Pharmaceutical Care Research Group, Pharmazentrum, Basel, Switzerland.
Swiss Med Wkly. 2010 Feb 20;140(7-8):105-10. doi: 10.4414/smw.2010.12953.
QUESTION UNDER STUDY / PRINCIPLES: Scored tablets are often split to facilitate swallowing or to fractionate the dose. In the latter case, the fragments of the tablet should comply with the content or mass uniformity requirements of the European Pharmacopoeia. For health professionals the splitting information is expected to be in the Summary of Product Characteristics (SPCs), the package leaflets (PLs) or Hospital Drug Formularies. We investigated the accuracy of splitting statements in these three sources of drug information.
We selected the tablets mentioned as "scored" in the Swiss Compendium Online and in the Drug Formulary of Basel University Hospital, and screened the corresponding SPCs and PLs for information on divisibility and fractional dosing. Missing information was obtained from the drug marketing licence holder.
The Swiss Compendium Online contained 698 different scored tablets whose SPCs mentioned fractional dosing for 43.8% and explicitly forbade it for 2.7%. The Hospital Drug Formulary indexed 188 items as scored tablets. The corresponding SPCs mentioned fractional dosing for 107 (59.4%) and a sentence forbidding it for 5 (2.8%). The manufacturers' answers permitted fractional dosing for 49 (27.2%) of the remaining tablets and forbade it for 19 (10.5%). Lack of dosage uniformity or presence of "historic decorative" score-lines were the reasons given.
For the majority of scored tablets the official sources of drug information contained no explicit indication on fractional dosing. Improvement of splitting information is necessary to avoid potential medication errors.
研究/原理：评分片剂通常被分割以方便吞咽或分割剂量。在后一种情况下，片剂的碎片应符合欧洲药典的含量或质量均匀性要求。对于卫生专业人员，分割信息预计将在产品特性摘要（SPC）、包装说明书（PL）或医院药物配方中。我们调查了这三种药物信息来源中分割声明的准确性。
我们选择了在瑞士在线药典和巴塞尔大学医院药物配方中被标记为“评分”的片剂，并筛选了相应的 SPC 和 PL，以获取有关可分割性和分数剂量的信息。缺失的信息从药物营销许可证持有人处获得。
瑞士在线药典包含 698 种不同的评分片剂，其 SPC 中提到分数剂量的占 43.8%，明确禁止的占 2.7%。医院药物配方索引了 188 项评分片剂。相应的 SPC 提到分数剂量的占 59.4%，禁止的占 2.8%。制造商的回答允许剩余片剂中的 49 片（27.2%）进行分数剂量，禁止 19 片（10.5%）进行分数剂量。缺乏剂量均匀性或存在“历史装饰”评分线是给出的原因。
对于大多数评分片剂，药物信息的官方来源没有明确说明分数剂量。需要改进分割信息以避免潜在的用药错误。
