Simoens Steven
Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, O&N 2, Herestraat 49, PO Box 521, 3000 Leuven, Belgium.
Ann Pharmacother. 2009 Oct;43(10):1701-6. doi: 10.1345/aph.1M215. Epub 2009 Sep 8.
Authentication processes based on mass serialization technology may help to make the drug supply more secure for patients.
To analyze the AegateProtect service, a new drug authentication service implemented in Belgian and Greek community pharmacies.
A prospective analysis conducted via a mystery shopper audit assessed the reliability of the authentication service in a sample of Belgian community pharmacies. A retrospective analysis evaluated the effectiveness of the authentication service in Belgian and Greek community pharmacies in terms of the number of scans relating to authentic, recalled, expired, and suspicious products. Also, the costs of providing an authentication service in a hypothetical country were weighed against the benefits in terms of preventing the dispensing of substandard drugs.
The authentication service attained a sample reliability of 100% (95% CI 99.8 to 100) in Belgium. The 220,751 scans tested in Belgium during June-August 2008 consisted of authentic products (96.13% of scans), recalled products (0.74%), products that may be recalled (3.00%), and expired products (0.13%). No suspicious products were identified. Similar results were observed in Greece. For a hypothetical country, a modeling exercise showed that an authentication service would become cost-neutral in a scenario in which 0.47% of products per year are identified as recalled or expired.
A drug authentication process such as the AegateProtect service is reliable and effective in identifying recalled, expired, and suspicious drugs in community pharmacies at the point of dispensing. The proportion of products identified as recalled, expired, or suspicious in a given country determines the level of cost benefits of an authentication service.
基于大规模序列化技术的认证流程可能有助于为患者提供更安全的药品供应。
分析在比利时和希腊社区药房实施的一种新型药品认证服务——AegateProtect服务。
通过神秘顾客审计进行前瞻性分析，评估比利时社区药房样本中认证服务的可靠性。回顾性分析根据与正品、召回、过期和可疑产品相关的扫描数量，评估比利时和希腊社区药房认证服务的有效性。此外，还权衡了在一个假设国家提供认证服务的成本与预防不合格药品配药方面的收益。
在比利时，认证服务的样本可靠性达到100%（95%可信区间为99.8至100）。2008年6月至8月在比利时测试的220,751次扫描包括正品（扫描次数的96.13%）、召回产品（0.74%）、可能被召回的产品（3.00%）和过期产品（0.13%）。未发现可疑产品。在希腊也观察到了类似结果。对于一个假设国家，一项建模分析表明，在每年0.47%的产品被确定为召回或过期的情况下，认证服务将实现成本平衡。
诸如AegateProtect服务这样的药品认证流程在社区药房配药时识别召回、过期和可疑药品方面是可靠且有效的。在一个特定国家中被确定为召回、过期或可疑的产品比例决定了认证服务的成本效益水平。
