Quinzler R, Gasse C, Schneider A, Kaufmann-Kolle P, Szecsenyi J, Haefeli W E
Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.
Eur J Clin Pharmacol. 2006 Dec;62(12):1065-73. doi: 10.1007/s00228-006-0202-3. Epub 2006 Oct 6.
We assessed the frequency and determinants of tablet splitting in primary care in Germany and evaluated the quality of information on divisibility in the Summary of Product Characteristics (SPCs) and in the Package Leaflet (PL) as legal sources of information for health care providers and patients.
We performed a cross-sectional questionnaire survey among patients of 59 general practitioners in the German Federal State Saxony-Anhalt in 2005 in order to collect detailed information on all drugs of patients maintained on more than three drugs.
The response rate was 82.1% (n=905) and 3,158 drugs (tablets and dragées) were included in the analyses. Of all drugs, 24.1% were split (762 of 3,158): 8.7% of all split tablets were unscored (66 of 762) and 3.8% of all split tablets were not allowed to be split (29 of 762). Tablets of the higher price categories and higher strengths were twice as likely to be split. Only 22.5% of the SPCs (9 of 40) of the split unscored tablet brands contained explicit information on divisibility and only 36.4% of the PLs (8 of 22) of the split brands that were not allowed to be split stated that splitting was not appropriate.
The splitting of tablets in primary care is a frequent habit likely driven by medical and economic considerations. Almost 1% of all tablets are split that must not be fragmented. However, the SPC and PL provide only limited information on divisibility stressing the need to improve this information promptly to avoid medication errors.
我们评估了德国初级保健中片剂掰开的频率和决定因素，并评估了作为医疗保健提供者和患者法定信息来源的产品特性摘要（SPC）和包装说明书（PL）中关于可分割性的信息质量。
2005年，我们对德国萨克森-安哈尔特州59名全科医生的患者进行了横断面问卷调查，以收集关于服用三种以上药物的患者所使用的所有药物的详细信息。
应答率为82.1%（n = 905），分析纳入了3158种药物（片剂和糖衣丸）。在所有药物中，24.1%被掰开（3158种中的762种）：所有掰开片剂中，8.7%没有刻痕（762种中的66种），3.8%不允许掰开（762种中的29种）。价格较高类别和较高规格的片剂被掰开的可能性是其他片剂的两倍。掰开的无刻痕片剂品牌的SPC中只有22.5%（40种中的9种）包含关于可分割性的明确信息，不允许掰开的掰开品牌的PL中只有36.4%（22种中的8种）表明掰开不合适。
初级保健中片剂掰开是一种常见习惯，可能是由医学和经济因素驱动的。所有片剂中近1%被掰开但不应该掰开。然而，SPC和PL提供的关于可分割性的信息有限，强调需要迅速改进此信息以避免用药错误。
