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Ministry of Health Italy PDF

15 Pages·2008·1.7 MB·English
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The drug tracking system in Italy Claudia Biffoli Head of Unit General Directorate for the Information System Ministry of Health – Italy Granada, 12th February 2008 Agenda (cid:1) Normative context (cid:1) STEP 1 :The identification system of drugs wrappings (cid:1) STEP 2: the central database (cid:1) Project phase 1 - overview (cid:1) Other gathering information systems (cid:1) Project phase 2 - objectives (cid:1) Project phase 2 - approach (cid:1) Key Points (cid:1) Next steps 2 2 Normative context From a European directive to a national initiative… (cid:2) The EU Parliament and Council Directive 2001/83/CE, article 35, declares: (cid:2) “It is necessary to exercise control over the entire chain of distribution of medicinal products, …. The requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products”. Through some normative interventions, the "Monitoring of drug packages within the distribution system" has been introduced in Italy DDeeccrreeee ooff tthhee MMHH -- 22nndd AAuugguusstt:: iinnttrroodduuccttiioonn ooff aann 22000011 aaddhheessiivvee pprrooggrreessssiivvee nnuummeerriicc IIDD ccooddee ((““BBoolllliinnoo””)) ffoorr aallll mmeeddiicciinneess rreeiimmbbuurrsseedd bbyy tthhee NNHHSS Step 1: “Bollino” ID system DDeeccrreeee ooff tthhee MMHH -- 11sstt FFeebbrruuaarryy:: iinnttrroodduuccttiioonn ooff tthhee 22000022 ““BBoolllliinnoo”” ssyysstteemm ffoorr aallll mmeeddiicciinneess ffoorr hhuummaann uussaaggee LLaaww 3399 -- 11sstt MMaarrcchh ((aarrtt.. 4400)):: ccrreeaattiioonn,, aatt tthhee MMiinniissttrryy ooff 22000022 HHeeaalltthh,, ooff aa CCeennttrraall DDaattaabbaassee rreeccoorrddiinngg,, oonn tthhee bbaassee ooff tthhee ““BBoolllliinnoo”” ssyysstteemm,, aallll mmoovveemmeennttss ooff eeaacchh ddrruugg ppaacckkaaggee vviiaa tthhee Step 2: pprroodduucctt ccooddee ffoorr eeaacchh ppllaayyeerr iinnvvoollvveedd iinn tthhee ddiissttrriibbuuttiioonn cchhaaiinn.. Central Database LLaaww 1144 -- 33rrdd FFeebbrruuaarryy:: iimmpplleemmeennttaattiioonn ooff EEUU PPaarrlliiaammeenntt CCeennttrraall 22000033 aanndd CCoouunncciill DDiirreeccttiivvee 22000011//8833//CCEE aanndd aaddooppttiioonn ooff tthhee eexxppeecctteedd DDaattaabbaassee uunniivvooccaall ddrruugg ccooddiinngg ssyysstteemm bbyy tthhee 11sstt JJuullyy 22000044 DDeeccrreeee ooff tthhee MMHH –– 1155tthh JJuullyy:: tteecchhnniiccaall ssppeecciiffiiccaattiioonn ffoorr tthhee 22000044 iimmpplleemmeennttaattiioonn ooff tthhee pprroojjeecctt 3 3 STEP 1 :The identification system of drugs wrappings In Italy is commonly used the AIC code for identification of drugs: AIC code is the number of the authorization for the commerce (9 digits) of a drug package. Mint Producer Today each package has an adhesive label (bollino) displaying: PPRROODDUUCCTT XX • A.I.C. code of the drug package that is the authorisation L1E0L1E02424ooxx33//22pptt44ii::5500rr00ii66nnxx77ggyy ddzzaattee:: number issued by the Italian Drugs Agency (AIFA) for commercialisation PRODUCT X • Drug denomination • A.I.C. owner or legal representative of foreign owner Lot: 123456xyz • Progressive identification code of the single package Expiration date: (Serial number) 04/2007 The AIC code and the serial number are in clear text and in bar code on the label A national institute (IPZS – Mint Institute) produces adhesive labels with serial number to apply on the drugs in commerce in Italy. 4 4 STEP 2: the central database DDeeccrreeee ooff tthhee MMiinniissttrryy ooff HHeeaalltthh LLaaww 3399 11ssttMMaarrcchh 22000022 ––((aarrtt.. 4400)) 1155tthhJJuullyy 22000044 LABELLING CENTERS PRODUCERS AGENTS CCeennttrraall DDaattaabbaassee WHOLESALERS Project for the “Monitoring of drugs packages all along the distribution channel, by the tracking of sticky progressive PHARMACIES/ HOSPITALS/STORES identification codes (“bollini”). PATIENTS 57,000,000 The article 40 of the law 39, foresees the creation of a central database: all the movements of drugs (with serial number) on the Italian territory, from the production to the distribution in the hospitals or in the pharmacies, must reach the central database. Every actor of the supply channel must record and send to the central database, the id code + serial numbers of the drugs that he send to the downstream partner, and the actor that receives drugs must records the serial numbers of the drugs received. The Decree (July 2004) defines the technical rules for the feed of the Central DB. 5 5 STEP 2: the central database - Project working model Data transmission of all drugs movement to a Central Database (cid:1) Each player involved is considered as a warehouse with inward (loading) and Mint Producer S outward (unloading) movements, each u linked to a “reason for movement”. p p li (cid:1) The sender has to transmit the outward e PRODUCT X r movements and the related addressees to L1E024ox3/pt2:4i0r50in67xgy dzate: the system (cid:1) The addressee, before using the received D i products, has to check the delivery s Agents t r connecting to the Central Database, in order i b to obtain the information related to the u t incoming drugs. i o Wholesalers n (cid:1) The addressee has to communicate any c CCeennttrraall DDBB h anomaly and eventually the exit of the a drugs from the distribution channel (loss, n Pharmacy/ n theft, disposal, export). Hospital/ e l Stores* (cid:1) All movements have to be transmitted within 24 hours with digital signature. Final consumer * Licensed to sell drugs available without prescription and Over The Counter since 4 July 2006 (decree 223/2006 ) 6 6 Project phase 1 - overview To obtain some first results in the short time and to mitigate the system impact on the involved players, was adopted a progressive approach based on phases. Information gathered: Phase 1 Started on June 2005 (cid:2) outbound movements (number of drugs packages per AIC) within 24 hours from expedition, included number of LABELLING CENTERS DDBB ““BBoolllliinnii”” “Bollini” destroyed, without serial number; (cid:2) data related to the supply of Bollini by the IPZS (the PRODUCERS national mint); Sell out (cid:2) value of all drugs supplied to facilities of the NHS. AGENTS CCEENNTTRRAALL DDBB UUnnllooaaddiinngg oonnllyy Sell out Some figures up to now*: WHOLESALERS (cid:1) Number of movements tracked: Sell out 1.629.275.561 PHARMACIES/ HOSPITALS/STORES (cid:1) Logistic sites mapped: ־ Producers: 593 ־ Agents: 633 PATIENTS ־ Wholesalers: 1.000 57,000,000 ־ Pharmacies: 19.674 ־ Stores: 2.263 ־ Discharge operator: 372 * Since 1 Jenuary 2006 7 7 Other gathering information systems Italy presents several active information systems gathering pharmaceutical data: Transmission of data related to the NHS pharmaceutical prescriptions provided to consumers by pharmacies. The system is based on the linkage between the prescription code, the patient identification number (fiscal code) and the A.I.C code with its bar code. Prescription Tracking system for NHS dgrpvn75m01a prescriptions PRODUCT X L1E024ox3/pt2:4i0r50in67xgy dzate: A.I.C code Fiscal code The tracking system for NHS has been working for about 20 years with recent changes 8 8 Project phase 2 - objectives Phase 2 To accomplish a complete tracking, as declared by Decree July 2004, through gathering information not included in phase 1: Serial number of drug packages, involved in all movements; (cid:3) Inward movements; (cid:3) Data about lot and expiration date (cid:3) Tracking movements on final distribution and on exit from distribution channel (cid:3) Harmonization with other information flow (cid:3) Set up of a Technical Working Team including all relevant stakeholders (producers, agents and wholesalers, Regional Authorities, Pharmacies Hospital Pharmacies and discharge operators) to manage the project towards the implementation of the Technical working team regimen. TWT started on March 2007. 9 9 Project phase 2 - approach In order to guarantee the organizational and technical sustainability of the initiative and to reduce the risks related to the complexity of the solution, it has been decided, together with the players involved, to analyze the system based on the following working hypotheses: Use Datamatrix as vector Tracking of outward movement only • Align tracking Italian system with main • Guarantee more sustainability of the international developments identified solution compared to complete • Allow to store more information, as tracking of inward – outward movements settled from Decree 15th July 2004, on the vector than the present solution (barcode code-32/ITF) Actor 1 Sell Out Tracked Sell In Not tracked 6 mm Actor 2 10 10

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number issued by the Italian Drugs Agency (AIFA) for In Italy is commonly used the AIC code for identification of drugs: AIC code is the number of the
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