The use of opioid analgesics in palliative care in Ukraine: Changes in legislation and availability
, 1
Abstract
Introduction: The main task of palliative care is to improve the quality of life of a patient, and the therapy
of chronic pain with opioids is a significant problem for palliative care patients in Ukraine. Therefore,
this study aimed to assess the opioid availability for palliative care patients in Ukraine.
Methods: Analysis of the list and consumption of opioids according to the scientific publications and
legal documents.
Results: It was found that in Ukraine as of June 2021, 12 international non-proprietary names of opioids
were registered, most of which are represented by several dosage forms, which makes it possible for
patients to receive adequate pain relief through non–invasive therapy with oral forms. It was shown
that two thirds (63.2%) of trade names of opioids registered in Ukraine were of domestic origin. Based
on a comparative analysis of the range of opioids, available in current regulatory documents, it was
established that in the State Register of Medicines of Ukraine and the Unified clinical protocol there is
an almost identical list of opioids (12 drugs). However, in the State Drug Formulary and the National
List of Essential Medicines, this list is much smaller (8 and 5 drugs, respectively). Since 2013 changes in
the regulatory documents on the medical use of opioids in Ukraine have occurred, and oral morphine
was registered for the first time, allowing access to adequate pain relief. Analysis of the morphine consumption
level by dosage forms has shown that before 2013, the pharmacies sold only morphine in
injections, and since 2013, the consumption of oral morphine increased.
Conclusions: Changes in regulatory documents partially simplified the complicated process of obtaining
opioids by patients. However, more than 80% of patients still do not receive adequate pain therapy due
to the hesitancy of doctors to prescribe opioids and an extremely insufficient number of pharmacies
(1.8%) that sell opioids for the population.
Keywords: palliative carepalliative care patientchronic painopioid analgesicsrangeregulatory document
References
- Order of the Ministry of Health of Ukraine № 1308 «On improving the organization of palliative care in Ukraine» [Internet] dated 04.06.2020. https://zakon.rada.gov.ua/laws/show/z0609-20#Text. (8 September 2021).
- Order of the Ministry of Health of Ukraine № 311 «On approval and introduction of medical and technical documents to standardize palliative medical care for chronic pain syndrome» [Internet] dated 25.04.2012. https://zakon.rada.gov.ua/rada/show/v0311282-12#Text (8 September 2021).
- WHO guidelines for the pharmacological and radiotherapeutic management of cancer pain in adults and adolescents [Internet]. https://apps.who.int/iris/bitstream/handle/10665/279700/9789241550390-eng.pdf. (8 September 2021).
- Fallon M, Giusti R, Aielli F, et al. ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org, ESMO Guidelines Committee. Management of cancer pain in adult patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2018; 29(Suppl 4): iv166–iv191.
- Caraceni A, Hanks G, Kaasa S, et al. European Palliative Care Research Collaborative (EPCRC), European Association for Palliative Care (EAPC). Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol. 2012; 13(2): e58–e68.
- Yang J, Bauer BA, Wahner-Roedler DL, et al. The Modified WHO Analgesic Ladder: Is It Appropriate for Chronic Non-Cancer Pain? J Pain Res. 2020; 13: 411–417.
- Medical Care Standard "Mental and Behavioral Disorders Due to Opioid Use". Order of the Ministry of Health of Ukraine № 2555 dated 09.11.2020 [Internet]. https://www.dec.gov.ua/mtd/psyhichni-ta-povedinkovi-rozlady-syndrom-zalezhnosti-vnaslidok-vzhyvannya-opioyidyiv/. (8 September 2021).
- International Statistical Classification of Diseases and Related Health Problems 10th Revision [Internet]. https://icd.who.int/browse10/2019/en. (20 December 2021).
- International Narcotics Control Board. Yellow List: List of Narcotic Drugs Under International Control [Internet]. https://www.incb.org/incb/en/narcotic-drugs/Yellowlist/yellow-list.html. (20 December 2021).
- Nadeau S, Wu J, Lawhern R. Opioids and Chronic Pain: An Analytic Review of the Clinical Evidence. Frontiers in Pain Research. 2021(2): 1–15.
- Vowles KE, McEntee ML, Julnes PS, et al. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015; 156(4): 569–576.
- State Register of Medicines of Ukraine [Internet]. http://www.drlz.com.ua. (8 September 2021).
- Resolution of the Cabinet of Ministers of Ukraine № 333 from 25.03.2009 «On some issues of state regulation of prices for medicines and medicinal products» [Internet] [cited 2021 Sep 8]. Available from: https://zakon.rada.g. https://zakon.rada.gov.ua/laws/show/333-2009-%D0%BF#n15. (8 September 2021).
- State Expert Center of the Ministry of Health of Ukraine. Archive of orders on approval of the State Drug Formulary of Ukraine [Internet]. https://www.dec.gov.ua/materials/arhiv-nakaziv-pro-zatverdzhennya-derzhavnogo-formulyara-likarskih-zasobiv/?role=applicant. (8 September 2021).
- Order of the Ministry of Health of Ukraine dated 22.04.2021 № 792 "On approval of the 13th issue of the State Drug Formulary and ensuring its availability" [Internet] . https://www.dec.gov.ua/materials/chinnij-vipusk-derzhavnogo-formulyara-likarskih-zasobiv/?role=applicant. (8 September 2021).
- The analytical report. The opioid consumption in Ukraine [Internet]. http://budgetadvocacy.ua/wp-content/uploads/2018/12/opium-2011-2016-final.pdf. (18 December 2021).
- Order of the Ministry of Health of Ukraine dated 01.02.2013 № 77 «About the state registration (re-registration) of medicines and modification of registration materials» [Internet]. https://zakon.rada.gov.ua/rada/show/v0077282-13#Text. (8 September 2021).
- World Standards for Cancer Pain Management. Health of Ukraine. Thematic issue Oncology, Hematology, Chemotherapy. 2021; 4 (71): 52–53. https://health-ua.com/multimedia/6/7/2/0/3/1638534804.pdf. (20 December 2021).
- The WHO Model List of Essential Medicines. 22nd List (2021) [Internet] . https://apps.who.int/iris/bitstream/handle/10665/345533/WHO-MHP-HPS-EML-2021.02-eng.pdf. (20 December 2021).
- IAHPC List of Essential Medicines for Palliative Care [Internet] . https://hospicecare.com/what-we-do/projects/palliative-care-essentials/iahpc-essential-medicines-for-palliative-care/. (20 December 2021).
- State Service of Ukraine on Medicines and Drugs Control [Internet]. https://www.dls.gov.ua/. (3 January 2022).
- Shunkina S, Hromovyk B, Dorykevych K, et al. Access to opioid analgesics for palliative care patients in Ukraine: problems of past and present. Palliative Medicine in Practice. 2020; 13(4): 187–196.
- Knaul F, Farmer P, Krakauer E, et al. Alleviating the access abyss in palliative care and pain relief—an imperative of universal health coverage: the Lancet Commission report. The Lancet. 2018; 391(10128): 1391–1454.
