Gradl Gabriele, Krieg Eva-Maria, Schulz Martin
Research Associate, German Institute for Drug Use Evaluation (DAPI). Berlin ( Germany ).
Director Pharmacy, German Institute for Drug Use Evaluation (DAPI), Berlin; & Adjunct Professor Goethe-University Frankfurt; Lecturer, Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin . Berlin ( Germany ).
Pharm Pract (Granada). 2016 Jul-Sep;14(3):786. doi: 10.18549/PharmPract.2016.03.786. Epub 2016 Sep 15.
Generic substitution can have unintended consequences. In Germany, brand name to generic or generic to generic switching is mainly driven by rebate contracts. Frequent switching may raise concerns about bio- and therapeutic equivalence. Expected patient confusion may result in compromised medication adherence or new onset of other drug-related problems. Since 2008, pharmacists are allowed to deviate from rebate contracts by denying substitution due to pharmaceutical concerns on an individual basis.
To explore the frequency of documented pharmaceutical concerns in Germany between July 2011 and December 2013 and to identify the medicines most frequently related to pharmaceutical concerns in 2013.
We analyzed documented pharmaceutical concerns in all prescribed drugs at the expense of any statutory health insurance company requiring pharmacies' generic substitution according to rebate contracts.
Since July 2011, the frequency of documented pharmaceutical concerns in relation to prescribed drug products with rebate contracts requiring substitution increased consistently and doubled between July 2011 and July 2013. Overall in 2013, the trend of the two previous years continued and reached approximately 1.5%. The most affected drugs/drug classes were thyroid hormones (in particular combinations with iodide; 15.9%) followed by ondansetron (12.5%), and levothyroxine (11.3%). For all drugs/drug classes under investigation, product-, patient- or disease-related aspects could be identified which are potential reasons to deny substitution and to document pharmaceutical concerns.
Although there is no electronic recording of the specific reasons for pharmaceutical concerns in claims data, our analyses support the assumption that pharmacists make use of this instrument based on individual clinical decisions and as required by contract. Pharmaceutical concerns are, therefore, an important instrument for pharmacies to refuse generic substitution. They are considered to prevent compromised medication safety and to assure pharmacotherapy effectiveness in a generic substitution environment driven by low drug prizes above all.
非专利药替换可能会产生意想不到的后果。在德国，品牌药替换为非专利药或非专利药之间的替换主要由返利合同推动。频繁替换可能会引发对生物等效性和治疗等效性的担忧。患者可能会因此感到困惑，从而导致用药依从性下降或出现其他与药物相关的新问题。自2008年以来，药剂师可以基于药学方面的考虑，个别拒绝替换，从而偏离返利合同。
探讨2011年7月至2013年12月德国记录在案的药学方面考虑因素的频率，并确定2013年与药学方面考虑因素最相关的药物。
我们分析了所有法定健康保险公司为支付费用而开具的处方药中记录在案的药学方面考虑因素，这些处方药根据返利合同要求药店进行非专利药替换。
自2011年7月以来，与需要替换的有返利合同的处方药产品相关的记录在案的药学方面考虑因素的频率持续上升，在2011年7月至2013年7月期间翻了一番。2013年总体上，前两年的趋势继续，达到约1.5%。受影响最大的药物/药物类别是甲状腺激素（特别是与碘化物的组合；15.9%），其次是昂丹司琼（12.5%）和左甲状腺素（11.3%）。对于所有调查的药物/药物类别，可以确定与产品、患者或疾病相关的方面，这些是拒绝替换并记录药学方面考虑因素的潜在原因。
尽管理赔数据中没有对药学方面考虑因素的具体原因进行电子记录，但我们的分析支持这样一种假设，即药剂师根据个人临床决策并按照合同要求使用这一手段。因此，药学方面考虑因素是药店拒绝非专利药替换的一项重要手段。它们被认为可以防止用药安全性受损，并在主要由低价药物驱动的非专利药替换环境中确保药物治疗的有效性。
