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' u .-,. _ • ......,. ... - 'j - -- ~~" ItfUJI • " ' UIlIU I •• # ~ .,."w, ruta 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. 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