Pharmaceutical Commerce - June 2018 - 20

F E AT U R E

How tackling counterfeit drugs will drive
Big Data and AI will bring value beyond compliance
BY JALEEL SHUJATH, OPENTEXT

W

ith the US and EU about to implement the next stage of
their 'track and trace' legislation to combat illegal drugs in
the pharmaceutical supply chain. Whether illegally diverted

from the supply chain through theft or introduced into the supply chain via
counterfeits, every company must prepare to ensure compliance. This is a
challenge. It's also a major opportunity. Artificial Intelligence (AI) will allow companies to use their
'track and trace' programs to deliver new levels of transparency and visibility to their supply chains.
Counterfeit goods are a major issue in every industry.
Analyst firm PWC estimates that counterfeit products have
cost almost $1.6 trillion in the 2010s, more than tripling
from the decade before. With annual sales of over $1 trillion,
prescription drugs lead the list of products counterfeited. [1]
The effects of these drugs can be devastating. It's
estimated that one million patients die each year through
toxic or ineffective counterfeit product and that there are as
many as 450,000 preventable malaria deaths annually from
counterfeit pills.
No one in the life sciences industries is opposed to
measures to help ensure the integrity of the pharmaceutical
supply chain. Properly implemented, track and trace should
provide a "virtuous cycle" that benefits government, the
pharmaceutical companies and patients. If we can always
prove that drugs are what they say they are then the entire
industry can drive improvements in patient outcomes
worldwide.

Track & trace: A catalyst for change

In November 2018, pharmaceutical manufacturers
will need to deliver lot-level traceability with product
serialization at an individual unit level to comply with
the Drug Supply Security Act (DSCSA). Mandated details

20 \ Visit our website at www.PharmaceuticalCommerce.com \ 06.2018

include product identifier, serial number, lot number and
expiration date. By 2023, there must be complete product
traceability from manufacturer to dispenser.
The EU Falsified Medicines Directive (EU FMD) brings
similar track and trace requirements to all EU countries in
2019. This activity sits within a global environment where
more than 40 countries already have or are implementing a
track and trace regime.
The pharmaceutical sector is an increasingly global
business. Pharmaceutical manufacturers have operations
throughout the world. The production of drugs often
involves processes taking place in multiple different
locations. The shape and nature of the global pharmaceutical
supply chain is changing. Contract manufacturers and
contract packagers are becoming more prominent and
the supply chain is based on collaboration rather than
distribution.
The linear supply chain operation from manufacturer to
patient is being replaced by a networked environment where
supply chain partners work more closely together and role
definitions blur (Fig. 1). For instance, major manufacturers
are acting as distributors to other manufacturers in some
territories and pharmacists are acting as wholesalers to
other pharmacists where it makes sense.


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - June 2018

Table of Contents
Pharmaceutical Commerce - June 2018 - Cover1
Pharmaceutical Commerce - June 2018 - Cover2
Pharmaceutical Commerce - June 2018 - Table of Contents
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Pharmaceutical Commerce - June 2018 - Cover3
Pharmaceutical Commerce - June 2018 - Cover4
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