Senior Research Officer (former), Department of Pharmacology and Clinical Pharmacology, Christian Medical College, Vellore, Tamil Nadu;Corresponding Author.
Additional Professor, Department of Pharmacology, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh.
J Assoc Physicians India. 2023 Feb;71(2):11-12. doi: 10.5005/japi-11001-0175.
Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs.
This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities.
A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs.
Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.
药品不合理使用是一个全球性问题。在印度,一个促成因素是大量固定剂量组合(FDC)的存在。为了改善合理用药并加强政策,评估 FDC 的使用模式和合理性非常重要。
本研究是在印度 13 家三级保健医院的门诊进行的为期 1 年的前瞻性横断面分析的一部分。对每个中心最常开的 5 种 FDC 进行了分析。此外,所有开出的 FDC 均按照 Kokate 委员会的分类进行了分类,并注意到是否有任何 FDC 根据监管机构发布的参考清单是不合理的或被禁止的。
共分析了 4838 份处方。其中,2093 份(43.3%)处方至少有一种 FDC。这 2093 份处方有 366 种不同的 FDC。在 366 种 FDC 中,241 种是合理的;10 种是不合理的;14 种需要进一步生成数据;其余 96 种 FDC 无法归入上述任何一种。维生素和矿物质/补品、全身用抗菌药以及用于胃食管反流病(GERD)和消化性溃疡的药物是最常用的 FDC。
根据一些处方含有不合理 FDC 的发现,建议实施严格、定期和统一的评估方法来批准/禁止 FDC,并定期通知开处方者关于禁令的状况。