IMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS. Pedro Ferreira ANF
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1 IMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS Pedro Ferreira ANF
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4 What are falsified medicines? Growing threat to public health and safety in Europe Counterfeit medicines seized at the outer border of the EU tripled between 2006 and 2009, reaching approximately 7.5 million items Over 30 million counterfeit medicines have been seized by customs at EU borders, internal and external, over the last five years Fake medicines may: Contain low quality ingredients or the wrong doses Have their identity or source deliberately mislabelled Have fake packaging or the wrong ingredients
5 Introduction of the Falsified Medicines Directive
6 Introduction of the Falsified Medicines Directive
7 10 Core Principles to Protect Patients from Falsified Medicines European Stekholder Model Parteners are set to consult and engage patient groups
8 European Stakeholder Model
9 European Stakeholder Model
10 European Stakeholder Model
11 The Nacional Blueprint approach
12 The Nacional Blueprint approach
13 Technology behind pharmacy Hub Command and Query Responsibility Segregation Secure Web services (REST) Cloud frontend HTML5 for Administration and monitorization
14 Which medicines should have Security Devices? RULE: All prescriptions medicines should have Security Device White List Black List Risk assessment Over the Counter with high risk of falsification Example: Omeprazole 20mg
15 Safety Features Anti-Tampering Device Safety Features Unique identifiers
16 Unique identifiers Unique identifiers - the sequence of numeric or alphabetic character per package, determinate by algorithm (max. 20) (serial number) - product code - national reimbursement or other number that identifies the product The unique identifier should be printed on the packaging in human-readable format, if possible near the two dimensional barcode: - serial number - product code - national reimbursement or other number that identifies the product
17 Unique identifiers Unique identifiers Authenticable Medicine Falsified medicine Who does the verification? Pharmacies (Community and Hospital), Distributors and Manufacturers
18 Unique identifiers When shall the verification /deactivation of the unique identifier done? Make sure that the unique identifier has the correct information and is legible Manufacturer Verifies the unique identifier and disactivate it before he changes it (parallel Importers)
19 Safety Features Tamper Evident Ensures that the packaging of the medicine was not opened or tampered Ensures the integrity of the product.
20 Safety Features Unique Identifier Bar Code RFID Code 2D Code Manufacturers should encode the unique identifier into a bar code (Two-dimensional). The 2D bar code must be a data matrix (data matrix), Machine-readable, printed on the package on a smooth surface, Uniform and slightly reflective
21 Safety Features
22 Repository System All the information about the Unique Identifiers Lies in the Repository System, enabling them to be checked and deactivated European HUB Nacional Repository OR Supranacional Repository
23 Portuguese Model Fits the blueprint model Most appropriate solution to the model of operation of Portuguese pharmacies More efficient, as it allows the use of existing technological infrastructures Facilitates interoperability with other technological systems medicines reimbursement
24 System Advantages Increased safety for manufacturers of Drugs that reach the Users
25 System Advantages Greater protection of citizens' health Less Fraud
26 Challenges Security of information and access to the repositories
27 Challenges Adaptation of the computer systems to all stakeholdes in the medicines circuit
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