Pharmaceutical Commerce - November/December 2016 - 9


Top News
The fentanyl-opioid crisis is a counterfeiting crisis
More evidence that drug abusers are at risk from counterfeiters
An epidemic that has been brewing
for months now is coming into clearer
focus: the use of fentanyl to lace illicit
opioid-based drugs with higher potency,
resulting in thousands of deaths nationally.
The topic made Page 1 news on the Wall
Street Journal recently with a somewhat
innocuous headline, "The pill makers next
door," but the details in that story should be
of concern to many drugmakers, including
generic oral solids manufacturers.
The current fentanyl-opioid epidemic
has seen deaths from overdoses nearly
doubling from 2013 to 2014 with some
5,500 deaths in that year according to
CDC statistics. Academic papers published
earlier this year* cautioned emergency
room physicians to test for the presence of
fentanyl when overdose patients arrive; the
proper diagnosis can help recovery.
DEA and other federal agencies have
been tracking the growth of opioid drugs
mixed with fentanyl for a couple of years;
a recently published Intelligence Brief
notes that much of the fentanyl comes
from labs in China, especially after a lab
in Mexico was shut down in 2006. At that
time, most of the fentanyl was being used
to increase the potency of heroin; now,
it's going into pills, and some of the pills
are formed to simulate the trade dress of
legitimately produced opioid medications.
The insidiousness of this is two-fold: street
prices for pills that look like prescription
products can sell for a premium (in fact,
heroin and other drugs have long been
"branded" in various ways); and as the US
drug supply and distribution system gets
better at managing the use of legitimate
opioid-based medicines, the value of the
counterfeited product goes up. (In early
October, DEA issued its so-called Aggregate
Production Quota for 2017, the volume of
opiate APIs used to produce prescription
products and research purposes, by 25% or
* http://pharmaceuticalcommerce.com/latest-news/fakedrugs-intrusion-us-twist/

more in some cases, based on the declining
rate of prescribing going on now.)
The other aspect of concern is that it is
ridiculously easy to counterfeit currently
manufactured opiates. The generic products
have some simple cut lines or letter-number
combinations (see photo); these pills are

is becoming a trend, not a series of isolated
incidents," warns DEA.
Fentanyl is 50 times as potent as heroin;
if there are more than two milligrams of
fentanyl in an opioid pill, it can be fatal.
DEA says that a kilo of fentanyl can be
purchased for prices ranging from $1,700 to

Evidence bag of counterfeit pain pills. Credit: DEA

being counterfeited by hand using simple
pill presses that cost around $1,000. (DEA
actually tries to control the import of pill
presses, but they can get through Customs
by being delivered as parts claimed to be
other types of equipment.) The "next door"
pill maker highlighted in the WSJ article
was a husband-and-wife couple operating
out of a two-bedroom San Francisco, CA
apartment. "The seizures of fentanyl-laced
pills and clandestine pill press operations
all across North America indicate that this

$3,500; at 1 mg per pill, that kilo translates
into $10-20 million in profit at street prices
of $10-20 per pill.
Manufacturer countermeasures
Mallinckrodt, like most other makers
of opioid-based medications, has been
fighting energetically to prevent abuse
of its legally prescribed prescription
products; now it is dealing with counterfeits
displaying the same "M367" trade dress
on its pills. "We have been working with

the US DEA concerning their investigation
into the California incidents. More broadly,
Mallinckrodt has supported and worked
over multiple years with law enforcement at
all levels concerning counterfeit versions of
products the company manufactures," the
company told Pharmaceutical Commerce
after the WSJ ar ticle app eared. For
conventional abuse (if such a concept is
even meaningful), the company's actions
have included "opioid educational efforts,
monitoring for suspicious orders of
controlled substances, drug deactivation
and disposal programs, and research
into abuse-deter rent technolog ies;"
it also supports the establishment of
prescription drug monitoring programs
(PDMPs), which are state-level actions to
prevent doctor-shopping to fill multiple
p re s c r i p t i o n s f o r o p i o i d p ro d u c t s .
(Ironically, Missouri, the home state of
Mallinckrodt, is the only one lacking such
a program.)
DEA's Intelligence Brief notes that
there are other counterfeiting activities
going on; one cited is counterfeit Xanax
(benzodiazepine). This indicates that
drug traffickers "are also willing to utilize
fentanyls in other non-opiate drugs
with exploitable user populations," DEA
concludes.
There are criminal penalties for both
drug counterfeiting and for illegal drug
distribution; generally speaking, the
penalties for the latter are more severe than
the former. So it might make some sense that
the homebrew counterfeiter is getting more
attention from DEA than from FDA. But
the enormous profits available to fentanylcontaining counterfeiting, combined with
the lethality of the practice, might change
law enforcement's thinking. Bills have
been introduced to Congress in multiple
recent years to increase the penalties
of counterfeiting to include life in prison
or other penalties, but have not passed
to date.

Veeva shakes up clinical, quality management IT landscape
Steady uptake in clients highlights the company's Vault cloud-computing platform
Veeva isn't the only IT company
putting life sciences data into cloud-based
data storage, and it has many competitors
for applications in clinical research and
quality management. But the combination
of the two, propelled by the company's
prior success in salesforce automation and
document management, points to a change
in internal life sciences data-management
practices.
Some 600 clients, prospects and industry
leaders gathered in Philadelphia, PA at the
company's R&D Summit to ponder these
changes. Veeva touted its success in getting
new clients for Veeva Vault QMS and Veeva

Vault QualityDocs (now in use at 79 life
sciences organizations). A varying number
of clients are also using Veeva Clinical
Suite, with recently introduced Vault EDC
(electronic data capture) Vault Study
Startup, Vault eTMF (trial master file) and
Vault CTMS (clinical trial management
system).
Market research by the firm indicates
that conveying data from a CTMS to a TMF
system is a nagging problem for half of life
sciences research organizations; it also cites
the explosion of data being reported during
trials-Phase III data has grown by 50%
since 2000. inVentiv Health, a leading CRO

that has been using Vault eTMF, announced
the addition of Vault Study Startup.
"Combining the Vault platform and with
our comprehensive global regulatory and
start-up expertise, encompassing highquality essential document collection
and rapid side contracting, enhances our
approach to site activation," said Susan
Stansfield, PhD, EVP, Site Centricity Unit,
inVentiv. (A "site centricity" business
function is telling, in itself, of the complexity
of managing trial sites.)
Many of the quality management
applications Veeva is talking about are
relevant to clinical research; however,

the company is also seeking to combine
the quality work going on in that setting
with others, such as manufacturing and
regulatory compliance. Dealing with quality
management functions across contract
providers adds to the data management
problem. Some pharma companies are
structured with an enterprise-wide quality
management function, but others handle
this by each operating unit, such as clinical,
manufacturing, distribution and others. A
unified IT approach could lead to a unified
quality management function.

November | December 2016 Visit our website at www.PharmaceuticalCommerce.com 9


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2016

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Pharmaceutical Commerce - November/December 2016 - Table of Contents
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Pharmaceutical Commerce - November/December 2016 - Cover4
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