Ministry of Health Italy

15 Pages·2008·1.7 MB·English

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
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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
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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.
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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.
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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 )
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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
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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
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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.
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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
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