Wednesday 19 Dec 2012

Pharmacy Daily Wednesday 19th December 2012 T 1300 799 220 W www.pharmacydaily.com.au page 1

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Fluarix approved for US GLAXOSMITHKLINE’S four-strainseasonal influenza vaccine, FluarixQuadrivalent has received US FDAapproval for the immunisation ofchildren (three years and older) andadults to help prevent diseasecaused by seasonal influenza (flu)virus subtypes A and type Bcontained in the vaccine. Fluarix Quadrivalent is the firstintramuscular vaccine to coveragainst four influenza strains.

EMA committs for 2013 THE European Medicines Agencyhas outlined its 2013 priority asensuring that assessment activitiesare conducted to the higheststandards of quality, regulatory andscientific consistency. To this end the EMA has said thata “number of initiatives are takingplace to increase the support to thescientific committees and tofurther assure the quality andconsistency of the Agency'sscientific outputs”. “These include a review andoptimisation of the scientificprocesses, including thecoordination among thecommittees, and the continuingimplementation of the conflicts ofinterest policies and theirmonitoring,” the EMA added.

Morphine shortage THE Therapeutic GoodsAdministration is quelling fearsover shortages of morphine, issuinga statement that it has secured analternative to Hospira’s 10mg/1mLinjections. The furor started when thecompany advised the TGA that anupgrade problem at it’s Europeanmanufacturing plant was set tocause shortages of the it’s morphine10mg/1mL injections. The company also told the TGAthat it expects the shortages wouldlast up to the first half of 2013. To offset this issue the TGAworked Hospira, and has nowconfirmed that it has secured analternative supply of the injectablemorphine from another source. “We are confident that there willbe no shortage of morphine 10mg/1ml injections in Australia,” the TGAsaid in a statement.

A FIFTEEN month review ofAnticoagulation Therapies in AtrialFibrillation has set a stumblingblock on the road to PBS listing fornew anticoagulant therapies suchas Boehringer Ingelheim's Pradaxa,with its recommendation that thePBAC review its previousrecommendations of new (or novel)oral anticoagulants (NOACs). Penned by Emeritus ProfessorLloyd Sansom, the review statedthat “while warfarin will retain a placein the management of stroke risk inpatients with atrial fibrillation (AF),NOACs offer an important clinicalbenefit in reducing the incidence ofintracranial haemorrhages in AFpatients who receive anticoagulantsand offer patients who are unable totake warfarin an effective alternative”. “However, the net overall benefitof NOACs in clinical practice and thesubsequent impact on cost-effectiveness is uncertain at thisstage, given the further informationabout dabigatran use that hasbecome available since thePBAC decision regarding this NOACin 2011,” the review added. As such, the review recommendedthat the PBAC consider theestablishment of a managed entryscheme for the PBS availability ofNOACs which would take into

account the identified uncertaintieswhile acknowledging the need foreffective alternatives to warfarin. “In considering a managed entryscheme, PBAC should evaluate theentry price that addresses theuncertainties and what ‘fit forpurpose’ evidence would berequired to address these to ensurethat acceptable,” the review said. In addition, the review advisedthe PBAC to consider the PBS listingof NOACs as a restricted benefit forpatients unable to tolerate warfarintherapy and/or who are unable toobtain satisfactory INR controldespite specific measures. “There would need to be adefinition of ‘satisfactory INR control’together with a price–volumearrangement which addresses the riskto the Government of use beyondany restriction,” the review said. The review has unsurprisinglydrawn the ire of BoehringerIngelheim, which responded to thereport by saying it “is extremelyconcerned that a new delay in theform of yet another PBAC reviewwill further postpone patients’access to new treatment options”. “Today is a sad day for manyatrial fibrillation patients and theirfamilies,” the company added. MEANWHILE the PSA haswelcomed the review, in particularits recommendations for sharedcare and collaboration betweenhealth professionals in themanagement of anticoagulationtherapy in patients with AF. One such recommendation wasthe use of point-of-care testing forthe measurement of INR values,which determine appropriatedosing, as an option for warfarinmanagement, particularly in thecommunity setting. The report also pointed to theneed for the development ofresources to improve the healthoutcomes of patients with AF. “Pharmacists could potentiallybecome more involved in theidentification of people with AF,helping to implement guidelines,educate patients, improve the useof anticoagulant medications andmonitor patients,” the PSA said in astatement.

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Wednesday 19 Dec 2012

Pharmacy Daily Wednesday 19th December 2012 T 1300 799 220 W www.pharmacydaily.com.au page 2

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WIN A HYDRALYTE PRIZE PACKEvery day this week Pharmacy Daily is giving

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Congratulations to yesterday’s lucky winners, Lynda Carter from Flinders Medical Centre, April Pearce of Ayr District Hospital, Barbara Wager from The Pharmacy Guild of Australia and Anna Develin from The Pharmacy Guild of Australia.

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FOBruary campaign LET’S Beat Bowel Cancer andBowel Cancer Australia are gettingbehind Australian pharmacists in abid to raise awareness aboutFOBruary 2013. The initiative urges Australiansaged 50 and over to take a FOB(Faecal Occult Blood) Test duringthe month of February to screenfor bowel cancer. From January 2013, the NationalBowel Cancer Screening Programwill send an iFOB Test to Aussiesturning 50, 55, 60 and 65 only,excluding millions of people. As such, the duo are urgingpharmacists to encourage relevantpatients aged 50 and over topurchase a FOB Test. “Pharmacists will be supported bya national advertising campaign,highlighting the need to do a FOBTest and the options for purchasinga BowelScreen Australia test kit,” saidJulien Wiggins, Chief Executive,Bowel Cancer Australia. Pharmacies interested inproviding the BowelScreenAustralia Program should call1800 55 65 75 (option 3).

Poison amendments THE Poisons StandardAmendment No. 5 of 2012 hasbeen registered on the FederalRegister of Legislative Instrumentsthis week. Changes in the Standard includean amendment to ibuprofen,placing it in Schedule 2 when inpreparations for oral use whenlabelled with a recommended dailydose of 1200 mg or less ofibuprofen: in liquid preparationswhen sold in the manufacturer’soriginal pack containing 8 grams orless of ibuprofen; or in dividedpreparations, each containing 200mgor less of ibuprofen, in packs of notmore than 100 dosage units exceptwhen: as the only therapeuticallyactive constituent (other thanphenylephrine or when combinedwith an effervescent agent); packedin blister or strip packaging or in acontainer with a child-resistantclosure; in a primary pack containingnot more than 25 dosage units;compliant with the requirements ofthe Required Advisory Statementsfor Medicine Labels; not labelledfor the treatment of children 6years of age or less; and notlabelled for the treatment ofchildren under 12 years of agewhen combined with phenylephrine. Moreover the amended schedulealso sees five new entries toSchedule 4: abiraterone acetate,boceprevir, fidaxomicin,ridaforolimus, and telaprevir. Penflufen andaminocyclopyrachlor have alsobeen added to Schedule 5, with theamendments effective from 01 Jan. To view the amendmentsCLICK HERE.

THE Federal Court has todayapproved the proposed settlementof the long-running class actionbrought against SigmaPharmaceuticals (PD 24 Oct), whichwill see the company make a $57.5million payout without admissionof any liability. The case related to claims thatthe company did not disclosematerial information to the stockmarket when it was raising capital,prior to a shock downgrade in thevalue of its generics business. According to an update issuedthis morning, settlement of theaction was conditional uponapproval by the Federal Court ofAustralia, and now that this hasgone through payment is expectedto be made within a week. “As a result of the Federal Courtapproval, the settlement paymentwill now be distributed to classmembers by Slater & Gordon,”Sigma said, with the matter then tocome back before the court forFinal Orders, including that theclass action be dismissed.

Sigma said the settlementpayment will be reported as a“material non-recurring item” in its2012/13 full year results. MEANWHILE Sigma has alsoissued a trading update, saying thatbusiness in the second half of theyear has “continued to be in linewith expectations”. Sales have been slightly stronger,which is expected to flow throughto gross profit, however consistentwith the first half result “logisticcosts have been higher thanexpected”. Sigma also disclosed a recentrefrigeration failure at its NewcastleDistribution Centre, which willresult in an unbudgeted expense ofaround $3 million. The company said that cash at theend of the financial year will belower, reflecting the payment ofthe $57.5 million class actionsettlement as well as its ongoingshare buyback program, dividendpayments “and some incrementalinvestment in inventory levels toimprove customer service levels”.

Sigma settlement approved

New medical grants $127.9 MILLION has beenannounced by the Department ofHealth, to fund 151 grants for“ground-breaking health andmedical research” across Australia. Grants are being directed to arange of key areas including chronicdiseases (cardiovascular, cancer,diabetes, arthritis, asthma andobesity); ageing; mental health;child health and HIV. See www.health.gov.au.

Wednesday 19 Dec 2012

Pharmacy Daily Wednesday 7th November 2012 T 1300 799 220 W www.pharmacydaily.com.au page 2

Weekly Comment

EDITORS Bruce Piper and Amanda Collins EMAIL info@pharmacydaily.com.au ADVERTISING Magda Herdzik EMAIL advertising@pharmacydaily.com.au page 3

Lean and mean in 2013Aminoplex Lean is crafted using high quality protein from wholegrain brown rice withgreen coffee, green tea, chia fibre, probiotics, digestive enzymes, medium chaintriglycerides, l-carnitine, l-glutamine, vitamins and minerals. It is formulated tonourish the body during a weight loss program and is intended to be used inconjunction with a balanced diet and appropriate exercise. Key features of theproduct include 23g protein per serve, and probiotic strains lactobacillus acidophilusand bifidobacterium lactis to support healthy digestive bacteria balance. The productis vanilla flavoured and is suitable for both vegetarians and vegans.RRP: $39.95Stockist: 1300 650 455Website: www.bioceuticals.com.au

LIVING dangerously. Russia's Plosky Tolbachikvolcano is drawing thousands ofthrill seeking tourists, after iterupted. The volcano which has beendormant for four decades, beganto spew forth hot magma,volcanic ash and gases from itsunderground magma chamberrecently, which instead of causingwidespread panic across thecountry, caused a tourism boom. So fierce was Plosky’s wraththat it destroyed a nearbyrecreational base and set thesurrounding forest on fire. But this was not enough to keepthe thrill seeking tourists away,with some vying for the 2012Darwin Awards by posing forpictures close to lava flows andburning trees. “It was worth doing it, it'smarvelous, incredibly beautiful,you can't express it with words,you should just see it, feel it,touch it with your own hands, it'sjust great,” said one tourist tomedia after paying to take a tripto the smoking volcano.

DO not rest in peace. A Swedish inventor, FredrikHjelmquist, has debuted anunusual new invention tailoredfor those that love their music, acoffin with an in-built stereo system. The CataCombo Sound Systemis being dubbed as the “perfectgift for music lovers who do notwant to rest in peace”. Purchasers of the coffin are ableto create their own afterlife playlist, which will be streamed intotheir coffin after they are interredunder six feet of earth. The system includes two-wayfront speakers, four-inch midbassdrivers, tweeters and an-eight-inch subwoofer, and has a 2.1amp power supply with a coolingsystem to prevent overheating. For those that are concernedabout disturbing the peace oftheir resting neighbours,Hjelmquist said that the system iscompletely soundproof.

For details call us today: 1300 799 220

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Go underground this ChristmasEstee Lauder’s new Pure Color Violet Underground is glam rock at its best,offering a line-up of deep, vibrant violet and fuchsia tones. Featured in thecollection is a Pure Color Five Color EyeShadow Palette which includes a mix ofdeep violet, crimson and fuchsia powders with pale pink and matte black shade atthe center. The powders are formulated using 'tribrid' technology that allows fortwo finish options: apply wet for a vibrant-chrome charged flash of colour or dryfor a subtle shine finish. This is then combined with a cyber-metallic finish that cancreate a range of daring looks.

RRP: $90.00Stockist: 1800 061 326Website: www.esteelauder.com.au

The lashes you always wished you hadDesigner Brands pre-glued, self-adhesive, reusable Lashes are designed toprovide fast, easy, and affordable glam. The handmade lashes are lightweight, so they don’t sit heavily on your lids, and unlike most adhesivelashes on the market, they do not require glue. They come with an adhesivestrip already attached, so that it is simple to remove them from the pack, cutto size and then press on. As an added bonus the lashes come withadditional adhesive strips. The Lashes come in several styles ranging inlevels of dramatic effect, from Adorable, Tempt, Glamorous, Delicate,Tender, Lofty, Whispering, Charming, to Sunburst and Lovely.

RRP: $8.99Stockist: 02 9817 8731Website: www.dbcosmetics.com.au

Purify the party out of your skinPalmer’s Cocoa Butter Purifying Mask is formulated with kaolin clay and sweet almondoil as its base. Kaolin clay is a natural Chinese clay that gently absorbs oil on the surface ofskin and helps clear breakouts, whilst sweet almond oil is a non-greasy, supermoisturizing, emollient which is rich in Vitamins B1, B6, B2 and E, as well as Omega-9 andOmega-6 fatty acids. With these key ingredients, the mask works to dry and draw outimpurities, whilst other ingredients, including shea butter (naturally high in Vitamins A, Eand F), and Vitamin E work to nourish the skin.RRP: $9.99Stockist: 1300 191 918Website: www.palmersaustralia.com.au