Docket reference 2003N - 0361 Anti-Counterfeit Drug Initiative

Novel method of authenticating pharmaceutical products

PA Consulting Group has identified a novel method of authenticating
pharmaceutical products to avoid fraudulent products including
counterfeits being given to patients, ensuring their safety.

The WHO (World Health Organisation) estimates 10% of medicines worldwide
are counterfeit. This is often considered a problem of the developing
world (where the proportion can be as high as 40%). Recent cases of
counterfeit medicines discovered in the US supply chain (including
Procrit, Lipitor, Zyprexa, Serostim and Oxycontin) have shaken consumer
confidence, with some post-consumption discoveries leading to law suits
against distributors by affected patients.

Many manufacturers already include covert identification features and /
or taggants in their products. These enable in-house company experts to
carry out investigations and forensic analysis to determine whether a
product is genuine or not, the type of fraudulent supply concerned and
the country of origin.

Healthcare professionals and patients do not have access to the
instruments and analytical techniques for this type of testing. Instead
they rely on the overt features (that can be seen by the naked eye) put
onto packs by the manufacturers to help identify counterfeit product.

However, inspection of the overt features cannot be relied upon to
prevent patients from receiving or taking fraudulently supplied
medicines. The reasons for this include:

-   **The quality of counterfeits is very good**

This is now so good that they are almost indistinguishable from the
genuine product. Guidance on the FDA website acknowledges that company
packaging experts may be required to determine whether a particular
product is genuine. Counterfeiters have access to component suppliers,
technology and the ready finance to ensure that their copies are as
close as possible to the real thing. As well as products the paperwork
e.g. export import licenses that accompanies consignments, is also being
copied

-   **Human inspection is inconsistent, with individual and task factors
    contributing to this variability.**

> We are all different: gender, age, dexterity, spatial ability, memory,
> eyesight, motivation, concentration, education, hearing, experience
> and language are some of the individual factors that mean the
> performance in carrying out inspection tasks varies from person to
> person.

The process of inspection is inconsistent. When to inspect? On receipt
at the pharmacy, or by the patient when they obtain the dispensed
product? Where to do the inspection? In the Pharmacy or at home, or on
the end of a cramped dispensing bench or secluded quiet area? What to
look for? What are the features that should be checked, all of them or
just a single key feature?

The procedure for how to carry out the inspection including training is
critical. Important factors include background noise and activity,
interruptions, lighting, time available to carry out the inspection and
whether more than one activity is being carried out at the same time.
These will change with location, time of day and random events. eg. a
phone ringing can cause distractions leading to someone forgetting
whether or not they have carried out the inspection.

-   **The number of manufacturers, range of products and strengths make
    it an impossible task to remember all the overt features associated
    with a particular product**.

There is no single standard for overt features, which include holograms,
colour change inks and complex designs with each manufacturer selecting
and using different technologies. With hundreds of manufacturers and
thousands of branded products. Different strengths and generic products
add to this complexity

-   **Not all fraudulently supplied product has counterfeit packaging**

> Stolen product, diverted product and product that has been produced
> using stolen genuine packaging are examples where the product would
> pass human inspection for overt features.

For these reasons the process for identifying fraudulent product must

-   not rely on manual visual inspection by patient or healthcare
    professionals

-   enable authentication to take place automatically across the range
    of pharmaceutical dosage forms and presentations

-   be a global solution, able to be implemented in the USA and other
    developed markets as well as those in developing countries

-   be applicable to a variety of technologies which can uniquely
    identify each pack, not just product or batch number.

PA agrees with the FDA conclusions that there is no one single magic
bullet that will prevent fraudulent pharmaceuticals entering the supply
chain.

PA believes that one major improvement in security is by providing
product authentication at the point of dispensing.

This provides assurance that at the time of authentication the pack is
genuine. It also allows checks to be made that the product is within
shelf life, not subject to any recall or similar notice, and also
provides an alert check for any labelling and indication and
contra-indication changes.

The real time identification of fraudulent packs enables the healthcare
professional to remove product from the supply chain and not dispense to
patients. Once removed, company experts can investigate the case
involving regulatory agencies as appropriate.

For products are purchased via the internet, authentication can be
carried out by the patient at the point of receipt in the comfort of
their home.

# 

# How it works

PA's method involves uniquely identifying each product pack and a
secure database which is accessible at the point of dispensing.

As well as the product identifier bar code. Manufacturers add a unique
identifier onto each pack. This could be either be in a barcode format
or RFID tag. The selection of which barcode format or RFID
identification technology is for the manufacturer to decide. This will
depend on company policy as well as the particular product.

At the time of manufacture the pack identity is read and entered into
the secure database.

On dispensing the pack is scanned using a scanner that picks up the
product identifier and pack unique identifier. Scanner is unique in
having ability to read different types of bar codes and RFID

This information is sorted and compared with the list of valid
identities for that product, held in the secure database.

A message is then sent to the dispenser that the identity is valid or
not. Information on expiry, recall and labelling/indication changes are
communicated at this point.

# Anti-counterfeiting Security

# 

# Application of unique identities on the manufacturing line and reading the identity into a secure database at the time of manufacturing provides a barrier for counterfeiters

# 

# It is possible to copy bar codes but as each contains the unique identifier each bar code can only be used once. Increasing complexity for counterfeiters and limiting the opportunity for quick returns.

# 

# RFID's can't easily be cloned, using read only tags which only contain only the unique identity number and no other information limits the misuse potential in the event that they are stolen A further level of security is provided by random supply of tags to manufacturers.

# 

# Bulk Packs

The wide use of bulk packs for oral products in the USA is a concern. It
is envisaged that bulk packs will have their own unique identity. Stock
control on the quantity dispensed from a bulk container, and
authentication each time a quantity is dispensed will indicate when no
further stock can be authenticated from that bulk. Thereby preventing
widespread dilution of product or refilling used bulk containers with
counterfeits.

**UK Pilot**

PA is planning a pilot in the UK involving manufacturers, wholesalers,
retail pharmacists and hospitals. This will take place during Q1 and Q2
in 2004 and has support from professional and trade associations as well
as a variety of government departments.

**USA**

The manufacturers involved in the UK pilot are all global suppliers.
They are watching the UK pilot with great interest and also waiting for
the FDA anti-counterfeiting task force final report (January 2004)
before deciding on any particular strategy for the USA market

The process described above uses existing proven technologies, this will
provide a comprehensive safeguard for patients that the product they are
taking is genuine and will maintain professional and public confidence

**Andrew Gill**\
Product and Process Engineering

**PA Consulting Group**\
Cambridge Technology Centre\
Melbourn\
Hertfordshire SG8 6DP

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