Making Oral Opioids Available in Eastern Europe and Central Asia

Ainur Shakenova, LLM, Specialization in Medical Law

According to the data of the International Committee on Drug Turnover Monitoring as of 2012, Kazakhstan ranks No. 115 in terms of opioid consumption volume per capita per year, sharing this place with Guatemala. Our closest “neighbors” are Azerbaijan, Myanmar,  Peru; the former Soviet States didn’t advance as well.  Considering situation comparatively, the patients in the US  the morphine consumption is 348-times (!) and in Norway 125-times higher that in Kazakhstan. In practice this means that the Kazakhstani patients, suffering from severe pain due to the end-stage disease (cancer, AIDS, tuberculosis) are not adequately analgized. Who is responsible for such situation?

I used to hear often that Kazakhstan, which ratified a Single Convention on Narcotic Drugs as of 1961 and UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, as well, strictly adheres to the international rules in the area of legal drug turnover. However, both USA and England, and many other countries, where pain management is delivered at much higher level, are parties to the Convention, i.e. Convention absolutely has nothing to do with it. Another issue is that Convention  itself does not prohibit building up higher security management regimens. This issue is subject to draw one’s attention in addressing the problem of pain management in the Republic of Kazakhstan (RoK).  We have to revise the national drug monitoring regimen, and this should include not only Illicit Traffic and Transfer to Illicit Traffic in Narcotic Drugs Program, but also sufficient amount of narcotic drugs provision for medical and research purposes. One has to draw attention to our legislation bearing many limitations, declined by many countries long ago, for example, a restricted highest single dose of analgesic available to a patient suffering from severe pain, or short action time of the prescription, and overspecified narcotic analgesic residues storage and  destruction procedures for such residues. It is also essential to draw attention to national opioid demand development- why demand in Kazakhstan is that low? Whether this data annually submitted to the International Narcotic Control Board (INCB) corresponds to reality? Indeed, INCB once and again reminded states on their obligation to submit an application based on real demands from entire population rather than historic data.

We also have to consider oral morphine registration in Kazakhstan and available opioid analgesic list extension in general, as the same INCB recommends to include the statements on narcotic drug recognition as vital for pain and suffering relief into national legislation, and on state obligations to provide their availability for medical purpose.

All this, together with organization of special training in palliative care for doctors and medical attendants, should facilitate an adequate treatment for our patients suffering from severe pain.

Making Oral Opioids Available in Eastern Europe and Central Asia: the industry speaks out.

March 4thand 5th marked a momentous occasion for Eastern Europe and Central Asia (EECA) when the pharmaceutical industry, government officials, palliative care experts and national competent authorities for narcotics control from five EECA countries for the first time met to discuss and seek ways to address challenges for making opioids available in the region.

It is important for countries to explore ways to balance and accommodate the interests of morphine manufacturers in line with the World Health Organization guidelines.

Organised to coincide with the 56th session of the UN commission on Narcotic drugs and co-sponsored by the International Palliative Care Initiative (IPCI) of the Open Society Foundations (OSF), Global Access to Pain Relief Initiative (GAPRI), the Worldwide Palliative Care Alliance (WPCA) and the Pain and Policy Studies Group (PPSG) at the University of Wisconsin, 50 participants gathered in Vienna, to explore the challenges that hinder access to oral morphine for pain treatment in Ukraine, Tajikistan, Kyrgyzstan, Kazakhstan and Armenia and to discuss approaches that can be used to address these challenges. Representing the pharmaceutical industry, five companies that manufacture oral morphine products including; Interchem SLC, I. Molteni& Co, RusanPharma Ltd, Verve Human Care, Covidian AG attended the meeting.

Presenting the access challenges, it was noted that as former soviet republics all the five countries have similar prohibitive policies which severely limit access to morphine. The country representatives shared their challenges which ranged from drug registration procedures, prescribing policies, attitude of health professionals, drug control processes and geographical locations of patients. For example, in Kyrgyzstan injectable morphine is only accessible to patients with stage 4 cancer disease and the prescription amount and duration is limited to 20 vials of morphine for 10 days and regulated to a maximum of 300 vials per year.

In Tajikistan, injectable morphine is also the only available form of morphine and it is controlled through 16 regulation documents which make it severely complex to navigate. Moreover, with the mountainous regions landlocked for eight months per year due to severe winter conditions, this creates an additional barrier for patients to access this vital medication as they cannot self-administer the injections and health professionals cannot reach them.

Armenia has seven types of analgesics, but similar to the rest of the countries, they too only have injectable morphine and access issues are similar to those of Tajikistan.

Kazakhstan’s injectable morphine is also allocated via a quota system and reaching less than 1% of those who need the medication. It was also noted that there is an imbalance between the control of narcotics for medical use and combating access to illicit drugs. Addressing this imbalance will improve access issues but will require education and awareness among the local authorities.

While injectable morphine is sufficient to address severe pain in acute cases, for chronic severe pain  palliative care experts recommend  the use of oral morphine as in many cases it is easier to self-administer and can be used around the clock as needed. In the countries mentioned here, oral morphine is not available and therefore it is hard to achieve good pain control.

Addressing this discrepancy, Ukraine has registered the production of oral morphine in tablet form, this paves the way for better pain management in Ukraine. However representatives from Ukraine noted that they still have to address prescription challenges and attitudes towards morphine use among health professionals and drug control agencies.

Despite the challenges mentioned, further discussions on the level of need for morphine in the five countries showed that the region has a low need and therefore supply could be achieved fairly quickly if the right systems are in place. Market forecasts tabulated by GAPRI indicated that a supply of 74 kg of morphine could fulfil the current gaps in pain medication for those who need it in the five countries.

Responding to the challenges presented and to the market projections, the pharmaceutical industry noted that the size of need is too small to motivate the industry to navigate the complex and tedious opioid registration procedures. The pharmaceutical representatives went on to highlight several challenges that hinder industry involvement in opioid supply, these include:

• doctors not ready or willing to prescribe resulting to low demand
• registration standards that require drug samples for quality control but with no clear procedures for sample importation
• international drug registration requirement for continuous need for quality control for medications produced more than 4 years ago, a category which morphine falls into
• countries not knowing how to issue import licenses and creating tedious and bureaucratic processes which could be expensive with no matched returns on investments
• sometimes no clear understanding between the narcotic bureaus and the registration board with regard to drug control procedures
• limited or small orders that are not cost-effective to produce
• lack of ownership at the government level
• transport issues, especially regulations for transit countries as some countries do not allow transit of narcotics and this is difficult for countries that have no direct access routes
• morphine’s demand is too low and therefore a risky product from a business point of view and therefore the industry might see it as more of a social duty and many might be unwilling to undertake the social duty.

Discussions with the competent authorities confirmed that there was perhaps an over emphasis to keep illicit drugs out of the countries and this might have had an indirect impact on access to opioids for medical use. They however noted that there is an understanding that opioids are required to address severe pain. With this they emphasized the need to harmonize the regulations and to use the systems in place as benchmark for development. They also noted that it was important for countries to also explore ways to balance and accommodate the interests of manufacturers in line with the World Health Organization guidelines.

source:

http://www.ehospice.com