Consumption of opioid analgesics in Ukraine. 2011-2016

P O L I C Y PA P E R Consumption of Opioid Analgesics in Ukraine.

2011 – 2016

Institute of Analysis and Advocacy

Iнститут аналітики та адвокації

Access to adequate pain management is an undeniable right of a person. Moderate and severe pain syndromes often are typical symptoms of an oncological condition as well as other serious diseases. Incurable pain greatly disturbs a patient and reduces their quality of life to zero. Pain shall be treated in accordance with the recognized practices, international recommendations, developed based on the principles of evidence-based medicine in patients of all ages, regardless of their place of stay or residence. Currently all the up-to-date medicinal products used to treat chronic pain are accessible in Ukraine.

Nevertheless, access to opioid analgesics, which are essential medicinal products for severe pain treatment, as well as access to high quality palliative care services, is a global human rights problem not only in Ukraine, but all over the world.

The present study identifies the current situation with medical use of narcotic drugs, assesses accessibility of opioid analgesics and offers suggestions regarding improvement of internal health care processes pertaining to issues mentioned above. Special attention was given to description of trends in the use of opioid analgesics across oblasts (regions) of Ukraine.

Information contained in the report will prove useful to general public, as palliative care and adequate pain management is about an inherent right of every person to a quality life till the last breath.

The study was carried out in 2016 – 2018 by NGO Institute of Analysis and Advocacy with the support from International Renaissance Foundation.

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Author: Oleksandr Tkachenko Senior analyst at NGO Institute of Analysis and Advocacy Nataliia Datsiuk Assistant professor at Department of pharmacy organization and economics of Bogomolets National Medical University Yuriy Romanov Lawer at NGO Institute of Analysis and Advocacy Eugeniia Kozun Analyst at NGO Institute of Analysis and Advocacy Yana Klochko Media manager at NGO Institute of Analysis and Advocacy Rostislav Puzyriaka External data analyst

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Design and graphics: Kateryna Kysla Graphic designer at NGO Institute of Analysis and Advocacy The study was carried out in the framework of Building models of reporting data related to narcotic analgesics project, which was implemented by NGO Institute of Analysis and Advocacy with support from International Renaissance Foundation. © NGO Institute of Analysis and Advocacy, 2018

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G C

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TA B L E O F C O N T E N T S LIST OF ACRONYMS

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GLOSSARY

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FOREWORD

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SUMMARY

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INTRODUCTION

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STUDY METHODOLOGY

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1.

NARCOTIC DRUGS CIRCULATION

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2.

USE OF NARCOTIC DRUGS AT MEDICAL AND PREVENTIVE TREATMENT FACILITIES

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2.1 Pan-Ukrainian Trends 2.2 Regional Trends of Using Morphine-based drugs 2.3 Morphine-based drugs Consumption with a Breakdown into Pharmaceutical Form 3.

DISPENSING SALE OF NARCOTIC DRUGS BY PHARMACIES USING PRESCRIPTION FORM NO. 3 (F. NO. 3)

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3.1 Pan-Ukrainian Trends 3.2 Dispensing of Prescription Morphine-based drugs with a Breakdown into Pharmaceutical Form 3.3 Regional Trends of Dispensing sale of Prescription Morphine-based drugs 4.

NEED IN AND ACTUAL AVAILABILITY OF MORPHINE

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CONCLUSIONS

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SUGGESTIONS

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ANNEX 1 Establishing a Representative Data Period to Analyze Dispensing sale of Prescription Opioid Analgesics in Regions of Ukraine

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ANNEX 2 Codeine consumption

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ANNEX 3 Morphine consumption

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ANNEX 4 Tramadol consumption

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ANNEX 5 Trimeperidine consumption

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ANNEX 6 Fentanyl consumption

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ANNEX 7 Buprenorphine consumption

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ANNEX 8 Methadone consumption

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ACKNOWLEDGEMENTS

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REFERENCES

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L I S T O F A C R O NY M S IAA

NGO Institute of Analysis and Advocacy

ALC

Additional Liability Company

CBEP

Central body of executive power

CMU

Cabinet of Ministers of Ukraine

CRP

Central regional pharmacy

EU

European Union

F. No. 3

Prescription Form No. 3

HA

Health administration

HC

Health care

HCD/HA

Health Care Department of Oblast State Administration, Health Administration of Oblast State Administration

HCI

Health care institution

INCB

International Narcotics Control Board

LLC

Limited Liability Company

MoH

Ministry of Health

Monitoring centre

State agency Centre for Mental Health and Monitoring of Drugs and Alcohol of the Ministry of Health of Ukraine

OSA

Oblast State Administration

PE

Public enterprise

SDCS

State Drugs Control Service

SJSC

State joint-stock company

SMT

Substitution maintenance therapy

SSMDC

State Service for Medicines and Drugs Control

UN

United Nations

WHO

World Health Organization

4

GLOSSARY The present study uses the terms in their meaning as follows: PHARMACY shall mean a place where ďŹ nished or pharmacy-produced pharmaceutical products are sold, which is equipped in compliance with all the applicable licensing requirements.

PHARMACY ENTERPRISE shall mean an economic entity carrying out wholesale and / or retail sales of medicinal products, which owns or manages one or several pharmacies.1 OPIOID (NARCOTIC) ANALGESICS shall mean medicinal products, which are used to treat a chronic pain syndrome and contain controlled drugs, included into tables II and III of a list of narcotic drugs, psychotropic substances and precursors, approved by the Resolution of the CMU as of May 06, 2000 No. 770 in a quantity exceeding their maximum permissible amount, stipulated by the Resolution of the CMU as of October 10, 2007 No. 1203. Circulation of these medicinal products are regulated by international and local regulations on circulation of narcotic drugs, psychotropic substances and precursors.

PALLIATIVE CARE shall mean a comprehensive approach, aimed at improving the quality of life of patients suffering from incurable (terminal) diseases and members of their families by preventing and alleviating suffering, in particular due to early detection and accurate diagnostics (assessment) and treatment of pain and other physical, psychological and mental problems.

REGION shall mean the territory of the Autonomous Republic of Crimea, the oblast, the cities of Kyiv and Sevastopol.

1 Terms pharmacy and pharmacy enterprise are differentiated in this report to identify a separate physical place of opioid analgesics sale (pharmacy) and an enterprise, which can be comprised of several pharmacies (pharmacy enterprise). At the very same time a pharmacy enterprise can be comprised of one pharmacy only.

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FOREWORD Traditionally it is not common to speak openly about problems faced by a patient suffering from a serious disease in Ukraine. A disease, which can be life-threatening for a patient, is perceived as grossly unjust life circumstances, while the suffering, which may be caused by progression of a disease – as an inherent part of human experience.

Health care and pharmaceutical industry are constantly evolving and to be frank a physician in charge and a pharmacist have sufficient amount of resources to prevent patients from suffering, even under the most complicated circumstances.

Pain, as one of the key symptoms indicating development of a serious disease, may and must be treated. Pain, especially a chronic, persisting, round the clock one drives a person into a state, when they do not even notice life and is not willing to live at all. Namely the opioid analgesics is the main therapy which allows relieving manifested pain syndrome. Currently opioid analgesics in a form of injection, tablets and syrup are available in Ukraine for both adults and children.

But even today a lot of patients with chronic pain cannot gain access to adequate pain management. Human rights advocacy organisations are registering such facts on a permanent basis. A separate report Uncontrolled pain: 2016. What has changed?, which was presented in December 2016, highlights more than 100 stories of families having to deal with serious diseases and inability to provide pain management for a seriously ill patient.

In the second part of the ХХ century the country of Ukraine ratified a range of documents, covenants that prohibit cruel, inhuman treatment and torture. To be more specific, Article 3 of the European Convention on Human Rights (ECHR) (formally the Convention for the Protection of Human Rights and Fundamental Freedoms) on Prohibition of torture mentions: No one shall be subjected to torture or to inhuman or degrading treatment or punishment.

By becoming a party to the International Covenant on Economic, Social and Cultural Rights (ICESCR) Ukraine recognized the right of everyone to the enjoyment of the highest attainable standard of physical and mental health (Article 12). The notion the highest attainable standard of health of Article 12.1 is also based on biological and social and economic precondition of a person's development, such as available state resources. A right to health shall be interpreted as a right to enjoy a range of various interventions, services and conditions, necessary for fulfillment of the right to the highest attainable standard of health. It remains without saying that denial of pain relief – is a cruel, inhuman treatment of a sick person, which can be equated with torture.

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Ensuring its compliance with the International Covenant on Economic, Social and Cultural Rights the health care system undertakes an obligation to ensure: 1. Availability of health care services in the scope that satisfies the demand (with due account of the state of the country's economic development).

2. Accessibility of health care services, with due account of non-discrimination, physical and geographical accessibility, needs of special groups (children, elderly people), accessibility of information regarding the possible treatment methods and schemes.

3. Acceptance of health care services from the ethical point of view (consent, confidentiality), taking into account the needs of each individual person, minorities and communities, as well as vulnerable populations.

4. Quality of health care services, with the latter being substantiated from the scientific and medical points of view.

Analytical report Use of opioid analgesics in Ukraine. 2011 – 2016 was dedicated to clarifying an important issue regarding Ukraine's fulfilling its international obligations. To be more specific the question is in what way the state is ensuring availability and accessibility of opioid analgesics in the country, whether it scrutinizes the demand for these essential medicinal products to ensure uninterrupted supply to health care institutions.

Suggestions and recommendations provided by the study are quite practical.

Provided their implementation Ukraine will get a transparent, clear and understandable system of needs assessment, distribution and use of opioid analgesics and reporting on such use for the medical purposes.

Andrii Rokhanskyi Chief of NGO Legal Analitics and Strategies Institute

Kseniia Shapoval-Deineha Public Health program manager, International Renaissance Foundation

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SUMMARY In the recent years Ukraine has witnesses regulatory changes in the area of medical use of narcotic drugs. The goal was to simplify the existing system of providing patients with appropriate medication. At the very same time the problem of adequate pain management still remains relevant.2 The main task of the study is to analyze trends in the use of opioid analgesics in the oblasts of Ukraine. Based on the trends identified it was possible to assess the dynamics in accessibility of pain management for Ukrainians in the context of the most recent regulatory changes.

Legislative acts, data from the Register of licensees carrying out activities related to narcotic drugs, annual reports form the mentioned licensees submitted to the State Service for Medicines and Drugs Control, analytical reports of the Monitoring centre, as well as data from Health Care Departments and Health Administrations of Oblast State Administrations served as the main sources of information.

By way of sending information requests the researchers addressed: џ

282 pharmacy enterprises, which have the right to sell opioid analgesics in 518 pharmacies;

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individual medical and preventive treatment facilities;

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Central bodies of executive power (CBEP), which have certain medical institutions in their subordination.

In case of this study the diversified approach to obtaining information from several sources yielded a minimal benefit, as the arrays of information were mostly contradictory.

Analysis of regulatory documents demonstrated that the issues of collecting and analyzing data on needs and consumption of opioid analgesics for medical use are insufficiently regulated. The existing system of reporting to the State Service for Medicines and Drugs Control and collection of information by a Monitoring centre does not allow getting complete and reliable data.

It was identified that within the period of 2011 – 2015 the use of morphine, tramadol and fentanyl in medical and preventive treatment facilities has been gradually increasing. The above mentioned and other opioid analgesics were used less in 2016.

2

Uncontrolled pain – 2016: what has changed?: a report by human rights advocacy organisations / A.O. Rokhanskyi; Institute for Legal Studies and Strategies NGO

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Having analyzed the information obtained from 67 pharmacy enterprises, the study contributors noticed an increase in pharmacies' sales of morphine-based drugs within the period of 2011 – 2015 in most oblasts of Ukraine. This was mostly due to tablet formulation of an analgesic.

The most complete data on sale and dispensing of prescription narcotic drugs was collected in Vinnytsia, Cherkasy, Chernivtsi, Ivano-Frankivsk, Poltava oblasts and the city of Kyiv. Using the methodology of calculating needs in morphine-based drugs, accessibility of “a golden standard of pain management” 3– morphine – was verified for the mentioned oblasts. Within the period of 2012 – 2016 the level of availability varied from 11,2% to 14,3%.

For the moment liberalization of legislation in the area of narcotic drugs circulation for medical use has not yet resulted in proper provision of Ukrainians with adequate pain management. At the very same time an increase in sales of prescription morphine and increase in the share of the tablet formulation of an analgesic compared to other pharmaceutical forms and presentations is a positive trend.

3

Increasing Patient Access to Pain Medicines around the World: A Framework to Improve National Policies that Govern Drug Distribution. Pain & Policy Studies Group.University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, 2008.

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INTRODUCTION Since 2013 Ukrainian government has taken a range of positive steps to introduce balanced and humane approaches to ensuring rights of seriously ill patients to adequate pain management.

In the majority of cases, whenever a person suffers from moderate or strong pain, it is necessary to use medicinal products, which contain narcotic substances – opioid analgesics.

The second decade of 2000 brought simplification of narcotic drugs control to Ukraine equating it with an acceptable European level. The main goal of such changes was to promote access of Ukrainians to adequate pain management. However irrespective of the bureaucratic liberalization the current regulatory framework does not provide for collection of sufficient information needed to define accessibility of pain management.

The present report offers an overview of regulatory changes in the area of medical use of narcotic drugs and analysis of the opioid analgesics consumption in every oblast of Ukraine. Despite the lack of sufficient official statistical information, the study contributors have managed to get some of the necessary data, identify a range of problems as well as express suggestions on how to solve them.

Informational requests were used for the collection of data. 282 pharmacy enterprises, pharmacies (518) of which had a license for performing activities related to narcotic drugs as of the moment of carrying out the study, certain medical and preventive treatment facilities, Health Care Departments of Oblast State Administrations, State Service of Ukraine on Medicines and Drugs Control, Monitoring centre, MoH and other CBEP, which have certain medical institutions in their subordination were, the addressees (respondents). Data from the Register of licensees carrying out activities related to the narcotic drugs, annual reports form the mentioned licensees and Health Care Departments was used.

The analysis offered in this report shall be brought to the attention of a wide range of people in general, and patients, health professionals, public activists and government officials in particular. In the first place the conducted study has a value for development of palliative care in Ukraine and increasing accessibility of adequate pain management.

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STUDY METHODOLOGY The goal of the study was to identify tendencies in the consumption of opioid analgesics in all the oblasts of Ukraine and collect data on the consumption of medicinal products used for substitution maintenance therapy. For this purpose the study contributors collected information on the scope of the use of narcotic drugs by medical and preventive treatment facilities and their dispensing by pharmacy enterprises as prescription drugs.

All the information, contained in the report, is provided in terms of the equivalent amount of active substance. The analysis is solely focused on narcotic medicinal products, which contain substances as follows:

b codeine

morphine

trimeperidine (promedol)

tramadol

fentanyl

buprenorphine

methadone

Omnopon medicinal product, which is a combination drug, is widely used in Ukraine. Among other substances it contains morphine and codeine. This being the case, Omnopon is not separately considered by this report, but the volumes of its consumption are reected in the presented volumes of codeine and morphine.

Based on the analysis of the legislative framework (see Section 1 Narcotic drugs circulation), it was decided to obtain the necessary data with the use of information requests submitted to data owners as follows: DATA OWNER

DATA OBTAINED

State Service of Ukraine on Medicines and Drugs Control

List of licensees allowed to carry out activities related to the narcotic drugs, copies of annual reports on consumption of opioid analgesics by health care institutions, data on the quotas approved in 2010 – 2014

Monitoring centre

Analytical reports of the Monitoring centre and reports of the regional health care departments on the use of opioid analgesics

Pharmacy enterprises

Information on the volumes of prescription drugs dispensing

Certain medical and preventive treatment facilities

It was identiďŹ ed that the facilities do not participate in the process of allocating quotas

Health Care Departments and Health Administrations of Oblast State Administrations

Annual reports on the use of opioid analgesics

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Having used a risk diversification tool, the study contributors received identical information on the use of opioid analgesics in medical and preventive treatment facilities from different data owners: oblast level health care departments, Monitoring centre and State Service for Medicines and Drugs Control.

Due to often improper practices of filling in the reporting forms by health care institutions (see Section 1) it was decided not to take into account the information provided by the State Service for Medicines and Drugs Control, which accumulates annual reports from hospitals, and only use data provided by the Monitoring centre (2014 – 2016) and oblast level health care departments (2012). There is no data for 2011 and 2013.

Information provided by pharmacy enterprises on dispensing of prescription opioid analgesics was the other type of data collected. Their information covers various time frames. After this the study contributors established a representative data period, meaning a time frame, within which it was possible to obtain the most complete data, for example:

2011

2012

2013

2014

2015

2016

2017

Pharmacy 1 Pharmacy 1 ...

Pharmacy n availability of information

lack of information

representative period

It is obvious that the largest amount of data was received within the period of 2013 – 2015, so namely this period was used for the analysis. The same information availability assessment was carried out for every oblast of Ukraine and helped establishing individual representative data periods. The consumption volumes within those years, which were not included into the representative periods, are not mentioned in the report. See Annex 1 for more details on establishing a representative data period.

It was possible to get a lot of information on prescription drugs sale in certain oblasts so information on accessibility of morphine in these oblast is provided at the end of the report. For this purpose the need in morphine was calculated and compared to overall volume of analgesics' use in medical and preventive treatment facilities and its dispensing as prescription drug.

To calculate the needs in morphine the mortality data-based methodology of calculation was used 4 (WHO/INCB, 2012):

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80% of patients, who die of cancer, and 50% of those, who die of AIDS, require on average 75 mg of oral morphine a day within the period of 90 days;

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15% of patients, who die of sustained trauma (other external causes), require pain management in the amount of 75 mg of oral morphine a day within the period of 5 days.

4

Guide on Estimating Requirements for Substances under International Control. Developed by the International Narcotics Control Board and the World Health Organization for use by Competent National Authorities. – New York: United Nations, 2012. – 43 p.

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The volumes required for pain management in patients with other diseases, as well as for treatment of acute pain, amount to not less than 10% out of above calculated volume.5 The calculated general need was compared to the overall consumption.

The injectable dosage forms of morphine and its share in Omnopon was recalculated in terms of the equivalent amount of oral dosage form, with their values being multiplied by three, for the representativeness of the analysis. As a result of it a level of morphine supply was identified.

Analysis of regulatory documents from the viewpoint of functioning of the area of narcotic drugs use in health care institutions is provided in the next section.

5 A first comparison between the consumption of and the need for opioid analgesics at country, regional, and global levels / M. Seya, S. Gelders, O. Achara [et al.] // Journal of Pain & Palliative Care Pharmacotherapy. – 2011. – №25 (1). – P. 6–18.

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1. NARCOTIC DRUGS CIRCULATION The study of opioid analgesics consumption trends covers the period of 2011 – 2016. Within this period of time the domestic legislation on the circulation of narcotic substances for medical use has significantly changed with the weakening of bureaucratic pressure on health care personnel and introduction of a more balanced approach: џ

all the economic entities received a right to carry out their activities in this particular area, including individual entrepreneurs;

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the validity period of the prescription form No. 3 for narcotic drugs (F. No. 3) was increased from five to ten days;

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opioid analgesics medicinal products may be bought as prescription drugs in a pharmacy of any oblast without any reference to the hospital location;

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physician in charge may independently prescribe narcotic analgesics without a need to convene a medical commission6;

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morphine was registered in tablet formulation 7.

The notion of quotas is an inherent component of the area of circulationof narcotic drugs and psychotropic substances. Quota means a maximum amount of narcotic drugs and psychotropic substances in Ukraine within which the following is allowed: growing of plants, which contain narcotic substances; џ their production and manufacturing; џ storage; џ importation to and exportation from Ukraine. џ

On an annual basis the Cabinet of Ministers of Ukraine (CMU) shall approve controlled drugs quota. In the course of the study it was identified that the last year when the CMU approved controlled drugs quota 8 was 2014. Quotas for 2015 – 2018 were not approved.

Since recently Ukraine has changed its mechanism of quotas approval. At first the State Service of Ukraine on Medicines and Drugs Control carries out calculations and submits its suggestions to the Ministry of Health of Ukraine (MoH). The Ministry makes a corresponding submission to the CMU for approval of the quotas. Approval of such mechanism coincided in time with absence of the approved 6

Resolution of the Cabinet of Ministers of Ukraine No. 333 as of May 13, 2013 On Approval of the Procedure for Acquisition, Transportation, Storage, Dispensing, Use and Destruction of Narcotic Drugs, Psychotropic Substances and Precursors in Health Care Institutions

7 Order of the Ministry of Health of Ukraine No. 77 as of February 01, 2013 On State Registration (Re-registration) of Medicinal Products and Introduction of Amendments to Registration Materials 8 Resolution of the Cabinet of Ministers of Ukraine No. 209 as of June 25, 2014 On 209 On Approval of Quotas for 2014 on Growing of Plants Containing Narcotic Drugs and Psychotropic Substances, Production, Manufacture, Storage, Importation to and Exportation from Ukraine of Narcotic Drugs and Psychotropic Substances

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quotas. Up to the year of 2014, when quotas where still approved, State Drugs Control Service (currently – State Service of Ukraine on Medicines and Drugs Control) with no contribution from MoH was submitting recommendations to the CMU to define the quotas scope 9.

QUOTAS ALGORITHM up to 2014

since 2014 quota applications

CMU

Quotas

CMU

Quotas quota suggestion

MoH State Drugs Control Service State Service of Ukraine on Medicines and Drugs Control (ех-State Drugs Control Service)

submission for quota assigning

quotas approval Licensee*

Licensee*

*Licensee shall mean an economic entity (pharmacy, medical and preventive treatment facilities, manufacturer, enterprise from beyond the health care sector, etc.), which has received a license for any activities related to manufacture, production, storage, transportation, procuring, sale (dispensing), importation to and exportation from Ukraine, use and disposal of narcotic drugs. Such activities are not possible without holding a license.

In accordance with the updated legal framework the State Service of Ukraine on Medicines and Drugs Control shall be performing calculations and make recommendations regarding the quotas scope. This process must be logically connected to two other: џ џ

reporting on the sold, used and consumed medicinal products; formation of annual demand.

All the economic entities, which work with narcotic substances, are obliged to report to the State Service for Medicines and Drugs Control on the volumes of produced, manufactured, imported to and exported from Ukraine, sold or used narcotic drugs on an annual basis till March 31. As a result it was identified by the study that within the period of 2010 – 2015: џ џ џ

the State Service of Ukraine on Medicines and Drugs Control received about 3000 paper reports on an annual basis; almost 30% of licensees did not report at all; improper reports filling in was a common problem.

This being the case there are some doubts regarding the accuracy and completeness of the data received by the State Service for Medicines and Drugs Control. At the very same time the Service did not participate in the process of forecasting the needs in narcotic substances for medical use. In accordance with the legislation, all these processes are taking place within the level of Health Care Departments and Health Administrations of Oblast State Administrations, which submit calculated needs in narcotic medicinal products to MoH on an annual basis up to November 15.

There is an approved form of needs forecasting, nevertheless there is no procedure or methodology of need calculation approved. To forecast an annual need Health Care Departments and Health Administrations of Oblast State Administrations collect information from medical and preventive treatment facilities. With due account of the above mentioned legislative gaps, the hospitals at their own 9

Decree of the President of Ukraine on the State Service for Medicines and Drugs Control

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discretion calculate (usually based on the level of consumption for the previous year) their needs, while Health Care Departments and Health Administrations collect data and summarize the oblast level need in the same manner.

It is also worth mentioning that since 2003 the function of monitoring drugs-related situation was entrusted to the State Service for Medicines and Drugs Control and its predecessors. However the Medical and Monitoring Centre on Drugs and Alcohol of the Ministry of Health of Ukraine (today – Centre for Mental Health and Monitoring of Drugs and Alcohol of the Ministry of Health of Ukraine) was created in 2009 by the Order of the MoH. The Monitoring centre was also entrusted with the function of monitoring drugs-related situation in Ukraine 10.

Institution collects information on the use of narcotic drugs. With the support of the MoH Health Care Departments and Health Administrations of Oblast State Administrations are collecting data for the Monitoring centre from the medical and preventive treatment facilities which report to them. Neither pharmacies, nor private treatment facilities are obliged to provide information to Health Care Departments and Health Administrations of Oblast State Administrations. This translates into a risk of incomprehensive monitoring, carried out by the Center.

Actual scheme of narcotic drugs sphere functioning submission of oblast's estimated needs in narcotic drugs

CMU MoH

Monitoring centre

State Service of Ukraine on Medicines and Drugs Control

Health care departments

Medical and preventive treatment facilities

All the licensees working with narcotic substances

submission of reports on the use and sale of narcotic drugs suggestions regarding quotas defining quotas submission

Apart from liberalization of the sector of circulation of narcotic substances for medical use, a range of deficiencies in the area reformation process was identified within the period of the study: there is no approved methodology and procedure for forecasting needs of Ukraine in narcotic drugs; џ there is no approved procedure and mechanism of assigning and splitting quotas for circulation of narcotic drugs; џ obsolete mechanism of licensees' reporting on their activities related to circulation of narcotic drugs; џ health care institutions are not obliged to report to Health Administrations of Oblast State Administrations and MoH, which results in the latter being not knowledgeable about information on the volumes of narcotic drugs consumption. џ

Findings of the study on opioid analgesics consumption for medical purposes are highlighted in the following sections of the report.

10

Order of the Ministry of Health of Ukraine No. 268 as of May 11, 2006 On Organizing Activities Related to Monitoring Situation with Alcohol and Drugs in Ukraine

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2. USE OF NARCOTIC DRUGS AT MEDICAL AND PREVENTIVE TREATMENT FACILITIES Ukrainian patients are administered narcotic drugs in hospitals or in pharmacies as prescription drugs11.

In the first instance medicinal products are being used immediately in medical and preventive treatment facilities or in at-home inpatient settings.

Pharmacies are dispensing the necessary prescription medicinal products. A patient receives a prescription form No. 3 (F. No. 3) from the physician, using which they are being dispensed appropriate narcotic drug on preferential terms, or buy it at full cost12.

Patients, including palliative ones, are usually provided with prescription drugs using the resources of primary health care level. Dispensing of prescription opioid analgesics is an indicator of medicinal products' availability to patients. Apart from this, dispensing of prescription drugs ensures comfortable and independent (with no need to constantly visit hospitals) consumption of medicinal products domiciliary.

Apart from dispensing of prescription drugs pharmacy enterprises may sell opioid analgesics to medical and preventive treatment facilities. All types of such activities are performed as authorized under a license for carrying out of economic activities related to storage and sale (dispensing) of narcotic drugs.

At first let us consider the use of opioid analgesics in medical and preventive treatment facilities of Ukraine.

2.1 Pan-Ukrainian Trends The systematic collection of information on the consumption of narcotic drugs in Ukraine was launched in 2014. Monitoring centre addressed Health Care Departments and Health Administrations of Oblast State Administrations with an official request to provide the necessary information. This is the process 13 used till today .

The study contributors have also received similar data for 2012, which were collected by experts of the State Drugs Control Service (which merged with the State Service for Medicines September 201414 ).

11

Resolution of the Cabinet of Ministers of Ukraine No. 333 as of May 13, 2013 On Approval of the Procedure for Acquisition, Transportation, Storage, Dispensing, Use and Destruction of Narcotic Drugs, Psychotropic Substances and Precursors in Health Care Institutions

12 Order of the Ministry of Health of Ukraine No. 360 as of July 19, 2005 On Approval of the Rules of Writing Prescriptions and Orders for Medications and Medical Products, Procedure of dispensing of Medications and Medical Products in Pharmacies and their Structural Subdivisions, Instructions on the Procedure for Keeping and Disposal of Prescription Forms and Orders 13

Drawing up of an analytical report Use of opioid analgesics in Ukraine. 2011-2016. took place in May 2018

14 Resolution of the Cabinet of Ministers of Ukraine No. 442 as of September 10, 2014 On Optimization of the System of Central Executive Authorities

17

Further in the text we are presenting data on the use of opioid analgesics in medical and preventive treatment facilities within the period of 2011 – 2016 (there is no information for 2013): ANALGESIC (in grams)

Codeine

Morphine

Tramadol

Trimeperidine

Fentanyl

2012

2013

2014

2015

2016

846,39

814,96

932,45

558,22

14 777,08

15 181,22

21 358,18

11 709,72

43 704,89

74 658,1

80 716,89

34 164,75

8 597,1

6 282,66

7 203,2004

5 827,24

231,64

230,15

1 053,83

644,81

In terms of morphine, tramadol and fentanyl 2011 – 2015 saw an increase in volumes of consumption of appropriate medicinal products. Volumes of codeine and trimeperidine use were variable within the researched period. The study contributors noticed the highest values in 2015. All the values of 2016 are smaller than those of the previous year. Consumption of medicinal products, which contain morphine, in medical and preventive treatment facilities (hereinafter referred to as morphine based medicinal products), will be considered further as the text goes.

2.2 Regional Trends of Using Morphine-based drugs With due account of the volumes of morphine-based drugs consumption in medical and preventive treatment facilities and having used statistical data on residential population size, the volumes of morphine consumption was calculated per 100 thousand people. This step allowed making a departure from absolute values and compare level of morphine consumption avoiding bias (error) due to different density of population in various oblasts of Ukrainian.

Having calculated relative values per 100 thousand people, the ranges of annual values of morphinebased drugs consumption in the hospitals were split between three conditional baskets: LOWER THAN AVERAGE LEVEL

AVERAGE LEVEL

The findings of the analysis are presented further as the text goes.

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HIGHER THAN AVERAGE LEVEL

grams / 100 thousand people

2012

–

34.34

g/100 thousand people

CHERNIHIV

33.15* KYIV

34.42 *

53.15 * KYIV CITY

61.28

0.0

CHERKASY

ZAPORIZHIA

*

52.80

29.22

–

60.56 KHERSON

–

CRIMEA

MYKOLAIV

VINNYTSIA

–

ODESA

71.97

–

DONETSK

*

DNIPROPETROVSK

*

– KHMELNYTSKYI

VOLYN

11.77

POLTAVA

KIROVOHRAD

RIVNE

36.66

84.64 *

65.32

ZHYTOMYR

28,67*

KHARKIV

46.57 SUMY

24.28*

UKRAINE

*

LUHANSK

39.41

TERNOPIL

LVIV

40.84*

IVANOFRANKIVSK

–

CHERNIVTSI

79.82

* with no regard for Omnopon medicinal product due to incorrectly drawn up annual report

ZAKARPATTIA

In 2012 the overwhelming majority of oblasts was characterized by average level of morphine-based drugs consumption in the hospitals. The best results were achieved by the following oblasts: Donetsk, Ternopil and Chernivtsi oblast. Dnipropetrovsk, Mykolaiv, Rivne, Cherkasy and Chernihiv oblasts were identified as laggards.

grams / 100 thousand people

2014

58.98

35.50

g/100 thousand people

87.20

UKRAINE

64.29

CHERNIHIV

KHARKIV SUMY

36.71

–

60.96

POLTAVA

12.81

11.18

42.66 KYIV CITY

32.33

– 32.34 KIROVOHRAD 40.30

69.23

VOLYN

KHMELNYTSKYI

44.33 LVIV

46.32

CHERKASY

ZHYTOMYR

RIVNE

27.45

49.31

VINNYTSIA

DONETSK

DNIPROPETROVSK

25.08 KYIV

–

LUHANSK

MYKOLAIV

ZAPORIZHIA

56.85 KHERSON

–

CRIMEA

17.92 ODESA

TERNOPIL

41.66 16.48

IVANOFRANKIVSK

CHERNIVTSI

53.15

ZAKARPATTIA

In 2014 the number of oblasts with a conditionally low level of morphine-based drugs consumption increased (Volyn, Zhytomyr, Zakarpattia, Kyiv, Odesa, Rivne, Ternopil and Cherkasy oblast) due to better dissemination of related information.

Conditionally high level of morphine consumption was registered in medical and preventive treatment facilities of Vinnytsia and Chernihiv oblasts.

19

00–32 g / 100 thousand people 33–66 g / 100 thousand people from 67 g / 100 thousand people

grams / 100 thousand people

2015

LUHANSK

17.54

50.15

g/100 thousand people

80.47

31.60

SUMY

19.31 57.65

CHERNIHIV

POLTAVA

UKRAINE

32.18 KYIV

KYIV CITY

38.12

36.75

11.66

VOLYN

73.51 76.85

49.07

KHERSON

–

MYKOLAIV

CRIMEA

VINNYTSIA ODESA

68,83

34.01

58.80

ZAPORIZHIA

KIROVOHRAD

46.15

KHMELNYTSKYI

DONETSK

77.53 DNIPROPETROVSK

86.09

CHERKASY

ZHYTOMYR

RIVNE

170.04

66.24

30.15

KHARKIV

TERNOPIL

LVIV

63.71 38.13

39.04

CHERNIVTSI

IVANOFRANKIVSK

21.81

ZAKARPATTIA

In 2015 the study contributors relied on the information from all the oblasts. Number of oblasts characterized by low level of morphine consumption decreased (Donetsk, Kyiv, Luhansk, Rivne, Sumy, Kharkiv and Chernivtsi oblast). Volyn, Dnipropetrovsk, Zaporizhia, Kirovohrad, Mykolaiv, Khmelnytskyi and Chernihiv oblast were among champions.

grams / 100 thousand people

2016

10.00

27.60

g/100 thousand people

48.52

UKRAINE

KYIV

36.56 9.57

KYIV CITY

SUMY

CHERKASY

18.00

KHMELNYTSKYI

11.11 DONETSK

23.15

18.71 POLTAVA

DNIPROPETROVSK

39.69

10.93

KIROVOHRAD

28.39

28.47

VOLYN

LVIV

56.37

KHARKIV

ZHYTOMYR

RIVNE

35.49

34.38

CHERNIHIV

42.63

23.74

LUHANSK

32.35

MYKOLAIV

ZAPORIZHIA

26.38 KHERSON

–

CRIMEA

VINNYTSIA

20.26 66.35

ODESA

TERNOPIL

18.92 14.07

IVANOFRANKIVSK

15.46

CHERNIVTSI

28.22

ZAKARPATTIA

00–32 g / 100 thousand people Estimated values of 2016 have fallen into low and average level of consumption.

Morphine-based drugs consumption increased in hospitals of Kyiv, Sumy, Kharkiv and Chernivtsi oblasts only. In general treatment facilities of other oblasts decreased the level of morphine based medicinal products use in their practice.

20

33–66 g / 100 thousand people from 67 g / 100 thousand people

For majority of oblasts the year of 2015 was characterized by the highest values of morphine consumption, while 2016 – was characterized by the lowest one. The bottom line is that there was no clearly deďŹ ned tendency in consumption of medicinal products in various oblasts noticed by the study contributors.

At the very same time there are several exceptions. Smaller volumes of morphine were used in Vinnytsia, Donetsk, Rivne, Kherson and Chernivtsi oblast annually. A relatively positive dynamics can be traced in Khmelnytskyi oblast.

2.3 Morphine-based drugs Consumption with a Breakdown into Pharmaceutical Form Another important approach to scrutinizing opioid analgesics sphere is the analysis of morphine-based drugs consumption with a breakdown into pharmaceutical form: injectable dosage form and tablet formulation. The study contributors had the data from 2012 and 2016 at their disposal. Since tablet formulation of morphine appeared in Ukraine in 2013, let us consider the situation through the lens of 2016: PHARMACEUTICAL FORM

CONSUMPTION VOLUMES

86%

SOLUTION FOR INJECTION, %/g

9 927,12

14%

TABLETS, %/g

1 682,70

Ukrainian medical and preventive treatment facilities are usually using morphine in a form of solution for injection (86%). The share of the consumed tableted analgesics amounts to 14%.

21

3. DISPENSING SALE OF NARCOTIC DRUGS

BY PHARMACIES USING PRESCRIPTION FORM NO. 3 (F. NO. 3) As in the previous section, which pertained to the use of opioid analgesics in general and morphinebased drugs in particular in medical and preventive treatment facilities, let us consider the situation with prescription dispensing of narcotic drugs to patients by pharmacies.

As the study was launched 282 pharmacy enterprises, which owned 518 places of economic activity – pharmacies – had a license for retail sales of opioid analgesics.

What is peculiar about this section is that the study contributors received information from 67 pharmacy enterprises from among 282. Subsequently they received data on opioid analgesics dispensing by 170 pharmacies from among 518.

Other important aspect here would be absolutely different time intervals within which the information was received. That is why a so-called representative period – time span with the greatest amount of information from an oblast – was defined. Analysis of every separate oblast was carried out within the framework of the above mentioned period.

Since 2016 the Monitoring centre started collecting information on the consumed medicinal products, which were dispensed by prescription form No. 3 from Health Care Departments and Health Administrations of Oblast State Administrations. Report contributors decided not to use these data with due account of the reasons given below.

The obtained data significantly differed from pharmacies-declared values for 2011 – 2016. For the most part, the obtained figures were higher. However in some instances prescription drugs sale figures obtained from Health Care Departments and Health Administrations of Oblast State Administrations were lower than those obtained from pharmacies.

22

3.1 Pan-Ukrainian Trends The period of 2011 – 2015 was selected as a representative period for the whole Ukraine. Dynamics of dispensing of prescription opioid analgesics in 170 pharmacies (33%) was as follows: ANALGESIC (in grams)

2011

2012

2013

2014

2015

2,24

15,08

94,78

84,47

44,87

59,83

385,67

796,47

2 383,09

3 772,05

33 649,85

45 456,24

46 870,24

54 730,88

51 029,00

21,44

69,44

63,70

178,30

48,92

0,00

0,26

2,23

7,50

0,00

Codeine

Morphine

Tramadol

Trimeperidine Fentanyl

Within the period of 2011 – 2015 dispensing of prescription morphine-based drugs by Ukrainian pharmacies increased. Other opioid analgesics were characterized by positive trends up to 2013 (codeine) or up to 2014 (tramadol, trimeperidine, fentanyl); other years saw a decrease in their prescription dispensing.

Let us consider dispensing of prescription morphine-based drugs in more details.

3.2 Dispensing of Prescription Morphine-based drugs with a Breakdown into Pharmaceutical Form In terms of prescription drugs sale – namely dispensing of oral (non-injectable) dosage forms of morphine is of special relevance. Its use relies on tree step ladder scheme of oncological patients' pain 15 management, recommended by WHO , as well as on international clinical recommendations on pain 16 management for palliative patients the use of oral dosage forms ensures comfortable and independent consumption of medicinal products by the patients. Below you may find information on sale of prescription morphine-based drugs with a breakdown into pharmaceutical form:

15 16

Cancer Pain Relief: With a Guide to Opioid Availability, World Health Organization. – Geneva, 1996.

Palliative care for adults: strong opioids for pain relief. Clinical guideline, National Institute for Health and Care Excellence. – 2012.

23

MORPHINE

2011

2012

2013

2014

2015

Injectable dosage form, g/%

59,83

385,67

438,37

800,63

1 219,42

100%

100%

55%

34%

32%

0,00

0,00

358,10

1 582,46

2 552,63

45%

66%

68%

796,47

2 383,09

3 772,05

Oral dosage form (tablet formulation), g/% TOTAL, g

59,83

385,67

Up to 2013 only injectable dosage form of morphine had a state registration in Ukraine. Within the period of 2013 – 2015 the share of tablet formulation dispensing increased. In 2015 the share of tablet formulation of morphine sold by prescription form was two times higher than share of its injectable dosage forms.

Further in the text you will find data on sales of prescription morphine in every oblast of Ukraine.

3.3 Regional Trends of Sale of Prescription Morphine-based drugs 2011 – 2016 was the time frame of this analysis. Volumes of pharmacies' sales were calculated by adding information, received from all the pharmacies of the oblast. All the pharmaceutical forms of morphine-based drugs were taken into account while carrying out calculation. Conclusions on opioid analgesics consumption trends were drawn up based on the mentioned information.

AUTONOMOUS REPUBLIC OF CRIMEA AND SEVASTOPOL CITY Territory of the Autonomous Republic of Crimea and Sevastopol City are currently defined as a temporarily occupied territories17. Such temporarily occupied territories are subject to special legal regime of crossing the demarcation line of temporarily occupied territories, separate procedures of settlement of transaction, conducting elections and referenda, realization of other human rights and freedoms.

It is temporarily not possible to get information on the consumption of narcotic drugs within the territory of the Autonomous Republic of Crimea.

VINNYTSIA OBLAST From among twelve pharmacy enterprises of the oblast, holding a license, the necessary information on opioid analgesics dispensing was provided by half of the respondents. 2012 – 2015 was defined as representative period of prescription drugs sale. There is no data on any peculiar issues related to dispensing of morphine-based drugs in Vinnytsia oblast:

17

The Law of Ukraine On Ensuring the Rights and Freedoms of Citizens and Legal Regime in the Temporarily Occupied Territory of Ukraine

24

(in grams)

338,34

year

392,20

427,15

2014

2015

303,94

2012

2013

Dispensing of prescription morphine-based drugs was gradually growing within the period of 2013 – 2015.

VOLYN OBLAST 9 pharmacies owned by Volynpharmpostach state production and technical company were officially allowed to carry out dispensing of opioid analgesics in Volyn oblast as of December 2016. Volyn pharmacists did not provide any requested information, which is why it was not possible to identify any prevailing trends in Volyn consumption of opioid analgesics.

DNIPROPETROVSK OBLAST The study contributors addressed all the pharmacy enterprises of Dnipropetrovsk oblast, holding appropriate licenses. Positive responses were provided by five out of six enterprises, comprised of 10 pharmacies (33%), at different time intervals.

2011 – 2016 was defined as representative period of prescription drugs sale. At the very same time the most powerful enterprise of the oblast – Pharmacia oblast level public enterprise (23 pharmacies as of the date of conducting the study) – did not provide any information, which prevented the study contributors from making precise conclusions for the oblast in general. Let us analyze dispensing of morphine-based drugs using the available data:

49,88

(in grams)

22,53 0,46 year

2011

0 2012

2013

1,90

2,08

2014

2015

2016

Pharmacies were dispensing relatively small volumes of medicinal products, with the exception of the highest values in 2012 and 2016.

DONETSK OBLAST Pharmacies of the oblast, which were duly licensed to work with narcotic drugs, did not provide any information on sales and dispensing of prescription drugs.

ZHYTOMYR OBLAST Twenty pharmacy enterprises in the oblast had a license to work with opioids through 20 pharmacies.

The information on prescription drugs sale was received from 5 pharmacies (25%). The

25

most complete data was collected for the period of 2013 – 2015. This period was selected as a representative one. Let us analyze sales of morphine-based drugs in the oblast:

70,85

(in grams)

34,32

27,16

2013

year

2014

2015

Within the period of 2013 – 2015 dispensing of prescription morphine-based drugs was growing.

ZAKARPATTIA OBLAST From among 10 pharmacy enterprises, holding a license to carry out sale in 10 pharmacies, the prescription data was received from two pharmacies – 20%. All the received information pertained to the period of 2011 – 2015. Let us consider the trends in dispensing of morphine-based drugs in Zakarpattia oblast:

47,66

(in grams)

27,75

year

0

0

2011

2012

8,05 2013

2014

2015

Morphine based medicinal products started being dispensed in 2013. The dispensing volumes were growing up to 2015.

ZAPORIZHIA OBLAST 13 pharmacy enterprises had a license for dispensing of opioid analgesics in Zaporizhia oblast. Opioid analgesics were sold in 20 pharmacies. Only one pharmacy (5% from among 20 pharmacies) provided information for 2011 – 2016 to the study contributors. Below is the data on dispensing of morphinebased drugs in the oblast: (in grams)

year

0

0

0

2011

2012

2013

0,85 2014

17,79

21,64

2015

2016

Prescription dispensing was launched in 2014 and was growing gradually.

IVANO-FRANKIVSK OBLAST Data on prescription drugs sale for 2011 – 2015 was provided by local Health Care Department in IvanoFrankivsk oblast. Pharmacies did not provide any information. Let us consider dynamics of morphinebased drugs dispensing:

26

21,70

(in grams)

year

14,19

0,10

0

0

2011

2012

2013

2014

2015

Dispensing of prescription morphine-based drugs was launched in 2013. Volumes of dispensing increased in 2014, but decreased in 2015.

KYIV CITY 8 pharmacy enterprises, comprised of 49 pharmacies, were dispensing opioid analgesics in Kyiv city.

The study contributors received information from Pharmacia public enterprise for 2011 – 2016. The mentioned enterprise occupies a dominant position in the city – having pharmacy No. 41 within its structure. The available information is sufficient for making representative conclusions. Let us consider dispensing of morphine-based drugs in the capital of Ukraine:

928,26

(in grams)

623,72

254,10

49,3

year

0

0

2011

2012

2013

2014

2015

2016

Morphine based medicinal products were sold via Pharmacia public enterprise since 2013. The stable trends of increase in volumes of medicinal products dispensing were registered.

KYIV OBLAST Nineteen pharmacy enterprises of Kyiv oblast had a license for dispensing in 19 pharmacies. The study contributors received data on prescription drugs sale in eight pharmacies (42%). 2012 – 2015 is a representative period. Let us analyze sales of prescription morphine-based drugs: (in grams)

106,79

110,52

2014

2015

54,43 0,31 year

2012

2013

Dispensing volumes of prescription morphine-based drugs were growing annually.

KIROVOHRAD OBLAST Analysis of the prescription consumption of the oblast was based on the information from one

27

pharmacy – satellite pharmacy No. 15 of Liky Ukrainy Subsidiary Enterprise of a State Joint-Stock Company – for 2011 – 2016. 4 pharmacy enterprises (5 pharmacies in general) had a license for dispensing of narcotic drugs in the oblast. The picture of sale of morphine-based drugs in Kirovohrad oblast is as follows: (in grams)

year

0

0

0

0

0

0

2011

2012

2013

2014

2015

2016

Prescription dispensing was not carried out by the pharmacy within the period of 2011 – 2016.

LUHANSK OBLAST Neither of two pharmacy enterprises, holding a license for dispensing of narcotic drugs within 16 pharmacies, provided the information.

LVIV OBLAST Thirty four pharmacy enterprises carrying out activities through 34 pharmacies have a license to work with controlled drugs in Lviv oblast. The necessary data was provided by five out of them – 15%. The most complete data were collected for the period of 2011 – 2015, which was selected as a representative one. Let us analyze consumption of prescription morphine-based drugs:

52,26

(in grams)

17,30 year

0

0

0

2011

2012

2013

2014

2015

Prescription dispensing was launched in 2014 and the volume increased the next year.

MYKOLAIV OBLAST From among four pharmacy enterprises, holding a license for dispensing through eighteen pharmacies of the oblast, the data on prescription drugs sale was received from one pharmacy only (6%). The provided information covered the period of 2011 – 2016. The general picture of dispensing of morphine based medicinal products was as follows:

21,92

(in grams)

year

0

0

2011

2012

7,0 2013

14,35

11,60

2014

2015

2016

With the exception of 2015 the oblast was characterized by a gradual increase in volumes of medicinal product dispensing by pharmacies. Dispensing was launched in 2013.

ODESA OBLAST From among seven pharmacy enterprises (comprised of one pharmacy each), holding a license,

28

data on prescription drugs sale was provided by two (29%). The most complete information was gathered for 2014 – 2015. However 2011 – 2016 was chosen as a representative period, as information from Odesapharm public enterprise allows identifying appropriate trends. Let us consider characteristic features of sale of prescription morphine-based drugs:

191,50

(in grams)

178,30 159,10 17,41 year

0

0

2011

2012

2013

2014

2015

2016

Morphine based medicinal products sold by prescription became available for residents of the oblast since 2013. Every subsequent year was characterized by positive dynamics expressed in increase in dispensing volumes.

POLTAVA OBLAST Poltavapharm Poltava oblast public enterprise, the structure of which comprises of 27 pharmacies, is carrying out prescription dispensing of narcotic drugs within the territory of Poltava oblast. 2012 - 2016 is a representative period for Poltava oblast. With due account of Poltavapharm Poltava oblast public enterprise's dominant position, the obtained data properly reflect the volumes of prescription drugs sale within the whole oblast. Dynamics of morphine dispensing was as follows:

917,61 (in grams)

731,67 309,63

48,77 3,02 year

2012

2013

2014

2015

2016

Poltava oblast was characterized by annual increase in dispensing of prescription morphine-based drugs.

RIVNE OBLAST From among 12 pharmacy enterprises of Rivne oblast, which had appropriate license and carried out dispensing in 21 pharmacies within the period of the study implementation, three pharmacies – 14% – shared their data. 2011 – 2016 was selected as a representative period. Let us consider characteristic features of dispensing of prescription morphine-based drugs:

29

175,39 (in grams)

28,13

year

4,20

1,40

2011

2012

8,75

7,51 2013

2014

2015

2016

There was not a single trend within the period of 2011 – 2016. The highest values of prescription drugs sale was noticed by the study contributors in 2016, while the lowest was registered in 2012.

SUMY OBLAST Twelve pharmacy enterprises of Sumy oblast had a license which allowed working with narcotic drugs and were carrying out dispensing in 15 pharmacies. Five enterprises comprised of seven pharmacies (47%) provided information on prescription drugs sale. The period of 2012 – 2015 is the most representative. Let us consider the trends in consumption of morphine-based drugs in the oblast:

284,24

(in grams)

122,72

year

10,35

2,15

2012

2013

2014

2015

Within the period of 2013 – 2015 the study contributors noticed positive dynamics in dispensing of prescription morphine-based drugs.

TERNOPIL OBLAST Eleven pharmacy enterprises had license entitling them to sell through 11 pharmacies. Data on prescription drugs sale was provided by three pharmacies (27%). The period of 2011 – 2016 was selected as a representative one. Let us analyze dispensing of prescription morphine-based drugs of the oblast.

384,89

(in grams)

310,76

302,59

94,44 19,42 year

2011

9,47 2012

2013

2014

2015

2016

The period of 2012 – 2015 was characterized by an increase in consumption volumes of morphinebased drugs sold by the prescription. There was a slight decline in 2016. At the very same time there is no sufficient information from Zbarazh oblast public central regional pharmacy No. 26 for 2016. Even if the pharmacy had repeated its 2015 volume of sales in 2016, the total volume for the oblast in general would have remained lower.

30

KHARKIV OBLAST Within the period under consideration fifteen pharmacy enterprises had licenses for dispensing pain management products in 24 pharmacies of Kharkiv oblast. Data on prescription drugs sale was provided by two pharmacies (8%). The period of 2011 – 2012 is the most representative one. However let us consider 2011 – 2015 for a better analysis scope. Data on sale of prescription morphine-based drugs is provided below:

11,10

(in grams)

year

0

0

0

2011

2012

2013

3,00 2014

2015

Sale of prescription morphine-based drugs started in 2014 and ended in 2015.

KHERSON OBLAST From among twenty pharmacy enterprises (23 pharmacies in general), holding a license, only three (13%) provided the data on prescription drugs sale. 2011 – 2015 was chosen as a representative period.

Let us analyze the sale of morphine-based drugs in Kherson oblast:

44,85

(in grams)

30,90

11,15 year

0

0

2011

2012

2013

2014

2015

Within the period of 2013 – 2014 there was an increase in the volume of consumed prescription medicinal products. In 2015 the study contributors noticed a decline by one third.

KHMELNYTSKYI OBLAST 22 pharmacy enterprises (24 pharmacies in general) from Khmelnytskyi oblast had a license. Three pharmacies (13%) provided their information. 2012 – 2015 is the most representative period. Let us consider this period in terms of sale of prescription morphine-based drugs:

112,20

(in grams)

85,15

71,50

0 year

2012

2013

2014

2015

Unlike in the majority of oblasts of Ukraine, prescription dispensing of morphine in Khmelnytskyi oblast was decreasing within the period of 2013 – 2015.

CHERKASY OBLAST Seventeen pharmacy enterprises had a license and were dispensing medicinal products through

31

32 pharmacies. The data on sales of opioid analgesics was provided by twenty pharmacies (63%). 2011 – 2015 was selected as a representative period. Let us analyze consumption of morphine-based drugs in Cherkasy oblast: (in grams)

525,55 320,50

48,85 year

0

0

2011

2012

2013

2014

2015

Dispensing of prescription morphine was launched in 2013 and its volumes were significantly increasing by 2015.

CHERNIVTSI OBLAST Eleven pharmacy enterprises (11 pharmacies in general) had a license in Chernivtsi oblast. Sales data was provided by three pharmacies (27%). The period of 2011 – 2016 was selected for the purposes of the analysis. Let us consider consumption of morphine-based drugs in the oblast: (in grams)

167,35

168,26

2015

2016

136,16

4,00 year

2011

2012

2013

2014

Within the period of 2013 – 2016 dispensing of prescription morphine-based drugs in the oblast was growing.

CHERNIHIV OBLAST Two pharmacy enterprises, which sell through 27 pharmacies, are functioning in Chernihiv oblast. One of them – Liky Ukrainy public enterprise (26 places of supply) – is the oblast's monopolist. The enterprise did not provide any data on prescription drugs sale. This being the case it was not possible to identify the trends in consumption of prescription opioid analgesics by residents of the oblast.

32

4. NEED IN AND ACTUAL AVAILABILITY OF MORPHINE Morphine is a golden standard of pain management. Internationally accessibility of pain management in the country is assessed by the indicators of its morphine consumption. WHO and INCB offered a formula to calculate the need in morphine (see Section Study methodology) in 2012, which was used for the purposes of this report.

The calculated need was compared against an indicator of total morphine consumption in medical and preventive treatment facilities and volume of its dispensing as prescription drug by pharmacies. As a result of this process accessibility was defined. Analysis was taking into account data for the representative period which varied for different oblasts.

Five oblasts were selected for the calculation purposes: Vinnytsia, Ivano-Frankivsk, Poltava, Cherkasy, Chernivtsi and the city of Kyiv. These regions are differentiated from other administrative units by availability of more complete data on prescription drugs sale rather than just data on consumption in medical and preventive treatment facilities.

For Ivano-Frankivsk and Poltava oblasts as well as the city of Kyiv the calculation is as representative as possible. Other three regions are characterized by lower representativeness of the data.

Let us calculate the accessibility of morphine in Vinnytsia oblast:

2014

INDICATOR

* the volumes of morphine consumption in medical and preventive treatment facilities were recalculated in terms of the equivalent amount of oral dosage; it was done by multiplying the obtained values by 2.5 coefficient (which demonstrates hospitals' use of other pharmaceutical forms, including tablet formulation)

2015

Consumption, g

3 896,74*

3 076,59*

Need, g

18 425, 14

18 877,13

Accessibility

21%

16%

Within the period of 2014 – 2015 the accessibility of morphine in Vinnytsia oblast reduced from 21% to 16%. Analysis of availability in Ivano-Frankivsk oblast is as follows:

INDICATOR

2012

Consumption, g

1 686,99*

Need, g

13 628,03

Accessibility

12%

2013

13 651,17

33

2014

2015

1 479,06**

2 225,37**

12 924,02

13 795,71

11%

16%

* with no regard for use of Omnopon medicinal product by medical and preventive treatment facilities due to incorrectly drawn up annual report; ** the volumes of morphine consumption in medical and preventive treatment facilities were recalculated in terms of the equivalent amount of oral dosage; it was done by multiplying the obtained values by 2.5 coefficient.

The accessibility of morphine in Ivano-Frankivsk oblast in 2012 and 2014 amounted to 11%-12%, while in 2015 the accessibility level increased to 16%.

Let us perform the calculation of morphine accessibility in the capital of Ukraine (Kyiv city): INDICATOR

2012

Consumption, g

4 470,15*

Need, g

31 755,92

Accessibility

14%

2013

30 967,26

2014

2015

2016

3 289,74**

5 401,41**

5 505,15**

32 071,73

33 196,99

32 329,07

10%

16%

17%

* with no regard for use of Omnopon medicinal product by medical and preventive treatment facilities due to incorrectly drawn up annual report; ** the volumes of morphine consumption in medical and preventive treatment facilities were recalculated in terms of the equivalent amount of oral dosage; it was done by multiplying the obtained values by 2.5 coefficient.

Within the period of 2014 – 2016 accessibility of morphine in the capital was increasing from 10% to 17%. Let us have a look at supply of morphine in Poltava oblast.

INDICATOR

2012

Consumption, g

2 869,94

Need, g

20 533,65

Accessibility

14%

2013

20 444,61

2014

2015

2016

2 443,16

3 079,00

2 391,98

20 392,14

21 120,04

20 042,36

12%

15%

12%

Accessibility in the oblast ranged within (12–15)%.

Let us consider the situation in Cherkasy oblast: INDICATOR

2012

Consumption, g

0,09

Need, g

15 072,44

Accessibility

0

2013

14 469,84

2014

2015

1 334,09*

1 669,04

15 177,0

14 847,59

9%

11%

* the volumes of morphine consumption in medical and preventive treatment facilities were recalculated in terms of the equivalent amount of oral dosage; it was done by multiplying the obtained values by 2.5 coefficient.

34

Within the period of 2014 – 2015 Cherkasy oblast was ensured with morphine – within the level of 9% and 11%, respectively. The same indicator for 2012 was equal to zero.

Let us perform the calculation of accessibility in Chernivtsi oblast: INDICATOR

2012

2013

Consumption, g

2 164,99

Need, g

10 015,40

Accessibility

22%

9 776,13

2014

2015

2016

1 342,08*

744,04*

1 106,63

9 848,40

10 057,22

9 980,87

14%

7%

11%

* the volumes of morphine consumption in medical and preventive treatment facilities were recalculated in terms of the equivalent amount of oral dosage; it was done by multiplying the obtained values by 2.5 coefficient.

Accessibility of morphine in the oblast was decreasing within the period of 2012 – 2015 and increased in 2016.

Calculation of accessibility for six oblasts:

INDICATOR

2012

ACCESSIBILITY

12,4%

2013

2014

2015

2016

11,2%

14,3%

14%

The average values of accessibility fall within the interval from 11,2% to 14,3%. This means that the area of sale and dispensing of narcotic drugs is still not sufficiently functional. Numerous regulatory changes, which took place in the recent years, had little influence on accessibility of pain management for Ukrainians.

35

CONCLUSIONS Within the period of 2010 – 2015 the domestic legislation on the circulation of narcotic substances for medical use has significantly changed. In general the process was characterized by a liberal nature. At the very same time the system of circulation of narcotic drugs in terms of reporting, forecasting the need and defining quotas remains under-regulated. Information on consumption of and needs in opioid analgesics for medical use does not get systematized and is not being analyzed at the level of government authorities.

The existing system of reporting to the State Service for Medicines and Drugs Control is characterized by: improper level of annual reports filling-in by entities, which have an appropriate license; high share of licensees, who do not submit reports; џ inability to obtain complete data on the use of opioid analgesics for medical purposes, particularly in the context of prescription drugs dispensing. џ

џ

It is worth mentioning that the system of collecting information from the Monitoring centre on the use of opioid analgesics by health care institutions: is not regulated; is locally coordinated by Health Care Departments and Health Administrations of Oblast State Administrations, meaning information is being collected from institutions subordinated to them only; џ does not provide for collection of information from pharmacy enterprises. џ

џ

Also there is no full-fledged mechanism, which could support calculation of quotas on the basis of consumption data and needs forecasts.

It is also worth mentioning that QUOTAS FOR 2015 – 2018 WERE NOT APPROVED. Low quality and incomplete data make it not possible to identify precise regional and country level trends in the use of narcotic drugs for medical purposes in Ukraine. џ

Trends of Opioid Analgesics Use in Medical and Preventive Treatment Facilities

The study contributors noticed an increase in volumes of consumption of morphine, tramadol and fentanyl within the period of 2011 – 2015 in medical and preventive treatment facilities. In 2016 the use of all the above mentioned opioid analgesics has decreased, including codeine and trimeperidine, the consumption volumes of which were variable within the researched period.

It was identified that for majority of oblasts 2015 was characterized by the highest values of morphine consumption per 100 thousand of residential population, while 2016 – by the lowest. There was no clearly defined tendency in consumption of medicinal products in various oblasts noticed by the study contributors. The volumes of morphine consumption were decreasing annually in medical and preventive treatment facilities of Vinnytsia, Donetsk, Rivne, Kherson and Chernivtsi oblast. A relatively positive dynamics can be traced in Khmelnytskyi oblast.

36

Ukrainian medical and preventive treatment facilities are usually using morphine in a form of solution for injection (86%). The share of the consumed tableted analgesics amounts to 14%. џ

Trends in Dispensing Sale of Opioid Analgesics by Pharmacies Using Prescription Form No. 3

Having analyzed the information obtained from 67 pharmacy enterprises, the study contributors noticed an increase in pharmacies' sales of morphine-based drugs within the period of 2011 – 2015 in most oblasts of Ukraine. This was mostly due to tablet formulation of an analgesic. The share of its sales increased to 68% in 2015. Injectable dosage form volumes decreased to 32% compared against total volumes of dispensing.

At the very same time the study contributors noticed, that 2013 marked the launch of prescription morphine dispensing in the majority of oblasts. This is associated with approval of the Resolution of the Cabinet of Ministers of Ukraine No. 333 as of May 13, 2013 and registration of tablet formulation in Ukraine.

The most complete data on sale and dispensing of prescription narcotic drugs was collected in Vinnytsia, Cherkasy, Chernivtsi, Ivano-Frankivsk, Poltava oblasts and the city of Kyiv. Annual increase in volumes of dispensed morphine was also registered in these regions. џ

Supply of Morphine

Based on the amounts used in the hospitals and dispensed by the pharmacies accessibility of “a golden standard of pain management” – morphine – was calculated for Vinnytsia, Cherkasy, Chernivtsi, IvanoFrankivsk, Poltava oblasts and the city of Kyiv. Within the period of 2012 – 2016 the average level of supply varied from 11.2% to 14.3%.

This being the case, liberalization of legislation in the area of narcotic drugs circulation for medical use has not yet resulted in proper provision of Ukrainians with adequate pain management. At the very same time the study contributors noticed an increase in sales of prescription morphine by Ukrainian pharmacies in general and its tablet formulation in particular.

37

Based on the given conclusions we want to express suggestions regarding improvements in the area of circulation of narcotic substances. The summary of the key changes is as follows:

develop an algorithm of determining quotas by the State Service for Medicines and Drugs Control on the basis of:

Establishing a Representative Data Period to Analyze Dispensing Sales of Prescription Opioid Analgesics in Regions of Ukraine

HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3

HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3

HCI F. No. 3

HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3 HCI F. No. 3

*

2011

2012

2013

2014

2015

2016

– 2,77

531,37 10,35

– 2,15

720,90 122,72

351,12 284,24

378,93 –

HCI F. No. 3

– 19,42

773,03 9,47

– 94,44

292,81 302,59

361,38 384,89

213,97 310,76

HCI F. No. 3

– 0,00

1075,39 0,00

– 0,00

1601,63 3,00

474,14 11,10

868,84 –

HCI F. No. 3

– 0,00

652,07 0,00

519,82 11,15

606,28 44,85

520,58 30,90

278,10 –

HCI F. No. 3

– 0,00

– 0,00

– 112,20

640,02 85,15

888,80 71,50

850,69 0,58

HCI F. No. 3

– 0,00

0,03 0,00

– 48,85

403,72 320,50

455,45 525,55

220,97 46,65

HCI F. No. 3

– 0,00

721,66 0,00

– 4,00

482,05 136,16

197,79 167,35

255,45 168,26

HCI F. No. 3

– –

259,64* –

– –

913,13 –

834,06 –

497,28 –

HCI F. No. 3

– 59,83

14777,08 385,67

– 796,47

15181,22 2383,09

21358,18 3772,05

11709,72 3013,09

HCI F. No. 3

with no regard for Omnopon due to incorrectly drawn up annual report

48

ANNEX 4 TRAMADOL CONSUMPTION

in grams

2011

2012

2013

2014

2015

2016

– 5829,35

– 5728,25

– 5380,50

10449,60 6596,70

5208,58 6530,75

1664,60 2545,05

HCI F. No. 3

– –

359,75 –

– –

107,90 –

18,40 –

86,20 –

HCI F. No. 3

– 249,00

2223,20 1785,50

– 454,00

14047,05 1539,00

12233,60 2433,25

1355,40 873,00

HCI F. No. 3

– –

–* –

– –

– –

1380,75 –

1205,60 –

HCI F. No. 3

– 56,00

833,70 137,00

– 636,20

100,90 720,00

680,75 582,50

1307,25 –

HCI F. No. 3

– 399,30

– 327,50

– 366,50

249,95 625,50

1412,40 601,00

536,55 –

HCI F. No. 3

– 92,00

8292,10 200,50

– 192,50

2866,85 195,70

6588,40 275,70

3722,35 293,60

HCI F. No. 3

– 988,10

1700,65 320,40

– 473,40

498,62 522,10

2333,45 645,40

6,00 –

HCI F. No. 3

– 10741,25

–* 10972,90

– 10547,50

10741,80 10997,20

6158,60 9848,40

5619,90 10839,70

HCI F. No. 3

– 440,50

6360,60 2844,70

– 2384,40

3104,20 2459,90

2817,85 2365,70

315,45 2,50

HCI F. No. 3

– 42,50

3470,20 40,50

– 78,00

– 130,00

3082,00 134,00

424,90 55,50

HCI F. No. 3

– –

– –

– –

– –

4022,16 –

2264,50 –

HCI F. No. 3

– 0,00

– 34,10

– 51,00

2524,65 62,50

4388,30 38,50

2259,70 –

HCI F. No. 3

– 37,50

925,25 49,50

– 76,50

613,95 96,50

4438,40 94,00

527,65 127,00

HCI F. No. 3

– 6924,50

– 6374,50

– 5236,50

1069,40 6381,50

3107,65 1874,00

550,35 4511,00

HCI F. No. 3

– –

10532,69 8621,90

– 8066,09

2027,95 9762,30

9138,85 9956,40

2901,55 9860,40

HCI F. No. 3

– 310,50

–* 303,50

– 174,20

347,00 173,49

274,40 283,01

120,70 85,00

HCI F. No. 3

49

ANNEX 4 TRAMADOL CONSUMPTION

*

in grams

2011

2012

2013

2014

2015

2016

– 1031,00

–* 1659,00

– 2386,70

4544,15 2390,50

1323,35 1867,90

783,45 –

HCI F. No. 3

– 984,60

–* 1128,50

– 1146,80

446,20 1556,00

468,80 1216,80

180,25 1222,60

HCI F. No. 3

– 278,50

3170,30 212,50

– 6,50

11822,85 28,50

941,30 33,50

3351,80 –

HCI F. No. 3

– 487,25

952,45 416,00

548,60 799,05

778,35 697,25

3243,75 750,20

1099,00 –

HCI F. No. 3

– 0,00

– 530,50

– 1055,90

1977,33 764,90

2656,65 1255,70

1998,85 385,00

HCI F. No. 3

– 3783,50

0 2838,50

– 6038,00

1117,90 6612,95

1126,55 6769,00

1020,10 351,50

HCI F. No. 3

– 974,50

4884,00 930,50

– 1320,00

3951,00 2418,40

1600,45 3473,30

314,75 2929,80

HCI F. No. 3

– –

–* –

– –

1270,50 –

2071,5 –

547,9 –

HCI F. No. 3

– 33649,85

43704,89 45456,24

– 46870,24

74658,10 54730,88

80716,89 51029,00

4164,75 34081,65

HCI F. No. 3

incorrectly drawn up annual report

50

ANNEX 5 TRIMEPERIDINE CONSUMPTION

in grams

2011

2012

2013

2014

2015

2016

– 7,40

– 22,26

– 30,54

61,78 29,52

53,56 12,74

50,72 7,50

HCI F. No. 3

– –

231,68 –

– –

0,46 –

278,14 –

96,96 –

HCI F. No. 3

– 3,80

54,04 11,30

– 4,90

776,96 2,00

570,68 0,10

151,08 0,00

HCI F. No. 3

– –

2648,48 –

– –

– –

108,68 –

86,30 –

HCI F. No. 3

– 10,00

654,06 3,00

– 0,44

25,52 0,00

331,38 0,00

701,26 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

686,32 10,00

603,48 10,70

307,68 –

HCI F. No. 3

– 0,00

483,04 0,00

– 0,00

346,62 0,00

391,70 0,00

198,20 0,00

HCI F. No. 3

– 0,00

57,40 0,00

– 0,00

17,54 0,00

26,6 0,00

17,2 –

HCI F. No. 3

– 0,00

641,22 0,00

– 0,00

314,22 0,00

951,52 0,00

304,72 1,80

HCI F. No. 3

– 0,00

337,14 0,00

– 0,00

165,10 0,00

124,50 0,00

90,18 0,00

HCI F. No. 3

– 0,00

392,70 0,00

– 0,00

– 0,00

197,58 0,00

195,92 0,00

HCI F. No. 3

– –

– –

– –

– –

101,24 –

127,08 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

790,94 0,00

1085,92 0,00

1067,30 –

HCI F. No. 3

– 0,00

175,40 0,00

– 0,00

169,02 0,00

115,40 0,00

71,96 0,00

HCI F. No. 3

– 0,00

– 0,00

– 0,00

335,28 0,00

446,78 0,00

161,90 0,00

HCI F. No. 3

– –

793,22 32,40

– 23,18

660,72 92,80

412,20 5,34

429,10 5,10

HCI F. No. 3

– 0,00

82,16 0,00

– 0,00

62,76 0,00

18,22 0,00

34,34 0,00

HCI F. No. 3

51

ANNEX 5 TRIMEPERIDINE CONSUMPTION

in grams

2011

2012

2013

2014

2015

2016

– 0,00

76,76 0,00

– 0,00

97,66 0,00

23,22 0,00

32,70 0,00

HCI F. No. 3

– 0,24

179,98 0,48

– 2,86

152,88 33,24

144,11 9,14

224,24 21,84

HCI F. No. 3

– 0,00

965,78 0,00

– 0,00

404,18 0,00

153,63 0,00

437,00 –

HCI F. No. 3

– 0,00

71,36 0,00

62,60 0,00

49,56 0,00

39,22 0,00

20,16 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

493,62 0,00

452,03 0,00

268,60 0,00

HCI F. No. 3

– 0,00

0 0,00

– 0,00

135,84 0,00

124,88 0,00

154,24 0,00

HCI F. No. 3

– 0,00

415,10 0,00

– 0,00

273,00 0,00

275,60 0,90

229,18 0,40

HCI F. No. 3

– –

337,58 –

– –

262,64 –

172,94 –

369,22 –

HCI F. No. 3

– 21,44

8597,16 9,44

– 63,70

6282,66 178,30

7203,20 48,92

5827,24 36,64

HCI F. No. 3

52

ANNEX 6 FENTANYL CONSUMPTION

in grams

2011

2012

2013

2014

2015

2016

– 0,00

– 0,00

– 0,46

7,78 4,26

23,51 0,00

9,04 0,00

HCI F. No. 3

– –

6,45 –

– –

1,00 –

5,70 –

7,45 –

HCI F. No. 3

– 0,00

2,60 0,26

– 1,26

18,02 0,00

16,91 0,00

47,97 0,00

HCI F. No. 3

– –

86,82 –

– –

– –

3,37 –

7,93 –

HCI F. No. 3

– 0,00

19,30 0,00

– 0,00

0,52 0,00

2,85 0,00

5,58 0,00

HCI F. No. 3

– 0,00

– 0,00

– 0,00

2,99 0,00

14,78 0,00

2,37 –

HCI F. No. 3

– 0,00

16,82 0,00

– 0,00

9,41 0,03

139,77 0,00

24,42 0,00

HCI F. No. 3

– 0,00

5,01 0,00

– 0,00

3,20 0,00

43,75 0,00

2,81 –

HCI F. No. 3

– 0,00

28,77 0,00

– 0,23

17,75 2,46

20,23 0,00

35,76 0,00

HCI F. No. 3

– 0,00

–* 0,00

– 0,00

3,47 0,00

32,88 0,00

15,38 0,00

HCI F. No. 3

– 0,00

4,94 0,00

– 0,00

– 0,00

186,28 0,00

12,28 0,00

HCI F. No. 3

– –

– –

– –

– –

62,94 –

4,56 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

9,80 0,00

209,89 0,00

29,95 –

HCI F. No. 3

– 0,00

8,05 0,00

– 0,00

5,27 0,00

125,52 0,00

5,79 0,00

HCI F. No. 3

– 0,00

– 0,00

– 0,00

4,63 0,00

12,94 0,00

3,92 0,00

HCI F. No. 3

– –

9,49 0,00

– 0,00

7,83 0,00

6,74 0,00

8,91 0,00

HCI F. No. 3

– 0,00

8,08 0,00

– 0,00

0,96 0,00

0,75 0,00

1,90 0,00

HCI F. No. 3

53

ANNEX 6 FENTANYL CONSUMPTION

*

in grams

2011

2012

2013

2014

2015

2016

– 0,00

3,57 0,00

– 0,00

3,79 0,00

2,21 0,00

3,74 0,00

HCI F. No. 3

– 0,00

4,91 0,00

– 0,00

3,45 0,00

4,09 0,00

90,68 0,00

HCI F. No. 3

– 0,00

5,41 0,00

– 0,00

76,59 0,00

44,62 0,00

285,60 –

HCI F. No. 3

– 0,00

8,11 0,00

7,44 0,00

36,38 0,00

8,06 0,00

11,17 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

4,05 0,00

6,15 0,00

6,60 0,00

HCI F. No. 3

– 0,00

0,00 0,00

– 0,20

5,83 0,58

4,11 0,00

11,65 0,00

HCI F. No. 3

– 0,00

4,68 0,00

– 0,06

2,75 0,12

63,63 0,00

3,61 0,00

HCI F. No. 3

– –

8,62 –

– –

4,68 –

12,15 –

5,76 –

HCI F. No. 3

– 0,00

231,64 0,26

– 2,23

230,15 7,50

1053,83 0,00

644,81 0,00

HCI F. No. 3

incorrectly drawn up annual report

54

ANNEX 7 BUPRENORPHINE CONSUMPTION

in grams

2011

2012

2013

2014

2015

2016

– 1,16

– 1,26

– 2,78

184,98 35,75

8,22 83,90

17,01 52,88

HCI F. No. 3

– –

89,11 –

– –

69,24 –

92,67 –

84,77 –

HCI F. No. 3

– 0,07

119,69 3,71

– 29,97

269,73 27,97

321,36 73,24

1,11 0,00

HCI F. No. 3

– –

265,04 –

– –

– –

19,43 –

85,94 –

HCI F. No. 3

– 0,00

14,19 0,00

– 0,10

16,32 0,44

17,74 0,24

11,14 –

HCI F. No. 3

– 3,36

– 8,89

– 13,56

27,47 11,89

23,02 4,80

27,94 –

HCI F. No. 3

– 0,00

172,73 0,00

– 0,01

108,42 0,00

231,99 0,00

299,20 0,00

HCI F. No. 3

– –

209,26 –

– –

100,33 –

46,77 –

55,65 –

HCI F. No. 3

– 3,00

717,73 15,59

– 20,38

923,48 118,12

418,46 720,70

142,56* 2218,86

HCI F. No. 3

– 0,00

50,12 0,26

– 12,92

74,27 23,50

16,49 22,75

36,86* 0,00

HCI F. No. 3

– 0,00

80,68 0,00

– 0,00

– 0,00

94,96 0,00

94,57 0,00

HCI F. No. 3

– –

– –

– –

– –

0,67 –

1,36 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

28,69 0,00

25,93 0,00

122,39 0,00

HCI F. No. 3

– 0,00

157,15 0,00

– 0,00

171,47 0,00

202,42 0,00

211,92 0,00

HCI F. No. 3

– 8,02

– 13,05

– 21,87

57,70 24,16

224,19 11,34

245,27 30,84

HCI F. No. 3

– –

9,53 0,00

– 0,00

195,02 1,00

248,22 1,88

162,78 138,74

HCI F. No. 3

– 0,00

3,58 0,00

– 0,00

91,15 43,36

27,08 50,76

52,01 46,02

HCI F. No. 3

55

ANNEX 7 BUPRENORPHINE CONSUMPTION

*

in grams

2011

2012

2013

2014

2015

2016

– 0,00

106,78 0,00

– 0,00

120,56 0,01

155,12 0,24

128,19 –

HCI F. No. 3

– 0,00

56,24 0,00

– 0,00

85,44 0,00

102,70 0,00

71,70 0,00

HCI F. No. 3

– 0,00

5,75 0,00

– 0,00

87,63 0,00

8,33 0,00

86,40 –

HCI F. No. 3

– 0,00

106,13 0,00

1,93 0,00

139,09 0,12

109,45 0,12

164,97 –

HCI F. No. 3

– 0,00

– 0,51

– 4,70

29,32 0,50

2,45 0,00

11,04 –

HCI F. No. 3

– 0,00

89,65 0,00

– 0,13

81,95 24,30

79,17 55,94

118,02 0,00

HCI F. No. 3

– 0,00

52,68 0,00

– 0,08

1,60 0,60

25,65 1,19

24,37 1,45

HCI F. No. 3

– –

23,34 –

– –

52,90 –

58,60 –

23,40 –

HCI F. No. 3

– 15,61

2329,37 43,261

– 106,51

2916,74 311,71

2561,12 1027,09

2280,57 2488,79

HCI F. No. 3

data from substitution therapy sites is not included

56

ANNEX 8 METHADONE CONSUMPTION

in grams

2011

2012

2013

2014

2015

2016

– 0,00

– 0,00

– 0,00

5870,50 0,00

1 741,00 0,00

5029,54 0,00

HCI F. No. 3

– –

1583,65 –

– –

2325,24 –

3 077,96 –

3233,28 –

HCI F. No. 3

– 0,00

23210,43 0,00

– 0,00

29090,01 0,00

29 390,84 0,00

4774,77 0,00

HCI F. No. 3

– –

12244,98 –

– –

– –

1 929,55 –

14452,97 –

HCI F. No. 3

– 0,00

1465,00 0,00

– 0,00

1 932,72 0,00

3 220,15 0,00

5125,27 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

680,82 0,00

3 182,51 0,00

806,45 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

3 323,23 0,00

18 429,55 0,00

9150,77 0,00

HCI F. No. 3

– –

3516,50 –

– –

4 126,83 –

3 757,52 –

4496,65 –

HCI F. No. 3

– 0,00

13614,56 0,00

– 0,00

301 587,92 0,00

9 806,73 0,00

9680,67* 2742,30

HCI F. No. 3

– 0,00

1914,45 0,00

– 0,00

2 345,57 0,00

1 295,77 0,00

3198,46* 0,00

HCI F. No. 3

– 0,00

3867,25 0,00

– 0,00

– 0,00

7 473,35 0,00

8140,53 0,00

HCI F. No. 3

– –

– –

– –

– –

30 501,26 –

5137,46 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

3 377,20 0,00

8 301,52 0,00

7335,74 0,00

HCI F. No. 3

– 0,00

11348,55 0,00

– 0,00

16 783,34 0,00

16022,35 0,00

32753,14 0,00

HCI F. No. 3

– 0,00

– 0,00

– 0,00

1 001,83 0,00

5 841,72 0,00

9333,26 0,00

HCI F. No. 3

– –

5926,50 0,00

– 0,00

12 085,16 0,00

15 210,81 0,00

14585,03 0,00

HCI F. No. 3

– 0,00

326,80 0,00

– 0,00

82 205,79 0,00

61 238,90 0,00

2633,20 176,00

HCI F. No. 3

57

ANNEX 8 METHADONE CONSUMPTION

*

in grams

2011

2012

2013

2014

2015

2016

– 0,00

3657,95 0,00

– 0,00

6 555,48 0,00

8 827,66 0,00

8666,03 –

HCI F. No. 3

– 0,00

3006,04 0,00

– 0,00

1 372,19 0,00

3 251,51 0,00

5989,34 0,00

HCI F. No. 3

– 0,00

1603,26 0,00

– 0,00

18 187,34 0,00

63 695,46 0,00

17157,22 –

HCI F. No. 3

– 0,00

3701,55 0,00

0 0,00

4 974,58 0,00

4 169,67 0,00

8655,08 –

HCI F. No. 3

– 0,00

– 0,00

– 0,00

16 604,74 0,00

11 701,12 0,00

25 506,06 0,00

HCI F. No. 3

– 0,00

1940,37 0,00

– 0,00

3 180,69 0,00

2 949,28 0,00

4825,32 0,00

HCI F. No. 3

– 0,00

1311,50 0,00

– 0,00

4,18 0,00

13 668,80 0,00

1427,18 0,00

HCI F. No. 3

– –

3766,60 –

– –

3 285,25 –

4 236,00 –

3528,47 –

HCI F. No. 3

– 0,00

98005,90 0,00

– 0,00

520900,57 0,00

332920,94 0,00

215621,85 2918,30

HCI F. No. 3

data from substitution therapy sites is not included

58

ACKNOWLEDGEMENTS

The present report provides information on dispensing of narcotic drugs by pharmacies with the use of prescription Form No. 3 (F. NO. 3) within the period of 2011 – 2016. In the context of the above mentioned it is important to understand whether Ukrainian citizens have access to opioid analgesics as prescription drugs dispensed at a pharmacy.

Pharmacies sell medicinal products to citizens as well as to medical and preventive treatment facilities.

At the very same time the current regulatory framework does not require pharmacies to report on the volumes of their sales of narcotic drugs to medical and preventive treatment facilities and citizens separately. They highlight total amounts in the reports submitted to the State Service for Medicines and 18 Drugs Control .

Specialists of NGO Institute of Analysis and Advocacy generated information requests to every pharmaceutical enterprise, holding a license for dispensing of narcotic drugs in Ukraine. Within the period of the study analysts have submitted about 300 requests, asking to provide information on dispensing of prescription opioid analgesics.

IAA analysts received the most diverse answers. While some pharmacies refused to provide information, other submitted all the necessary data. This being the case IAA expresses gratitude to 67 pharmacy enterprises out of 282, which took the time and responded to the research requests. This is a big step towards the development of palliative care and accessible pain management in Ukraine. The Annex 1 contains a list of pharmacy enterprises which provided the necessary information.

Special gratitude of NGO Institute of Analysis and Advocacy goes to the State Service for Medicines and Drugs Control, State agency Centre for Mental Health and Monitoring of Drugs and Alcohol of the Ministry of Health of Ukraine, as well as Poltavapharm poltava oblast public enterprise for active cooperation in the course of the study.

18

Resolution of the Cabinet of Ministers of Ukraine No. 589 as of June 03, 2009 On Approval of the Procedure of Activity Connected with Circulation of Narcotic and Psychotropic Substances, their Analogs and Precursors, and Control of their Circulation

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Resolution of the Cabinet of Ministers of Ukraine No. 333 as of May 13, 2013 On Approval of the Procedure for Acquisition, Transportation, Storage, Dispensing, Use and Destruction of Narcotic Drugs, Psychotropic Substances and Precursors in Health Care Institutions: zakon2.rada.gov.ua/laws/show 7. Resolution of the Cabinet of Ministers of Ukraine No. 770 as of May 06, 2000 On Approval of the List of Narcotic and Psychotropic Substances, and Precursors: zakon3.rada.gov.ua/laws/show 8. Resolution of the Cabinet of Ministers of Ukraine No. 647 as of August 12, 2015 On Approval of the Regulation for the State Service of Ukraine on Medicines and Drugs Control: zakon3.rada.gov.ua/laws/show 9. Resolution of the Cabinet of Ministers of Ukraine No. 1071 as of September 05, 1996 On the Procedure for the Procurement of Medicines by Health Care Institutions and Facilities Financed from the Budget: zakon2.rada.gov.ua/laws/show 10. 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Rokhanskyi; Institute for Legal Studies and Strategies NGO. – Kharkiv, 2017. – 123 p.: www.irf.ua/content/files/nekontrolyuvany_bil 26. Increasing Patient Access to Pain Medicines around the World: A Framework to Improve National Policies that Govern Drug Distribution. Pain & Policy Studies Group. University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, 2008; 27. Guide on Estimating Requirements for Substances under International Control. Developed by the International Narcotics Control Board and the World Health Organization for use by Competent National Authorities. – New York: United Nations, 2012. – 43 p; 28. A first comparison between the consumption of and the need for opioid analgesics at country, regional, and global levels / M. Seya, S. Gelders, O. Achara [et al.]//Journal of Pain & Palliative Care Pharmacotherapy. – 2011. – No. 25 (1). – P. 6–18.

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