Levitra Precio En Bogota | Approved Canadian Medications

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Levitra Precio En Bogota | Approved Canadian Medications
Manufacturing
& Packaging
Compliance packaging gets smarter
Unit-dose (compliance) packaging Is providing more patient connectivity and more
patient education, with the goal of raising medication adherence
BV F. J. Quinn
FIg. 1. Uhlmann's Blister Express Center JOO combfnes blis ter assembly and cdrtoonfng, and Is ck!slgned for qukk changeover.
Credit: Uhlmann
The (scalating dialogue on the" importance of incTtasing
p..1tiellll1lcdkatiotl adhuence and reducing heahhcare waste
is helping (uel further inn o'~Jlion in compliance packaging,
obscrV(f'$ report. The latest breakthroughs center on "smart"
packagi ng incorporating automated reminder fea tures
through el«lroni..: d(\;c~ that remind (-",tk llts when to take
their dos.1ge.
"Like ea rly MPJ phl)'ers, the cOllcepts n eed additional
lime and technological d e\'e!opmcnl," S3)'S Bob Gaumonl,
packaging enginuri ng manager at Nosco (Waukegan, Il), a
packaging solutions provider. "Innovation netJs to hap~n
from the package design stage lhrou~ to the human interface
side to make the conapt more widely acceploo,less costly and
truly user-friendly."
Snl3lt packaging might be the key to break the standoff that
h,u existed b.::tw~en compli,mce packaging and cOlwentional
bulk shipping. Compliance packaging is commonly used
for starter kits or ph)~icians' samples, but less frequently for
ddivering ongoing refiil s. Outside the US, it is much more
comlllon, as patients are accustomed to receiving refills in
specific counls from local pharmacies (and where generics
have had a slower take-up than ill the US). The US system,
howe\'tr, is set up for bulk deliveries to distribution centers,
and th(n to rt lail pharmaC)' outielS, ..... here pharmacislS spend
a considerablc portion of their time counting out pills and
filling unbrandcd )'cllow bOltles. One of the obstaclcs 10
compliance packaging is the belicf that it would significanti),
increase the shelf space lI«nsary for k« ping drugs in stock at
the pharnlaC)',
The slakes are high, as mOTe th an 100,000 pcople die
annually in the US for f.!,iling to follo\\' mcdication Ttgimclls,
..... hile the pharm3 industry losts cou ntlcss billions of dollars
from unfilled Rx drugs, according to indu stry estimatcs,
Unlike the cOI1\'cntional 30-count boulc commonly used
throughout North Amcrica, wlit-do.se (adherence) packaging
(UDP) is designed with a focus on unit dosing, reminder
prompting, printed instru ctions, time dating and other
features that enable delivery of thc right dose at the right
time, Adherence packaging safety is enhanccd through childresistance (eiHures and adult-friendly attributes, which make
the p.1,kage ~ASiu for patients to open.
"Thcre is an influx of !lCW packs and ideas," sa}'s Dirk
Corstcn, managing director, Uhlmann Packaging Systems
(TowJ.co, NJ), "And mrut of them are ingenious designs that
are relatively easy to use and also help impro\'e compliance
and patient adherence."
While dcsigns for intclligent packaging ha\'e been around
for more than 20 )'cars, supplicrs report pharnla companies
are growing more receptive to new sophisticated concepts
for various Tusons. For starters, drug makers ha\'(' a bellcr
understanding of the utility of patient data. and smart
packaging elcetronic componc nt costs ha\'e decreased_
Meanwhile, reu-a rchers involved in Phase II and lit clinical
trials are said to "alue the patient data produced, which they
can usc retrospectively to compare pharmacokinetics and
rdattJ medk'1tl rcsullS,
"Another benefit of the d ata collec ted from smart
packaging is that it CAn illuminate h'hat is happening with
patient adherence at both the site and patient le\'d," notes
David Dwrcr, VP, gJobal strategic marketing, healthcare-, at
MeadWu tvaco (MWVi Richmond, VA). "We are sta rling
to see some customcrs measu re the adhere nce levels of
patients assigncd to different silc personnel, so they can better
undcrstand which ~rsolll\eI effeetiydy educale participanlS
on study protocol infonnatioll_"
Historically, R&D emph asized visual communication
through ilu\o\',uiw ~\,lckaging designs such as calendar p3cks.
....ith the belicfthat it would facilitate compliance, "Such \isual
communication a10nc is 1I0t able to sol\'e the issue," declares
Ajith Nair, SVP of g1ob.11 R&D, Dilcare Rese-.lTch {Phoenooille,
PAl, "Inlllost cases, it is patients forgctting to lake th( dos."Igcor knowingly a\'oidillg to adhere to the prescribed dosage
regimen."
$e"eral studies completcd in 2011 suggest that properly
designed pa{kaging ca n pro\ide customers \\ith compliance
solutions that posi!ive\y impact palien,e ad herence and
trcal ment outcomes, Last May, Catalent Pharma Solutions
(Somerset, NI). a providcr or drug deli\'ery technologies and
packaging solutions, announce<! the resuilS of an independent
study ill which ullit-dose patient ad hcrence packaging was
associated with a 17-point incrcase in patient persis!ency
to a drug over 12 months, compared to 30-count bottle
packaging. Persistcncy rates were defined as the pc!rcent3.g~
of patients who remaincd compliant or r('$tarted theropy owr
the trocking cyclc.
The stud}' utili zed data (rom SDI (now pari o( IMS
Health), a prm;der of anOIl}1110llS patient-oosed prescription
data. "We believe that C\·ti)' element of dasc= (onn and package
design call be selected to improve patient treatments,"
Cornell Stamorall, Calalent's VP of strategy and corporate
de\"!~lopment , statc-d in a relcast, "For the fiut time, we ha"e
quantified the real-world patient adhcrcnce bcncfit that
ad\'3nced drug packaging cail provide," Catalcnl's Delpouch
Starter Kit, a unit-dose topi cal treatment design, fcatures
Media Enhanced Packaging te.:hnology that offeu patienlS a
g.1teway to specific, product-centered contcnt \i.l thc Internet,
a smart phone application and all embeddcd watem13rk built
into the package.
Evaluating the real-world eff« ti\'eneu or a calendarizcd
blister pack compared with traditional pill vials on longterm prescription rctill behavior w-as thc aim of a large-scale
pharnlacoepidcllliologic anal)'Sis funded by MWV_ The stud),.
publishcd in the Ma)' 20 11 issue of pee r-rc\;ewed journal
Cliui((ll Thefllptllti<s, examincd phamlacy claims dala rTOm
morc than 3,1 million paticnts receiving either Iisinopril
in MWV's Shcllpak or cnalapril ill viais. The significant
improvement in rcfill persistcnce and adherence shown in this
study supports the h)l>othcsis that interwntions that impro\'e
adhucl\ce, like Shcllpak, have the potential to improve longtcrm health outcomes, [).V)'er sal's_
"These: robust dala pro\ide compelling scientific rndence
supporting the value of Shcllpak as a premier solution to
drive better paticnt adherencc-, which leads 10 increased brand
pecfornlance." he adds. MWV claims ilS study showed refill
persistellce ratu were 17% higher among new medication
users usingShel.lpak.
Connecling package technologv
Solutions providcrs say they are taking a new approach
for enabling pharma companies to conne,t with patients
by integrating smart packaging features into compliance
packaging. These solutions include barcod~, RFID and other
acti\'e elect ronic means to capture the patient's usage data
from packagu. This infonlla(ion (',t il be us.:d for monitoring
and actiyely changing compliance patterns of pa.tienlS.
"The kcy benefits would be instant fewback to the user
about incorrect adhercn{c, proacth'e fcedback 10 the user
about noncompliance, pOlilive reinrorcemcnt with proper
adheuncc, and dala gathering automaticall), without human
interaclion," Nosco's Gaumont ~)"S. "Privacy laws also Ilud
to be considered and customcr acceptance of this technology
in their homes needs to be addressed as well." Nosco offers
a solution that utilizes a highly !Ccure encrypted code that
doubld as an authentication device, as well as a link to \'3rious
media_
Indeed, connecting to patienlS takes on sexera! fornlS. For
example, the inclusion ofQR codes on a ~lJtien t slarter-dose
package can enable access to a company website_ The site
can cncourage and Illonitor compliance, while channeli ng
thcl'''-J)(utic tategory cducalion and pro\;ding support by
building a direct relationship \"';th the patient.
"By scan ning the codcs , individuals would be linked to
a website containing additional information on thc drug,
patient compliance aiw or w ritication of a scrialnumber (or
authentication," S3)"S Joe Lally, marketing manager, PJckaging
conl1nued on page 28
HIY I ? JM lOll Villi ... ft . . . . . bll" It ........ III1"'ln~Uc'IC ......" • •u'" 27
Manufacturing
& Packaging
Compliance packaging gets smarter
conllnued from page 27
for pharma..:eutk.ds, Howell Packaging (Elmira, NY). ''The incre-.u<d pace of adoption of I~W
mobile phone technologies is (\ident, (ven in older population stgrnenlS," Howdl produces
wallet-style packaging programs containing indi\idualiud aca.ss code.s that (all ~ used [or
olle-time access to a pham13 \""OllIpany's S('(\lre wehsite, where patiellts O1n C'stablish their own
passwords.
Embedded RFIO can protide record keeping of doses taken. But unless the device that
d0C5lhc n~ading prm;des feedbJek to caregivers in realtime, the risk is I(.lnting about palient
noncompliance after the (a..1. "The Holy Grail is embedded eledrunics with cellular O1pability,
and there are set'eral solutions in the marketplace," rtporU Walter Berghahn. executive
cerepak'
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Fig. 2. HeddWeslvdco's Cerepak incoporales ele<tronk
capture to record compliance,' the
stored ddfa can be uploaded for overall compliance or patient-safety processes. Credit: NWV
dire..:tor. Healthcare Compliance Packaging Council (Hepe; Bon Air, VA), "Not onlr is this a
possibility (or packaging. it is a reality (or many de,;c<!S in the market today."
One such product that received numerous awards (or de5ign and technology is Glo,..Caps
from Vitality, a producer of (niCOlet-connected products. The smart pill bottle illuminate.!,
plars a melody. and can send a celllllar signal over AT&T's \\;reles,s network to trigger a t~1
message or ring a home pholle. so p.:op\e are prompted to lake their medications. GlowCaps
Fig. 3. The Ecoslide container Irom Keystone Fok/ing Box Co, has outer packaging 01 reqded
paper, and mlnllTldl foil and film to enhanced environmental friendliness. Credit: Keystone.
feature an embedded "push-to-refill" button which contacts thC! patient's pharmacy to
aulomale refills.
Smart packaging "ilh thC! greate~t utility a!.Surf'S dilta is (".uily transferud from the padclge
to a server wher.:: it C".m be storoo, combined and analyzed. "Customers who are (".m), adopters
demand wireless connectivit), between m.::dication packaging and servers, and this is a
particular focus for MWV," Dwyer !ilYS. "There arC! many wa}'Sto achieve this go-'ll. including
RFiD. as well as Diuetooth, ligBN'. SIM and othC!rs." For sptC!nu de~igllcd to pr011l0tc! patient
adherenc.::. p.. 'IWV research shows that conn«thit}' must be completely pa!.Sh·e 10 the p.1lienl.
While such d.::vc!opments arc promising. observers sar, combining the fe-Atures of rcminding
patients to take thC!ir Rx drugs with motivating them to comply remains a critkal initiatiw.
"AU of th~ te..:hnologies are being used in compliance packs," observes Corsten of Uhlmann
Packaging Systems. "For example. sOllie scnd a message to a physician e\'uy tillie a patient
takes medirntion and, if this message is not r«eivcd, the physician "'ill send )'ou a lext message
HCPC announces winners of Its Compliance Package of the Year competition
Novarlls Tasigna physician sample package takes lop honors; Innovative design award goes 10 Burgopak Slider
By NIcholas Basta
At its annual RxAdherence meeting. the HC"dlthcafl! Compliance Packaging Coundl (HCPC;
Richmond. VA) ga\'e top honoN to a 1SOI200-mg sample pa..:kage froill NOl<lrt;s for its Tasign3
(nilotinib) product, a treatment for chronic llI)'cloid leukemia. NOY3rt;s is on a rolli it also
won the 20 10 award from HCPC for its Diovan (\'alsartan) package. Both were produced
for Novart;s by Anduson Packaging (RO(kford, ILl. And at this point, Anderson Packaging
pmctically 0\\11$ the Package of the Ye.U' fran.:hisc, which it has now WOI\ mrte years running.
The Tasigna 5.1mpie--actually. a starter kit- has a calendarizcd unit-dose pack for $(v('n days
oftherap)'. utilizing the DoscJXlk child-resistant design from McadWest\'3co. This componenl
is conlainM \\ithin a larger slet\,t' that has an instructional card for patient education; a DVDj
a USB device with more «Iucational11l3terialsi a dosage-cakulator wh«l; and infomtation on
reimbu~ment and patient assistance. The comparison between a p;1ckage like this and a bottle
of pills and inkjet-printC!d phanuacy flrer is night and da}'. Tasigna sells (or more: than $5,000
a month, according to websit('$j a package IikC! this giws the patient a solid fowldalion in what
thC! produ<t's value is, and the cost of the packaging is likely to be well-justified in hight'r patient
adherence.
The ruuner-up win Her was Fortst Pharmaccuticals' Viibryd 30-day starter pack. also
supplied by Anderson Packaging. but using that company's InwiDose package, a wallet-t)'Vt'
container for a blister card that has detailed time/dosage il1$tructions,
The Innovative De~ign winner was the Burgopak Slider, offered in thC! US by McKesson
lb:Pak (!I.-Iemphis, TN). which has a push-tab mechanism that is casil)' engaged (seniorfriendly) },et child-resistant (p<:r requirements of the US Consumer Safet)' Commission}. ThC!
design allO\ys for patient-safel}' and Nucation mat~rialsto be pr~lIt alongside th.:: dosages.
HCpe runs this competition as part of its allnuallb:Adherenct meeting, which in
turn supports the association's efforts to promote unit-dose packaging as an adherence·
improvement altemath-e to conventional pa..."kaging. Its members compri.s.:= many of the le.lding
contract packagers in the US. Mor.:: details are a'OlilablC! at unitdose.org. 1I35
28 VIlli
u, 1It..- wlbtll •• 1..-_.'hl'"IC •• UcllCI"''''''' ... IrI HII r Ju'W 20ll
flovartis' Tasfgna Physkian
sample package
Forest P~m'laCeutrcals'
Viibryd 3D-day starter pack
Manufacturing
& Packaging
and/or call )'Ou."
Bikare Resean:h says it has developed a
new technology, Dikarc nonClonable ID,
which can ~ incorporated into the pJ.ckaging
it~elfwhere the use of mob He phones for
dosage reminders, pack reminders, ctc., arc
possible, The lIonClonable ID technology
also scn'es as a track-and-trace function nnd
protection ag.tinst counterfeiting.
"In the case of non CIon able, each pack
can be cOllne.:ted to the patient "ia a secure
selVer," Nair explains. "The s)'Stem captuces
the repurchase of new packs and the resulting
data~which is true compliance~and
links with 1lI0ti\'ational programs we call
'compliance fuUiUment progr.mu',"
Gaining an edge
Contract p.1ckagers sa)' lheir ability to offer
cost-effecth·e compliance p.1ckaging solutions
is critical to the success of the brands they
package for customers. Ther claim to of(er
flexibility and an ability to respond to \vhal
is working \\;lh respect to adherence fe.uures
on a specific UDP, and adjust to il11pro\'e
other (e-dtures that pro\'oo to ha\'e less utility
than cxpc~1ed. "We belie\'e smarter packaging
.sen'es a purpose be)'ond simply 'containing'
an item and prot«ting the physical integrity
of the contents," Dwyer says. "Packaging
impJ.rls \'alue to the user, the manufacturtr
and the distribution chain." lI.HVV boasts
more than 35 commerdalized applications of
its adherence packagC;i.
Dilcare Res earch is pois ed to o(fer
complete solutions to address the
ph arm a industry's "5 C's" -colllplianc~,
counterfeiting, communication, convcnience
and cost- through its packaging materials
and research s~rvices, Nair says. Th e
compJ.ny claims its BilcarcOptima is the first
scientific packaging dc\'elopment method for
identifying the most cost-eITectil'e packaging
without compromising on quality, within
six weeks time, and without going through
conventional stability studies. BikarcOptima
can also be used for faster optimization of
fomlulation.
"Bilcare also introduced a number of
innovative materials in blister packaging to
create brand identity to lhe product and also
for swtainability," Nair sa)'S . "(The) recently
introduced Bilcarc Protect and ECOmply
Films/Package also .serve for these pllfJ>O$¢$ of
brand identity and sustainability,"
Pharmaceutical marketers understand
that along with the standard product sales
message, the)' need to provide value in
tenus of educational and/or practice-related
materials to truly differentiate thelllseh'es.
Compliance-oriented detail packages
can be utilized by pharmaceutical sales
representatives to gain acass to physicians
and nurse practitioners. ''The packages arc
intended to enhance patient compliance, but
they also StrW to reinforce the brand and
connect the product and pharmaceutical
company to a patieut-centric approach,"
Howdl's W)' 5a)'S.
The company recently produced an
example of this type of compliance package;
it consisted of a training kit that contained a
blunt needle, syringe, pral1ice pad and related
materials to teach the self-injection t«hnique.
"There were al$O patiellt lo~, where the time
and date of the injection could be recordoo,"
Lally ex-piains. "This package was personally
delhwoo by the sale~ representati\'\! and ga\'e
them an oPl~rtunity not only to detail their
product, but also to leave behind material
that supported patient compliance strategies."
Industry numbeu anticipate adoption
rates for smart packaging uS( with approved,
commercialiud products will steadil)'
increase as more phanna pJ.ckaging designers
are won over. Blood prrs.sure cuffs, ox)'gen
pulse monitors, glucose monitors and scale.s
ar.: just a few oflhe devices that have chips
and comlllunication devices embedded for
realtime feed back to l,.""1.lregi\"ers, 'the adwllt
of truly smart packaging for phannaceuticais
is here," HCPe's lkrghahn declares. "Brood
adoption of these solutions will be driven by
the caregiver and insurance industry where
the 5:1\;ngs from improvcd patient outcomes
will be realized."
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