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
dispensing.
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
to http://bit.ly/2tYJ6WA.
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.
naspmeeting.com.

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
<797>).
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-
*https://www.fda.gov/drugs/
guidancecomplianceregulatoryinformation/
pharmacycompounding/ucm378645.htm

8 Visit our website at www.PharmaceuticalCommerce.com 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
participants."
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.


http://www.bit.ly/2tYJ6WA http://www.naspmeeting.com http://www.naspmeeting.com https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm http://www.PharmaceuticalCommerce.com

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

Table of Contents
Pharmaceutical Commerce - July/August 2017 - Cover1
Pharmaceutical Commerce - July/August 2017 - Cover2
Pharmaceutical Commerce - July/August 2017 - Table of Contents
Pharmaceutical Commerce - July/August 2017 - 4
Pharmaceutical Commerce - July/August 2017 - 5
Pharmaceutical Commerce - July/August 2017 - 6
Pharmaceutical Commerce - July/August 2017 - 7
Pharmaceutical Commerce - July/August 2017 - 8
Pharmaceutical Commerce - July/August 2017 - 9
Pharmaceutical Commerce - July/August 2017 - 10
Pharmaceutical Commerce - July/August 2017 - 11
Pharmaceutical Commerce - July/August 2017 - 12
Pharmaceutical Commerce - July/August 2017 - 13
Pharmaceutical Commerce - July/August 2017 - 14
Pharmaceutical Commerce - July/August 2017 - 15
Pharmaceutical Commerce - July/August 2017 - 16
Pharmaceutical Commerce - July/August 2017 - 17
Pharmaceutical Commerce - July/August 2017 - 18
Pharmaceutical Commerce - July/August 2017 - 19
Pharmaceutical Commerce - July/August 2017 - 20
Pharmaceutical Commerce - July/August 2017 - 21
Pharmaceutical Commerce - July/August 2017 - 22
Pharmaceutical Commerce - July/August 2017 - 23
Pharmaceutical Commerce - July/August 2017 - 24
Pharmaceutical Commerce - July/August 2017 - 25
Pharmaceutical Commerce - July/August 2017 - 26
Pharmaceutical Commerce - July/August 2017 - 27
Pharmaceutical Commerce - July/August 2017 - Cover4
https://www.nxtbook.com/nxtbooks/pharmcomm/202006
https://www.nxtbook.com/nxtbooks/pharmcomm/202003
https://www.nxtbook.com/nxtbooks/pharmcomm/201911
https://www.nxtbook.com/nxtbooks/pharmcomm/201909
https://www.nxtbook.com/nxtbooks/pharmcomm/201906
https://www.nxtbook.com/nxtbooks/pharmcomm/201903
https://www.nxtbook.com/nxtbooks/pharmcomm/201811
https://www.nxtbook.com/nxtbooks/pharmcomm/201809
https://www.nxtbook.com/nxtbooks/pharmcomm/201806
https://www.nxtbook.com/nxtbooks/pharmcomm/20180304
https://www.nxtbook.com/nxtbooks/pharmcomm/20171112
https://www.nxtbook.com/nxtbooks/pharmcomm/20170910
https://www.nxtbook.com/nxtbooks/pharmcomm/20170708
https://www.nxtbook.com/nxtbooks/pharmcomm/20170506
https://www.nxtbook.com/nxtbooks/pharmcomm/20170304
https://www.nxtbook.com/nxtbooks/pharmcomm/20170102
https://www.nxtbook.com/nxtbooks/pharmcomm/20161112
https://www.nxtbook.com/nxtbooks/pharmcomm/20160910
https://www.nxtbook.com/nxtbooks/pharmcomm/20160708
https://www.nxtbook.com/nxtbooks/pharmcomm/20160506
https://www.nxtbook.com/nxtbooks/pharmcomm/20160304
https://www.nxtbook.com/nxtbooks/pharmcomm/20160102
https://www.nxtbook.com/nxtbooks/pharmcomm/20151112
https://www.nxtbook.com/nxtbooks/pharmcomm/20150910
https://www.nxtbook.com/nxtbooks/pharmcomm/20150708
https://www.nxtbook.com/nxtbooks/pharmcomm/20150506
https://www.nxtbook.com/nxtbooks/pharmcomm/20150304
https://www.nxtbook.com/nxtbooks/pharmcomm/20150102
https://www.nxtbook.com/nxtbooks/pharmcomm/20141112
https://www.nxtbook.com/nxtbooks/pharmcomm/coldchaindirectory2014
https://www.nxtbook.com/nxtbooks/pharmcomm/20140910
https://www.nxtbook.com/nxtbooks/pharmcomm/20140708
https://www.nxtbook.com/nxtbooks/pharmcomm/20140506
https://www.nxtbook.com/nxtbooks/pharmcomm/20140304
https://www.nxtbook.com/nxtbooks/pharmcomm/20140102
https://www.nxtbook.com/nxtbooks/pharmcomm/dataservicedirectory
https://www.nxtbook.com/nxtbooks/pharmcomm/20131112
https://www.nxtbook.com/nxtbooks/pharmcomm/20130910_hubreport
https://www.nxtbook.com/nxtbooks/pharmcomm/20130910
https://www.nxtbook.com/nxtbooks/pharmcomm/20130708
https://www.nxtbook.com/nxtbooks/pharmcomm/20130506
https://www.nxtbook.com/nxtbooks/pharmcomm/coldchain2013
https://www.nxtbook.com/nxtbooks/pharmcomm/20130304
https://www.nxtbook.com/nxtbooks/pharmcomm/20130102
https://www.nxtbook.com/nxtbooks/pharmcomm/20121112
https://www.nxtbook.com/nxtbooks/pharmcomm/20120910
https://www.nxtbook.com/nxtbooks/pharmcomm/20120708
https://www.nxtbook.com/nxtbooks/pharmcomm/20120506
https://www.nxtbook.com/nxtbooks/pharmcomm/20120506_coldchain
https://www.nxtbook.com/nxtbooks/pharmcomm/20120304
https://www.nxtbook.com/nxtbooks/pharmcomm/20120102
https://www.nxtbook.com/nxtbooks/pharmcomm/20111112
https://www.nxtbook.com/nxtbooks/pharmcomm/20110910
https://www.nxtbook.com/nxtbooks/pharmcomm/20110708
https://www.nxtbook.com/nxtbooks/pharmcomm/20110506
https://www.nxtbook.com/nxtbooks/pharmcomm/20110304
https://www.nxtbook.com/nxtbooks/pharmcomm/20110102
https://www.nxtbook.com/nxtbooks/pharmcomm/20101112
https://www.nxtbook.com/nxtbooks/pharmcomm/20100910
https://www.nxtbook.com/nxtbooks/pharmcomm/20100708
https://www.nxtbook.com/nxtbooks/pharmcomm/20100506
https://www.nxtbook.com/nxtbooks/pharmcomm/201004
https://www.nxtbook.com/nxtbooks/pharmcomm/201003
https://www.nxtbook.com/nxtbooks/pharmcomm/20100102
https://www.nxtbook.com/nxtbooks/pharmcomm/20091112
https://www.nxtbookmedia.com