Beyond Simple Pedigrees:
Achieving Concordance
To maintain patient trust, tamper evidence must back up pedigree programs.
By Ralph L. Dillon and Joseph F. Noferi
Compliance Surety Associates (Chicago)
Beyond any pedigree legislation or
company-instituted requirement
is an underlying desire for safe
medicine. Pharmaceuticals (like food
products) are highly vulnerable to
deliberate and/or accidental disruption. Yet pharmaceutical products are
critical to the social, economic, and
political stability of societies around
the world. No other economic sector
is more dependent on consumer confidence. Consumers, voters, and legislators all believe that people in
medical need should get the proper
medicine, in the proper way, and then
be able to use it compliantly.
Pharmaceutical manufacturers
hold an almost sacred trust, given to
them by their customers, to provide
safe and effective therapeutic products. A bare, unlabeled tablet has
almost no intrinsic value on its own—
the value is derived from the pedigree
of the manufacturer and the belief
that the therapy will change life for
the better.
Counterfeit drugs breach this trust
so carefully established by the legitimate healthcare industry. After previous tampering and counterfeiting
incidents, legislatures have rushed to
pass laws that will make constituents
feel safe again. Twenty-five years ago,
with over-the-counter products in the
United States, the legislative reaction
to an infamous tampering incident in
Chicago resulted in laws for “tamper
evidence.” Currently, legislative
attempts to solve the “new” problem
of counterfeiting are the various
pedigree laws and associated rules in
various jurisdictions. Each pedigree
Concordance means
fully meeting the
intent of
rules and
expectations.
New rules will probably include additional reporting requirements and
organizational structure modifications that will increase the cost of
doing business. Pharmaceutical companies will necessarily center on the
quality systems, communication pathways, and business processes supporting such operations. Companies can
rush to comply with the pedigree
rules, but unless these are worked
into, and in conjunction with, other
safety-driven technologies, such as
tamper evidence, the intent of the
legislation will be missed.
law’s intent is to help ensure that
drugs are safe.
Legislative proceedings will most
likely continue for years to come.
CONCORDANCE
In the factories and laboratories,
GMPs drive accountability and traceability for all activities. Moving into
Risk of inappropriate
product use
Product
Level of Care
Level of Care
• Concordance
Appropriate good product enhances health
because taken properly and monitored
• Compliance
Good product delivered properly
• Supply Chain
Good product delivered
• Product
Manufacturing makes product well
Increasing
Legal
Standard
0 ➜ Substantial
Figure 1. Patients expect drugs to be safe and effective. Consequently, for today’s healthcare product packagers, the highest standards of concordance should be applied well before every sale to
ensure the customer gets what they intended and expected each and every time.
