Steven Simoens1. 1. Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, O&N 2, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. steven.simoens@pharm.kuleuven.be
Abstract
BACKGROUND: Authentication processes based on mass serialization technology may help to make the drug supply more secure for patients. OBJECTIVE: To analyze the AegateProtect service, a new drug authentication service implemented in Belgian and Greek community pharmacies. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: Authentication processes based on mass serialization technology may help to make the drug supply more secure for patients. OBJECTIVE: To analyze the AegateProtect service, a new drug authentication service implemented in Belgian and Greek community pharmacies. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.