Troškovi i potrošnja analgetika, sa specijalnim osvrtom na opijate u Srbiji i Crnoj Gori od 2015. do 2019.
Sažetak
Uvod/Cilj. Pacijenti u zemljama u razvoju nemaju uvek adekvatan tretman za ublažavanje bolova. Praćenje potrošnje analgetika je od velike važnosti, jer može pomoći u proceni kvaliteta upravljanja terapijom bolnih stanja. Cilj rada bio je da predstavi petogodišnju potrošnju i troškove lekova sa analgetskim dejstvom u zemljama u razvoju, na primerima Srbije i Crne Gore, i ukaže na glavne razloge njihovog (ne)adekvatnog propisivanja. Metode. Opservaciona, retrospektivna studija preseka sprovedena je kako bi se analizirala potrošnja svih analgetika, opioidnih i neopioidnih, u Srbiji i Crnoj Gori kao zemljama u razvoju. Podaci koji se odnose na potrošnju lekova i nastale troškove korišćeni su iz publikacija koje svake godine izdaju naconalne agencije za lekove i medicinska sredstva Srbije i Crne Gore. U okviru ovih publikacija korišćena je metodologija Svetske zdravstvene organizacije sa definisanom dnevnom dozom (DDD) kao jedinicom mere (broj DDD na 1000 stanovnika na dan). Rezultati. Tokom petogodišnjeg perioda (od 2015. do 2019. godine) ukupna izdvajanja za terapiju analgeticima u Srbiji pokazala su trend porasta (od oko 43,6 miliona na 63,3 miliona evra), dok su troškovi u Crnoj Gori varirali na godišnjem nivou, sa najvišim vrednostima 2018. godine. Najveći deo sredstava u obe zemlje bio je investiran u lekove grupe M01A, za koje je ujedno pokazana i najveća potrošnja. Značajno viša potrošnja opioidnih analgetika u Crnoj Gori, u poređenju sa Srbijom, zapažena je u ovom periodu i ona prevashodno odražava razlike u propisivanju fentanila (N02AB03, transdermalni flaster). U Crnoj Gori potrošnja lekova iz grupe M01AB bila je značajno viša u poređenju sa potrošnjom iz grupe M01AE u toku celog petogodišnjeg perioda, slično kao i u Srbiji, gde to nije bio slučaj samo u 2018. godini. Zaključak. Uzimajući u obzir značaj analgetika kao grupe lekova za svakodnevnu lekarsku praksu, neophodno je njihovo racionalnije propisivanje i u Srbiji i u Crnoj Gori u budućem periodu.
Reference
1. Cousins MJ, Brennan F, Carr DB. Pain relief: a universal human right. Pain 2004; 112(1‒2): 1‒4.
2. Seya MJ, Gelders SF, Achara OU, Milani B, Scholten WK. A first comparison between the consumption of and the need for opioid analgesics at country, regional, and global levels. J Pain Palliat Care Pharmacother 2011; 25(1): 6‒18.
3. Bond M. Pain education issues in developing countries and responses to them by the International Association for the Study of Pain. Pain Res Manag 2011; 16(6): 404‒6.
4. World Health Organization. WHO model lists of essential medicines. 22nd List (2021). Available from: https://www.who.int
/>/publications/i/item/WHO-MHP-HPS-EML-2021.02.
5. Connor SR, Sepulveda Bermedo MC. Global atlas of palliative care at the end of life. 2nd ed. Geneva: World Health Organization; 2014.
6. De Lima L, Sweeney C, Palmer JL, Bruera E. Potent analgesics are more expensive for patients in developing countries: a comparative study. J Pain Palliat Care Pharmacother 2004; 18(1): 59‒70.
7. Cleary J, Powell RA, Munene G, Mwangi-Powell FN, Luyirika E, Kiyange F, et al. Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Africa: a report from the Global Opioid Policy Initiative (GOPI). Ann Oncol 2013; 24(Suppl 11): xi14‒23.
8. Miljković M, Rančić N, Dragojević Simić V. Over-the-counter medications: the current position of nonsteroidal anti-inflammatory drugs. BOL Bilten udruženja za istraživanje i tretman bola Srbije 2014; 6: 7‒13. (Serbian)
9. Ogura S, Jakovljević M. Health financing constrained by population aging: An opportunity to learn from Japanese experience. Ser J Exp Clin Res 2014; 15(4): 175‒81.
10. Prostran M, Vujović KS, Vučković S, Medić B, Srebro D, Divac N, et al. Pharmacotherapy of Pain in the Older Population: The Place of Opioids. Front Aging Neurosci 2016; 8: 144.
11. Wiffen PJ, Derry S, Moore RA. Impact of morphine, fentanyl, oxycodone or codeine on patient consciousness, appetite and thirst when used to treat cancer pain. Cochrane Database Syst Rev 2014; 2014(5): CD011056.
12. Pjević M. Pain: Brief facts about chronic non-cancerous and cancerous pain. 2013. Available from: http://uitbs.org.rs/wp-content/uploads/2017/11/bol_brosura1.pdf style="mso-spacerun: yes;"> (Serbian)
13. Geppetti P, Benemei S. Pain treatment with opioids: achieving the minimal effective and the minimal interacting dose. Clin Drug Investig 2009; 29(Suppl 1): 3‒16.
14. World Bank. How to classify countries. Available from: http://data.worldbank.org/about/country-classifications
15. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index. 2016. Available from: http://www.who
/>cc.no/atc_ddd_index/
16. Ugrešic N. Pharmacotherapeutic Guide 5. Belgrade: Medicines and Medical Devices Agency of Serbia; 2011.
17. World Health Organization. The ATC/DDD Methodology. Available from: https://www.who.int/tools/atc-ddd-toolkit
/>/methodology
18. Ministry of health of the Republic of Serbia. The highest prices of medicines. Available from: https://www.zdravlje.gov.rs/
19. Agency for Medicinal Products and Medical Devices of Croatia, HALMED. 2021. Available from: https://www.hal
/>med.hr/Promet-proizvodnja-i-inspekcija/Promet/Potrosnja-lijekova/Izvjesca-o-prometu-lijekova/
20. Bosetti C, Santucci C, Radrezza S, Erthal J, Berterame S, Corli O. Trends in the consumption of opioids for the treatment of severe pain in Europe, 1990-2016. Eur J Pain 2019; 23(4): 697‒707.
21. Rančić N, Stamenković D, Dragojević-Simić V. Opioid analgesic consumption in Serbia during two years period (opioid analgesic consumption in Serbia). SJAIT 2016; 38(5–6): 145–53.
22. Patarica-Huber E, Boškov N. Hurdles in successful treatment of cancer pain caused by primary healthcare. Arch Oncol 2010; 18(3): 65‒70.
23. Krnic D, Anic-Matic A, Dosenovic S, Draganic P, Zezelic S, Puljak L. National consumption of opioid and nonopioid analgesics in Croatia: 2007-2013. Ther Clin Risk Manag 2015; 11: 1305‒14.
24. Berterame S, Erthal J, Thomas J, Fellner S, Vosse B, Clare P, et al. Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study. Lancet 2016; 387(10028): 1644‒56.
25. Vranken MJ, Linge-Dahl L, Mantel-Teeuwisse AK, Radbruch L, Schutjens MD, Scholten W, et al. The perception of barriers concerning opioid medicines: A survey examining differences between policy makers, healthcare professionals and other stakeholders. Palliat Med 2020; 34(4): 493‒503.
26. Duthey B, Scholten W. Adequacy of opioid analgesic consumption at country, global and regional level in 2010, its relation to development level and changes compared to 2006. J Pain Symptom Manage 2014; 47(2): 283‒97.
27. Ylinen S, Hämeen-Anttila K, Sepponen K, Lindblad AK, Ahonen R. The use of prescription medicines and self-medication among children - a population-based study in Finland. Pharmacoepidemiol Drug Saf 2010; 19(10): 1000‒8.
28. World Health Organization. ATC/DDD Index 2012. 2012. Available from: http:// www.whocc.no/atc_ddd_index/
29. World Health Organization. Fact sheet number 325. Medicines: essential medicines. 2010. Available from: http://www.who.
/>int/mediacentre/factsheets/fs325/en/ index.html
30. De Lima L, Pastrana T, Radbruch L, Wenk R. Cross-sectional pilot study to monitor the availability, dispensed prices, and affordability of opioids around the globe. J Pain Symptom Manage 2014; 48(4): 649‒59.e1.
31. Dragojevic-Simic V, Rancic N, Stamenkovic D, Simic R. Utilization of Parenteral Morphine by Application of ATC/DDD Methodology: Retrospective Study in the Referral Teaching Hospital. Front Public Health 2017; 5: 232.
32. De Lima L, Arias Casais N, Wenk R, Radbruch L, Pastrana T. Opioid Medications in Expensive Formulations Are Sold at a Lower Price than Immediate-Release Morphine in Countries throughout the World: Third Phase of Opioid Price Watch Cross-Sectional Study. J Palliat Med 2018; 21(10): 1458‒65.
33. Persaud N, Jiang M, Shaikh R, Bali A, Oronsaye E, Woods H, et al. Comparison of essential medicines lists in 137 countries. Bull World Health Organ 2019; 97(6): 394‒404C.
34. World Health Organization. Essential medicines selection. 2012. Available from: http://www.who.int/selection_medicines/cou
/>ntry_lists/en/index.html
35. Miljkovic M, Dragojevic-Simic V, Rancic N, Simic R, Pekez-Pavlisko T, Kovacevic A, et al. Metamizole Utilization and Expenditure During 6-Year Period: Serbia vs. Croatia. Front Public Health 2018; 6: 213.
36. de Leeuw TG, Dirckx M, Gonzalez Candel A, Scoones GP, Huygen FJPM, de Wildt SN. The use of dipyrone (metamizol) as an analgesic in children: What is the evidence? A review. Paediatr Anaesth 2017; 27(12): 1193‒201.
37. Mijatović V, Calasan J, Horvat O, Sabo A, Tomić Z, Radulović V. Consumption of non-steroidal anti-inflammatory drugs in Serbia: a comparison with Croatia and Denmark during 2005-2008. Eur J Clin Pharmacol 2011; 67(2): 203‒7.
38. Schmidt M, Sørensen HT, Pedersen L. Diclofenac use and cardiovascular risks: series of nationwide cohort studies. BMJ 2018; 362: k3426.
39. European Medicines Agency. Assessment report for diclofenac containing medicinal products (systemic formulations). European Medicines Agency, 2013. Available from: https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-prac-assessment-report_en.pdf
40. Morales DR, Morant SV, MacDonald TM, Mackenzie IS, Doney ASF, Mitchell L, et al. Impact of EMA regulatory label changes on systemic diclofenac initiation, discontinuation, and switching to other pain medicines in Scotland, England, Denmark, and The Netherlands. Pharmacoepidemiol Drug Saf 2020; 29(3): 296‒305.
41. Calasan J, Mijatović V, Horvat O, Varga J, Sabo A, Stilinović N. The outpatient utilization of non-steroidal anti-inflammatory drugs in South Bačka District, Serbia. Int J Clin Pharm 2011; 33(2): 246‒51.
42. Curtis E, Fuggle N, Shaw S, Spooner L, Ntani G, Parsons C, et al. Safety of Cyclooxygenase-2 Inhibitors in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis. Drugs Aging 2019; 36(Suppl 1): 25‒44.
43. Celecoxib 200mg capsules. Summary of product characteristics. Available from: https://www.medicines.org.uk/emc/
/>product/2116/smpc#gref
44. Gilson AM, Maurer MA, Lebaron VT, Ryan KM, Cleary JF. Multivariate analysis of countries' government and health-care system influences on opioid availability for cancer pain relief and palliative care: more than a function of human development. Palliat Med 2013; 27(2): 105‒14.
45. World Health Organization. The Selection and Use of Essential Medicine. WHO Technical Report Series 1021. 2019. Available from: https://www.who.int/publications/i/item/WHOMVP
/>EMPIAU2019.06