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Monday 20 Mar 2017

NSAID controversy
Non-steroidal anti-
$30m Yasmin patent payout Etopophos shortages
The Therapeutic Goods
inflammatory drugs (NSAIDs) have Bayer will receive more than Without the protection of their Administration (TGA) has advised
been shown to be associated $30 million in damages and intellectual property, research- that supply shortages of Etopophos
with up to a 50% increased risk of interest after receiving a favourable driven pharmaceutical companies etoposide 1 g (as phosphate) and
an out-of-hospital cardiac arrest judgement in its long-running case cannot bring new medical Etopophos etoposide phosphate
(OHCA). with Generic Health over patent innovations to those patients who 113.6 mg (equivalent to 100 mg
The case-time-control study out infringement for its Yasmin and YAZ need them most, Ambrogio said. etoposide) powder for injection
of Copenhagen University Hospital, oral contraceptives. vials are expected to continue until
Denmark, investigated the records The Federal Court of Australia 01 Aug 2017.
of 28,947 people with OHCA, 3,376 ruling found Generic Health had Chemotherapy Previously, health professionals
of whom were treated with an infringed Bayers patent on the were advised that supply would
NSAID up to 30 days prior. products by manufacturing and
change deferred resume next month.
The Australian Self-Medication selling the oral contraceptive The Health Department has The TGA advises that the
Industry (ASMI) acknowledged known as Isabelle. advised of an extension for alternative product Etoposide 100
the study, with spokesman Steve The original judgement was the mandatory inclusion of the mg/5 mL is available.
Scarff saying, it is important to handed down in 2013 but was Compounder ID with eligible claims For more info contact the TGA on
note that the study was conducted stayed pending an appeal, which under the Efficient Funding for medicine.shortages@tga.gov.au.
in patients with an average age was later dismissed along with Chemotherapy (EFC) scheme.
of 70 years who were prescribed an application for special leave to Previously it was intended that
NSAIDs, usually at higher doses appeal to the High Court in 2014. the compounder ID would become Vit B protects against
and for longer duration than are Bayers claim for damages compulsory for claims lodged air pollution effects?
recommended and available for amounted to $25 million, based effective from 01 Apr 2017.
a SMALL scale human trial has
OTC use. on an assessment of its lost profits However according to an update
suggested that high doses of
These elderly patients had where each sale of Isabelle, and on Fri, a number of approved
vitamin B supplements (2.5mg of
pre-existing health conditions and of Petibelle, a generic version of suppliers have indicated that the
folic acid, 50mg of vitamin B6, and
were on other medications, some Yasmin introduced by Bayer, was necessary amendments to their
1mg of vitamin B12) may offset the
of which could have increased their taken to be a lost sale of Yasmin. dispensing software may not be
damage caused by fine particulate
risk factors, he said. Nelson Ambrogio, gm of Bayer ready in time to facilitate this.
matter as found in heavily polluted
Scarff said consumers should note Pharmaceuticals Australia/NZ, The department says it will now
places like Beijing or Mexico.
label warnings on NSAIDs and seek said the decision confirms the provide three months notice before
The most dangerous of these
the advice of their pharmacist or companys intellectual property the field becomes mandatory.
particles is referred to as PM2.5,
doctor if they have certain existing rights relating to Yasmin and YAZ. Until then claims submitted
with a diameter of less than 2.5
health problems, require longer We will always defend these without the compounder ID will
micrometres, coming from diesel
term treatment or if they are taking rights whenever this becomes continue to generate a warning but
cars and wood burning stoves.
other medicines. necessary and will continue to do so. will not be rejected.
CLICK HERE to access the research.

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SHPA transparency call Blackmores China fine


Blackmores has been fined
FIP abstracts sought
THe International Pharmaceutical
The Society of and rationale for almost $70,000 in China for Federation (FIP) is reminding
Hospital Pharmacists regulatory decisions violating advertising laws, with the delegates to this years 77th
of Australia (SHPA) would also be penalty related to a social media World Congress of Pharmacy and
has supported pertinent information video featuring tennis star Li Na, in Pharmaceutical Sciences in Seoul,
the concept of full and open for Drug and Therapeutic which the company claimed to be South Korea, that the deadline for
transparency on the part of the Committees (DTC) and Medication Australias number one, and that submissions of abstracts is 01 Apr.
Therapeutic Goods Administration Advisory Committees (MAC) of its products could treat conditions The theme for 2017 is Medicines
(TGA) in its submission to the TGA health service facilities. such as cardiovascular disease and and beyond! The soul of pharmacy
relating to Expedited pathways for This will inform their decisions arthritis, reports Fairfax media. - new ways for pharmacy to provide
prescription medicines. when considering additions and Apparently this type of more than just medicines.
SHPA believes that TGA decisions amendments to formularies, superlative language is no longer FIP says one of the congress
should be published as soon as individual patient usage allowed in China, with the company streams will focus on Precision
possible with as much detail as applications, as well as stewardship saying it had amended its collateral Pharmacotherapy - an emerging
possible, to support the notion and governance activities. as soon as it had been made aware model which seeks to harness
that these are transparent process Making such information of the breach. shared molecular and cellular
and consolidate the consumer and available to DTCs and MACs Chinas annual Consumer Rights biomarkers to customise therapy to
industry confidence that the TGA would also aid in the detection Day also highlighted a range of subpopulation patient groups.
holds, the submission reads. and reporting of adverse events other major brands fined, including The conference takes place 10-14
Further, the hospital pharmacy and contribute to post-market Nike and Japanese retailer Muji. Sep - register at fip.org/seoul2017.
group said that on a local level the surveillance activities, the Society
publication of assessment reports said.
In addition, the SHPA said it Priceline Festival Towers takes the cake
believed it was important that the Priceline
UK online guidelines TGA made objective determinations Pharmacy Festival
Britains Medicines and as to what constituted a major Towers in Brisbane
Healthcare products Regulatory therapeutic advantage, when such celebrated its 10th
Agency has updated its guidance claims were made by sponsors birthday earlier
for people supplying medicines seeking priority review and this month.
online to countries across Europe. provisional approval. The milestone
The revised document makes Objective measures suggested by was marked with
it clear that online retailers the SHPA were decreases/increases a party in Albert
must comply with the law of the in biological markers, length of Street, which was
country they are selling to - and remission periods or improved closed off for the
in particular that medicines are scores for clinically validated tools event with the
authorised for use in each country - such as cognition or movement help of Brisbane
CLICK HERE for details. tests - submissions at tga.gov.au. City Council and Albert Street customers, with vendors including
Traders. Swisse, Avene, La Roche-Posay,
The store was opened in 2007 Neutrogena and Chemcorp
by Terry Herefort, James & Carmel donating goodies and prizes.
Delahunty and Justin Walters, and The day wrapped with a speech
This week Pharmacy Daily and INNOXA are giving away each day ten years on put on an event fit for from pharmacist Terry Herefort,
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Check here tomorrow for todays winner. ALWAYS READ THE LABEL. USE ONLY AS DIRECTED. IF SYMPTOMS PERSIST SEE YOUR HEALTHCARE PROFESSIONAL.* This statement was correct at time of production.

Pharmacy Daily Monday 20th March 2017 t 1300 799 220 w www.pharmacydaily.com.au page 2
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Monday 20 Mar 2017 breaking news as it comes to hand

Diabetologist accused NZ cold sore trial


Dispensary British consultant diabetologist A number of pharmacies in Weekly
Paul Grant, who edited the British
Corner Journal of Diabetes from 2014 to
New Zealand are participating in
a national clinical trial of medical Comment
2016, is facing allegations by the grade Kanuka honey for the
cat lovers across the globe will General Medical Council that he treatment of cold sores. Welcome to PDs
be rejoicing this week, after the fabricated research data. Patients presenting with herpes weekly comment
US release of a new perfume Grant was also appointed editor simplex virus are blindly allocated feature. This weeks
formulated to smell exactly like in chief of Clinical Medicine, the either the standard treatment contributor is
kitten fur. journal of the Royal College of Teresa Di Franco,
or the honey, and will also be
The brainchild of New York- Pharmacist and
Physicians, before the allegations compensated NZ$25 at the end of
based Demeter Fragrance Library, CDE, Perth Diabetes Care.
emerged but never took up the post. the trial which aims to enlist 950
the product (pictured) apparently At a four week hearing of the patients nationally. Implementing the
smells just like the PURRfect Medical Practitioners Tribunal Pharmacies also receive a New Golden Rules of
spot behind a kittens neck, a Service that opened on 13 Mar, payment for each patient enlisted. Injection Technique in
promotional blurb enthuses. the GMC accused Grant of a range Study lead Dr Alex Semprini said Pharmacy
15 years in the making, weve of research misconduct, including earlier small scale trials had shown RECENTLY, U.S journal Mayo
captured the olfactory essence of forging the signatures of coauthors, a positive response for the honey, Clinic Proceedings published new
warmth and comfort...cat lover listing doctors who had not which must be applied to the cold insulin delivery recommendations
or not, this scent is sure to satisfy significantly contributed to papers sore five times per day over a 14 for healthcare professionals who
your curiosity! the company said. as coauthors, and fabricating data. day period. care for patients who inject their
Other unusual fragrances diabetes medication.
A number of recommendations
available from Demeter include
cannabis flower, baby powder and
MyDNA reveals dairy intolerance at APP and subsequently the Golden
even gin and tonic. About 40% Rules of injection technique -
have been developed for adults
of the 300 APP
and children with diabetes.
delegates who
The Golden Rules outline
were tested the key considerations for
at the myDNA correct injection technique and
stand during optimised medication delivery for
the conference customers (or parents of children)
learnt that their who inject diabetes medication.
stomachs may We cant assume these
not cope well conversations are happening with
An ENTERPRISING Chinese their GP or diabetes educator
with more than
business has come up with an so it is a great opportunity for
one glass of milk
ideal solution to the countrys pharmacists to get involved.
per day.
ever-more frequent smog alerts. The Golden Rules also challenge
The myDNA pop-up lab and swab they should to relieve a headache.
Forget inhalers for asthma the current use of larger needles
squad tested attendees (pictured Our easy-to-understand reports
symptoms - Sanquin Forest (such as 8mm and 12mm) and
above) and returned their results reveal exactly what a persons calls on pharmacists to review
Industry is selling bottles of
less than 48 hours later. genetic code is telling their bodies needle length suitability in each
simple fresh air, gathered from a
myDNA ceo Lior Rauchberger to do - in response to different individual patient.
remote forest in western China.
said the APP appearance was a medicines, different foods, or to By taking on the Golden Rules as
Sales manager Zhai Wenjun said
sneak peek at the companys new lifestyle factors like alcohol or clinical best practice, pharmacists
we set up a factory in Ningdong
wellness and nutrition genetic tests exercise, he said. will be better placed to support
Forest Park in Shaanxi province
which would soon be available on There was genuine excitement their customers who inject their
and compress air directly into the diabetes medication.
pharmacy shelves. at seeing this DNA technology in
bottle...consumers will feel like The FITTER* recommendations,
He said the tests also found action, Rauchenberger said.
they are breathing in the forest. including the Golden Rules of
one in six of the APP delegates The new myDNA wellness and
The luxurious fresh air doesnt Injection Technique, can be
risked negative side effects if nutrition genetic test kits will be
come cheap, costing 48 yuan accessed HERE.
taking certain anti-inflammatory added to the companys existing
(about A$9) for a bottle which *FITTER stands for the Forum for
medicines - explaining why certain suite of pharmacogenomic tests Injection Technique & Therapy
is good for just two minutes of
medicines may not work the way from next month. Expert Recommendations and is an
uninterrupted use. international program sponsored by BD.

Pharmacy Daily is Australias favourite pharmacy industry publication. Publisher/Editor in chief: Bruce Piper Editorial: info@pharmacydaily.com.au
Sign up free at www.pharmacydaily.com.au. Managing Editor: Jon Murrie
Postal address: PO Box 1010, Epping, NSW 1710 Australia Reporter: Mal Smith
Street address: Level 2, Suite 1 64 Talavera Rd, Macquarie Park NSW 2113 Australia Contributors: Matt Bell, Rebecca Le Bas, Jasmine ODonoghue
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Pharmacy Daily is a publication of Pharmacy Daily Pty Ltd ABN 97 124 094 604. All content fully protected by copyright. Please obtain written permission to reproduce any material. While every care has been taken in the preparation of
the newsletter no liability can be accepted for errors or omissions. Information is published in good faith to stimulate independent investigation of the matters canvassed. Responsibility for editorial comment is taken by Bruce Piper.

Pharmacy Daily Monday 20th March 2017 t 1300 799 220 w www.pharmacydaily.com.au page 3

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