Pharmaceutical Commerce - September/October 2017 - 18

Market Access
Is the opioid crisis a national emergency?
Commission issues interim report with numerous calls to action, while manufacturers and distributors
contend with multiple DEA penalties
If the position of the Commission on
Combating Drug Addiction and the Opioid
Crisis is to be believed, the US is in the
midst of a national public health emergency
on par with a natural disaster or terrorist
attack, and immediate action is called
for. Yet, this interim report was prepared
in the midst of the rancorous debate over
repealing Obamacare-regarded by its
opponents as an unnecessary intrusion of
the federal government into healthcare-
and so the result is an odd combination of
a call to action combined with "listening
sessions" and public hearings, and a goal
of issuing a final report Oct. 1. (The
Commission missed the original deadline
for submitting an interim report, as
specified by President Trump's March 29
executive order, by a month already.) In
August, President Trump acknowledged
that the crisis is emergency-level, but as of
press time had not directed any new federal
effort.
Some of the delay might be the cognitive
dissonance between the actions at the
federal level called for while Congress has
been debating many ways to reduce federal
healthcare support. Among other items, the
Commission calls for:
* E xpa nding t he avai labi lit y of
Me d ic a id f u n d s for m e nt a l h e a lt h
programs (which would include substance
abuse disorders [SUDs])
* Mandating additiona l physician
training, by HHS, for physicians involved
in opioid prescribing
* Funding more medication-assisted
t re at ment (M AT), w h ic h wou ld b e
a boon for a nt i-abuse d r ugs such as
buprenorphine; there's also mention of
having NIH "to begin to immediately
work with the pharmaceutical industry" to
develop non-opioid pain relievers
* Federal funding to expand datasharing across state lines in prescription
drug monitoring programs (PDMPs),
currently in use in 49 states.
All of these call for increased federal
funding and agency involvement in
healthcare industry practices; some of them
could be implemented immediately, raising
the question of what is the holdup?
Suspicious order monitoring
The Drug Enforcement Administration
(DEA) shows up in the interim report
as the enforcer of additional education
verification for prescribers, and as one of the
agencies to combat the illegal importation
of fentanyl, heroin and other opioid-based
drugs. In the past year, besides the everyday
interdiction that DEA (and other agencies)
perform, DEA and the Dept. of Justice
have been levying heavy fines against both
drug distributors (each of the Big three has

been hit, most notably McKesson's record
$150-million settlement in January) and
manufacturers. The manufacturer targeting
is a new development: now, manufacturers
are being called on to maintain "suspicious
order monitoring" (SOM) systems, just
like distributors. In early July, Mallinckrodt
settled with DoJ on a $35-million civil
fine; Mallinckrodt is one of the largest
manufacturers of generic oxycodone. The
DoJ statement noted that:
[T]he government learned that
manufacturers of pharmaceuticals offer
discounts, known as 'chargebacks,' based
on sales to certain downstream customers.
Distributors provide information on the
downstream customer purchases to obtain the
discount. The groundbreaking nature of the
settlement involves requiring a manufacturer
to utilize chargeback and similar data to
monitor and report to DEA suspicious sales
of its oxycodone at the next level in the supply
chain, typically sales from distributors to
independent and small chain pharmacy and
pain clinic customers.
It has not been the case, historically, that
manufacturer chargeback management is
a resource for preventing drug abuse; that
might now be changing.
At first glance, the settlements with
DoJ are surprising, given that a law, the
Ensuring Patient Access and Effective
Drug Enforcement Act, was passed in early
2016 specifically to create coordination
between DEA and drug wholesalers and
manufacturers over SOM. An interagency
report to Congress was to have been
developed by last April on how the involved
parties could work together (as opposed to
DEA simply shutting down warehouses of
legitimate, registered businesses). Also, the
members of the Healthcare Distribution
Alliance (which lobbied energetically for the

law) "await DEA's guidance on suspicious
order monitoring, which will go a long way
to provide the additional clarity we seek on
how we can be a productive and cooperative
partner in the fight against prescription
drug abuse," according to John Parker, SVP,
communications, at HDA.
Most of the recent settlements between
industr y and DoJ involve situations
from the mid-2000s to the early 2010s-
before the law was passed. Nevertheless,
t h e s e t t l e m e n t s a re b o u n d to ke e p
manufacturers and distributors on edge-
as maybe they should be.
S O M , i n t h e o r y, s h o u l d n o t b e
profoundly difficult to implement (and to
be sure, most major manufacturers and
distributors have an SOM system in place-
DEA, however, cites companies ignoring
the output of their own SOM systems in
some cases). The companies are supposed
to use statistical techniques to watch for
unusually high levels of opioid transactions,
and question the legitimacy of those orders.
Sumeet Singh, president of Five Rivers RX
(King of Prussia, PA) says that his company
offers a relatively low-cost statistical
package suitable for small distributors
to address DEA inspections, as well as
consulting for overall DEA compliance.
The company, which recently joined the
Healthcare Distribution Alliance, has a
primary business in assisting distributors in
meeting the Verified-Accredited Wholesale
D i s t r i b u to r ( VAW D ) a cc re d i t a t i o n
program of the National Assn. of Boards of
Pharmacy.
DEA was also in the news in August when
it issued its Aggregate Production Quotas
(APQs) for Schedule I and II controlled
substances for 2018. (The list includes a
group of ephedrine and pseudoephedrine
Schedule I chemicals as well.) It has
proposed to reduce overall volumes by 20%,
citing the reduced amount of synthetic

opioid prescription consumption in the US.
The action, while legitimate and necessary,
seems to be comparable to the Dutch boy
with the finger in the dike, given the massive
volumes of opioids being illegally conveyed
into the countr y-including opioids
counterfeited to appear like legitimate
prescription drugs, which tend to have a
higher street value.
Abuse deterrence
It would seem reasonable that if
opioid drugs were less easy to abuse, that
abuse would decline. Purdue Pharma
reformulated its extended-release
Oxycontin with abuse deterrent features
in 2010, and nearly all current Oxycontin
prescriptions have been shifted over by
now. But the jury is decidedly out on how
abuse deterrent formulations (ADFs) would
play out in the US healthcare system for
other opioid formulations. Prescription
opioid manufacturers (there are more than
a dozen that belong to the Abuse Deterrence
Coalition, a trade group) have been
lobbying for legislation to compel FDA to

Five ways to reinforce an SOM program
QuintilesIMS Compliance Solutions
(formerly BuzzeoPDMA) has published
a white paper* on suspicious order
monitoring; here are its five points for an
effective SOM program:
1. A defensible SOM model. The model
identifies orders that fit any of the three
criteria:
orders of unusual size, orders deviating
substantially from a normal pattern and
orders of unusual frequency. The most
defensible models are statistically based-
employing advanced mathematics rather
than arbitrary thresholds.
2. Appropriate due diligence, including

18 Visit our website at www.PharmaceuticalCommerce.com September | October 2017

"Know Your Customer" activities. This
can include a range of activities, such
as questionnaires sent to customers and
on-site visits that may be made initially, and
even periodically, over time.
3 . A p p r o p r i a t e r e v i e w a n d /o r
investigations of "pended" orders. Because
labeling an order "suspicious" triggers a set
of reporting requirements, QuintilesIMS
recommends using a term like "pended" to
indicate potentially suspicious orders. That
way, an organization knows to launch its
own internal investigation, which likely will
include contacting the customer via phone
and/or email.
4. Clear, comprehensive SOM standard

operating procedures (SOPs). Ensure that
the organization has a methodology for
how it manages SOM and the supporting
processes.
5. Management support and employee
training. Finally, of course, is creating
an environment of compliance. From
management to front-line employees, the
organizational culture should be committed
to complying with all regulations, including
SOM.
* http://response.us.imshealth.com/suspicious-ordermonitoring-dea/?utm_source=linkedin&utm_
medium=social&utm_campaign=som-compliancewp


http://response.us.imshealth.com/suspicious-order-monitoring-dea/?utm_source=linkedin&utm_ medium=social&utm_campaign=som-compliance-wp http://response.us.imshealth.com/suspicious-order-monitoring-dea/?utm_source=linkedin&utm_ medium=social&utm_campaign=som-compliance-wp http://response.us.imshealth.com/suspicious-order-monitoring-dea/?utm_source=linkedin&utm_ medium=social&utm_campaign=som-compliance-wp http://response.us.imshealth.com/suspicious-order-monitoring-dea/?utm_source=linkedin&utm_ medium=social&utm_campaign=som-compliance-wp http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2017

Table of Contents
Pharmaceutical Commerce - September/October 2017 - Cover1
Pharmaceutical Commerce - September/October 2017 - Cover2
Pharmaceutical Commerce - September/October 2017 - Table of Contents
Pharmaceutical Commerce - September/October 2017 - 4
Pharmaceutical Commerce - September/October 2017 - 5
Pharmaceutical Commerce - September/October 2017 - 6
Pharmaceutical Commerce - September/October 2017 - 7
Pharmaceutical Commerce - September/October 2017 - 8
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Pharmaceutical Commerce - September/October 2017 - 18
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Pharmaceutical Commerce - September/October 2017 - 21
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Pharmaceutical Commerce - September/October 2017 - 24
Pharmaceutical Commerce - September/October 2017 - 25
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Pharmaceutical Commerce - September/October 2017 - 28
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Pharmaceutical Commerce - September/October 2017 - 30
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Pharmaceutical Commerce - September/October 2017 - 34
Pharmaceutical Commerce - September/October 2017 - Cover3
Pharmaceutical Commerce - September/October 2017 - Cover4
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