Medicine Traceability & AUthenticity

Transcription

1 Medicine Traceability & AUthenticity Overview Universidad de Belgrano 18 Mayo, Universidad de Belgrano Medicine Traceability Overview 18 Mayo, 2010

2 1. A Glance on CTP 2. Introduction 3. Good and Bad Distribution Practice (& COUNTERFEITING measures) 4. Available Models Common Identification Tecniques 5. International Requirements Overview 6. Data Matrix 7. Track&Trace Actually 2 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

3 2. A Glance on CTP 3 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, 2010

4 4 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

5 5 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

6 R&D Regulatory Engineering Engineering & Validation Process & Quality IT to Compliance GMP System Integration Support Business Development Support Auditing & Quality in Outsourcing Training Basic Chemical & Microbiological Analysis Formulation Development Support Stability Studies Support (ICH/ASEAN) Analytical Methods & Library Development & Validation Analytical Support for Regulatory Issues (Dossier, re-testing. etc.) Raw Material Qualification Analytical Support (D.Lgs 219/06) Methods Transfer & Labs Qualification Methods Transfer & Labs Qualification Equipment Qualification Validation of Sanitizing products 6 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

7 AAA Abbott Acom ACRAF Acs Dobfar Alfa Wassermann Antibioticos Astra Zeneca Bausch & Lomb Baxter Bayer Boehringer-Ingelheim Bracco Bristol-Myers Squibb Cambrex Chemifarma Chiesi Farmaceutici CCT Di pharma Dompé Doppel DSM Edmond Pharma Eli Lilly E-pharma Eurand Fidia FIS Flamma Formenti Gambro GE GelfiPharma, Gnosis GSK Hardis Helsinn Hospira IBA IBN Savio Infra Italfarmaco ITEL Janssen-Cilag Kedrion Menarini Merck-Serono NSA Novartis Opocrin Patheon Pfizer Pierrel Procos RBM Recordati Sanofi-Aventis Schering-Plough Sigma-Tau S.I.M.S. Takeda Temmler Wyeth Zambon 7 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

8 2. Introduction 8 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, 2010

9 Security Complexity Patient safety Uninterrupted supply chain to patients Regulatory compliance Operational excellence and inventory control Regional capabilities and access Produt supply strategies Customer service levels 9 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

10 A safe, reliable and cost-effective global supply chain Managing the supply chain as a whole Source Supplier s Supplier Supplier Make Chemical / Biologic Galenic Plant Warehouse/DC Deliver Wholesaler Pharmacist/Hospital Patient 10 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

11 11 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

12 Counterfeit medical products put patients at risk. They undermine the credibility of health systems, waste money, and reduce confidence in the authorities responsible for public safety Dr Margaret Chan, Director General, WHO, January Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

13 HEROIN Cost: 237 /Kg Street value: /Kg VIAGRA (sildenafil citrate) Cost of active ingredient: 47 /Kg Street value: /Kg Counterfeiting is shown to be significantly more profitable than illicit drugs. 13 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

14 Counterfeits dispensed via the internet were manufactured at this site in china. The network included hundreds of brokers in US and EU. 14 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

15 15 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

16 No active pharmaceutical ingredient (Norvasc Canada) Wrong active pharmaceutical ingredient (Lipitor UK) Too much active pharmaceutical ingredient (Viagra South Korea) Completely different active pharmaceutical ingredient (Viagra Hungary) Toxic substances (Ponstan Columbia) 16 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

17 Counterfeiting is an increasing business 10% of the overall good is counterfeited Medicines and Medical Devices are the third counterfeited categoty The WHO estimates that 8-10% of the world's supply of medicines is counterfeit Counterfeit medicines estimated volume in 2010: $ 200 billion. 50% of products sold via the internet could be counterfeit or have a lower quality 30% of certain drugs consumed in developing countries is counterfeit 17 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

18 Not just patent protected medicines: Pfizer is seeing increases in counterfeiting of its off-patent medicines such as Lincocin (an antibiotic), Cytotec (used to protect against stomach ulcers caused by pain medication) and Xanax (to treat panic disorders) Not just lifestyle medicines: range of medicines counterfeited now includes biologicals (Pfizer has seen its growth hormone Genotropin counterfeited in Sweden 2007 and South Africa 2008) Not just high value medicines: recent seizures have included the Medifake EU-wide operation in which over 34 million illegal medicines were seized in only a two-month period. This included the biggest single seizure of illegal medicines ever recorded in Europe at Brussels airport: reportedly 2.2 million tablets (including 1.6 million painkillers) increasingly life-saving medicines are at risk PDA-EMEA 2009 Joint Conference Andrew Bonser Pfizer 18 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

19 Manufacturer Wholesaler(s) Pharmacist 19 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

20 20 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

21 The legal supply chain of pharmaceuticals within the EU often covers actors in different Member States. The risk of distributing counterfeited medicines has therefore a significant cross-border aspect which calls for harmonised action at EU level. European Commission s draft pharmaceuticals package (DG ENTRE): Citizen s Summary. March Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

22 Proposed Draft EU legislation recommends measures to increase the security of medicines and the medicines supply chain; Measures to enforce Good Manufacturing and Good Distribution Practices Measures to improve supervision of actors in the distribution chain (e.g. wholesalers, traders) Measures to improve the security and safety of Active Pharmaceutical Ingredients Prescription medicines may need to have: a) Covert, overt, and forensic devices b) Tamper evident features c) Identification at individual pack level but how to identify individual packs? what type of technology is needed? and how can it be applied across Europe and integrated into differing national technologies? 22 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

23 Supports anti-counterfeiting and public health Combats fraud and prevents reimbursement fraud Reduces dispensing errors Gives quality assurance for patients Provides common standards across Europe, allowing inter-operability Offers a cost-effective solution for all parties provides the most effective method of ensuring product security 23 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

24 Supply Chain and Brand protection 24 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

25 Define rules to guarantee customer safety seems to be indespensable. 25 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00

26 Traceability enabling technologies Technology epedigree Serialization Authentication RFID * Datamatrix or barcode Fast and reliable printing In-line printing controls Invisible taggant * Optical Variable Devices DNA- or chemicalbased security tag * Probably not the best solution. 26 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, rev. 00