Transcript The Impacts of Pharmaceutical & Retail Legislation

The Impacts of Pharmaceutical
& Retail Legislation
Melvin Fletcher
Datalinx Computer Systems
Introduction
• Datalinx Computer Systems
Our business today
• Changes to Food Labelling
EU 1169/2011
• Verification of Pharmaceutical Products at the point of
dispense
The EFPIA Project
European Federation of Pharmaceutical Industries and Associations
Sage approved:
“Centre of Excellence for Warehouse Management”
Sage 50 customers
Sage 200 customers
Sage Line 500/1000
Customers
Sage ERP X3 (Product launched in August 2013)
Sage 200 Functionality and Sites
• Deeply embedded into Sage 200
• Inbound
• Outbound – Sales order picking and packing
• Stock taking
• Manufacturing
• Movements
• GS1 compliance
• Smallest site 1 hand held scanner – largest 52
Sage 500/1000 Functionality Sites
• Deeply embedded into Sage 500/1000
• In bound
• Outbound – Sales order picking and packing
• Stock taking
• Manufacturing
• Movements
• GS1 compliance
• Smallest site 1 hand held scanner – largest 98
• 4 new sites in 2013
Datalinx
If you want to know more about our applications –
Come and talk to us
Changes to food labelling
EU 1169/2011
Ref: GS1 UK and “Brandbank”
Ready for change
• Background to the new regulation
• Who will be effected
• Key changes you need to be aware of
• How this will impact your business
• Key deadlines
• More information
Goal of the Legislation
• Ensure that consumers can make informed decisions about
food they purchase
• Increase the amount of mandatory information
• New rules about how information is displayed on products
• The requirement for information to be accessible prior to
purchase if the product can be bought online
Who will be affected
The legislation applies to Food Business Operators (FBOs) at all
stages of the food chain, where their activities concern the
provision of food information to consumers including;
• Food Manufacturers
• Food Retailers
• Online Retailers
• Catering Organisations
• Food Services
• Food Distributors
• Upstream Suppliers
Who’s responsible
• There is joint responsibility between the supplier and the
retailer.
• It is the responsibility of the supplier to provide the data
and the responsibility of the retailer to display it
correctly.
• Blame would be apportioned accordingly upon an
instance of non-compliance.
Key information
• Instructions for use
• Name and Address
• Nutrition
Declaration
• Storage Conditions
• Quantity of
Ingredients
• Origins
• Name of Business
2nd Nov 2013
• Date Marks
• Net Quantity
• Product Name
• Allergens
Key Information
This information has to be available any time and any
where:
• Online
• Delicatessen
• Retail outlet
• Restaurant
• Available to back office systems
Centralised data
• GS1 managed product identification numbers
• Working with Brandbank to provide a single trusted
source of product information and digital assets based
on global standards
Key Dates
1st January 2014
Specific requirements regarding minced meat composition and labelling
13th December 2016
Mandatory nutrition declaration needed for most Pre-packed food
New nutrition declaration applies for all other foods
2014
2015
2016
13th December 2014
Mandatory allergen information and general labelling rules
Nutritional declaration provided on a voluntary basis must comply
with new regulations
Foods placed on sale or labelled prior to the above dates that do not
meet the requirements of the new regulations (but are compliant
with existing rules) may be marketed until stocks are exhausted.
2017
For more information visit
www.datalinx.co.uk/gs1
Verification of Pharmaceutical
Products at the point of dispense
The EFPIA Project
European Federation of Pharmaceutical Industries and Associations
Who is EFPIA
The European Federation of Pharmaceutical Industries and
Associations (EFPIA)
– Represents the R&D based pharmaceutical industry operating in
Europe
– Direct membership of 31 national associations and 44 leading
pharmaceutical companies
– EFPIA is the voice of 2,200 companies committed to researching,
developing and bringing new medicines to patients that will
improve health and the quality of life around the world
Objectives of verification
Improving patient safety
• Reduce the risk of counterfeit products being dispensed
• Detect expired products automatically
• Perform product recalls more effectively and efficiently
• Deliver the right product to the right patient
These systems will also have other benefits such as supporting
governments with their reimbursement processes
EFPIA Product Coding
Recommendations in Europe
Secondary Pack
• Guarantee the integrity of the original manufacturer’s pack
throughout the entire supply chain
• Use of overt and covert features to authenticate products
• Use of harmonised coding and identification systems for secondary
packs of pharmaceuticals
Specifications provided in EFPIA’s
“European Pack Coding Guidelines”
Pilot Project Overview
25 pharmacies in the greater Stockholm area
with a total of 180 dispensing points
25 Products (SKUs)
with total of 100,000
packs
95,000 packs verified
14 manufactures
4 months duration of
operational phase
Wholesalers labelled products
Response times:
• 99.9% of transactions
completed in <2.0 sec
• System 99.9% online
Response from pharmacists
Positive Feedback
Issues identified
• Ease of use of the system
• Additional effort when
(94% of pharmacists found the
scanning – scanners read
system easy or very easy to use)
linear bar code instead of the
• Little additional effort to
verify (96% of pharmacists found
the level of effort acceptable or
better)
• Good experience with the
scanning equipment
85% found the system fast
2D
• Some process variation
resulted in some packs on the
shelf showing as being
dispensed
Key Conclusions from Pilot
•
The presence of more than one code on the pack causes confusion for the user and will jeopardise user acceptance
•
The practicalities of code location and application need to be considered
•
Understanding the processes is critical to ensure the system works
•
Support and buy in from the people scanning is important -involve in design
•
System availability and performance allow pharmacists to work at normal pace and without significant additional
effort
•
System is easy to use when fully integrated into pharmacy workflow and existing IT system
•
System should be customised to existing pharmacy workflow, processes, local conditions and regulatory
requirement. It is therefore recommended to run a pilot phase for each deployment (region) so that defects can be
eliminated before roll-out
•
The model EFPIA supports works in practice and allows for effective identification of fake packs
•
System must provide correct answer to all transaction requests to achieve sustained credibility
•
Pharmacists are highly interested to get expiry date and batch number in machine readable form through the 2D data
matrix
•
Necessary data segregation and security can be technically ensured
Credits and more information
Thank you to GS1 UK and EFPIA for their assistance with this
presentation. If you would like more information on any of the points
covered please contact Datalinx, GS1 UK or click on any of the links
below.
GS1 UK
Brandbank
EFPIA
Download the EU1169/2011 pdf overview
Reference has been made to the EFPIA Project
Read more about healthcare GTIN allocation rules