pedigree information is still meaningful. Disruption of tamper evidence,
identified in the supply chain, gives the
manufacturer investigational keys to
correct any systemic problems.
For example, consider the recent
instance of a hospital nurse in Mankato, MN, who was found to be withdrawing Fentanyl from vials and replacing it
with a saline solution. The nurse had
worked at the hospital for eight years.
Fentanyl is a painkiller similar to morphine (but considerably more powerful),
reports the National Institute on Drug
Abuse at the National Institutes of
Health. It goes by several street names,
including “murder 8” and “TNT” and
is sometimes mixed with heroin or
cocaine to amplify their potency.
Such tampering resulted in diluted
medication, which could have led to
less-effective sedation and pain management. The hospital issued 335 letters to patients who had procedures
involving sedation in affected laboratories during all of February 2008 and in
early March, explaining the situation
and inviting them to contact the hospi-
The most unusual aspect of this case
Each pedigree law’s
intent is to help ensure
that drugs are safe.
Concordance
(from the Oxford English Dictionary)
/k∂nkord’ns/
• noun 1.) an alphabetical list of the important words in a text, usually with
citations of the passages concerned; 2.) formal agreement.
ORIGIN from Latin concordare: “agree on.”
Concordance, in the world of
pharmaceutical and medical devices,
means fully meeting the intent of the
rules and expectations of all the parties—manufacturers, clinicians,
patients, payers, etc. For manufacturers, it means providing to the customer what the customer expects in a
way in which the customer will use it.
Patient compliance closes the concordance loop.
Concordance, as a term, may not
be as familiar to North Americans as it
is to others throughout the world. But
as a concept, concordance has been
ingrained in commerce since the day
in 1927 when Sears & Roebuck proclaimed, “Satisfaction or your money
back.” Hard goods had the advantage
that, generally speaking, the “return of
money” would make a buyer whole if
the goods didn’t meet expectations.
In pharmaceuticals and medical
devices, though, if there is a problem,
there can be severe consequences
that cannot be remediated by simply
returning money. To that very fact,
Sears & Roebuck had dropped the
sale of “patent medicines” in 1913, in
part because the company recognized
that consistently delivering high-quality
medicine that met expectations was a
bit more complicated than delivering
other products.
Concordance is the underlying precept that allows people to buy with
confidence products that are made by
people in different cultures with different languages and different rules. Likewise, it allows us to make products for
other countries where we do not
speak their language and are not able
to directly read their language. People
take medicine with the expectation
that it is safe and will make them well.
Concordance speaks to that higher
purpose as an objective.
Consequently, for today’s healthcare product packagers, the highest
standards of concordance should be
applied well before every sale, to
ensure that the customer gets what
they intended and expected each
and every time.
is probably not that it happened,
because this type of diversion occurs
all the time with narcotics and high-value products. (Drugs and other
accessible items with a street value
have been stolen from helpless patients
for as long as there have been patients
and a drug industry.) The unusual
aspect is that it happened, and it was
caught, and it became public.
Good pedigree systems standing
alone would not have precluded this
incident. Remembering that the intent
of all pedigree legislation is “safe medicine,” a package professional will serve
his or her company well by supporting
and improving the tamper evidence of
all packaging as part and parcel of any
pedigree projects.
In our next pedigree installment,
scheduled for the Fall 2008 issue of
Tracking & Tracing Pharmaceutical
Products, we will explore tamper-evident measures that manufacturers and
distributors can take to fortify their
supply chain, to help ensure the
integrity of their pedigree systems.
For further information, please contact the authors at CSA.chicago@
yahoo.com. ■
To read more from authors
Ralph Dillon and Joseph Noferi,
please see the article “Clearing
the Bar” in the March 2008 issue
of Pharmaceutical&Medical
Packaging News at
www.pmpnews.com
