flexibility to administer it when most convenient for them. But it also places a significant burden on families who have to travel every three days to the central district hospital to collect medications.

The deputy chief doctor at the central district hospital recalled an elderly lady who had been coming to the central district hospital every three days for the last 18 months to pick up pain medications for her husband, a cancer patient. Even though there is a health clinic a kilometer from her house, she has to travel 20 kilometers every third day to the district center because the local clinic does not have a narcotics license. [69] A nurse at the central district hospital recalled a woman who had to leave her village at 4 a.m. every third day in order to catch a minibus to the district center and be able to make it back home the same day. [70]

Svitlana Bulanova told us of her sister’s plight caring for her daughter, Irina, a young woman with cervical cancer. She said that after Irina’s cancer had metastasized to her bones, she often screamed in agony due to the pain. Her doctors prescribed morphine but their local clinic did not have a narcotics license. So Irina’s parents had to travel the 25 kilometers to the district center every third day on public transport, a five-hour round trip that involved walking to the main road, waiting for a mini-bus to the district center, walking to the central district hospital to get the medications, and then repeating the journey on the way back.[71]

Pharmacies and Opioid Analgesics

Pharmacies play a limited role in distributing strong opioid analgesics to patients in Ukraine because most doctors prescribe these medications from hospital stock. But they do play a significant role in distributing tramadol, a weak opioid analgesic widely used in Ukraine.

Pharmacies must have a narcotics license before they can stock and dispense medications like morphine or tramadol. Yet, few pharmacies in rural areas have such licenses. The head of Ukraine’s National Drug Control Committee, the government agency responsible for issuing licenses, told Human Rights Watch in October 2010 that in Kirovohradskaia province there were only four pharmacies with such a license for 1.1 million people. [72] He said the situation in other provinces was somewhat less extreme but still highly problematic. [73]

This means that patients or their relatives often have to travel to district centers to fill their prescriptions, encountering the same challenges as described above. The chief doctor at the central district hospital in district 3, for example, said that in his district there is not a single pharmacy with a narcotics license so patients have to travel to the next district to fill prescriptions for tramadol. The doctor noted that there are just two buses per day to the town, making the trip very burdensome for people without their own transportation.

Ukraine’s drug regulations impose a strict limit on the amount of medication that can be prescribed per prescription. Table 3 shows the maximum amounts for several medications commonly used in pain management. This means that the patient or relatives have to obtain a new prescription every few days and then travel to the licensed pharmacy to fill it.

TABLE 3

Medication

Maximum amount per prescription [74]

In special cases of “lingering and chronic forms of disease”

Typical daily dose

Average time covered per prescription (in special cases)

Tramadol injectable (1 ml – 50 mg; 2 ml – 100 mg)

10 ampoules

20 ampoules

Up to 600 mg/day

2 (4) days

Tramadol tablets (50mg)

30 tablets

60 tablets

Up to 400 mg/day

4 (8) days

Morphine (8.6 mg)

10 ampoules

20 ampoules

20-25 mg / day [75]

4 (8) days

[47] Human Rights Watch interview with Konstantin Zvarich (not his real name), April 13, 2010.

[48] Ibid.

[49] An ambulatoria is an outpatient clinic. A feldshrsko-akusherski punkt is a health point that provides basic procedures, including prenatal care and first aid. These health centers are run by feldshers, physician assistants trained in vocational medical schools and provide routine checkups, immunizations, and emergency first-aid, and midwives. There are no physicians at these clinics.

[50] Statoids, “Raions of Ukraine,” 2005, http://www.statoids.com/yua.html (accessed February 24, 2011).

[51]Human Rights Watch and Institute of Legal Research and Strategies interview with the district oncologist in district 1, April 16, 2010.

[52]Human Rights Watch and Institute of Legal Research and Strategies interview with the district oncologist in district 2, April 16, 2010.

[53] Human Rights Watch and Institute of Legal Research and Strategies interview with the chief doctor of the central district hospital in district 3, April 14, 2010.

[54] Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with HIV interview with the deputy chief doctor of the central district hospital.

[55] All-Ukrainian Network of People Living with HIV, Rivne branch, interview with the chief doctor of the central district hospital in district 5, May 12, 2010.

[56] Correspondence with doctors in district 6, February 24, 2011.

[57] Ministry of Health Order 11 of 2010, para. 3.11.

[58]Feldshers are physician assistants trained at nursing schools and provide routine checkups, immunizations, and emergency first-aid. While some feldshers are supervised by doctors in large hospitals, many work in rural areas where they run small outpatient posts.

[59]Human Rights Watch and Institute of Legal Research and Strategies interview with the district oncologist in district 2, April 16, 2010.

[60] All-Ukrainian Network of People Living with HIV, Rivne branch, interview with the chief doctor of the central district hospital in district 5, May 12, 2010.

[61] Human Rights Watch and Institute of Legal Research and Strategies interview with nurse in district 1, April 16, 2010.

[62] Human Rights Watch and Institute of Legal Research and Strategies interview with Yakiv Kovalenko (not his real name), April 16, 2010.

[63] Human Rights Watch and Institute of Legal Research and Strategies interview with nurse in district 1, April 16, 2010.

[64] Ibid.

[65] Ibid.

[66] All-Ukrainian Network of People Living with HIV, Rivne branch, interview with the chief doctor of the central district hospital in district 5, May 12, 2010.

[67] Human Rights Watch and Institute of Legal Research and Strategies interview with the chief doctor of the central district hospital in district 3, April 14, 2010

[68] Ibid.

[69] Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with HIV interview with the deputy chief doctor of the central district hospital.

[70] Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with HIV interview with a nurse of the central district hospital.

[71] Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with HIV interview with Svitlana Bulanova (not her real name), April 21, 2010.

[72] The population of Kirovohradskaia province is 1,133,052, see: Statoids, “Regions of Ukraine”, 2005, http://www.statoids.com/yua.html (accessed March 14, 2011).

[73]Human Rights Watch and International Renaissance Foundation meeting with Volodymyr Tymoshenko, head of the National Drug Control Committee, Kiev, October 22, 2010. In follow-up conversations, Tymoshenko has told the International Renaissance Foundation that Odessa province also has only four pharmacies with narcotics licenses and that Crimea has just seven.

[74] Ministry of Health Order 11 of January 21, 2010, para. 3.8; and Ministry of Health Order 360 of July 19, 2005.

[75] A typical daily dose is 60-75 mg of oral morphine. See: Kathleen M. Foley, et al., "Pain Control for People with Cancer and AIDS," in Disease Control Priorities in Developing Countries, 2nd ed., (New York: Oxford University Press, 2003), pp. 981-994.

The equivalent for injectable morphine is indicated here.