May 12, 2011

IV. Exploring the Causes of Untreated Pain

The World Health Organization has urged countries to adopt national or state policies that support pain relief and palliative care; enact educational programs for the public, healthcare personnel, regulators, and other relevant parties; and modify laws and regulations to improve the availability and accessibility of drugs, especially opioid analgesics.[142] It has noted that such measures, fundamental for the development of palliative care, “cost very little but can have a significant effect.”[143]

The WHO’s recommendations correspond closely with several core obligations, which countries must meet regardless of resource availability, under the right to health. The Committee on Economic, Social and Cultural Rights (CESCR), which monitors implementation of the right to health as articulated in the International Covenant on Economic, Social and Cultural Rights (ICESCR),[144] has held that countries must adopt and implement a national public health strategy and plan of action and ensure access to essential drugs as defined by the WHO.[145] It has identified providing appropriate training for health personnel as an obligation “of comparable priority.”[146]

The Ukrainian government’s failure to take sufficient steps in these three areas not only violates the right to health, it is the primary reason for problems with palliative care and pain treatment identified in previous chapters. While the government has created a significant number of palliative care beds in public hospices and hospitals, as well as an Institute of Palliative and Hospice Medicine in the Ministry of Health, it has not taken adequate steps to ensure availability of essential palliative care medicines like oral morphine, develop a system of home-based palliative care, improve instruction for healthcare workers, or address major drug regulatory problems.

Policy

To successfully address the problems described above, a concerted and coordinated effort by a broad range of governmental and other stakeholders is needed: oral morphine must be introduced, a home-based palliative care model developed, instruction for health workers revamped, and drug regulations reformed.

As a party to the International Covenant on Economic, Social and Cultural Rights, the government has the responsibility to ensure that people with life-limiting illnesses can enjoy their right to health. It thus has to take the lead in addressing the barriers that currently impede the availability of good palliative care and pain treatment.

The Ukrainian government needs to play a much more proactive role, although it has started to take some policy steps in this direction. In 2008 it established an Institute of Palliative and Hospice Medicine within the Ministry of Health and named Professor Yuri Gubsky as its head. The institute’s mandate includes developing state programs and control over their implementation; coordinating efforts to establish a network of health institutions that provide palliative care; providing organizational and methodological support to such institutions; and conducting research.[147] Tasked with developing the government’s approach to palliative care, the institute has developed a draft national palliative care concept program that was submitted to the cabinet of ministers in October 2008.[148] The draft concept was sent back to the Ministry of Health a month later for technical reasons. To date, a new draft concept program has not yet been submitted to the cabinet of ministers, leaving Ukraine without a clear plan for developing palliative care.

As a result, Ukraine’s efforts to develop palliative care have lacked cohesion, urgency, and coordination. While the government has taken a number of important steps to enhance palliative care provision in healthcare institutions, it has not done so to ensure oral morphine becomes available, or to promote home-based palliative care. While the Institute of Palliative and Hospice Medicine has started continuing medical education courses on palliative care, there have been no centralized efforts to incorporate adequate palliative care instruction into medical school curricula or to develop a palliative care treatment guideline. While Ukraine’s drug regulators have made some changes to drug regulations to improve the availability of controlled medications, they have not addressed some of the most problematic provisions.

Education of Healthcare Workers

Lack of knowledge among healthcare workers about palliative and pain treatment services is one of the biggest obstacles to palliative care in many countries around the world. A dearth of training on the topic means that many healthcare workers do not fully understand palliative care or have the skills to provide it and subscribe to a variety of myths and misconceptions about strong opioid analgesics.

Most healthcare workers interviewed were unaware or only partially aware of international best practices for pain treatment. Many doctors and nurses expressed the erroneous belief that giving patients morphine would turn them into “drug addicts”; confused physical dependence and tolerance with dependence syndrome (addiction); interpreted patient requests for more morphine as a sign of “addiction” rather than as a sign that the current dose was insufficient; believed that one dose of morphine could provide relief far beyond the four to six hours it is active; and that a maximum daily dose was appropriate.

Healthcare workers’ inadequate knowledge about palliative care and pain treatment appears to be a direct consequence of the failure of Ukraine’s medical schools, which are all public institutions, to provide sufficient instruction on pain management and palliative care for medical students. According to palliative care experts, few medical universities have introduced specific instruction on palliative care. The mandatory undergraduate curriculum in medical schools does not include any specific instruction on palliative care, and classes about pain treatment focus primarily on acute pain (post-surgical pain, for example) rather than chronic or cancer pain.[149] While the WHO pain relief ladder is briefly mentioned, it is not studied in any detail or used in practice. In pharmacology, students learn about the pharmacological characteristics of morphine rather than its use in clinical practice.

After medical school, graduates in Ukraine go through a two-year initial specialization phase and enroll into residency programs depending on their specialization. At present, only 2 of about 19 teaching institutions offer palliative care services so most doctors specializing in oncology or anesthesiology receive no practical exposure to palliative care and pain management. Even doctors specializing in oncology do not currently do rotations in hospices. As a result, the next generation of Ukrainian doctors is educated with very limited exposure to palliative care services.

At present, just two medical institutions in Ukraine offer continuing medical education courses in palliative care: the Shchupik National Medical Academy for Post-Graduate Education and the post-graduation faculty of the Ivano-Frankiivsk Medical University. Two departments of the National Academy offer such courses. In 2010 the department of palliative care of the National Academy started offering one and two-week courses on palliative care throughout the year for oncologists, general practitioners, and nurses. The courses include bedside training.[150] The department of gerontology has organized palliative care courses since December 2009. The Ivano-Frankiivsk Medical University has included forty hours of palliative care training, including clinical training in the local hospice and in its continuing medical education courses for general practitioners.[151] All general practitioners must complete post graduate education courses once every five years.

Our research also found a conspicuous absence of evidence-based resource materials on palliative care in Ukrainian. Apart from a treatment guideline on HIV and palliative care, the Ministry of Health and professional associations have not developed clinical guidelines for palliative care or pain treatment in patients with cancer and other conditions. Textbooks used in medical and nursing schools contains little information about palliative care.[152] Pharmacology textbooks used in Ukrainian medical schools are based on a Soviet-era book that contains inaccurate information about morphine dosing.[153]

All Ukraine’s medical schools are public institutions that operate under the auspices of the Ministry of Health. The government is thus clearly in a position to ensure that adequate instruction on palliative care is provided. Human Rights Watch believes that all medical students should receive basic instruction on palliative care and pain treatment. Those whose specialize in disciplines that frequently care for people with life-limiting illnesses should receive detailed instruction and exposure to clinical practice. Failure to do so will result in a violation of the right to health.

Drug Availability

Ukraine’s drug regulations are at the heart of several of the problems with palliative care and pain management identified in previous chapters. Very strict licensing requirements have made morphine unavailable in many rural areas, and the requirement that healthcare workers must directly administer morphine to patients has led to antiquated, non-evidence based pain treatment practices. But Ukraine’s drug regulations also create a significant administrative burden for healthcare workers who prescribe opioid medications and impose a very strict control regime that generates a sense of trepidation about prescribing opioid medications among many healthcare workers. These two factors likely contribute to the reluctance among many healthcare workers to prescribe these medications and an unwarranted delay in the onset of treatment for severe pain.

Under the 1961 Single Convention on Narcotic Drugs, governments must regulate the manufacture, distribution, and prescription of controlled substances to prevent their misuse. But the convention also recognizes that these substances are “indispensable for the relief of pain and suffering” and that states must make “adequate provision to ensure [their] availability … for such purposes.”[154] In the words of the International Narcotics Control Board, the body that monitors implementation of the UN drug conventions, the 1961 convention:

… establishes a dual drug control obligation: to ensure adequate availability of narcotic drugs, including opiates, for medical and scientific purposes, while at the same time preventing illicit production of, trafficking in and use of such drugs.[155]

The 1961 Single Convention on Narcotic Drugs lays out three minimum criteria that countries must observe when developing national regulations on handling controlled medications:

  • Individuals must be authorized to dispense opioids by their professional license to practice or be specially licensed to do so.
  • Movement of opioids may occur only between institutions or individuals so authorized under national law.
  • A medical prescription is required before opioids may be dispensed to a patient.

Additionally, countries also have to keep records on the use of controlled medications.[156]

Impact of Drug Control on Medicine Availability: The Example of Tramadol

Tramadol is a weak opioid pain medication used to treat moderate to severe pain. In Ukraine, as in most countries, it was a regular prescription medication widely used for pain management. Unlike morphine, the use of which was mired in bureaucracy around prescription, tramadol was a hassle-free pain medication that was significantly stronger than over-the-counter pain medications. Doctors could write a simple prescription and patients could buy the medication at any pharmacy. In fact, most pharmacists sold tramadol without a prescription as well.

However, the easy availability of the drug had adverse consequences. Although tramadol has unpleasant side effects, many drug users started using it to mitigate the effects of withdrawal when they did not have access to other drugs. Teenagers began experimenting with tramadol at schools; for many, tramadol was their first experience with drug use.

Ukraine’s law enforcement agencies became increasingly concerned about the way tramadol was being used for non-medical purposes. Instead of enforcing existing rules for prescription medications—stopping pharmacists from giving out such medications without a prescription—the government applied an increasingly restrictive prescription regime to the medication and, eventually, scheduled it as a narcotic drug in June 2008.

The effect of this decision on the availability of tramadol for legitimate medical purposes has been dramatic. According to the pharmacological center of the Ministry of Health, four producers of tramadol discontinued production. Many pharmacies were no longer allowed to stock the medication because they did not have narcotics licenses. For healthcare providers, it became as problematic to prescribe tramadol as morphine, so many stopped doing so. One oncologist told Human Rights Watch: “Prescribing tramadol is such a hassle that you might as well prescribe morphine.” A chief doctor at a central district hospital said there is not one pharmacy that stocks tramadol in his entire district of some 35 thousand people.

Government estimates for domestic production of tramadol show a dramatic decrease from 2008 to 2010. In 2008 the government estimated production at 19.5 and 6.5 million grams of oral and injectable tramadol for the year. In 2010, its estimate was 1.88 million grams of tramadol or almost 14 times less.

The convention permits governments to impose additional requirements if deemed necessary.[157] However, as WHO has observed that “this right must be continually balanced against the responsibility to ensure opioid availability for medical purposes.”[158] In other words, regulations should not unnecessarily impede access to controlled medications. WHO has developed guidelines that governments can use to develop what it has called a “practical system” of regulating healthcare workers’ handling of controlled medications, as well as guidelines for ensuring that drug control policies are properly balanced.[159]

Ukraine’s drug regulations have a strong focus on prevention of misuse of controlled medications, with many of their provisions going far beyond what is required by the UN drug conventions. Human Rights Watch recognizes that prevention of misuse is of particular importance in countries which, like Ukraine, face major problems with illicit drug use as well as significant corruption in the healthcare sector.[160] However, our research shows clearly that some provisions in Ukraine’s drug regulations are so burdensome and have such a restrictive impact on the availability of controlled medications for legitimate medical and health purposes that they lead to violations of the right to health.

Many of the healthcare workers we interviewed for this report were also concerned about the negative impact of drug regulations on legitimate medical practice. While all supported strict regulation of opioid analgesics, many felt the current regulatory regime was excessively and unnecessarily burdensome. They said that certain aspects of the regulations strongly interfered with the delivery of adequate pain treatment services and were not necessary to prevent misuse.

Ukraine’s government has begun to address some of the problematic provisions in its drug regulations. It has created a working group on pain treatment that is responsible for reviewing drug regulations. In 2010 Ukraine adopted a new regulation, Order 11, which somewhat relaxed the requirement that healthcare workers directly administer strong opioid medications by allowing self-administration of oral medications. This change means that if Ukraine introduces oral morphine, healthcare workers will be allowed to provide them with a take-home supply. In October 2010 in meetings with Human Rights Watch and the International Renaissance Foundation, Volodymyr Tymoshenko, the head of the National Drug Control Committee and Elena Koval of the department on licit narcotics circulation of the Interior Ministry stated that they were deeply concerned about the lack of narcotics licenses among rural pharmacies and health clinics.[161] Tymoshenko said that he had raised these concerns with regional officials and encouraged them to ensure that more pharmacies obtained narcotics licenses.[162]

Licensing Requirements

Under the UN drug conventions, controlled medicines may only be handled by individuals and institutions that are licensed to do so. This means that healthcare institutions and workers need to be licensed before they can stock, prescribe, or dispense opioid analgesics. Countries may set up a special licensing procedure for healthcare institutions and workers or permission to handle opioid medications can be part of the general license to operate a healthcare institution or professional license. Countries that require a separate license for institutions or healthcare workers should ensure that licensing requirements and procedures are transparent and efficient and do not create barriers to the availability and accessibility of these essential medications.

In Ukraine, healthcare institutions and pharmacies must obtain a special license from the National Drug Control Committee to be allowed to handle controlled medicines like morphine. This license also specifies which staff members of the institution are authorized to handle the medications. In interviews with Human Rights Watch, health administrators generally described the procedure for obtaining these licenses as smooth and unproblematic but said that some of the requirements a healthcare provider or pharmacy must meet to be able to get the license are problematic for many.[163] Health clinics known as feldshersko-akusherski punkty are ineligible to get a narcotics license.[164]

Ukraine’s regulations set out a number of criteria that a healthcare institution must meet before a license can be issued (summarized in Table 7).[165] Many of these requirements are significantly stricter than what is required by the UN drug conventions or is practiced in neighboring countries like Poland or Romania but most are not unreasonable. As long as they do not have an unjustifiably restrictive impact on the availability of controlled medicines for healthcare purposes, they are consistent with the right to health.

TABLE 7

Requirement

Details

Documents Required

Qualified Personnel

Management of facility must include a specialist with relevant professional training.

Personnel with access to controlled medications must have relevant professional training. This requirement is differentiated for different types of healthcare facilities and pharmacies, with fewer requirements for lower level facilities.

Certified copies of qualifications of management and personnel with access to the controlled medications.

No Counter Indications for Personnel

Personnel with access to controlled medicines may not have a mental disorder related to drug or alcohol abuse; may not have been declared ineligible to handle narcotics; may not have a criminal record related to illicit drugs and certain types of other criminal offenses.

Personnel must obtain relevant certificates from state drug treatment clinics and police once per year.

Appropriate Material Conditions

The facilities must be such that secure and safe conditions can be created for keeping and accounting for narcotics.

The Ministry of Interior must conduct an inspection at the site and issue a permit certifying that the premises meet requirements.

Appropriate Sanitary Conditions

Premises must meet the requirements of Ukraine’s sanitary norms and rules for storing of narcotics.

Conclusion from the State Sanitary-Epidemic Service.

Legal entity

The healthcare provider must be a legal entity.

 

But the requirements for storage premises (see Table 8) are highly problematic.[166] Most notably in practical terms for rural health clinics and pharmacies is the need for an alarm system. While there is no legal requirement that the alarm system be hooked up to the local police department, doctors at several rural hospitals said that this was a requirement in practice, and that the recurring monthly cost of such system, which one doctor put at 1400 hryvna (US$175), was too great for many clinics.

TABLE 8

Requirements for premises used for operations with narcotic drugs

 

Hospitals, pharmacies

Health clinics (ambulatoria)

Location of storage

 

Must be a separate room located in a “capital building.”

Walls

Walls must be equivalent in strength to a cement wall of a width of no less than 500 mm

No special requirements for the walls of the room.

Floors and ceilings

Floors and ceilings must be equivalent in their strength to a reinforced concrete plate no less than 180 mm wide

No special requirements for the floor/ceiling of the room.

 

 

 

If above requirements for walls, floors and ceilings are not met, the entire area of the walls, floor, and ceiling must be reinforced from the inside with steel bars of no less than 10 mm in diameter, and the size of openings no more than 150 x 150 mm. The bars must be welded to the walls or plates that are clear of laying and covered by anchors with diameter a no less than 12 mm and with a step of 500 x 500 mm. Where it is impossible to install anchors, fittings made of steel strips may be embedded with dimensions of 100 x 50 x 6 mm are attached to reinforced concrete surfaces with four dowels.

Entrance doors

 

Entrance doors must be durable, well fitted to the door frame; metal or wooden "full-body;" no less than 40 mm wide; must have two built-in, non-self-locking locks.

Entrance doors must be durable, well fitted to the door frame; metal or wooden "full-body"; no less than 40 mm wide; must have two built-in, non-self-locking locks.

Windows

Window openings must be equipped with metal bars from inside or between frames; it is permissible to use decorative bars or blinds with the strengths no less than that of the metal bars.

Window openings must be equipped with metal bars from inside or between frames; it is permissible to use decorative bars or blinds with the strengths no less than that of the metal bars.

Storage locker

No special requirements.

The premise must be equipped with vaults or metal boxes attached to the floor (walls).

Alarm system

The premise must be equipped with an alarm system that protects potential entry routs: window and door openings, ventilation routs, heat inputs, and other elements of the premise accessible for ingress from outside; the doors must be blocked for opening and breaking; the windows must be protected against opening and breaking of the window glass; non-capital walls, ceilings, places of service lines entry must be protected against breaking; capital walls, ventilation boxes must be protected against collapse and breaking force; the alarm signal must be transmitted to the board of centralized monitoring of a department of internal affairs.

The premise must be equipped with an autonomous alarm system that protects the inside space and surfaces of the premise, vaults (metal boxes) that are used for storage, and an alarm signal that transmits to the board of centralized monitoring or to local sound or light signaling devices.

Other requirements

 

 

Premises, vaults and metal boxes:

  • must be locked at the end of work with narcotic drugs;
  • at the end of a working day, must be sealed and turned over to the security.

Premises, vaults, and metal boxes:

  • must be locked at the end of work with narcotic drugs;
  • at the end of a working day, must be sealed and turned over to the security.

These requirements are the primary reason for the limited availability of opioid analgesics in rural clinics described in Chapter II. Healthcare workers at all central district hospitals we visited told us how problematic these requirements are for rural clinics and pharmacies. The chief doctor in district 3, for example, said:

We currently pay 1400 hryvna [about US$175] per month for [an alarm system at] one facility. [In this district, we have] 12 ambulatoria plus the central district hospital. You can calculate [the cost if all health clinics had narcotics licenses]…. It is just not rational.[167]
To outfit the room, the walls have to be a certain size, these kinds of bars, such a safe that is attached [to the floor], a door that is reinforced, and an alarm system. You know, we could build additional walls of the right width, change the bars if the railing isn’t adequate. But installing an alarm system for three ampoules and hook it up to the [police] point…
We have regulations that do not differentiate whether it’s a FAP, what quantities will be stored…. This is how thick the walls must be. This is how thick the bars have to be. It is nonsense to think that someone is going to try to get into the ambulatoria, saw through the bars, open the safe, to get three ampoules…. But we have one law for all. No matter whether it’s the central district hospital or a FAP.[168]

The requirements for storage premises pursue a legitimate aim, preventing theft of controlled substances from medical channels. But they have such a restrictive impact on the availability of these medications that they do not balance the competing interest of availability with drug control. As such they are inconsistent with the right to health and the principle of balance articulated in the UN drug conventions. Ukraine needs to urgently amend these requirements.

Prescribing Procedures

The 1961 Single Convention on Narcotics Drugs contains two simple requirements for dispensing opioid analgesics to patients: they can be dispensed only on a medical prescription, and a record must be kept. The convention allows governments to impose additional requirements “if deemed necessary or desirable,” such as requiring that all prescription be written on official forms provided by the government or authorized professional associations.[169] However, as the WHO has observed, “this right must be continually balanced against the responsibility to ensure opioid availability for medical purposes.”[170] The WHO Expert Committee on Cancer Pain Relief and Active Support Care has, however, observed that special multiple-copy prescription requirements “typically … reduce prescribing of covered drugs by 50 percent or more.”[171]

Ukraine’s drug regulations provide for some of the most complex and burdensome prescription procedures for opioid analgesics in the world. While in most countries a qualified medical doctor can independently prescribe morphine whenever he or she considers it appropriate, doctors in Ukraine can do so only for up to three days. Any prescription beyond that requires a decision by “Commission on Soundness of Prescription of Narcotic Drugs,” which consists of three doctors from the institution. The treating physician must prepare a detailed written conclusion regarding the need for opioid analgesics, which the commission uses as the basis for making its decision. If the commission decides opioid analgesics are in order, the chief or a deputy chief doctor of the health facility must approve the commission’s decision before the medications can be provided to the patient.[172] For any changes in dosage of the medication, the commission has to be reconvened.

Healthcare workers we interviewed consistently told us that prescribing morphine is a time consuming process that takes anywhere from 30 minutes to 2 hours. Although most said that this does not discourage them from prescribing the medication, a doctor at a polyclinic in Kharkiv said that while he supported strict regulation “to a certain extent patients do suffer from that strictness.”[173] Based on its research, Human Rights Watch believes that the complexity of the prescribing procedure creates a barrier to the timely initiation of treatment with morphine for patients with pain.

While Ukraine’s prescription procedures may pursue a legitimate aim—preventing theft and diversion of controlled medications—they are excessively cumbersome and an impractical use of limited medical resources. Medically, involving four doctors in prescribing opioid analgesics is unnecessary. In most patients, managing cancer pain is not especially complicated, no more so than many other cancer-related health problems about which oncologists in Ukraine are allowed to make decisions independently. Indeed, it is standard practice in most countries around the world for individual doctors to make decisions regarding prescriptions of opioid analgesics. A Human Rights Watch survey of barriers to palliative care in 40 countries across the world found that only 2 countries surveyed, Russia and Ukraine, required multiple doctors to sign off on morphine prescriptions.[174] From a drug control perspective, the prescription procedure also seems excessively burdensome. While Human Rights Watch is aware of allegations of corruption in Ukraine’s healthcare sector, it should be possible to prevent corruption with less burdensome regulations.

When doctors write prescriptions to be filled at pharmacies, which few doctors do, they must do so on a special prescription form, popularly known as “the red form.”[175] These forms must be signed and stamped with the personal seal of the prescribing doctor and of the health care establishment and must also be signed by the chief doctor of the health care establishment or the deputy responsible for medical matters. The prescription must be filled within 5 days of its issuance (ordinary prescriptions in Ukraine must be filled with 30 days). A maximum of 20 ampoules of morphine can be prescribed per prescription form (see also Pharmacies and Opioid Analgesics).

Dispensing Procedures

Ukraine’s drug regulations require that injectable opioid analgesics from hospital stock must be administered to patients directly by a healthcare worker even if the patient is at home.[176] This requirement is the single most problematic provision of Ukraine’s drug regulations.

Having nurses administer morphine directly may allow the healthcare system to monitor the use of the medication very closely and prevent misuse, but nothing in the UN drug conventions requires this level of control. This system interferes with good medical care, results in significant patient suffering, and is therefore not consistent with the requirements of the drug conventions or the right to health.

This level of control is also unnecessary. All European Union countries, as well as Ukraine’s other neighbors, allow patients to take home supplies of morphine and other strong opioid analgesics.[177] For the limited numbers of cases where a real risk of misuse exists, prescribing doctors and administering nurses should be responsible for taking measures to minimize that risk, monitor the patient closely, and act promptly if there is a suspicion that medications are not being used as prescribed (see, for example, text box on “Treating Patients in Pain with a History of Illicit Drug Use”, p 54).[178]

Several doctors interviewed said that they felt that the control measures were excessive. The oncologist at district 3, for example, said:

The [level of] control is unfounded. It is purely theoretical [that people would start selling morphine]. It is far from practice. The patients we have really need it. The whole family sees that. They do everything [they can] to lighten the condition of the patient. Therefore, why would they sell them? Those who encountered this among their own relatives will not sell it. You see your suffering relative—you’re not going to take the morphine yourself [or sell it]. [179]

Healthcare workers at the central district hospital in district 4, which does not comply with the requirement of direct administration and gives patients a three-day supply of morphine to take home and administer themselves, told us that in multiple years of giving patients or relatives injectable morphine to take home, they have never encountered evidence of misuse. They said that relatives faithfully return empty morphine ampoules to the clinic when they pick up their next supply. In rare cases that relatives drop an ampoule, healthcare workers said that they had brought back the broken pieces.[180]

The requirement is also unnecessary from a medical point of view. Patients in Ukraine and elsewhere routinely administer other injectable medications, such as insulin, themselves. There is no reason why, with adequate instruction from healthcare workers, relatives cannot do the same with morphine, particularly if it is administered subcutaneously. Indeed, Ukraine’s regulations allow patients to administer injectable morphine themselves if they obtain it on a prescription from a pharmacy. However, as noted above, very few doctors in Ukraine write such prescriptions.

Record Keeping

Under the 1961 Single Convention on Narcotic Drugs, governments must require hospitals and other institutions that handle opioid medications to keep “such records as will show the quantities … of each individual acquisition and disposal of drugs.”[181] These records must be preserved for no less than two years. The convention does not specify what kind of records must be kept, but an authoritative commentary states that “any usual form of recording business information in an orderly fashion would be permitted, not only in books, but also in card files.”[182]

In Ukraine, healthcare workers document almost literally every single movement of every single morphine ampoule. Nurses showed us an array of journals in which they signed for a bewildering range of transactions. The fact that morphine has been prescribed is not just recorded in the patient’s file but also in a separate journal on opioid medications by the senior nurse, who signs a journal at the pharmacy when she picks up the day’s supply of morphine ampoules for her department; the nurse who administers the morphine, who signs a journal when she picks up the ampoules, signs a second journal to indicate that she has administered the ampoule, and then a third when she returns the empty ampoule to the senior nurse.[183] Finally, every ten days, the Commission on the Destruction of Empty Ampoules, comprised of three hospital staff, including the chief or deputy chief doctor of the institution, count and dispose of empty ampoules and sign a report confirming how many ampoules were discarded.[184]

Healthcare workers, in particular the nurses responsible for maintaining the various journals, told us that they take these record keeping procedures very seriously. For many, they appeared to be a source of anxiety. Several nurses told us they regularly recount all the ampoules, afraid that there might be discrepancies. Others told us that any small errors in the records could lead to significant problems in case of an inspection. Several healthcare workers in different regions mentioned the problems they might face if the serial number of an ampoule was accidentally wiped. In that case, they said, it could not be certified that the empty ampoule was the same as the one that was given out. The oncologist in district 4 said:

Before a nurse draws morphine into the syringe, she has to disinfect it. But alcohol removes the blue serial number…. Those who don’t know have a big problem. Once people know, they know what to do [to avoid removing the number].[185]

Wasting Resources in a Resource Poor Healthcare System

Lack of adequate funding is a major problem for Ukraine’s public healthcare system. Health worker salaries are low; buildings housing hospital and clinics often in disrepair; and patients often have to pay for medications and other health services that are supposed to be free. Yet, as this report demonstrates, Ukraine spends significant resources, both financial and personnel, on procedures with opioid analgesics, some of which are medically unnecessary and are of questionable utility as drug control measures.

As noted, the direct administration of morphine by healthcare workers to patients in their homes is medically not necessary and interferes with good medical practice. But it does require significant resources. The chief doctor of a city polyclinic told us his clinic employs four nurses and four drivers and maintains two cars for the sole purpose to delivering pain medications to patients. A nurse at the same facility said:

We have a special car that does nothing else but deliver narcotics. We have a special room for the nurses, a room to rest. It has a couch and a safe. They cannot leave the clinic any time of the day because there may be delivery. At eight the shift changes and key and documents are handed from one nurse to the next.

On the day we visited, the nurse said that there were seven patients receiving opioid analgesics who needed shots at 6 a.m., 7 a.m., 9 a.m., 12 a.m., 6 p.m., 8 p.m., 10 p.m., 11 p.m. and midnight. This occupied the nurses for the entire day. If the seven patients received an average of two injections that day, the total work output of the two nurses and two drivers would be fourteen injections.

In many places, ambulances are involved in delivering morphine injections, taking time away from emergency response situations that ambulances are meant to respond to. For example, in district 3, ambulances service the whole district with morphine injections. On many days, it makes half a dozen to a dozen trips, often to remote places, just to inject morphine.

But the system also draws on the time of the doctors who prescribe opioid medications and the nurses who are responsible for record keeping. As mentioned, doctors estimated that preparing documents for a single prescription of morphine takes 30 minutes to 2 hours. The chief nurse at one central district hospital told us it takes her an average of two hours every day to hand out morphine ampoules, receive empty ones, keep the records and pick up a new supply from the pharmacy.

Staff at central district hospital in district 4, which gives patients a three-day supply to take home, told Human Rights Watch that it specifically instructs relatives to be careful not to wipe out the serial number on the ampoules: “We warn patients to be careful.”[1]

While the Single Convention allows countries to decide what record keeping system to put in place, Ukraine’s system seems both wasteful of scarce healthcare resources (see text box above) and likely to contribute to a reluctance to prescribe opioid analgesics, both because of the time drain it represents for healthcare workers and fear that potential mistakes in the maze of record keeping requirements could lead to investigation and potentially administrative or even criminal sanctions. It is questionable how much this complex accounting system actually contributes to its rationale: preventing diversion. The Ukrainian government should explore a simpler accounting system that does not interfere with good medical practice or waste resources.

Inspections

Under Ukrainian law, a large array of government agencies has the right to conduct inspections of healthcare institutions that use opioid medications. The National Drug Control Committee, the licensing agency, conducts both routine and surprise inspections. [186] The police and prosecutor’s office can conduct inspections when they receive information about potential misuse of controlled medications. The Ministry of Health and various other health agencies also conduct inspections of healthcare institutions regarding the use of opioid medications.

While some healthcare workers we interviewed said that their institutions had not been inspected in several years, others complained that the regularity of such inspections created a significant burden for staff. They often also expressed considerable apprehension about the checks. For example, the chief doctor in district 3 said that his hospital has faced repeated inspections from various different government agencies related to the use of opioid analgesics in the last year, including the narcotics committee, the province’s health department, the pharmacological inspection, the prosecutor’s office, the state security department, and the police department. He complained that there did not appear to be any coordination between these different agencies:

They come and say: “It’s your turn. We haven’t been with you for a long time.” [I say:] “But all the others have just been.” [They say:] “Have those been? Ok, show us the documents.”[187]

An oncologist at a polyclinic in Kharkiv, which had also faced multiple inspections in the last year, told Human Rights Watch:

We are afraid. If we put a comma somewhere wrong, we have an ocean of problems. Thank God we haven't had any situation in our hospital or the area that someone sold narcotics [illegally] or didn't prescribe correctly. We're very strict in that sense. There may be mechanical errors, administrative errors; in such cases, there is an administrative sanction. But we're careful. We know the system. We teach young doctors.[188]

The inspection of healthcare institutions that work with opioid analgesics is a normal government oversight function. However, government agencies should ensure such inspections are conducted in a reasonable manner so as to minimize their impact on the provision of and access to medical care. Any potential sanctions for violations of procedures should be proportionate and not affect patient access to pain medications.

Criminal Penalties for Mishandling Opioid Medications

Under the 1961 Single Convention on Narcotic Drugs, countries are required to make it a punishable offense to intentionally distribute controlled substances in violation of the convention.[189] In other words, a healthcare worker who deliberately provides people with morphine for non-medical use must face criminal sanctions. However, the convention does not require criminal sanctions for unintentional violations of the rules of handling opioid medications. Human Rights Watch believes that unintentional mistakes in handling such medications should not be a criminal offense and that acts that do not constitute criminal negligence should be subject to administrative or disciplinary oversight.

Ukraine’s criminal code—specifically the article regarding violations of the rules for handling controlled substances—does not differentiate between intentional and unintentional violations or consider the consequences of the violation (although courts do). It provides for up to three years imprisonment, other restrictions of freedom  of movement for up to four years, or a fine equivalent to fifty minimum incomes for violations of the “rules of…storing, accounting, release, distribution, sale…use of narcotics, psychotropic substances.”[190] This means that nurses who make small, unintentional record keeping errors could potentially face criminal charges, as could doctors and nurses who give patients a take-home supply of morphine or leave loaded syringes of morphine at patients’ homes.

A search of Ukraine’s court registry revealed several cases of criminal prosecutions for relatively minor violations of narcotics regulations that did not appear to have led to the diversion or misuse of opioid analgesics. For example, in January 2007 a court in Dobrovody, Zbarazhski district, in western Ukraine found the chief physician at an ambulatoria guilty of failing to properly document the use of narcotic drugs and unlicensed storage of two ampoules of tramadol. It imposed a fine of 680 hryvna (approximately US$85) and put him on probation.[191] In 2007 a court in Odessa province, southern Ukraine, found a surgeon guilty of improperly documenting the medical histories and opioid prescriptions for 5 patients, imposed a fine of 510 hryvna ($64), and removed him from his post for a year.[192] In April 2010 the Velikobelozerskiy county court in Zaporozhskaya province in eastern Ukraine found a midwife guilty of violating Ukraine’s drug regulations on storage and transportation of narcotic drugs. The midwife lost the purse in which she was carrying a seven-day supply of omnopon (twenty-one ampoules), which exceeded the three-day limit. The court imposed a fine of 510 hryvna (US$64).[193] Human Rights Watch believes that use of criminal law in such cases could be considered disproportionate to the harm caused by any failure to comply with the regulations, even if the penalties imposed are relatively light and may contribute to an atmosphere of fear when it comes to prescribing opioid medications. The Ukrainian government should review these rules so that unintentional violations of the rules are no longer a criminal offense.

A December 2007 case against the deputy chief physician of the Kamensko-Dnepr Central District Hospital in eastern Ukraine illustrates the need for regulatory reform in Ukraine. In this case, the doctor had ordered narcotic drugs from the district pharmacy despite the fact the hospital did not have a narcotics license and lacked rooms that met the requirements for storage of narcotic drugs. The prosecution alleged that the hospital and its subsidiaries illegally acquired and stored morphine, omnopon, and fentanyl between 2001 and 2004 but not that any of the drugs had been used for non-medical purposes. In her defense, the doctor argued that she was initially not aware of the requirement to obtain a narcotics license and that, when she had become cognizant of the regulations, had taken steps to fulfill the licensing requirements. She said that she had continued to order the medications because “the refusal of [narcotic] drugs to patients presents a threat to patient life and health” and would violate Ukraine’s constitution. The court rejected the defense, sentenced her to a fine of 850 hryvna ($106), and removed her from her post for a year.[194]

The Role of Pharmaceutical Company Zdorovye Narodu

The pharmaceutical company Zdorovye Narodu is the only company in Ukraine that supplies morphine. As such, it plays a crucial role in ensuring that patients with pain have access to appropriate treatment. Unfortunately, it has included a number of problematic provisions in the product information it circulates with the injectable morphine ampoules it manufactures, including the very low maximum daily dose recommendation discussed in Chapter III. Human Rights Watch has unsuccessfully sought meetings with the company to discuss these issues. A written request for clarifications was not answered.

Like other medications, morphine ampoules come with an insert that explains their uses, contraindications, and side effects. Unfortunately, the morphine insert contains a range of assertions that are factually incorrect and contribute to poor pain care for patients, including:

  • Maximum daily dose recommendation. The product information leaflet states: “Maximum dosage for adults in subcutaneous injection: one time – 2ml (20mg morphine), 24 hour period – 5ml (50 mg morphine).” The WHO guideline states that there is no maximum daily dose for morphine.
  • Warning about drug dependence.The insertstates that“In case of repeated morphine use, a psychological and physical dependency develops quickly (in 2-14 days from the beginning of treatment).” In fact, patients do not develop psychological dependence when they take morphine on a doctor’s prescription. They do build up tolerance and physical dependence over time, which the WHO calls “a normal pharmacological response.”[195] It means that treatment with morphine should not be abruptly discontinued even if the patient no longer experiences pain; instead, the dose of morphine should be gradually decreased to minimize the risk of abstinence (withdrawal) syndrome until treatment can be ended. This inaccurate information perpetuates common misconceptions about the risk that addiction to morphine poses.

Exacerbating the impact of the erroneous information in the insert, the Ministry of Health has included the insert’s text in its authoritative reference book on pharmaceuticals, thus endorsing it.[196]

The Role of the INCB and UNODC

The International Narcotics Control Board, an independent and quasi-judicial international body, has a mandate to monitor the implementation of the 1961 Single Convention on Narcotic Drugs and other international drug conventions. This mandate requires it to monitor efforts of governments to implement provisions of the conventions related to the prevention of illicit use of controlled substances, as well as efforts to ensure their adequate availability for medical and scientific purposes. However, it appears that in the past 10 years the INCB has monitored Ukraine’s efforts related to illicit drugs in Ukraine much more closely than those aimed at ensuring availability of controlled medications.

The INCB visited Ukraine in 2008 to examine its implementation of the UN drug conventions. While representatives of the INCB say it is standard practice to raise the issue of the availability of strong opioid analgesics on country visits, the press statement it issued following the visit states that it had discussed a variety of issues related to illicit drugs but makes no mention of any discussions regarding availability of controlled medications.[197]

A search of the INCB’s last 10 annual reports found a total of 46 mentions of Ukraine. Of those mentions, 43 concern illicit drugs and drug control and just 2 relate to licit drugs. (The final mention of Ukraine is not related to either topic). In its annual report for 2008, the INCB endorsed a new Ukrainian drug control law that strengthened control of licit narcotic drugs but did not note Ukraine’s low consumption of morphine, the problems caused by its overly stringent drug regulations, or make any reference to the treaty obligation that drug control measures be balanced and ensure adequate availability of licit drugs for medical and scientific purposes.[198]

In a March 2011 letter to Human Rights Watch, the INCB stated that it raised the issue of medical availability during its 2008 mission to Ukraine. It said that it considers the level of consumption of opioid analgesics there inadequate and that the “subject of adequate availability will continue to be prominent in the Board’s dialogue with the Government of Ukraine.” [199]

The UN Office on Drugs and Crime (UNODC) has a mandate to “assist Member States in their struggle against illicit drugs, crime and terrorism.”[200] Its activities consist of helping enhance the capacity of member states to counteract illicit drugs, crime, and terrorism; conducting research and analytical work to expand the evidence base for policy and operational decisions; and assistance with development of relevant laws and regulations. While UNODC runs a significant number of programs aimed at HIV prevention among drug users, including in Ukraine, it has traditionally done little to promote drug regulations and laws that balance availability of medications with prevention of misuse.[201] This has recently started to change. In March 2011 UNODC presented a report to the Commission on Narcotic Drugs on the issue of availability of opioid analgesics. It also mentioned the issue prominently in its World Drug Report for 2009. To date, UNODC’s work in Ukraine has not focused on ensuring that drug regulations ensure the adequate availability of controlled medications.

[142] WHO, “Cancer Pain Relief, Second Edition, With a guide to opioid availability,” 1996, p. 3.

[143] Ibid.

[144]International Covenant on Economic, Social and Cultural Rights (ICESCR), adopted December 16, 1966, G.A. Res. 2200A (XXI), 21 U.N. GAOR Supp. (No. 16) at 49, U.N. Doc. A/6316 (1966), 993 U.N.T.S. 3, entered into force January 3, 1976, art. 11; also in the Convention on the Rights of the Child (CRC), G.A. res. 44/25, annex, 44 U.N. GAOR Supp. (No. 49) at 167, U.N. Doc. A/44/49 (1989), entered into force September 2, 1990, art. 12.

[145]UN Committee on Economic, Social and Cultural Rights, “Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,” General Comment No. 14, The Right to the Highest Attainable Standard of Health, E/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915005090be?Opendocument (accessed May 11, 2006), para. 43.

[146] Ibid., para 44(f).

[147] Ministry of Health Order 159-0, July 24, 2008.

[148] On file with Human Rights Watch.

[149] Email correspondence with Ludmila Andrishina, January 5, 2011; correspondence with Olesya Bratyun, executive director of the Al-Ukrainian League for the Development of Palliative and Hospice Care, April 8, 2011.

[150]Letter from Yuri Gubski, the head of the department of palliative and hospice care of the National Medical Academy for Continuing Education, to chief doctors of healthcare institutions, December 24, 2010. The letter is on file with Human Rights Watch.

[151] Email correspondence with Liudmila Andrishina, chief doctor of Ivano-Frankivsk hospice, February 24, 2011.

[152] Ibid.

[153] Mashkovsky, M. D., Lekarstvennye sredstva [Pharmaceuticals] (Moscow: Meditsina,1984).

[154]  Preamble of the 1961 Single Convention on Narcotic Drugs, https://www.incb.org/convention_1961.html; and INCB, “Availability of Opiates for Medical Needs: Report of the International Narcotics Control Board for 1995,” p. 14, http://www.incb.org/pdf/e/ar/1995/suppl1en.pdf (accessed September 25, 2009).

[155] INCB. Availability of Opiates for Medical Needs: Report of the International Narcotics Control Board for 1995. Vienna: INCB. 1995, p. 1, http://www.incb.org/pdf/e/ar/1995/suppl1en.pdf (accessed January 15, 2009).

[156] 1961 Single Convention on Narcotic Drugs, art. 34(b).

[157]  Ibid., art. 30(2bii).

[158]  WHO, Cancer Pain Relief, Second Edition, With a guide to opioid availability, 1996, p. 9.

[159] Ibid., p. 10. See also: WHO, WHO Policy Guidelines Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility for Controlled Medicines, 2011, http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html (accessed March 29, 2011).

[160] USAID, “Corruption Assessment: Ukraine Final Report,” February 10, 2006, http://ukraine.usaid.gov/lib/evaluations/AntiCorruption.pdf (accessed March 14, 2011); Markovska, Anna, Isaeva, Anna, “Public Sector Corruption: Lessons to be learned from the Ukrainian Experience,” Crime Prevention and Community Safety, 2007, http://www.palgrave-journals.com/cpcs/journal/v9/n2/full/8150036a.html (accessed March 14, 2011); and Gorodnichenko, Yuriy, Sabirianova Peter, Klara, “Public Sector Pay and Corruption: measuring Bribery from Micro Data,” Journal of Public Economics, June 2007, vol. 91(5-6), pages 963-991.

[161] Human Rights Watch meeting with Volodymyr Tymoshenko, head of the National Drug Control Committee, Kiev, October 22, 2010. Human Rights Watch meeting with Elena Koval, section on licit narcotics circulation of the Ministry of Interior, October 22, 2010.

[162]Human Rights Watch meeting with Volodymyr Tymoshenko, head of the National Drug Control Committee, Kiev, October 22, 2010.

[163] Licenses are issued within ten days of submitting the application with all relevant documentation for a five-year period. Article 11 of the Law on Narcotic Substances, Psychotropic Substances and Precursors of February 15, 1999 (as amended on December 22, 2006), Directive of the Cabinet of Ministers of Ukraine “On Approval of the List of Documents that Must Be Added to the Application for License for Certain Types of Economic Activities No. 756 of July 4, 2001.

[164] Ministry of Health Order 356, the predecessor to Order 11, stated specifically that FAPs could receive opioid medications. That provision has been dropped from Order 11 so FAPs are no longer identified as health institutions that can obtain a narcotics license.

[165] Article 11 of the Law on Narcotic Substances, Psychotropic Substances and Precursors of February 15, 1999 (as amended on December 22, 2006), Directive of the Cabinet of Ministers of Ukraine “On Approval of the List of Documents that Must Be Added to the Application for License for Certain Types of Economic Activities No. 756 of July 4, 2001.

[166] Ministry of Internal Affairs Order 216 of May 15, 2009 on the “Requirements to Objects and Premises Designated for Conducting Activity related to Circulation of Narcotic Drugs, Psychotropic Substances, Precursors, and Storing of such Drugs and Substances Seized from Illegal Circulation”; Ministry of Health Order 11 of January 21, 2010.

[167] 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.

[168] Ibid.

[169] 1961 Single Convention on Narcotic Drugs, art. 30(2bii).

[170]  WHO, Cancer Pain Relief, Second Edition, With a guide to opioid availability, 1996, p. 9.

[171]  Ibid.

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

[173] Human Rights Watch and Institute of Legal Research and Strategies interview with a chief doctor at a polyclinic in Kharkiv, April 13, 2010.

[174]The findings of this survey will be published in a forthcoming Human Rights Watch report on the global state of palliative care.

[175] Ministry of Health Order 11 of January 21, 2010, para. 2.11.2.

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

[177] Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative, N. I. Cherny, J. Baselga, F. de Conno and L. Radbruch, Annals of Oncology Volume 21, Issue 3 Pp. 615-626; Human Rights Watch survey of barriers to palliative care, publication forthcoming.

[178] In the United States, the Federation of State Medical Boards has developed a guideline on pain treatment that outlines the responsibilities of medical doctors related both to the provision of pain management and the prevention of misuse of opioid medications. These include, among others, careful evaluation of patients, periodic review of treatment plan, keeping of accurate and complete medical records and compliance with controlled substances regulations, http://www.medsch.wisc.edu/painpolicy/domestic/model.htm (accessed February 24, 2011).

[179] Human Rights Watch and Institute of Legal Research and Strategies interview with the district oncologist in district 3, April 14, 2010.

[180] Human Rights Watch and Rivne Branch of All-Ukrainian Network of People Living with HIV interview with the head nurse of the central district hospital in district 4, April 21, 2010.

[181] 1961 Single Convention on Narcotic Drugs, art 34(2).

[183] Article 34 of the Law on Narcotic Drugs, Psychotropic Substances and Precursors; Section 16 and Addendum 5 to Directive 589 of June 3, 2009 of the Cabinet of Ministers on the “Order of Conducting Activity Related to Turnover of Narcotic Drugs, Psychotropic Substances and Precursors”; and para. 3.13 and 3.14 of the Ministry of Health Order 11 of January 21, 2010.

[184] Ministry of Health Order 11 of January 21, 2010, para. 1.10 and 1.11.

[185] 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 in district 4, April 21, 2010.

[186] Order on the State Committee of Ukraine on Drugs Control adopted by Directive of the Cabinet of Ministry No. 676 of July 28, 2010; Section 45 of the Order on Conducting Activity Related to Circulation of Narcotics, Psychotropic Substances and Precursors, and Controlling of their Circulation, adopted by Directive of the Cabinet of Ministry No. 589 of July 03, 2009.

[187] 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.

[188] Human Rights Watch and Institute of Legal Research and Strategies interview with a chief doctor at a polyclinic in Kharkiv, April 13, 2010.

[189] 1961 Single Convention on Narcotic Drugs, art 36(1a).

[190] Article 320(1) of Ukraine’s criminal code. The provision also provides for a three-year ban on certain types of employment and activities. In cases where the violation of the rules on handling controlled substances led to large quantities of missing narcotic drugs or where a person used their official position to steal, embezzle, or misappropriate narcotic drugs, the offense is punishable by the fine of up to the equivalence of 70 minimum incomes or three to five years of imprisonment, with prohibition to occupy certain employment positions or perform certain activity for up to 3 years (Article 320(2)).

[191] See: http://www.reyestr.court.gov.ua/Review/4003114 (accessed March 18, 2011).

[192] See: http://www.reyestr.court.gov.ua/Review/444550 (accessed March 18, 2011).

[193] See: http://www.reyestr.court.gov.ua/Review/11466588 (accessed March 18, 2011).

[194] See: http://www.reyestr.court.gov.ua/Review/5166603 (accessed March 18, 2011).

[195] WHO, “Cancer Pain Relief, Second Edition, With a guide to opioid availability,” 1996, p. 16.

[196] Ministry of Health, State Formulary of Pharmaceutical Substances and Ensuring their Accessibility, January 28, 2010, http://www.moz.gov.ua/ua/portal/dn_20100128_59.html (accessed February 26, 2011).

[197] See http://www.incb.org/incb/activities.html (accessed February 23, 2011).

[198] INCB, Report of the INCB for 2008, ID number, http://www.incb.org/incb/annual-report-2008.html (accessed February 24, 2011), para. 702.

[199] Letter from Jonathan Lucas, secretary of the International Narcotics Control Board, to Joseph Amon, Human Rights Watch, March 16, 2011.

[201] In fact, UNODC’s own model drug laws are not based on the principle of balance. See: the Model Law on the Classification of Narcotic Drugs, Psychotropic Substances and Precursors and on the Regulation of the Licit Cultivation, Production, Manufacture and Trading of Drugs; the Model Regulation Establishing an Interministerial Commission for the Coordination of Drug Control; and the Model Drug Abuse Bill, http://www.unodc.org/unodc/en/legaltools/Model.html (accessed January 24, 2009); A detailed analysis of provisions regarding controlled medications in the model laws and regulations can be found in a January 2009 report by the Pain & Policy Studies Group, entitled “Do International Model Drug Control Laws Provide for Drug Availability?” UNODC has recognized this problem and is planning on making the necessary changes to its model laws.