TAG Mail 27th May 2015
TAG MEETINGS
- DUE Support Group meeting, Wednesday 3 June 2015 3-5pm, NSW TAG
office/teleconference
TAG ACTIVITIES
- Email discussions
-- Use of smart pumps with drug libraries (closes 5 June 2015)
-- Prescribing of contrast media (closes 18 June 2015)
- Drug Shortage: Stock management principles need to be utilised for
metoclopramide 10mg/2mL injection BP while distributor/supplier stock of the
Pfizer product is depleted (and only the iNova product is available). This
disruption is estimated to resolve by mid-June.
- CATAG
-- Position Statement for the use of complementary and alternative medicines
http://www.catag.org.au
TAG WEBSITE
Nil
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
Development of a national education and training data standards strategy and
implementation plan
http://www.aihw.gov.au/publication-detail/?id=60129551063
**TGA
- TGA presentation given at the Sydney Children's Hospital Network Research
Governance, 31 March 2015 - an overview of the TGA's role in controlling access
to unapproved therapeutic goods, including in clinical trials
http://www.tga.gov.au/tga-presentation-given-sydney-childrens-hospitalnetwork-research-governance-31-march-2015
- Information for registered users of the Australian Adverse Drug Reaction
Reporting System
http://www.tga.gov.au/information-registered-users-australian-adverse-drugreaction-reporting-system
- Natalizumab and melanoma; Final update - no definite link established
http://www.tga.gov.au/monitoring-communication/natalizumab-and-melanoma
REPORTS AND PUBLICATIONS – INTERNATIONAL
**EMA
- First-in-class treatment to lower cholesterol; EMA has recommended
authorising Repatha (evolocumab)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news
/2015/05/news_detail_002336.jsp&mid=WC0b01ac058004d5c1
- New treatment option recommended for patients with advanced melanoma,
Keytruda (pembrolizumab)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news
/2015/05/news_detail_002334.jsp&mid=WC0b01ac058004d5c1
- New treatment option for patients with advanced lung cancer, Nivolumab BMS
(nivolumab)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news
/2015/05/news_detail_002335.jsp&mid=WC0b01ac058004d5c1
- EMA recommends treatment for rare cancer in children, Unituxin
(dinutuximab)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news
/2015/05/news_detail_002333.jsp&mid=WC0b01ac058004d5c1
- EMA recommends Imbruvica (ibrutinib) for the treatment of Waldenstrӧm’s
macroglobulinaemia, Imbruvica (ibrutinib)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news
/2015/05/news_detail_002332.jsp&mid=WC0b01ac058004d5c1
**Health Improvement Scotland-NHS boards and Area DTCs
Biosimilar medicines: A national prescribing framework
http://www.healthcareimprovementscotland.org/our_work/technologies_and_
medicines/programme_resources/biosimilar_medicines_framework.aspx
MEDICATION SAFETY
**EMA
Updated advice on use of high-dose ibuprofen
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news
/2015/05/news_detail_002337.jsp&mid=WC0b01ac058004d5c1
**FDA
- FDA Drug Safety Communication: FDA cautions about dose confusion and
medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam)
http://www.fda.gov/Drugs/DrugSafety/ucm445919.htm
- FDA Drug Safety Podcast: FDA warns that SGLT2 inhibitors for diabetes may
result in a serious condition of too much acid in the blood
http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm447651.htm
**ISMP
The absence of a drug-disease interaction alert leads to a child’s death
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=109
**MHRA
-Drug Safety Update, May 2015
-- Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe
bradycardia and heart block when taken with amiodarone
https://www.gov.uk/drug-safety-update/sofosbuvir-with-daclatasvir-sofosbuvirand-ledipasvir-risks-of-severe-bradycardia-and-heart-block-when-taken-withamiodarone
-- Pomalidomide (Imnovid▼): risks of cardiac failure, interstitial lung disease
and hepatotoxicity
https://www.gov.uk/drug-safety-update/pomalidomide-imnovid-risks-ofcardiac-failure-interstitial-lung-disease-and-hepatotoxicity
-- Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants
cannot be excluded
https://www.gov.uk/drug-safety-update/epoetin-beta-neorecormon-increasedrisk-of-retinopathy-in-preterm-infants-cannot-be-excluded
-- Fingolimod (▼Gilenya): first reported case of progressive multifocal
leukoencephalopathy in a multiple sclerosis patient taking fingolimod
https://assets.digital.cabinetoffice.gov.uk/media/555c338ced915d7ae5000007/Gilenya_DHPC_sent_29_April.
pdf
-- Topical ketoprofen and risk of photosensitivity reactions: reminder of risk
minimisation measures
https://assets.digital.cabinetoffice.gov.uk/media/555c335ce5274a74ca000009/Ketoprofen_DHPC_sent_20-042015.pdf
**NPS-MedicineWise
Reducing paracetamol misuse
http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/reducing-paracetamol-misuse
PAPERS OF INTEREST
**Ann Intern Med
- Longer Versus Shorter Duration Dual-Antiplatelet Therapy After Drug-Eluting
Stent Placement: A Systematic Review and Meta-analysis
http://annals.org/article.aspx?articleid=2297227
- Development of an "infusion pump safety score"
http://dx.doi.org/10.2146/ajhp140421
**BMJ
Use of combined oral contraceptives and risk of venous thromboembolism:
nested case-control studies using the QResearch and CPRD databases
http://www.bmj.com/content/350/bmj.h2135
**Circulation
Efficacy and Harms of Direct Oral Anticoagulants in the Elderly for Stroke
Prevention in Atrial Fibrillation and Secondary Prevention of Venous
Thromboembolism: Systematic Review and Meta-Analysis
http://circ.ahajournals.org/content/early/2015/05/15/CIRCULATIONAHA.114.0
13267.abstract
**Clin Transplant
Safety and efficacy of the switch to generic mycophenolate mofetil and
tacrolimus in heart-transplant patients
http://www.ncbi.nlm.nih.gov/pubmed/25981927
**Eur J Hosp Pharm
- A 2-year retrospective review of vial sharing options for the compounding of
cytotoxics
http://ejhp.bmj.com/content/22/3/161.abstract
- Evaluation of eight drug interaction databases commonly used in the German
healthcare system
http://ejhp.bmj.com/content/22/3/165.abstract
**JAMA
Stroke Prevention in Atrial Fibrillation: A Systematic Review
http://jama.jamanetwork.com/article.aspx?articleid=2293300
**JAMA Internal Medicine
Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review
http://archinte.jamanetwork.com/article.aspx?articleid=2294238
**JAMA Opthalmology
Risk of Substantial Intraocular Bleeding With Novel Oral Anticoagulants:
Systematic Review and Meta-analysis
http://archinte.jamanetwork.com/article.aspx?articleid=2294238
**J Thromb Thrombolysis
Chemical prophylaxis to prevent venous thromboembolism in morbid obesity:
literature review and dosing recommendations
http://www.ncbi.nlm.nih.gov/pubmed/25982217
**Lancet
- Comparative efficacy and safety of blood pressure-lowering agents in adults
with diabetes and kidney disease: a network meta-analysis
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624594/abstract
- Once-weekly dulaglutide versus bedtime insulin glargine, both in combination
with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a
randomised, open-label, phase 3, non-inferiority study
http://www.thelancet.com/journals/lancet/issue/current
- Heart failure and mortality outcomes in patients with type 2 diabetes taking
alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind
trial
http://www.thelancet.com/journals/lancet/issue/current
- Four-factor prothrombin complex concentrate versus plasma for rapid vitamin
K antagonist reversal in patients needing urgent surgical or invasive
interventions: a phase 3b, open-label, non-inferiority, randomised trial
http://www.thelancet.com/journals/lancet/issue/current
**Lancet –Haematology
Fiix-prothrombin time versus standard prothrombin time for monitoring of
warfarin anticoagulation: a single centre, double-blind, randomised, noninferiority trial
http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)000733/abstract
**NEJM
Trial of Short-Course Antimicrobial Therapy for Intraabdominal Infection
http://www.nejm.org/doi/full/10.1056/NEJMoa1411162?query=featured_home
CONSULTATIONS
**ACQSHC
Consultation on draft Delirium and Hip Fracture Care Clinical Care Standards.
Closes 3 July 2015
http://www.safetyandquality.gov.au/our-work/clinical-care-standards/currentconsultations/
**TGA
- Orphan drugs program (closes on 15 June 2015)
http://www.tga.gov.au/consultation/consultation-orphan-drugs-program
- Draft OTC medicine monographs for Bromhexine hydrochloride;
Dextromethorphan hydrobromide; Laxatives: Docusate sodium and/or
sennosides; Hand sanitisers (closes on 11 June 2015)
http://www.tga.gov.au/consultation/consultation-draft-otc-medicinemonographs-bromhexine-hydrochloride-dextromethorphan-hydrobromidelaxatives-docusate-sodium-andor-sennosides-hand-sanitisers
OTHER NEWS
**ACSQHC
The Commission has requested that any hospital orders for the 'Consumer
Information wallet' jointly developed with NPS be sent to
medsafety@safetyandquality.gov.au by 29 May 2015 stating the number of
wallets required, the contact person and the delivery address, including area or
department of the ordering hospital. Information about the wallets can be found
at this link:
http://www.safetyandquality.gov.au/our-work/medication-safety/medication-
reconciliation/consumer-resources/
**Centre for Health Systems and Safety Research-AIHI
Position: Research Fellow for NHMRC partnership grant “Delivering safe and
effective care for children in hospital with eHealth systems”, 3 year fixed-term.
Applications close 7th June 2015
http://jobs.mq.edu.au/cw/en/job/495778/research-fellow
**SSWAHS
Position: Maternity relief Director of Pharmacy , Canterbury Hospital, a 200+
bed metropolitan hospital in Inner West Sydney. Applications close 5 June 2015
https://nswhealth.erecruit.com.au/Dashboard/Requisitions/ManageRequest.asp
x?Id=248602
UPCOMING EVENTS (new additions in bold)
**Medscape
CME/CE Live Event. The Biosimilar Matrix: The Impact of Biosimilars in
Managing Neutropenia. Sunday, May 31, 2015 7:00 PM to 8:30 PM (Chicago time)
http://www.medscape.org/sites/townhall/public/biosimilar-matrix
**CEBM (Centre for Evidence-Based Medicine)
'Harms in Health Care' Five Day Workshop chaired by Jeffrey Aronson, 22-26 June
2015, Oxford, UK. NB Small registration numbers possible so don't delay
http://www.cebm.net/harms-health-care/
**Change Champions
Medication Safety and Mental Health, 20 August, Melbourne. Abstracts close 30
June 2015
http://www.changechampions.com.au/call-for-papers
**The AlfredTC-IFEM
The Alfred's 4th Annual International Emergency Care Conference, 26-28 Aug
2015. Abstracts close 1 June 2015
http://alfredetc-professional-development.cvent.com/events/internationalemergency-care-conference-2015/event-summarydbde3298352b47ffac653eab18bad52e.aspx
**ISQUA
'Building Quality and Safety into the Healthcare System', 4-7 October 2015,
Doha, Qatar. Early bird registrations close 15th July 2015
http://www.isqua.org/conference/doha-2015/registration2015?utm_source=Conference+-+Registration+Open++March+2015&utm_campaign=Conference+-+Reg+Open++March+2015&utm_medium=email
**AHRQ
Agency for Healthcare Research and Quality (AHRQ) research conference, 4–6
October, 2015, Crystal City, Virginia USA
Health care research and policy sessions on improving quality, safety, access and
value in health care
http://www.ahrq.gov/news/events/conference/index.html
*SHPA
Medicines Management 2015, 3-6 December 2015, Melbourne Convention Centre.
Call for abstracts now open - closes Friday 17 July 2015
http://mm2015shpa.com/