pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2019-7-4-215-223pmedpharm-427Research ArticleФАРМАКОЛОГИЯ И КЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯPHARMACOLOGY AND CLINICAL PHARMACOLOGYПРИМЕНЕНИЕ СИСТЕМЫ ПРОБЛЕМ, СВЯЗАННЫХ С ЛЕКАРСТВЕННЫМИ ПРЕПАРАТАМИ (DRUG-RELATED PROBLEMS), НА ПРИМЕРЕ ГРУППЫ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ СРЕДСТВAPPLICATION OF DRUG-RELATED PROBLEMS APPROACH TO ANALYSIS OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS’ SAFETYhttps://orcid.org/0000-0002-6636-3950МатвеевА. В.MatveevA. V.

кандидат медицинских наук, доцент кафедры внутренней медицины №1 с курсом клинической фармакологии Медицинской академии им. С.И. Георгиевского ФГАОУ ВО «КФУ им. В. И. Вернадского»; исполнительный директор АНО «Национальный научный центр фармаконадзора»

PhD (Medicine), docent of the Department of Internal Medicine No.1 with the course of Clinical Pharmacology of Medical Academy n.a. S.I. Georgievsky of Vernadskjy CFU; executive director of ANO “National Pharmacovigilance Research Center”

avmcsmu@gmail.comhttps://orcid.org/0000-0002-7791-6071КрашенинниковА. Е.KrasheninnikovA. E.

кандидат фармацевтических наук, генеральный директор

PhD (Pharmacy), CEO

anatoly.krasheninnikov@drugsafety.ruhttps://orcid.org/0000-0003-4012-2523ЕгороваЕ. А.EgorovaE. A.

кандидат фармацевтических наук, ассистент кафедры внутренней медицины №1 с курсом клинической фармакологии

PhD (Pharmacy), assistant of the Department of Internal Medicine No.1 with the course of Clinical Pharmacology

elena212007@rambler.ruКоняеваЕ. И.KonyaevaE. I.

кандидат медицинских наук, доцент кафедры внутренней медицины №1 с курсом клинической фармакологии

PhD (Medicine), docent of the Department of Internal Medicine No.1 with the course of Clinical Pharmacology

konyaeva.simferopol@gmail.comАвтономная некоммерческая организация «Национальный научный центр Фармаконадзора»; Медицинская академия им. С.И. Георгиевского ФГАОУ ВО «КФУ им. В.И. Вернадского»РоссияNational Pharmacovigilance Research Center; Medical Academy n. a. S.I. Georgievsky of Vernadskjy CFURussian FederationАвтономная некоммерческая организация «Национальный научный центр Фармаконадзора»РоссияNational Pharmacovigilance Research CenterRussian FederationМедицинская академия им. С.И. Георгиевского ФГАОУ ВО «КФУ им. В.И. Вернадского»РоссияMedical Academy n. a. S.I. Georgievsky of Vernadskjy CFURussian Federation20191009201974215223Copyright © Матвеев А.В., Крашенинников А.Е., Егорова Е.А., Коняева Е.И., 20192019Матвеев А.В., Крашенинников А.Е., Егорова Е.А., Коняева Е.И.Matveev A.V., Krasheninnikov A.E., Egorova E.A., Konyaeva E.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/427

Проблемы, связанные с лекарственными препаратами (drug-related problems, DRP), – это события или изменения, связанные с фармакотерапией, которые реально или потенциально препятствуют достижению желаемых результатов в процессе лечения.

Цель – анализ случаев нежелательных реакций (НР) на препараты группы нестероидных противовоспалительных средств (НПВС) с помощью квалификационной системы DRP PCNE V5.01.

Материалы и методы

Материалы и методы. Объектами исследования стали 415 карт-извещений о нежелательных реакциях НПВС, зарегистрированные в региональной базе спонтанных сообщений ARCADe (Adverse Reactions in Crimea, Autonomic Database) за период 2009–2018 гг. Изучение и анализ проблем, связанных с лекарственными препаратами, проводился с использованием квалификационной системы DRP PCNE V5.01 (Pharmaceutical Care Network Europe) 2006 г. в модификации А.Б. Зименковского.

Результаты

Результаты. «Лидерами» по частоте развития НР среди отдельных представителей группы НПВС стали препараты ибупрофен и диклофенак. Частота встречаемости случаев НР для ибупрофена составила 142 случая (34,22% от всего количества случаев НР на НПВС), а для диклофенака – 90 случаев (21,69%). Расчет значений DRP для каждого из представленных случаев НР позволил определить, что в 81 (19,51%) и 91 (21,9%) случае значение DRP было равно 6 и 7 соответственно. Значения DRP в пределах значений 8–10 встречались в 92 случаях. Наиболее высокие значения DRP наблюдались при назначении парекоксиба– 13 проблем (зарегистрирован 1 случай), декскетопрофена – 12,5 DRP (95% ДИ: 7–17) и комбинированных препаратов, содержащих диклофенак – 10 DRP (95% ДИ: 5–17 DRP). Минимальные значения DRP были выявлены при назначении напроксена, рофекоксиба и эторикоксиба.

Заключение

Заключение. Использование системы проблем, связанных с лекарственными препаратами (DRP), для проведения анализа нежелательных реакций препаратов группы НПВС позволило выделить отдельных представителей группы, обладающих высоким риском развития неблагоприятных последствий при их применении в практической медицине. Среди таких препаратов стоит отметить парекоксиб, декскетопрофен и комбинированные препараты, содержащие диклофенак. Назначение представленных выше препаратов должно проводиться со строгим учетом показаний и противопоказаний к применению, дозы и курса лечения, а также вероятности возможного взаимодействия этих препаратов с сопутствующими лекарственными средствами.

A Drug-Related Problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes.

The aim of the study was the analysis of the adverse drug reactions (ADR) associated with prescription of the non-steroidal anti-inflammatory drugs (NSAIDs) using the DRP PCNE V5.01 qualification system.

Materials and methods

Materials and methods. The objects of the study were 415 notification forms about adverse drug reactions of NSAIDs recorded in the regional database of spontaneous reports and called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 1 January 2009 to 31 December of 2018. The study and analysis of the problems associated with drugs were carried out using the qualification system DRP PCNE V5.01 (Pharmaceutical Care Network Europe) 2006 in the modification of Prof. Zimenkovsky.

Results

Results. Among other representatives of the NSAID group, Ibuprofen and Diclofenac became the “leaders” in the incidence of ADR. The frequency of ADR cases for Ibuprofen was 142 reports (34.22% of the total number of ADR for NSAIDs), and for Diclofenac it was 90 cases (21.69%). The calculation of DRP values for each of the presented cases made it possible to determine that in 81 (19.51%) and 91 (21.9%) cases, the DRP value was 6 and 7, respectively. DRP values in the range of 8–10 were found in 92 reports. The highest DRPs value was observed after the administration of Parecoxib (13 problems but only one case was found in the database), the DRPs value of Dexketoprofen was 12.5 (95% CI: 7–17) and the DRPs value of Diclofenac combinations was 10 DRPs; 95% CI: 5–17 DRP). The minimum DRPs values were associated with Naproxen, Rofecoxib, and Etoricoxib prescriptions.

Conclusion

Conclusion. Using the DRP system in the analysis of NSAIDs, ADRs allow to identify the medicines which have a high risk of causing safety problems, such as Parecoxib, Dexketoprofen and Diclofenac combinations. The prescription of these drugs should be carried out with special cautions and control to the indications and contraindications, the dose and duration of treatment, as well as to a possible interaction of them with concomitant drugs.

проблемысвязанные с лекарственными препаратамиDRPнестероидные противовоспалительные средстваdrug-related problems (DRPs)non-steroidal anti-inflammatory drugs (NSAIDs)adverse drug reactions (ADRs)Данное исследование не имело какой-либо финансовой поддержки от сторонних организаций.This study did not have any financial support from third parties.ReferencesBinu K.M., Nimmy N.J., Varghese G.P. A survey of Drug related problems identified by community pharmacy in South India // International Journal of Pharmaceutical, chemical and biological sciences. – 2012. – Vol. 2, №2. – P. 368–374.Binu K, Nimmy NJ, Varghese GP. A survey of Drug related problems identified by community pharmacy in South India. International Journal of Pharmaceutical, chemical and biological sciences. 2012;2(2):368–374.van Mil J.W., Westerlund L.O., Hersberger K.E., Schaefer M.A. Drug-related problem classification systems // Ann Pharmacother – 2004. – Vol. 38, №5. – P. 859–67.van Mil JW, Westerlund LO, Hersberger KE, Schaefer MA. Drug-related problem classification systems. Ann Pharmacother. 2004;38(5):859–67.Roberts M.S., Stokes J.A., King M.A., Lynne T.A., Purdie D.M., Glasziou P.P., Wilson D.A., McCarthy S.T., Brooks G.E., de Looze F.J., Del Mar C.B. Outcomes of a randomized controlled trial of a clinical pharmacy intervention in 52 nursing homes // Br J Clin Pharmacol. – 2001. – Vol. 51. – P. 257–265.Roberts MS, Stokes JA, King MA, Lynne TА, Purdie DM, Glasziou PP, et al. Outcomes of a randomized controlled trial of a clinical pharmacy intervention in 52 nursing homes. Br J Clin Pharmacol. 2001;51:257–265.Shareef J., Sandeep B., Shastry C.S. Assessment of Drug related problems in patients with cardiovascular diseases in a Tertiary care teaching hospital // Journal of Pharmaceutical Care. – 2014. – Vol. 2, №2. – P. 71–76.Shareef J, Sandeep B, Shastry CS. Assessment of Drug related problems in patients with cardiovascular diseases in a Tertiary care teaching hospital. Journal of Pharmaceuti-cal Care.2014;2(2):71–76.Adepu R., Adusumilli P.K. Assessment of Drug related problems in patients with chronic diseases through Health Status Survey in a South Indian Rural Community setting // Indian J Pharm Sci. – 2016. – Vol. 78, №4. – P. 537–542.Adepu R, Adusumilli PK. Assessment of Drug related problems in patients with chronic diseases through Health Status Survey in a South Indian Rural Community setting. Indian J Pharm Sci. 2016;78(4):537–542.Eichenberger P.M., Lambert M.L., Kahmann I.V., van Mil J.W., Hersberger K.E. Classification of drug-related problems with new prescriptions using a modified PCNE classification system // Pharmacy World & Science. – 2010. – Vol. 3, №32. – P. 362–372. doi: 10.1007/s11096-010-9377-x.Eichenberger PM, Lambert ML, Kahmann IV, van Mil JW, Hersberger KE. Classification of drug-related problems with new prescriptions using a modified PCNE classification system. Pharmacy World & Science.2010;3(32):362–372.Pfister B., Jonsson J., Gustafsson M. Drug-related problems and medication reviews among old people with dementia // BMC Pharmacol Toxicol. – 2017. – № 8. – P. 52. doi: 10.1186/s40360-017-0157-2.Pfister B, Jonsson J, Gustafsson M. Drug-related problems and medication reviews among old people with dementia. BMC Pharmacol Toxicol. 2017;8:52. doi:10.1186/s40360-017-0157-2.Fog A.F., Kvalvaag G., Engedal K., Straand J. Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway // Scand J Prim Health Care. – 2017. – Vol. 35, №4. – 329–335. doi: 10.1080/02813432.2017.1397246.Fog AF, Kvalvaag G, Engedal K, Straand J. Drug-related problems and changes in drug utilization aſter medication reviews in nursing homes in Oslo, Norway. Scand J Prim Health Care. 2017;35(4):329-335. doi:10.1080/02813432 .2017.1397246.Hong K., Hong Y.D., Cooke C.E. Medication errors in community pharmacies: The need for commitment, transparency, and research // Res Social Adm Pharm. – 2019. – Vol. 15, №7. – P. 823–826. doi: 10.1016/j. sapharm.2018.11.014.Hong K, Hong YD, Cooke CE. Medication errors in community pharmacies: The need for commitment, transparency, and research. Res Social Adm Pharm. 2019;15(7):823– 826. doi: 10.1016/j.sapharm.2018.11.014.Hammerlein A., Griese N., Schulz M. Survey of Drug-Related Problems Identified by Community Pharmacies // The Annals of Pharmacotherapy. – 2007. – №11. – P. 1852.Hammerlein A, Griese N, Schulz M. Survey of Drug-Related Problems Identified by Community Pharmacies. The Annals of Pharmacotherapy. 2007;11:1852.Борецька О.Б. Використання системи ліко-пов’язаних проблем (drug-related problems, DRP) для оцінки якості рецептурних призначень в аптечних закладах // Управління якістю медичної та фармацевтичної допомоги. – 2012. – №3. – С. 31–37.Boretska O.B. Vykorystannia systemy liko-poviazanykh problem (drug-related problems, DRP) dlia otsinky yakosti retsepturnykh pryznachen v aptechnykh zakladakh [Use of drug-related problems (DRP) to evaluate the quality of prescription at pharmacies]. Upravlinnia yakistiu medychnoi ta farmatsevtychnoi dopomohy. 2012;3:31–37. Ukrainian.Adusumilli P.K., Adepu R. Drug related problems: An overview of various classification systems // Asian J Pharm Clin Res. – 2014. – Vol. 7, №4. – P. 7–10.Adusumilli PK, Adepu R. Drug related problems: An overview of various classification systems. Asian J Pharm Clin Res. 2014;7(4):7–10.Wilmer C.M., Huiskes V.J.B., Natsch S., Rennings A.J.M., van den Bemt B.J.F., Bos L.M. Drug-related problems in a clinical setting: a literature review and cross-sectional study evaluating factors to identify patients at risk // European Journal of Hospital Pharmacy. – 2015. – Vol. 22, №4. – P. 229–235. Available at: https://ejhp.bmj. com/content/22/4/229.full.Wilmer CM, Huiskes VJB, Natsch S, Rennings AJM, van den Bemt BJF, Bos LM. Drug-related problems in a clinical setting: a literature review and cross-sectional study evaluating factors to identify patients at risk. European Journal of Hospital Pharmacy. 2015;22(4):229–235. Available at: https://ejhp.bmj.com/content/22/4/229.full.Parthasarathi G., Ramesh M., Kumar J.K., Madaki S. Assessment of Drug Related Problems and Clinical Pharmacists’ Interventions in an Indian teaching hospital // J Pharm Pract Res. – 2003. – №33. – P. 272–274. doi: 10.1002/jppr2003334272.Parthasarathi G, Ramesh M, Kumar JK, Madaki S. Assessment of DrugRelated Problems and Clinical Pharmacists’ Interventions in an Indian teaching hospital. J Pharm Pract Res 2003; 33:272-274. doi:10.1002/jppr2003334272.Abraham R.R. Drug Related Problems and Reactive Pharmacist Interventions for inpatients Receiving Cardiovascular Drugs // IJBMSP. – 2013. – Vol. 3, №2. – P. 42–48.Abraham RR. Drug Related Problems and Reactive Pharmacist Interventions for Inpatients Receiving Cardiovascular Drugs. IJBMSP. 2013; 3(2):42–48.Krähenbühl-Melcher A., Schlienger R, Lampert M, Haschke M., Drewe J., Krähenbühl S. Drug-related problems in hospitals: a review of the recent literature // Drug Saf. – 2007. – Vol. 30, №5. – P. 379–407.Krähenbühl MA, Schlienger R, Lampert M, Haschke M, Drewe J, Krähenbühl S. Drug-related problems in hospitals: a review of the recent literature. Drug Saf. 2007;30(5):379–407.Forster A.J., Murff H.J., Peterson J.F., Gandhi T.K., Bates D.W. The incidence and severity of adverse events affecting patients after discharge from the hospital // AnnInternMed. – 2003. – Vol. 138, №3. – P. 161–7.Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients aſter discharge from the hospital. Ann Intern Med. 2003;138(3):161–7.Schlienger R.G., Luscher T.F., Schoenenberger R.A., Haefeli W.E. Academic detailing improves identification and reporting of adverse drug events // Pharm World Sci. – 1999. – Vol. 21, №3. – P. 110–5.Schlienger RG, Luscher TF, Schoenenberger RA, Haefeli WE. Academic detailing improves identification and reporting of adverse drug events. Pharm World Sci. 1999;21(3):110–5.Greeshma M., Lincy S., Maheswari E., Tharanath S., Viswam S. Identification of Drug-related problems by Clinical Pharmacist in Prescription with Polypharmacy: a prospective interventional study // J Young Pharm. – 2018. – Vol. 10, №4. – P. 460–465. doi:10.5530/ jyp.2018.10.100.Greeshma M, Lincy S, Maheswari E, Tharanath S, Viswam S. Identification of Drug-related problems by Clinical Pharmacist in Prescription with Polypharmacy: a prospective interventional study. J Young Pharm. 2018;10(4):460–465. doi:10.5530/jyp.2018.10.100.Ayalew M.B., Megersa T.N., Mengistu Y.T. Drug-related problems in medical wards of Tikur Anbessa specialized hospital, Ethiopia // J ResPharmPract. – 2015. – Vol. 4, №4. – P. 216–21. doi: 10.4103/2279-042X.167048.Ayalew MB, Megersa TN, Mengistu YT. Drug-related problems in medical wards of Tikur Anbessa specialized hospital, Ethiopia. J Res Pharm Pract. 2015;4(4):216–21.чернов А.А., Клейменова Е.Б., Сычев Д.А., Абильмажинова А.А., Яшина Л.П., Отделенов В.А., Пающик С.А. Причины геморрагических осложнений у пациентов стационара, получающих лечебные дозы антикоагулянтов // Клиническая фармакология и терапия. – 2018. – т. 27, №5. – С. 23–29. doi: 10.32756/0869-5490-2018-5-23-29.Chernov AA, Klejmenova EB, Sychev DA, Abil’mazhinova AA, Yashina LP, Otdelenov VA, Payushchik SA. Prichiny gemorragicheskih oslozhnenij u pacientov stacionara, poluchayushchih lechebnye dozy antikoagulyantov [Causes of hemorrhagic complications in hospital patients receiving therapeutic doses of anticoagulants]. Klinicheskaya farmakologiya i terapiya. 2018;27(5):23–29. DOI 10.32756/0869-5490-2018-5-23-29. Russian.Matveev A.V., Egorova E.A., Matveeva N.V., Krasheninnikov A.E., Dormidor A.G. Adverse reactions of ACE inhibitors. Retrospective analysis of spontaneous reports in local database // The New Armenian Medical Journal. – 2019. – Vol. 13, №2. – P. 10–17. doi:10.1371/journal. pone.0155385.Matveev AV, Egorova EA, Matveeva NV, Krasheninnikov AE, Dormidor AG. Adverse reactions of ACE inhibitors. Retrospective analysis of spontaneous reports in local database. The New Armenian Medical Journal. 2019; 13(2): 10–17.ATC/DDD Index 2019. Available at: https://www.whocc. no/atc_ddd_index/.ATC/DDD Index 2019. Available at: https://www.whocc. no/atc_ddd_index/.Eichenberger P.M., Lampert M.L., Kahmann I.V. Classification of drug-related problems with new prescriptions using a modified PCNE classification system // Pharm World Sci. – 2010. – №32. – P. 362–372.Eichenberger PM, Lampert ML, Kahmann IV. Classification of drug-related problems with new prescriptions using a modified PCNE classification system. Pharm World Sci. 2010;32:362–372.Зіменковський А.Б., Ривак т.Б., Ханик Н.Л. Ліко-пов’язані проблеми фармакотерапії (DRP) та методологія їх оцінки і стандартизації // Раціональна фармакотерапія. – 2011. – №1–2. – С. 16–22.Zimenkovskyi A.B., Ryvak T.B., Khanyk N.L. Liko-poviazani problemy farmakoterapii (DRP) ta metodolohiia yikh otsinky i standartyzatsii [Pharmacotherapy-related pharmacotherapy (DRP) problems and methodology for their valuation and standardization]. Ratsionalna farmakoterapiia. 2011;1–2:16–22. Ukrainian.Зіменковський А.Б., Ривак т.Б., Ханик Н.Л. Концепція DRP як частина філософії раціональної фармакотерапії, інтегрованої з системою фармацевтичної опіки // Раціональна фармакотерапія. – 2011. – №1–2. – С. 23–29.Zimenkovskyi A.B., Ryvak T.B., Khanyk N.L. Kontseptsiia DRP yak chastyna filosofii ratsionalnoi farmakoterapii, intehrovanoi z systemoiu farmatsevtychnoi opiky [The concept of DRP as part of the philosophy of rational pharmacotherapy integrated with the pharmaceutical care system]. Ratsionalna farmakoterapiia. 2011;1–2:23–29. Ukrainian.Classification for Drug related problems. V 6.2. 14.01.2010. Pharmaceutical Care Network Europe Foundation. «The PCNE Classification V 6.2».Classification for Drug related problems. V 6.2. 14.01.2010. Pharmaceutical Care Network Europe Foundation. «The PCNE Classification V 6.2».Воронков А.В., Дьякова И.Н., Огурцов Ю.А., Жидкова Ю.Ю., Гамзелева О.Ю. Изучение влияния оригинальных многокомпонентных гелей на формирование патологического рубца с использованием нового методического подхода // Экспериментальная и клиническая фармакология. – 2014. – т. 77, №9. – С. 38–42.Voronkov A.V., D`yakova I.N., Ogurczov Yu.A., Zhidkova Yu.Yu., Gamzeleva O.Yu. Izuchenie vliyaniya original`ny`x mnogokomponentny`x gelej na formirovanie patologicheskogo rubcza s ispol`zovaniem novogo metodicheskogo podxoda [Study of the influence of original multicomponent gels on the process of pathological scar formation using new methodological approach]. Eksperimentalnaya i klinicheskaya farmakologiya. 2014; 77(9): 38–42. Russian.

The authors declare that there are no conflicts of interest present.