Vrhovac B, Vrhovac R
Klinicki bolnicki centar, Medicinski fakultet Sveucilista u Zagrebu.
Lijec Vjesn. 1990 May-Jun;112(5-6):131-7.
Changes and trends in the drug field in the world and in Yugoslavia in 1989 are presented and discussed. 1. World. There appeared only a few new drugs all over the world, and new chemical entities (NCE) rather rarely represent a significant contribution to materia medica. Japan is the first in producing NCE (12) followed by United Kingdom and the USA (4 NCE each). 2. Yugoslavia. In Yugoslavia were 125 drugs discussed approval, new dose, new formulation or generic parallel. More than 84% of these have been related to generic or clinical ("me too") parallels; less than 9% of drugs had a certain contribution to materia medica, while, according to the authors, the number of drugs that contributed significantly to the materia medica and of those which should not have been approved was equal (3.2%). Octreotide, erythropoietin, almitrine and flumazenil were placed in category A. Insulin appeared in the largest number of parallels (as many as 19) succeeded by cardiovascular, antimicrobial and gastrointestinal drugs. 3. Drug formularies exist in all the developed countries and represent a way of limiting prescribing. Yugoslav list of drugs expenses of which will be covered by the Health Insurance will be prepared. 4. The Federal Institute for Health Protection through its special committee for diagnostics, pharmacotherapy and side effects represents a useful activity in rationalizing drug use. 5. Yugoslav publication of defined daily doses (DDD) is being prepared. 6. A review of causes of deficient or inadequate drug supply in Yugoslavia, which still represents a major problem in this country, has been given at the end.
本文介绍并讨论了1989年世界及南斯拉夫药物领域的变化与趋势。1. 世界。全球仅出现了少数几种新药,新化学实体(NCE)对药物学的重大贡献极为罕见。日本在生产NCE方面位居第一(12种),其次是英国和美国(各4种NCE)。2. 南斯拉夫。在南斯拉夫,有125种药物涉及审批、新剂量、新剂型或仿制药等效。其中超过84%与仿制药或临床等效(“me too”)有关;对药物学有一定贡献的药物不到9%,而据作者称,对药物学有重大贡献的药物数量与不应获批的药物数量相等(3.2%)。奥曲肽、促红细胞生成素、阿米三嗪和氟马西尼被归入A类。胰岛素出现的等效品种最多(多达19种),其次是心血管、抗菌和胃肠道药物。3. 所有发达国家都有药物处方集,这是限制处方的一种方式。南斯拉夫将编制由健康保险支付费用的药物清单。4. 联邦卫生保护研究所通过其诊断、药物治疗和副作用特别委员会,在合理用药方面开展了有益的活动。5. 南斯拉夫正在编制限定日剂量(DDD)出版物。6. 最后对南斯拉夫药品供应不足或不充分的原因进行了综述,这在该国仍是一个主要问题。