背景和目的:非甾体类抗炎药(NSAIDs)的不合理使用是导致所有药物组的不良反应相关住院的主要原因,导致医疗费用急剧增加。药物流行病学研究可以部分揭示这些问题,并鼓励进一步的决策。因此,我们研究的目的是评估立陶宛非阿片类镇痛药(ATC分类N02B和M01A)的使用情况,并将其与其他波罗的海和斯堪的纳维亚国家在遵守世卫组织疼痛治疗指南和EMA关于NSAID使用的安全建议方面进行比较。材料和方法:配药数据来自波罗的海国家的销售分析软件提供商(SoftDent,Ltd.,考纳斯,立陶宛);立陶宛国家医学控制机构,拉脱维亚,和爱沙尼亚;挪威处方数据库;瑞典药品数据库;和丹麦处方数据库。数据包括处方药和非处方药的使用。利用以规定的日剂量(DDD)/1000居民/天表示。结果:在11年期间,N02B和M01A组的药物利用率增加了22.8%,立陶宛从2005年的58.37到2016年的71.68DDD/1000居民/天。与世卫组织疼痛管理指南相反,与其他镇痛药和退烧药相比,所有波罗的海国家更有可能使用NSAIDs:2015年,在立陶宛,M01A组的药物使用量分别是N02B的6.04、5.79和6.11倍,爱沙尼亚,拉脱维亚,分别,而斯堪的纳维亚国家更喜欢N02B而不是M01A:在丹麦和瑞典,其他镇痛药和退烧药的使用率分别为2.33和1.24,比NSAIDs高一倍。在挪威,两组的使用情况相似.在斯堪的纳维亚国家,扑热息痛是首选镇痛药,然而,在立陶宛,它只获得了第三名。立陶宛最受欢迎的药物是双氯芬酸,2016年,其使用率占所有非阿片类镇痛药的30.04%。尽管欧洲药品管理局(EMA)限制使用某些非甾体抗炎药,即,环氧合酶-2(COX-2)抑制剂,尼美舒利,和双氯芬酸,它们的使用量持续增加了15.91、2.83和1.41倍,分别,显示不符合国际准则。结论:关于NSAID使用的EMA安全政策和WHO疼痛治疗指南均未对立陶宛NSAID的合理使用产生足够的影响。EMA限制使用NSAIDs(双氯芬酸,COX-2抑制剂,尼美舒利,和吡罗昔康)保持较高甚至增加,而与斯堪的纳维亚国家相比,更安全的替代品(扑热息痛和萘普生)的利用率仍然相对较低。不遵守国际准则可能导致发病率增加,死亡率和更高的医疗保健成本。
Background and objective: Irrational use of nonsteroidal anti-inflammatory drugs (NSAIDs) is the main cause of adverse effects-associated hospitalizations among all medication groups leading to extremely increased costs for health care. Pharmacoepidemiological studies can partly reveal such issues and encourage further decisions. Therefore, the aim of our study was to evaluate the utilization of non-opioid analgesics (ATC classification N02B and M01A) in Lithuania, and to compare it with that of other Baltic and Scandinavian countries in terms of compliance to the WHO pain treatment
guidelines and the EMA safety recommendations on NSAID use. Materials and methods: The dispensing data were obtained from the sales analysis software provider in the Baltic countries (SoftDent, Ltd., Kaunas, Lithuania); State Medicine Control Agencies of Lithuania, Latvia, and Estonia; Norwegian Prescription Database; Swedish Database for Medicines; and Danish Prescription Database. Data included the utilization of both prescription and over-the-counter drugs. Utilization was expressed in defined daily doses (DDD)/1000 inhabitants/day. Results: During the 11-year period, the utilization of drugs belonging to the N02B and M01A groups increased by 22.8%, from 58.37 in 2005 to 71.68 DDD/1000 inhabitants/day in 2016 in Lithuania. Contrary to the WHO
guidelines on pain management, all Baltic countries were more likely to use NSAIDs than other analgesics and antipyretics: in 2015, the drugs of the M01A group were used 6.04, 5.79, and 6.11 times more than those of N02B in Lithuania, Estonia, and Latvia, respectively, whereas the Scandinavian countries preferred the N02B to the M01A group: in Denmark and Sweden, the utilization of other analgesics and antipyretics was 2.33 and 1.24, respectively, times higher than that of NSAIDs. In Norway, the use of both groups was similar. In the Scandinavian countries, paracetamol was the analgesic of first choice, whereas, in Lithuania, it took only the third place. The most popular drug in Lithuania was diclofenac, and its utilization accounted for 30.04% of all non-opioid analgesics in 2016. Although the European Medicines Agency (EMA) restricted the use of certain NSAIDs, i.e., cyclooxygenase-2 (COX-2) inhibitors, nimesulide, and diclofenac, their use consistently increased by 15.91, 2.83, and 1.41 times, respectively, showing incompliance with the international
guidelines. Conclusions: Neither the EMA safety policy on NSAID use nor the WHO pain treatment
guidelines had a sufficient impact on the rational use of NSAIDs in Lithuania. The use of NSAIDs restricted by the EMA (diclofenac, COX-2 inhibitors, nimesulide, and piroxicam) remains high or even increases, while the utilization of safer alternatives (paracetamol and naproxen) remains relatively low as compared with the Scandinavian countries. Incompliance with international
guidelines may result in increased morbidity, mortality and higher costs for health care.