Pharmaceutical Commerce - July/August 2017 - 8

Top News
URAC plans a specialty-pharmacy workshop in conjunction
with the NASP annual meeting
Specialty pharmacy accreditation attracts growing number of pharmacies
Immediately following the upcoming
National Assn. of Specialty Pharmacy
Annual Meeting (Washington, DC, Sept.
17-20), URAC, an independent healthcare
accreditor, will be holding a two-day
workshop (Sept. 21-22) on what it calls the
Pharmacy Core, Specialty Pharmacy (SP)
and Mail Service Pharmacy accreditation
standards. SP accreditation has been of
high interest to pharmacies (whether
chain, independent, or part of health
systems and other organizations) seeking
to handle the burgeoning field of specialty
pharmaceuticals; payers and manufacturers

look for URAC accreditation as part of
choosing which pharmacies to work within
specialty pharmaceutical distribution and
In the past couple years, the number
of pharmacies obtaining (or entering the
process for) URAC SP accreditation has
roughly doubled to more than 400, notes
Heather Bonome, PharmD, director
of pharmacy at URAC. "Payers, PBMs
and others look to URAC accreditation
as validation of the quality of service
the specialty pharmacy provides," she
comments, adding that in recent months,

there has been rising participation by
independent pharmacies, and by health
systems that are setting up their own SPs.
URAC's accreditation standards look
closely at how pharmacies document
their internal practices, and there is a new
emphasis on proper cold-chain practices to
ensure that temperature-sensitive specialty
pharmaceuticals are being handled safely.
Additionally, URAC has recently updated
its Pharmacy Core standard, and the new
elements of this standard will influence the
SP standard in the near future. (The current
SP standard, ver. 3.0, was last revised in

2015; a new one will be developed over the
next two years or so.) For more information
and to register for the two-day workshop, go
NASP is also scheduling a "CSP Prep
Course," a look at the testing requirements
of the Certified Specialty Pharmacist, a
professional credential that it has organized
as the function of the Center for Specialty
Pharmacy Education (CSPE). That will be
held on Sept. 18. More information at www.

Arxium promotes a
"Pharmacy 4.0" perspective
on automated compounding
Technology combines automated equipment with
workflow and analytic software
Over the past year or so, Arxium
(US HQ: Buffalo Grove, IL) has added
upgraded software to its RIVA pharmacycompounding system, which features
robotic arms, ISO Class 5 containment
of the filling space, and options for vial
or syringe packaging and labeling. The
Optifill material handling option
enables prescription fulfillment on the
order of tens of thousands per work
shift. Complementary software includes
RxWorks Pro, a scheduling and inventory
management system. Now, the company
is uniting all these capabilities under a
"Pharmacy 4.0" theme, which borrows
from a manufacturing automation trend,
Industry 4.0 (aka the "Smart Factory").
Software will enable better quality control
of the filling process, coordination with
order management, and analy tics to
monitor and improve overall equipment
effectiveness (OEE).
"We're t r y ing to br ing a moder n
manufacturing and supply chain
perspective to central fill pharmacies and
pharmacy compounding with Pharmacy
4.0," says Thomas Doherty, Arxium EVP.
"The trend in pharmacy is increasing
complexity and increasing volumes in
central fill functions, so that it looks more
like a manufacturing process taking in 'raw
materials' and distributing 'finished goods'
to customers."
Compounding is widely practiced in
the pharmacy community, but it is usually
a manual process, and there have been
painful lapses in product quality and
patient safety, notably the New England
Compounding Center scandal of 2012,

which was one of the factors leading to
passage of the Drug Quality and Security
Act in 2013 (Pharmaceutical Commerce,
Nov/Dec 2013, p. 31). DQSA, in turn,
created the 503b category of compounding
pharmacies, which are supposed to meet
cGMP standards (there are now just
over 70 pharmacy locations in the 503b
program; a significant number of them
have outstanding FDA 483 warning
letters*). Another relevant standard is USP
<797>; here, too, industry data indicates
that only some compounding pharmacies
meet that standard (all of Arxium's
installations are capable of meeting USP
Compounding is important whenever a
drug's dosage or method of administration
(injection, drinkable liquid or other
modifications) needs to be adjusted to
specific patients. That process has become
more critical for the newer biologics and
many traditional oncology drugs whose
dosage is tied to, for example, the patient's
weight. Doherty says that nearly 50 RIVA
systems have been installed in the past
nine years, and interest is rising within
health systems and integrated delivery
networks that have central-fill pharmacies.
Routinely, says Doherty, RIVA systems
open up already packaged pharmaceuticals
(including, it is worth noting, vibrationsensitive monoclonal antibodies) and
reconstitute or otherwise manipulate the
dosage. There will come a time-not yet-

8 Visit our website at July | August 2017

A suite of Riva drug-compounding stations is in place at Intermountain Healthcare.
Credit: Arxium

when pharma manufacturers who want to
supply health system pharmacies effectively
will be designing their containers to fit
with RIVA's automated processing.
Gottlieb weighs in
A ro u n d t h e t i m e o f t h e A r x i u m
announcement, FDA Commissioner Scott
Gottlieb assessed the current regulatory
situation with compounding pharmacies,
n o t i n g t h a t a s of Ju n e 1 , " F DA h a s
conducted more than 400 inspections,
including 109 inspections of outsourcing
facilities; issued more than 150 warning
letters advising compounders of significant
violations of federal law; issued more than
50 letters referring inspectional findings
to state regulatory agencies; overseen
over 125 recalls involving compounded
drugs; and worked with the Department of
Justice on a number of civil and criminal
enforcement actions.
"As part of the implementation of
DQSA," he went on to say, "we have
also issued 21 draft guidances, 10 final

guidances, three proposed rules, a final
rule and a draft memorandum of
understanding. We have taken a riskbased approach to all of these efforts, in
order to make sure that we are maximizing
the public health purpose of these new
provisions relative to the resources we use
to achieve them, and any obligations that
these new requirements place on market
Ironically, the NECC compounding
crisis that propelled all this activity
forward was also in the news recently: the
sentencing of Barry Cadden, co-owner of
the now-shuttered pharmacy, to nine years
in federal prison. He had been convicted
of fraud and racketeering in the case,
but not of second-degree murder, which
prosecutors had sought due to the deaths
of at least 60 victims of the contaminated
drug that NECC had compounded and
distributed nationally.

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2017

Table of Contents
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Pharmaceutical Commerce - July/August 2017 - Table of Contents
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Pharmaceutical Commerce - July/August 2017 - Cover4