TAG Mail 2014 (January - June)
Cumulative Listing of Reports, Publications, Medication Safety
Information and Papers of Interest
TAG Mail 25th June 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
- Australia's Health 2014
http://www.aihw.gov.au/publication-detail/?id=60129547205
- Acute coronary syndrome: validation of the method used to monitor incidence in
Australia
http://www.aihw.gov.au/publication-detail/?id=60129547563
**TGA
AusPARs added: Brentuximab vedotin, Turoctocog alfa (rch), Denosumab,
Dolutegravir (as sodium), Fentanyl (as citrate), Golimumab (rmc), Olodaterol (as
hydrochloride)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS – INTERNATIONAL
**Dept of Health (UK)
- UK 5 Year Antimicrobial Resistance (AMR) Strategy 2013-2018 - Measuring success
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/3
22358/Outcome_measures.pdf
- A new webpage is now available bringing together information on publications,
tools and resources and news items relevant to antimicrobial stewardship.
https://www.gov.uk/government/collections/antimicrobial-resistance-amrinformation-and-resources
**EMA
Posting of clinical trial summary results in European Clinical Trials Database
(EudraCT) to become mandatory for sponsors
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
14/06/news_detail_002127.jsp&mid=WC0b01ac058004d5c1
**FDA
- FDA approves Sivextro (tedizolid phosphate), a new antibacterial drug, to treat
adults with skin infections.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402174.htm
- FDA actions reduce drug shortages but critical issues remain
http://www.fda.gov/Drugs/NewsEvents/ucm401553.htm
**NICE
- Clinical Guideline CG180, Atrial fibrillation (update): the management of atrial
fibrillation
http://guidance.nice.org.uk/CG180
- Evidence Update 62, Antibiotics for early-onset neonatal infection. A summary of
selected new evidence relevant to NICE clinical guideline 149 ‘Antibiotics for earlyonset neonatal infection: antibiotics for the prevention and treatment of earlyonset neonatal infection’ (2012)
https://www.evidence.nhs.uk/evidence-update-62
- Evidence summary, new medicine: Psoriatic arthritis in adults: certolizumab pegol
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM42.jsp
MEDICATION SAFETY
**TGA
Monitoring communication: Ivabradine (Coralan) and cardiovascular events in
patients with angina
http://www.tga.gov.au/safety/ews-medicine-ivabradine-140623.htm
**FDA
- FDA Drug Safety Communications:
-- FDA review of cardiovascular risks for diabetics taking hypertension drug
olmesartan not conclusive; label updates required
http://www.fda.gov/Drugs/DrugSafety/ucm402323.htm
-- FDA warns that cancer drug docetaxel may cause symptoms of alcohol
intoxication after treatment
http://www.fda.gov/Drugs/DrugSafety/ucm401752.htm
- Consumer Information: Four Medication Safety Tips for Older Adults
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM399867.pdf
**ISMP
Some IV medications are diluted unnecessarily in patient care areas, creating undue
risk
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=82
**Joint Commission
Sentinel Event Alert Issue 52: Preventing infection from the misuse of vials
http://www.jointcommission.org/assets/1/6/SEA_52.pdf
**MHRA
Drug Safety Update, June 2014. Includes:
- Combination use of medicines from different classes of renin-angiotensin system
blocking agents: risk of hyperkalaemia, hypotension, and impaired renal function—
new warnings
- Ferumoxytol: serious hypersensitivity reactions—reminder of precautions to take
before and during administration
- Ivabradine: emerging clinical trial evidence of increased cardiovascular risk—
carefully monitor for bradycardia
- Chlorhexidine solutions: risk of chemical burn injury to skin in premature infants
http://www.mhra.gov.uk/home/groups/dsu/documents/publication/con428334.pd
f
PAPERS OF INTEREST
**Am J Cardiol
Meta-Analysis of Randomized Clinical Trials Comparing Short-Term Versus LongTerm Dual Antiplatelet Therapy Following Drug-Eluting Stents
http://www.sciencedirect.com/science/article/pii/S0002914914010492
**BMJ
- Drug treatment for attention-deficit/hyperactivity disorder and suicidal
behaviour: register based study
http://www.bmj.com/content/348/bmj.g3769
- Changes in antidepressant use by young people and suicidal behavior after FDA
warnings and media coverage: quasi-experimental study
http://www.bmj.com/content/348/bmj.g3596
- Revascularisation versus medical treatment in patients with stable coronary artery
disease: network meta-analysis
http://www.bmj.com/content/348/bmj.g3859
- Prescription charges: are they worth it?
http://www.bmj.com/content/348/bmj.g3944
- Vitamin D and mortality: meta-analysis of individual participant data from a large
consortium of cohort studies from Europe and the United States
http://www.bmj.com/content/348/bmj.g3656
**Circ Cardiovasc Interv
Heparin Monotherapy or Bivalirudin During Percutaneous Coronary Intervention in
Patients With Non–ST-Segment–Elevation Acute Coronary Syndromes or Stable
Ischemic Heart Disease: Results From the Evaluation of Drug-Eluting Stents and
Ischemic Events Registry
http://circinterventions.ahajournals.org/content/7/3/365.abstract?etoc
**Heart
Atrial fibrillation associated with ivabradine treatment: meta-analysis of
randomised controlled trials
http://heart.bmj.com/content/early/2014/06/20/heartjnl-2014-305482.abstract
**J Adv Nurs
Paediatric nurses' adherence to the double-checking process during medication
administration in a children's hospital: an observational study
http://onlinelibrary.wiley.com/doi/10.1111/jan.12303/abstract
**Lancet
Rituximab for childhood-onset, complicated, frequently relapsing nephrotic
syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind,
randomised, placebo-controlled trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)605419/abstract
**NEJM
- Antidepressant Use in Pregnancy and the Risk of Cardiac Defects
http://www.nejm.org/doi/full/10.1056/NEJMoa1312828
- Tofacitinib versus Methotrexate in Rheumatoid Arthritis
http://www.nejm.org/doi/full/10.1056/NEJMoa1310476
**JAMIA
How is the electronic health record being used? Use of EHR data to assess physicianlevel variability in technology use
http://jamia.bmj.com/content/early/2014/06/09/amiajnl-2013002627.short?g=w_jamia_ahead_tab
TAG Mail 18th June 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**NSW Health
Standards for Paediatric Intravenous Fluids
http://www0.health.nsw.gov.au/policies/gl/2014/GL2014_009.html
**NPS
NPS Direct, June 2014. Includes:
Is acupuncture effective for pain relief? e-Cigarettes: a safe way to quit? Childhood
antibiotics and links to asthma; Fast five – Good advice about common vices;
Enhanced monitoring for meningococcal B vaccine; EMA investigating safety of
ivabradine for coronary artery disease
http://www.nps.org.au/publications/health-professional/nps-direct/2014/june
**TGA
- Required Advisory Statements for Medicine Labels (RASML) and the Labelling Order
(TGO 69, effective 12 June 2014): Information for consumers, health professionals
and industry
http://www.tga.gov.au/newsroom/media-2014-rasml-tgo69-140613.htm
- BioCSL Fluvax - investigations into the cause of fevers in children under 5 years
http://www.tga.gov.au/safety/alerts-medicine-biocsl-fluvax-140612.htm
- AusPARs added: catridecacog (rys), etanercept (rch) and nonacog gamma
http://www.tga.gov.au/industry/pm-auspar.htm
**AIHW
- The measurement of patient experience in non-GP primary health care settings
http://www.aihw.gov.au/publication-detail/?id=60129547332
- Assessment of Global Burden of Disease 2010 methods for the Australian context:
Australian Burden of Disease Study Working paper No. 1
http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129547710
- National Opioid Pharmacotherapy Statistics 2013
http://www.aihw.gov.au/publication-detail/?id=60129547308
REPORTS AND PUBLICATIONS – INTERNATIONAL
**BTS
A UK based resource to support the monitoring and safe use of anti-tuberculosis
drugs and second line treatment of multidrug-resistant tuberculosis
http://www.tbdrugmonographs.co.uk/uploads/2/8/9/4/28941471/mdrtb_adr_moni
toring_guidancefinal.pdf
**NICE
Eyes on Evidence, June 2014. Includes:
Acid-suppressive drugs and oesophageal adenocarcinoma in Barrett's oesophagus;
Prescriptions for anxiolytics and hypnotics and risk of death; Assessment and
treatment of dementia in older adults
https://www.evidence.nhs.uk/eyes-on-evidence-june-2014.pdf
**PHE
'Don’t just screen, intervene': improved guidance from Public Health England to
improve the health of people living with a mental illness - the updated Lester Tool
https://www.gov.uk/government/news/dont-just-screen-intervene-improvedguidance-to-improve-the-health-of-people-living-with-a-mental-illness
MEDICATION SAFETY
**Dept of health (UK)
Estates and Facilities Alert: E-cigarettes, batteries and chargers, potential for fire
or explosion
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=1021
77
**FDA
Potential Signals of Serious Risks/New Safety Information Identified by the FDA
Adverse Event Reporting System (FAERS) between January – March 2014. Includes:
Brentuximab vedotin (Adcetris); Testosterone products; Antidepressant products
(except monoamine oxidase inhibitors (MAOIs))
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillanc
e/AdverseDrugEffects/ucm398223.htm
**Health Canada
Zofran (ondansetron) - Dosage and Administration of Intravenous Ondansetron in
Geriatrics (>65 years of age)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39943a-eng.php
**ISMP Canada Safety Bulletin, June 2014. Includes:
Safety checklist: a new approach to promote safe prescribing of and counselling for
DIANE-35 and its generics; Reported confusion with insulin syringe labelling;
Preventing harm from drug-food interactions
http://www.ismp-canada.org/download/safetyBulletins/2014/ISMPCSB20146_SafetyChecklist_DIANE-35.pdf#page=1
**Joint Commission
Speak Up: Anesthesia and Sedation - Infographic available to download
http://www.jointcommission.org/speakup_anesthesia_sedation/
PAPERS OF INTEREST
**Am J Health Syst Pharm
Impact of an antimicrobial stewardship program on patients with acute bacterial
skin and skin structure infections
http://www.ajhp.org/content/71/13/1136.abstract?etoc
**BMJ Quality and Safety
- Interventions employed to improve intrahospital handover: a systematic review
http://qualitysafety.bmj.com/content/23/7/600
- Collaborative pharmaceutical care in an Irish hospital: uncontrolled before-after
study
http://qualitysafety.bmj.com/content/23/7/574.full
- We need to talk: an observational study of the impact of electronic medical
record implementation on hospital communication
http://qualitysafety.bmj.com/content/23/7/584.abstract
**Cochrane
- Sumatriptan (all routes of administration) for acute migraine attacks in adults overview of Cochrane reviews
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009108.pub2/full
- Pericyazine for schizophrenia
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007479.pub2/full
- Antibiotic therapy versus no antibiotic therapy for children aged two to 59 months
with WHO-defined non-severe pneumonia and wheeze
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009576.pub2/full
- Blood pressure-lowering efficacy of monotherapy with thiazide diuretics for
primary hypertension
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003824.pub2/full
- Antibiotic therapy versus no antibiotic therapy for children aged two to 59 months
with WHO-defined non-severe pneumonia and wheeze
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009576.pub2/full
- Vitamin K for improved anticoagulation control in patients receiving warfarin
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009917.pub2/full
**Diabetes Care
Type 1 diabetes through the life span: A Position Statement of the American
Diabetes Association
http://care.diabetesjournals.org/content/early/2014/06/09/dc141140.full.pdf%20html
**Eur Heart J
- Systemic thrombolytic therapy for acute pulmonary embolism: a systematic
review and meta-analysis
http://eurheartj.oxfordjournals.org/content/early/2014/06/10/eurheartj.ehu218.
abstract
- Effect of B-type natriuretic peptide-guided treatment of chronic heart failure on
total mortality and hospitalization: an individual patient meta-analysis
http://eurheartj.oxfordjournals.org/content/35/23/1559.abstract
**Injury Prevention
Investigating the long-term consequences of adverse medical events among older
adults
http://injuryprevention.bmj.com/content/early/2014/04/21/injuryprev-2013041043
**Int J Clin Pharm
Look alike/sound alike drugs: a literature review on causes and solutions
http://link.springer.com/article/10.1007%2Fs11096-013-9885-6
**J Am Coll Surg
Reducing Postoperative Venous Thromboembolism Complications with a
Standardized Risk-Stratified Prophylaxis Protocol and Mobilization Program
http://www.journalacs.org/article/S1072-7515(14)00186-0/abstract
**JAMA
- Association Between Tumor Necrosis Factor-α Antagonists and Risk of Cancer in
Patients With Inflammatory Bowel Disease
http://jama.jamanetwork.com/article.aspx?articleid=1881309
- Thrombolysis for Pulmonary Embolism and Risk of All-Cause Mortality, Major
Bleeding, and Intracranial Hemorrhage: A Meta-analysis
http://jama.jamanetwork.com/article.aspx?articleid=1881311
**JAMA Intern Med
- Genotype-Guided vs Clinical Dosing of Warfarin and Its Analogues: Meta-analysis of
Randomized Clinical Trials
http://archinte.jamanetwork.com/article.aspx?articleid=1881013
- Preoperative β-Blocker Use in Coronary Artery Bypass Grafting Surgery: National
Database Analysis
http://archinte.jamanetwork.com/article.aspx?articleid=1881012
- Benefits and Risks of Anticoagulation Resumption Following Traumatic Brain Injury
http://archinte.jamanetwork.com/article.aspx?articleid=1878303
- Antibiotic Overuse and Clostridium difficile: A Teachable Moment
http://archinte.jamanetwork.com/article.aspx?articleid=1881016
**JAMA Pediatrics
Breastfeeding in Children of Women Taking Antiepileptic Drugs: Cognitive Outcomes
at Age 6 Years
http://archpedi.jamanetwork.com/article.aspx?articleid=1881246
**Lancet
Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors
compared with levodopa as initial treatment for Parkinson's disease (PD MED): a
large, open-label, pragmatic randomised trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)606838/abstract
**MJA
- Letter to the editor: Off label prescribing (M Gazarian, S Morris)
https://www.mja.com.au/journal/2014/200/11/label-prescribing
- A framework for overcoming disparities in management of acute coronary
syndromes in the Australian Aboriginal and Torres Strait Islander population
A consensus statement from the National Heart Foundation of Australia
https://www.mja.com.au/journal/2014/200/11/framework-overcomingdisparities-management-acute-coronary-syndromes-australian
**Pediatrics
Adverse Drug Event-Related Emergency Department Visits Associated With Complex
Chronic Conditions
http://pediatrics.aappublications.org/content/133/6/e1575
TAG Mail 11th June 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
- Projections of the prevalence of treated end-stage kidney disease in Australia:
2012-2020
http://www.aihw.gov.au/publication-detail/?id=60129547202
- Head and neck cancers in Australia
http://www.aihw.gov.au/publication-detail/?id=60129547291
**TGA
Behind the news: Liquid nicotine and personal importation for use in electronic
cigarettes
http://www.tga.gov.au/newsroom/btn-liquid-nicotine.htm
REPORTS AND PUBLICATIONS – INTERNATIONAL
**ABPI
ABPI position on biosimilar medicines
http://www.abpi.org.uk/_layouts/download.aspx?sourceurl=/ourwork/library/Documents/ABPI%20position%20on%20biosimilar%20medicines.pdf
**BNF
BNF Update, June 2014
- Changes in the legal classification of Tramadol, Lisdexamfetamine, Zaleplon, and
Zopiclone
- Dosing schedule for haloperidol
http://www.pharmpress.com/mailouts/bnf/jun14/BNF_enewsletter.html
**IHI
- Safety First Blog: Reducing C. diff, Everyone Has a Part to Play
http://www.ihi.org/communities/blogs/_layouts/ihi/community/blog/itemview.as
px?List=0f316db6-7f8a-430f-a63a-ed7602d1366a&ID=30
- New video added to the series The Science of Improvement on a Whiteboard:
Static vs. Dynamic Displays of Data
http://www.ihi.org/education/IHIOpenSchool/resources/Pages/BobLloydWhiteboar
d.aspx
**NICE
Evidence Summary: New Medicine
- ESNM41: Long-acting reversible contraception: levonorgestrel 13.5 mg intrauterine
delivery system
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM41.jsp
**NHS England
Patient Safety Alert Stage Three: Directive - Standardising the early identification
of Acute Kidney Injury
http://www.england.nhs.uk/2014/06/09/psa-aki/
**SIGN
Clinical Guideline: Management of primary cutaneous squamous cell carcinoma
http://www.sign.ac.uk/pdf/SIGN140.pdf
MEDICATION SAFETY
**CDC
Calls to Poison Centers for Exposures to Electronic Cigarettes — United States,
September 2010–February 2014
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm
**HQSC NZ
Medication Safety Watch, June 2014. Includes:
- Safe medicine administration through enteral feeding tubes
- Metoprolol alert
- England's medication error incident reporting and learning alert
- Intravenous administration of oral medicines
http://www.hqsc.govt.nz/our-programmes/medication-safety/publications-andresources/publication/1570/
**ISMP
Misidentification of alphanumeric symbols
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=81
**MHRA
Adrenaline Auto-injectors: A Review of Clinical and Quality Considerations
http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con423091.pdf
**TGA
- Accu-Chek Spirit Combo insulin pump - serial numbers 10171897 to 10281629:
Recall - potential for delay to treatment in rare cases
http://www.tga.gov.au/safety/alerts-device-accu-chek-insulin-pump-140606.htm
- Accu-Chek Mobile blood glucose meter: Recall for product correction - potential
for incorrect readings
http://www.tga.gov.au/safety/alerts-device-accu-chek-glucose-meter-140606.htm
PAPERS OF INTEREST
**Ann Intern Med
Rate- and Rhythm-Control Therapies in Patients With Atrial Fibrillation: A
Systematic Review
http://annals.org/article.aspx?articleid=1877019
**BMJ
- Benefits and harms in clinical trials of duloxetine for treatment of major
depressive disorder: comparison of clinical study reports, trial registries, and
publications
http://www.bmj.com/content/348/bmj.g3510
- Coding of adverse events of suicidality in clinical study reports of duloxetine for
the treatment of major depressive disorder: descriptive study
http://www.bmj.com/%5Bfield_highwire_a_cpath-raw%5D-5
**BMJ Qual Saf
Mitigating errors caused by interruptions during medication verification and
administration: interventions in a simulated ambulatory chemotherapy setting
http://qualitysafety.bmj.com/content/early/2014/06/06/bmjqs-2013002484.abstract
**Cochrane
- Adjuvant chemotherapy for advanced endometrial cancer
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010681.pub2/full
- Aminoadamantanes for chronic hepatitis C
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010125.pub2/full
- Antibiotic therapy versus no antibiotic therapy for children aged two to 59 months
with WHO-defined non-severe pneumonia and wheeze
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009576.pub2/full
- Antibody induction versus corticosteroid induction for liver transplant recipients
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010252.pub2/full
- HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not
requiring dialysis
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007784.pub2/abstract
**Eur J Hosp Pharm
- The impact of UK Medicines Information services on patient care, clinical
outcomes and medicines safety: an evaluation of healthcare professionals’ opinions
http://ejhp.bmj.com/content/early/2014/06/09/ejhpharm-2014-000462?papetoc
- Persistence with oral antiviral therapy in previously untreated patients with
chronic hepatitis B in Spain: the EUPTHEA study
http://ejhp.bmj.com/content/early/2014/06/06/ejhpharm-2014-000452?papetoc
- Economic impact of antifungal treatment in IFD by Candida species: anidulafungin
administration as a cost-effective alternative for critical care patients
http://ejhp.bmj.com/content/early/2014/06/05/ejhpharm-2013-000408?papetoc
**JAMA
- Association Between Intensification of Metformin Treatment With Insulin vs
Sulfonylureas and Cardiovascular Events and All-Cause Mortality Among Patients
With Diabetes
http://jama.jamanetwork.com/article.aspx?articleid=1878717
- Recurrence and Mortality Following Severe Cutaneous Adverse Reactions
http://jama.jamanetwork.com/article.aspx?articleid=1877196
- Association of Azithromycin With Mortality and Cardiovascular Events Among Older
Patients Hospitalized With Pneumonia
http://jama.jamanetwork.com/article.aspx?articleid=1877208
- Clinical Evidence Synopsis: Prophylactic Antibiotic Therapy in Chronic Obstructive
Pulmonary Disease
http://jama.jamanetwork.com/article.aspx?articleid=1877188
**JAMA Psych
Efficacy of Pharmacotherapy and Psychotherapy for Adult Psychiatric Disorders: A
Systematic Overview of Meta-analyses
http://archpsyc.jamanetwork.com/article.aspx?articleid=1865002
**J Intern Med
Statin use reduces the risk of dementia in elderly patients: a nationwide data
survey and propensity analysis
http://onlinelibrary.wiley.com/doi/10.1111/joim.12262/abstract;jsessionid=9B7FD
7C7069D059BBDA1003976C1E96C.f03t01
**Lancet Psych
Monitoring white blood cell count in adult patients with schizophrenia who are
taking clozapine: a cost-effectiveness analysis
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(14)702457/abstract
**Lancet Inf Dis
Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skinstructure infections (ESTABLISH-2): a randomised, double-blind, phase 3, noninferiority trial
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)707376/abstract
**NEJM
- Naloxegol for Opioid-Induced Constipation in Patients with Noncancer Pain
http://www.nejm.org/doi/full/10.1056/NEJMoa1310246
- Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection
http://www.nejm.org/doi/full/10.1056/NEJMoa1310480
- Single-Dose Oritavancin in the Treatment of Acute Bacterial Skin Infections
http://www.nejm.org/doi/full/10.1056/NEJMoa1310422
TAG Mail 3rd June 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**TGA
- Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches:
Safety advisory - potential bacterial contamination. Updates made to the statement
published on 9 May 2014 to include details about ongoing investigations into this
issue, including results of TGA testing of affected batches, and details of confirmed
cases of contamination with Ralstonia bacteria.
http://www.tga.gov.au/safety/alerts-medicine-provive-mct-lct-140530.htm
- AusPARs: added Loteprednol etabonate, Misoprostol, Palonosetron hydrochloride,
Pasireotide (as diaspartate), Afatinib (as dimaleate), Bevacizumab injection, Insulin
detemir (rys)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS – INTERNATIONAL
**AHRQ
Web M&M Spotlight Case Studies (with commentary):
- Medication Reconciliation With a Twist (or Dare We Say, a Patch?)
http://webmm.ahrq.gov/case.aspx?caseID=323
- Discontinued Medications: Are They Really Discontinued?
http://webmm.ahrq.gov/case.aspx?caseID=325
**CADTH
Rapid Response Reports:
- Fentanyl Transdermal Patches in Palliative Care: Clinical Effectiveness, Safety,
and Guidelines
http://www.cadth.ca/media/pdf/htis/jun2014/RB0685%20Fentanyl%20Transdermal%20Patch%20Final.pdf
- Bivalirudin Infusion Following Angioplasty: Safety
http://www.cadth.ca/media/pdf/htis/may2014/RB0689%20Bivalirudin%20Infusions%20Final.pdf
**FDA
Draft Guidance for Industry: Best Practices in Developing Proprietary Names for
Drugs
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation
/Guidances/UCM398997.pdf
**NHS Evidence
Evidence Update May 2014. Sickle cell acute painful episode: A summary of
selected new evidence relevant to NICE clinical guideline 143 ‘Sickle cell acute
painful episode: management of an acute painful sickle cell episode in hospital’
https://www.evidence.nhs.uk/evidence-update-60012
**NICE
Technology Appraisals
- TA313: Psoriatic arthritis (active) - ustekinumab
http://guidance.nice.org.uk/TA313
- TA312: Multiple sclerosis (relapsing-remitting) - alemtuzumab
http://guidance.nice.org.uk/TA312
MEDICATION SAFETY
**TGA
Medicines Safety Update, June 2014. In this issue:
- Bexsero meningococcal B vaccine - enhanced monitoring
- Strontium ranelate and cardiovascular and venous thromboembolic risks
- Complex regional pain syndrome and vaccines
- Azathioprine and cytomegalovirus reactivation
http://www.tga.gov.au/hp/msu-2014-06.htm
**MHRA
Drug Safety Update, May 2014. Includes:
- Domperidone: risks of cardiac side effects
- Voriconazole: reminder of risk of liver toxicity, phototoxicity, and squamous cell
carcinoma
- Adrenaline auto-injector advice for patients
- Statins benefits and risks
- Zolpidem: risk of drowsiness and reduced driving ability
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htm
PAPERS OF INTEREST
**BMJ
- Higher potency statins and the risk of new diabetes: multicentre, observational
study of administrative databases
http://www.bmj.com/content/348/bmj.g3244
- Effect of fixed dose combination treatment on adherence and risk factor control
among patients at high risk of cardiovascular disease: randomised controlled trial in
primary care
http://www.bmj.com/content/348/bmj.g3318
- Time to treatment with recombinant tissue plasminogen activator and outcome of
stroke in clinical practice: retrospective analysis of hospital quality assurance data
with comparison with results from randomised clinical trials
http://www.bmj.com/content/348/bmj.g3429
**Eur J Clin Pharmacol
Identifying high-risk medication: a systematic literature review
http://rd.springer.com/article/10.1007/s00228-014-1668-z
**Int J Qual Healthcare
Effects of patient-, environment- and medication-related factors on high-alert
medication incidents
http://intqhc.oxfordjournals.org/content/26/3/308
**JAMA Intern Med
5α-Reductase Inhibitors and Risk of High-Grade or Lethal Prostate Cancer
http://archinte.jamanetwork.com/article.aspx?articleid=1878668
**J Am Heart Assoc
- Delay in Filling First Clopidogrel Prescription After Coronary Stenting Is Associated
With an Increased Risk of Death and Myocardial Infarction
http://jaha.ahajournals.org/content/3/3/e000669.abstract.html?cpetoc
- The incidence of kidney injury for patients treated with a high-potency versus
moderate-potency statin regimen after an acute coronary syndrome
http://jaha.ahajournals.org/content/3/3/e000784.long
**J Clin Onc
- Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast
Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused
Update
http://jco.ascopubs.org/content/early/2014/05/20/JCO.2013.54.2258.abstract
- Series: Pain in patients with cancer
http://jco.ascopubs.org/content/current
**Lancet
- Global, regional, and national prevalence of overweight and obesity in children
and adults during 1980—2013: a systematic analysis for the Global Burden of Disease
Study 2013
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)604608/abstract
- Efficacy and safety of nebivolol and valsartan as fixed-dose combination in
hypertension: a randomised, multicentre study
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)606140/abstract
- Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks,
healthy life-years lost, and age-specific associations in 1·25 million people
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)606851/abstract
- Hypertension management in England: a serial cross-sectional study from 1994 to
2011
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)606887/abstract
**Lancet Resp Med
Azithromycin maintenance treatment in patients with frequent exacerbations of
chronic obstructive pulmonary disease (COLUMBUS): a randomised, double-blind,
placebo-controlled trial.
http://www.sciencedirect.com/science/article/pii/S2213260014700190
**Rheumatol
Safety of resuming tumour necrosis factor inhibitors in patients who developed
tuberculosis as a complication of previous TNF inhibitors.
http://rheumatology.oxfordjournals.org/content/early/2014/03/27/rheumatology.
keu041.long
**Stroke
Vitamin K Antagonists and Risk of Subdural Hematoma: Meta-Analysis of
Randomized Clinical Trials
http://stroke.ahajournals.org/content/early/2014/05/13/STROKEAHA.114.005430
28th May 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**ACSQHC
Exploring Healthcare Variation in Australia: Analyses Resulting from an OECD Study
http://www.safetyandquality.gov.au/publications/exploring-healthcare-variationin-australia/
**AIHW
Arthritis and other musculoskeletal conditions across the life stages
http://www.aihw.gov.au/publication-detail/?id=60129547059
**TGA
Medicine Shortages Information Initiative
http://www.tga.gov.au/hp/information-msi.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**AHRQ
Carbapenem-Resistant Enterobacteriaceae (CRE) Control and Prevention Toolkit
http://www.ahrq.gov/cretoolkit
**FDA
- FDA approves Dalvance (dalbavancin), a new antibacterial drug used to treat
adults with skin infections
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398724.htm
- FDA approves Entyvio (vedolizumab) injection to treat adult patients with
moderate to severe ulcerative colitis and adult patients with moderate to severe
Crohn‘s disease
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398065.htm
**NHS Evidence
Evidence Update May 2014. Opioids in palliative care: A summary of selected new
evidence relevant to NICE clinical guideline 140 ‘Opioids in palliative care: safe and
effective prescribing of strong opioids for pain in palliative care of adults’ (2012)
http://www.evidence.nhs.uk/evidence-update-58
**NIHT
What is the clinical effectiveness and cost-effectiveness of cytisine compared with
varenicline for smoking cessation? A systematic review and economic evaluation
http://www.journalslibrary.nihr.ac.uk/hta/volume-18/issue-33
MEDICATION SAFETY
**Health Canada
Vectibix (panitumumab) - Rare Cases of Stevens-Johnson Syndrome and Toxic
Epidermal Necrolysis
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39581a-eng.php
**ISMP
Administering just the diluent or one of two vaccine components leaves patients
unprotected
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=80
PAPERS OF INTEREST
**Am J Health Syst Pharm
Evaluation of dedicated infectious diseases pharmacists on antimicrobial
stewardship teams
http://www.ajhp.org/content/71/12/1019.abstract?etoc
**BMJ
Helicobacter pylori eradication therapy to prevent gastric cancer in healthy
asymptomatic infected individuals: systematic review and meta-analysis of
randomised controlled trials
http://www.bmj.com/content/348/bmj.g3174
**BMJ Qual Saf
Governance of quality of care: a qualitative study of health service boards in
Victoria, Australia
http://qualitysafety.bmj.com/content/23/6/474.abstract
**Diabetes Care
- Risk of Lactic Acidosis or Elevated Lactate Concentrations in Metformin Users With
Renal Impairment: A Population-Based Cohort Study
http://care.diabetesjournals.org/content/early/2014/05/14/dc13-3023.abstract
- Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2
Diabetes in a Randomized Controlled Trial (AWARD-3)
http://care.diabetesjournals.org/content/early/2014/05/14/dc13-2759.abstract
**Eur Heart J
Intravenous sodium nitrite in acute ST-elevation myocardial infarction: a
randomized controlled trial (NIAMI)
http://eurheartj.oxfordjournals.org/content/35/19/1255.abstract.html?etoc
**JAMA
- Durability of Class I American College of Cardiology/American Heart Association
Clinical Practice Guideline Recommendations
http://jama.jamanetwork.com/article.aspx?articleid=1874510
- Effect of a Perioperative, Cardiac Output–Guided Hemodynamic Therapy
Algorithm on Outcomes Following Major Gastrointestinal Surgery: A Randomized
Clinical Trial and Systematic Review
http://jama.jamanetwork.com/article.aspx?articleid=1873985
- Effectiveness of Paliperidone Palmitate vs Haloperidol Decanoate for Maintenance
Treatment of Schizophrenia: A Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleID=1872816
**JAMA Intern Med
- Low-Dose Estradiol and the Serotonin-Norepinephrine Reuptake Inhibitor
Venlafaxine for Vasomotor Symptoms: A Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1876676
- A Comparison of Live Counseling With a Web-Based Lifestyle and Medication
Intervention to Reduce Coronary Heart Disease Risk: A Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1876677
- Fracture Prediction After Discontinuation of 4 to 5 Years of Alendronate Therapy:
The FLEX Study
http://archinte.jamanetwork.com/article.aspx?articleid=1867177
- High-Risk Use by Patients Prescribed Opioids for Pain and Its Role in Overdose
Deaths
http://archinte.jamanetwork.com/article.aspx?articleid=1840033
- Informed Consent in Randomized Quality Improvement Trials: A Critical Barrier
for Learning Health Systems
http://archinte.jamanetwork.com/article.aspx?articleid=1835354
- Viewpoint: Why Does Antimicrobial Overuse in Hospitalized Patients Persist?
http://archinte.jamanetwork.com/article.aspx?articleid=1838720
- Approach to Overuse of Herbal and Dietary Supplements: A Teachable Moment
http://archinte.jamanetwork.com/article.aspx?articleid=1876678
- An Adverse Reaction to a Medication Given to Treat an Adverse Reaction: A
Teachable Moment
http://archinte.jamanetwork.com/article.aspx?articleid=1873081
**Lancet
Isoniazid plus antiretroviral therapy to prevent tuberculosis: a randomised doubleblind, placebo-controlled trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)601628/abstract
**MJA
Telemedicine — is the cart being put before the horse?
https://www.mja.com.au/journal/2014/200/9/telemedicine-cart-being-put-horse
21st May 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**NPS
NPS Direct May 2014, includes:
- Can oral zinc help prevent and treat the common cold?
- Opioid abuse: will tamper-proof oxycodone help?
- Saxagliptin and heart failure: what’s the risk?
http://www.nps.org.au/health-professionals/health-news-evidence
REPORTS AND PUBLICATIONS - INTERNATIONAL
**EMA
Transatlantic Taskforce on Antimicrobial Resistance: Progress report May 2014
http://ec.europa.eu/health/antimicrobial_resistance/docs/tatfar_progressreport_
2014_en.pdf
**MHRA
The benefits and risks of statins
http://www.mhra.gov.uk/NewsCentre/CON416702
**NICE
Evidence summary: new medicine
- ESNM40: Premature ejaculation - dapoxetine
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM40.jsp
**NHS Evidence
Eyes on Evidence May 2014. Includes:
- Ibuprofen compared with indometacin for patent ductus arteriosus
https://www.evidence.nhs.uk/eyes-on-evidence-may-2014.pdf
**NHS England
Vital support for young people with mental health problems: HeadMeds,
a unique new website about mental health medication for young people aged 1325, has been launched.
http://www.england.nhs.uk/2014/05/14/geraldine-strathdee-5/ and
http://www.headmeds.org.uk/
**PHE
- Electronic cigarettes: A report commissioned by Public Health England
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/3
11887/Ecigarettes_report.pdf
- E-cigarette uptake and marketing: A report commissioned by Public Health
England
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/3
11491/Ecigarette_uptake_and_marketing.pdf
MEDICATION SAFETY
**Health Canada
New safety information: Risk of serotonin syndrome associated with serotonin
blocking drugs used to treat nausea and vomiting
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39519a-eng.php
**ISMP Canada
Safety Bulletin May 2014, includes:
Preventable Death Highlights the Need for Improved Management of Known Drug
Interactions
http://www.ismp-canada.org/download/safetyBulletins/2014/ISMPCSB20145_KnownDrugInteractions.pdf#page=1
PAPERS OF INTEREST
**Am J Health Syst Pharm
Prophylaxis against venous thromboembolism in hospitalized medically ill
patients: Update and practical approach
http://www.ajhp.org/cgi/content/abstract/71/11/909?etoc
**Ann Intern Med
Biological Agents for Moderately to Severely Active Ulcerative Colitis: A Systematic
Review and Network Meta-analysis
http://annals.org/article.aspx?articleid=1872849
**Australian Health Review
-Ten clinician-driven strategies for maximising value of Australian health care
http://www.publish.csiro.au/?act=view_file&file_id=AH13248.pdf
**BMJ
Long term maintenance of weight loss with non-surgical interventions in obese
adults: systematic review and meta-analyses of randomised controlled trials
http://www.bmj.com/content/348/bmj.g2646
Comparative effectiveness of long term drug treatment strategies to prevent
asthma exacerbations: network meta-analysis
http://www.bmj.com/content/348/bmj.g3009
**Circulation
- Trends of Hospitalization for Atrial Fibrillation in the United States, 2000 Through
2010: Implications for Healthcare Planning
http://circ.ahajournals.org/content/early/2014/04/23/CIRCULATIONAHA.114.0082
01.abstract
- Editorial: Atrial Fibrillation Epidemic and Hospitalizations: How to Turn the Rising
Tide?
http://circ.ahajournals.org/content/early/2014/04/23/CIRCULATIONAHA.114.0100
73.abstract
- Lack of Concordance Between Empirical Scores and Physician Assessments of
Stroke and Bleeding Risk in Atrial Fibrillation: Results From the Outcomes Registry
for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry
http://circ.ahajournals.org/content/129/20/2005.abstract
- Association Between Antipsychotic Use and Risk of Acute Myocardial Infarction: A
Nationwide Case-Crossover Study
http://circ.ahajournals.org/content/early/2014/05/16/CIRCULATIONAHA.114.0087
79.abstract
**Cochrane
Interventions to improve safe and effective medicines use by consumers: an
overview of systematic reviews
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007768.pub3/abstract
**JAMA
- Preventing Health Care–Associated Harm in Children
http://jama.jamanetwork.com/article.aspx?articleid=1866118
- Effectiveness of Paliperidone Palmitate vs Haloperidol Decanoate for Maintenance
Treatment of Schizophrenia: A randomized clinical trial
http://jama.jamanetwork.com/article.aspx?articleid=1872816
**JAMA Intern Med
- National Estimates of Insulin-Related Hypoglycemia and Errors Leading to
Emergency Department Visits and Hospitalizations
http://archinte.jamanetwork.com/article.aspx?articleid=1835360
- Effect of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor
Blockers on All-Cause Mortality, Cardiovascular Deaths, and Cardiovascular Events
in Patients With Diabetes Mellitus: A Meta-analysis
http://archinte.jamanetwork.com/issue.aspx
**J Am Geriatr Soc
New Oral Anticoagulants in Elderly Adults: Evidence from a Meta-Analysis of
Randomized Trials
http://onlinelibrary.wiley.com/doi/10.1111/jgs.12799/abstract
**J Pediatr
Adverse Drug Event Detection in Pediatric Oncology and Hematology Patients: Using
Medication Triggers to Identify Patient Harm in a Specialized Pediatric Patient
Population
http://www.sciencedirect.com/science/article/pii/S002234761400287X
**Lancet
Antivirals for influenza: where now for clinical practice and pandemic
preparedness?
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)607261/fulltext
**MJA
A national study of the processes and outcomes of paediatric formulary applications
in Australia
https://www.mja.com.au/journal/2014/200/9/national-study-processes-andoutcomes-paediatric-formulary-applications-australia
**NEJM
- Randomized Trial of Acetylcysteine in Idiopathic Pulmonary Fibrosis
http://www.nejm.org/doi/full/10.1056/NEJMoa1401739
- Rosuvastatin for Sepsis-Associated Acute Respiratory Distress Syndrome
http://www.nejm.org/doi/full/10.1056/NEJMoa1401520
- Simvastatin for the Prevention of Exacerbations in Moderate-to-Severe COPD
http://www.nejm.org/doi/full/10.1056/NEJMoa1403086
**Vaccine
Vaccines are not associated with autism: An evidence-based meta-analysis of casecontrol and cohort studies
http://www.sciencedirect.com/science/article/pii/S0264410X14006367
14th May 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**TGA
Liquid nicotine and personal importation for use in electronic cigarettes: Public
notice
http://www.tga.gov.au/newsroom/btn-liquid-nicotine.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**BNF
BNF update May 2015. Includes: updated guidance on the treatment of epilepsy;
dose of IV metronidazole for neonates and children <2 months; introduction of a
Meningococcal group C conjugate vaccine catch-up programme; and restrictions on
the use of domperidone.
http://www.pharmpress.com/mailouts/bnf/may14/BNF_enewsletter.html
**FDA
FDA approves Zontivity (vorapaxar) tablets to reduce the risk of heart attack,
stroke, cardiovascular death in high risk patients.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm396585.htm
**NICE
QS62: Constipation in children and young people
http://publications.nice.org.uk/constipation-in-children-and-young-people-qs62
MEDICATION SAFETY
**FDA
- FDA study of Medicare patients finds risks lower for stroke and death but higher
for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin
http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm
- FDA permits manufacturers of oral health care benzocaine products to include a
methemoglobinemia warning
http://www.fda.gov/Drugs/DrugSafety/ucm396985.htm
**HQSC
Making health and disability services safer - Serious Adverse Events report 2012–13
http://www.hqsc.govt.nz/our-programmes/reportable-events/publications-andresources/publication/1190/
**ISMP
QuarterWatch: Drug hypersensitivity reactions - Allergic reactions second most
frequently reported serious event
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=79
**TGA
- Safety advisory - potential bacterial contamination: Provive and Sandoz propofol
1% emulsion for injection - all sizes and all batches. The statement was updated on
9th May 2014 to include details of the TGA's ongoing investigations into this issue.
http://www.tga.gov.au/safety/alerts-medicine-provive-mct-lct-140502.htm
- Alere INRatio2 PT/INR heparin-insensitive test strips: Safety alert - potential for
incorrect INR results
http://www.tga.gov.au/safety/alerts-device-alere-inratio2-140508.htm
**EMA
- EU review of hydroxyzine-containing medicines started
- EU review of ivabradine (Procoralan) started
- Ongoing EU review of safety of ferumoxytol (Rienso)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
14/05/news_detail_002094.jsp&mid=WC0b01ac058004d5c1
**Health Canada
Temozolomide - Risk of Liver Problems
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39335a-eng.php
PAPERS OF INTEREST
**Ann Oncol
Is oral chemotherapy prescription safe for patients? A cross-sectional survey
http://annonc.oxfordjournals.org/content/25/2/500
**Circ Cardiovasc Qual Outcomes
Stratifying the Risks of Oral Anticoagulation in Patients With Liver Disease
http://circoutcomes.ahajournals.org/content/early/2014/05/13/CIRCOUTCOMES.1
13.000817.abstract?papetoc
**Circulation
- E-Cigarettes: A Scientific Review
http://circ.ahajournals.org/content/129/19/1972.extract
- A New START for Sildenafil in Pediatric Pulmonary Hypertension: Reframing the
Dose–Survival Relationship in the STARTS-2 Trial
http://circ.ahajournals.org/content/129/19/1905.extract?etoc
**Lancet Diabetes Endocrin
Intensified insulin-based glycaemic control after myocardial infarction: mortality
during 20 year follow-up of the randomised Diabetes Mellitus Insulin Glucose
Infusion in Acute Myocardial Infarction (DIGAMI 1) trial
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)700889/abstract
**Cochrane
- Neuraminidase inhibitors for preventing and treating influenza in healthy adults
and children
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965.pub4/abstract;jse
ssionid=2CDA62817EF17B9A4F8A1F27F2DD3909.f03t04
- Treatment for peritoneal dialysis-associated peritonitis
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005284.pub3/abstract
- Gabapentin for chronic neuropathic pain and fibromyalgia in adults
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007938.pub3/full
- Low molecular weight heparin for prevention of venous thromboembolism in
patients with lower-leg immobilization
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006681.pub3/full
**Eur Heart J
- Expert position paper on the management of antiplatelet therapy in patients
undergoing coronary artery bypass graft surgery
http://eurheartj.oxfordjournals.org/content/early/2014/05/05/eurheartj.ehu158.f
ull.html?papetoc
- Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment
elevation myocardial infarction
http://eurheartj.oxfordjournals.org/content/early/2014/05/09/eurheartj.ehu182.
abstract.html?papetoc
**JAMA
- Effect of Evolocumab or Ezetimibe Added to Moderate- or High-Intensity Statin
Therapy on LDL-C Lowering in Patients With Hypercholesterolemia: The LAPLACE-2
Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1869210
- Pharmacotherapy for Adults With Alcohol Use Disorders in Outpatient Settings: A
Systematic Review and Meta-analysis
http://jama.jamanetwork.com/article.aspx?articleid=1869208
- Reducing the Trauma of Hospitalization
http://jama.jamanetwork.com/article.aspx?articleid=1867736
**JAMA Intern Med
Preventing 30-Day Hospital Readmissions: A Systematic Review and Meta-analysis of
Randomized Trials
http://archinte.jamanetwork.com/article.aspx?articleid=1868538
**J Pat Safety
Root Cause Analysis of Ambulatory Adverse Drug Events That Present to the
Emergency Department
http://journals.lww.com/journalpatientsafety/pages/articleviewer.aspx?year=9000
&issue=00000&article=99785&type=abstract
**Lancet
- Vitamin D supplementation and falls: a trial sequential meta-analysis
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)700683/fulltext
- Antibiotic use in Eastern Europe: a cross-national database study in coordination
with the WHO Regional Office for Europe
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)700714/fulltext
- Cardiovascular remodelling in coronary artery disease and heart failure
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)601070/abstract
**NEJM
- Letermovir for Cytomegalovirus Prophylaxis in Hematopoietic-Cell Transplantation
http://www.nejm.org/doi/full/10.1056/NEJMoa1309533
TAGMail 7th May 2014
REPORTS AND PUBLICATIONS - INTERNATIONAL
**CADTH
- Rapid response reports:
-- Direct Acting Antivirals for Chronic Hepatitis C genotype 1 in Select Populations:
Emerging Evidence of Clinical Effectiveness and Safety
http://www.cadth.ca/media/pdf/htis/may2014/RB0673%20DAAs%20for%20select%20populations%20Final.pdf
-- Re-treatment with Direct Acting Antivirals for Chronic Hepatitis C Genotype 1:
Emerging Evidence of Clinical Effectiveness and Safety
http://www.cadth.ca/media/pdf/htis/may2014/RB0672%20DAA%20treatment%20failure%20Final.pdf
-- Aspirating versus not Aspirating Prior to Injection of Medication: Comparative
Clinical Evidence and Guidelines
http://www.cadth.ca/media/pdf/htis/apr2014/RB0669%20Aspiration%20Prior%20to%20Injection%20Final.pdf
-- Short-Acting Intramuscular Olanzapine for Acute Agitation: Clinical and CostEffectiveness and Guidelines
http://www.cadth.ca/media/pdf/htis/may2014/RB0671%20IM%20Olanzapine%20Final.pdf
-- Apixaban and Rivaroxaban for Stroke Prevention in Atrial Fibrillation: Safety
http://www.cadth.ca/media/pdf/htis/apr2014/RA0668%20Apixaban%20and%20Rivaroxaban%20Final.pdf
**CDER
Impact of Abuse-Deterrent Formulations of Opioids – Presentation from the National
RxDrug Abuse Summit 2014
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProducts
andTobacco/CDER/UCM395804.pdf?source=govdelivery&utm_medium=email&utm_s
ource=govdelivery
**Dept of Health UK
Comorbidities: A framework of principles for system-wide action
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/3
07143/Comorbidities_framework.pdf
**EMA
New indication approved for Dabigatran (Pradaxa): treatment of deep vein
thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT
and PE in adults.
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/
human/000829/WC500165674.pdf
**FDA
- Use of Aspirin for Primary Prevention of Heart Attack and Stroke: Information for
consumers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm
- Consumer resource: Be An Active Member of Your Health Care Team
http://www.fda.gov/Drugs/ResourcesForYou/ucm079453.htm
- FDA proposes to extend its tobacco authority to additional tobacco products,
including e-cigarettes
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm
**RCP
Why asthma still kills: the Royal College of Physicians report of the National Review
of Asthma Deaths
http://www.rcplondon.ac.uk/projects/national-review-asthma-deaths
**SIGN
Care of deteriorating patients: Consensus recommendations
http://www.sign.ac.uk/pdf/SIGN139.pdf
**WHO
Antimicrobial resistance global report on surveillance: 2014
http://apps.who.int/iris/bitstream/10665/112642/1/9789241564748_eng.pdf?ua=1
MEDICATION SAFETY
**NSW Health
Safety Alert 002/14: Potential bacterial contamination of propofol
http://www.health.nsw.gov.au/sabs/Documents/2014-sa-002.pdf
**TGA
- Safety advisory - potential bacterial contamination: Provive and Sandoz propofol
1% emulsion for injection - all sizes and all batches
http://www.tga.gov.au/safety/alerts-medicine-provive-mct-lct140502.htm#.U2gm2od_W9I
- Medical Devices Safety Update, May 2014. In this issue: Alarm hazards - user error
a common contributing factor; Adjustments to syringe plunger forces for new BD 50
ml Plastipak syringes
http://www.tga.gov.au/hp/mdsu-2014-03.htm
**Health Canada
Canadian Adverse Reaction Newsletter April 2014. Includes:
- Quetiapine and acute liver failure
- Azithromycin and drug reaction with eosinophilia and systemic symptoms
- Clopidogrel and acquired hemophilia
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v24n2-eng.php
PAPERS OF INTEREST
**Am J Health Syst Pharm
Care Transitions Service: A pharmacy-driven program for medication reconciliation
through the continuum of care
http://www.ajhp.org/content/71/10/802.abstract
**Arthritis Rheum
- Long-term safety of subcutaneous abatacept in rheumatoid arthritis: Integrated
analysis of clinical trial data of up to 4.75 years of treatment
http://onlinelibrary.wiley.com/doi/10.1002/art.38687/abstract
- Pregnancy Outcome After Methotrexate Treatment for Rheumatic Disease Prior to
or During Early Pregnancy: A Prospective Multicenter Cohort Study
http://onlinelibrary.wiley.com/doi/10.1002/art.38368/abstract
**Cochrane
- Fixed-dose combination therapy for the prevention of cardiovascular disease
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009868.pub2/full
- Gabapentin for chronic neuropathic pain and fibromyalgia in adults
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007938.pub3/full
- Low molecular weight heparin for prevention of venous thromboembolism in
patients with lower-leg immobilization
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006681.pub3/full
**Eur Heart J
Early eplerenone treatment in patients with acute ST-elevation myocardial
infarction without heart failure: The Randomized Double-Blind Reminder Study
http://eurheartj.oxfordjournals.org/content/early/2014/04/23/eurheartj.ehu164.
abstract
**Eur J Hosp Pharm
Pharmacy care and adherence to primary and secondary prevention cardiovascular
medication: a systematic review of studies
http://ejhp.bmj.com/content/early/2014/05/02/ejhpharm-2014-000455?papetoc
**JAMA Intern Med
- Antidepressant Dose, Age, and the Risk of Deliberate Self-harm
http://archinte.jamanetwork.com/article.aspx?articleid=1863925
- The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir for
Chronic Hepatitis C Virus Infection
http://archinte.jamanetwork.com/article.aspx?articleid=1867174
**J Clin Onc
- Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor
Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical
Practice Guideline
http://jco.ascopubs.org/content/early/2014/05/05/JCO.2013.54.0948.abstract
- Recommendations on Disease Management for Patients With Advanced Human
Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases:
American Society of Clinical Oncology Clinical Practice Guideline
http://jco.ascopubs.org/content/early/2014/05/05/JCO.2013.54.0955.abstract
**J Crit Care
Computerized physician order entry in the cardiac intensive care unit: effects on
prescription errors and workflow conditions.
http://www.sciencedirect.com/science/article/pii/S0883944113003961
**Lancet Infect Dis
Early versus delayed initiation of highly active antiretroviral therapy for HIVpositive adults with newly diagnosed pulmonary tuberculosis (TB-HAART): a
prospective, international, randomised, placebo-controlled trial
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)707339/abstract
**Neurology
Systematic review: Efficacy and safety of medical marijuana in selected neurologic
disorders. Report of the Guideline Development Subcommittee of the American
Academy of Neurology
http://www.neurology.org/content/82/17/1556.abstract
**NEJM
- Antimicrobial Prophylaxis for Children with Vesicoureteral Reflux
http://www.nejm.org/doi/full/10.1056/NEJMoa1401811
- Darapladib for Preventing Ischemic Events in Stable Coronary Heart Disease
http://www.nejm.org/doi/full/10.1056/NEJMoa1315878
- A Randomized Trial of Protocol-Based Care for Early Septic Shock
http://www.nejm.org/doi/full/10.1056/NEJMoa1401602?query=infectious-disease
- Editorial: Therapy of Hepatitis C — Back to the Future
http://www.nejm.org/doi/full/10.1056/NEJMe1403619
**Pediatrics
Prenatal SSRI Use and Offspring With Autism Spectrum Disorder or Developmental
Delay
http://pediatrics.aappublications.org/content/current
TAG Mail 30th April 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
- Incidence of insulin-treated diabetes in Australia 2000-2011
http://www.aihw.gov.au/publication-detail/?id=60129546997
- Australia's hospital statistics 2012-13
http://www.aihw.gov.au/publication-detail/?id=60129546922
- Australia's hospitals at a glance 2012-13 (summary report)
http://www.aihw.gov.au/publication-detail/?id=60129547006
**BHI
- Healthcare in Focus: the Bureau of Health Information’s 2013 Annual Performance
Report
http://www.bhi.nsw.gov.au/publications/annual_performance_report_series/healt
hcare_in_focus_2013
- The Insights Series: 30-day mortality following hospitalisation, five clinical
conditions, NSW, July 2009 – 2012
http://www.bhi.nsw.gov.au/__data/assets/pdf_file/0018/204309/30-dayMortality_December2013.pdf
**Grattan Institute
Unlocking skills in hospitals: better jobs, more care
http://grattan.edu.au/static/files/assets/cf2cf3cc/810-unlocking-skills-inhospitals.pdf
**NHMRC
Talking with your patients about Complementary Medicine – a Resource for
Clinicians
http://www.nhmrc.gov.au/your-health/complementary-medicines/talking-yourpatients-about-complementary-medicine-resource-clin
**NHPA
Healthcare-associated Staphylococcus aureus bloodstream infections in 2012–13
http://www.myhospitals.gov.au/Content/Reports/sab/201403/pdf/HospitalPerformance_SAB_Infocus_2012_13.pdf
**NPS
NPS Direct, April 2014, includes:
- Statin use and haemorrhagic stroke
- Emergency contraception: a weighty concern for women > 70 kg
- Medicines in pregnancy — safe?
- Low-dose quetiapine: place in therapy?
http://www.nps.org.au/publications/health-professional/nps-direct/2014/april
**WCMICS
Australian consensus guidelines for the safe handling of monoclonal antibodies for
cancer treatment by healthcare personnel
http://www.wcmics.org/guidelines/20140422_MABs_Guidelines.pdf
REPORTS AND PUBLICATIONS - INTERNATIONAL
**BCSH
British Committee for Standards in Haematology. Guidelines for the diagnosis and
management of multiple myeloma 2014
http://www.bcshguidelines.com/documents/MYELOMA_GUIDELINE_Feb_2014_for_B
CSH.pdf
**EMA
2013 annual report on EudraVigilance: over 1 million adverse reaction reports
received and processed
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
14/04/news_detail_002088.jsp&mid=WC0b01ac058004d5c1
**FDA
- FDA grants accelerated approval to Zykadia (ceritinib) for patients with a certain
type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395299.htm
- FDA approves Sylvant (siltuximab) to treat patients with multicentric Castleman’s
disease (MCD), a rare disorder similar to lymphoma.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394522.htm
- FDA approves Cyramza (ramucirumab) to treat patients with advanced stomach
cancer or gastroesophageal junction adenocarcinoma
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394107.htm
- FDA approves Tanzeum (albiglutide) subcutaneous injection to improve glycemic
control, along with diet and exercise, in adults with type 2 diabetes.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm
**Joint Commission
- Sentinel Event Statistics as of March, 2014
http://www.jointcommission.org/sentinel_event_statistics_quarterly/
- Sentinel Event Statistics Data - Root Causes by Event Type (2004 - 2013)
http://www.jointcommission.org/Sentinel_Event_Statistics/
- Sentinel Event Statistics Data - Event Type by Year (1995 - 2013)
http://www.jointcommission.org/se_data_event_type_by_year_/
**NCPDP (US)
National Council for Prescription Drug Programs Recommendations and Guidance for
Standardizing the Dosing Designations on Prescription Container Labels of Oral
Liquid Medications
https://www.ncpdp.org/NCPDP/media/pdf/wp/DosingDesignations-OralLiquidMedicationLabels.pdf
**NICE
- Quality Standards
-- QS60 Induction of labour
http://guidance.nice.org.uk/QS60
-- QS61 Infection prevention and control
http://guidance.nice.org.uk/QS61
- Technology appraisals
-- TA310 Lung cancer (non small cell, EGFR mutation positive) – afatinib
http://guidance.nice.org.uk/TA310
-- TA309 Lung cancer (non small cell, non squamous) – pemetrexed
http://guidance.nice.org.uk/TA309
-- TA311 Multiple myeloma - bortezomib (induction therapy)
http://guidance.nice.org.uk/TA311
**NHS Evidence
Evidence Update - Venous thromboembolic diseases April 2014: A summary of
selected new evidence relevant to NICE clinical guideline 144 ‘Venous
thromboembolic diseases: the management of venous thromboembolic diseases and
the role of thrombophilia testing’ (2012)
http://arms.evidence.nhs.uk/resources/hub/1034187/attachment
**SIGN
Updated SIGN guidance: Antibiotic prophylaxis in surgery
http://www.sign.ac.uk/guidelines/fulltext/104/index.html
MEDICATION SAFETY
**TGA
Accu-Chek Mobile glucose tests: Recall for product correction - potential for the
antibiotic ceftriaxone to interfere with blood glucose test results
http://www.tga.gov.au/safety/alerts-device-accu-chek-mobile-140422.htm
**Health Canada
Progressive Multifocal Leukoencephalopathy (PML) reported in patients receiving
BENLYSTA (belimumab) for Systemic Lupus Erythematosus (SLE)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39189a-eng.php
**FDA
- FDA requires label changes to warn of rare but serious neurologic problems after
epidural corticosteroid injections for pain
http://www.fda.gov/Drugs/DrugSafety/ucm394280.htm
- New Safety Measures Announced for Extended-release and Long-acting Opioids
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm363722.htm
**ISMP
Medication Safety Newsletter: Disrespectful behaviors - Their impact, why they
arise and persist, and how to address them
http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=78
**ISMP Canada
Alert: Wrong Route Incidents with Epinephrine
http://www.ismp-canada.org/download/safetyBulletins/2014/ISMPCSB20144_Epinephrine.pdf#page=1
**MHRA
Domperidone: risk of cardiac side effects - restricted indication, new
contraindications, and reduced dose and duration of use
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=1021
55
PAPERS OF INTEREST
**BMJ
- Incretin based drugs and risk of acute pancreatitis in patients with type 2
diabetes: cohort study
http://www.bmj.com/content/348/bmj.g2780
- The impact of antibiotics on growth in children in low and middle income
countries: systematic review and meta-analysis of randomised controlled trials
http://www.bmj.com/content/348/bmj.g2267
- Chronic hypertension and pregnancy outcomes: systematic review and metaanalysis
http://www.bmj.com/content/348/bmj.g2301
**BMJ Qual Saf
Safety measurement and monitoring in healthcare: a framework to guide clinical
teams and healthcare organisations in maintaining safety
http://qualitysafety.bmj.com/content/early/2014/04/23/bmjqs-2013002757.short?g=w_qs_ahead_tab
**Br J Psych
Interventions for reducing benzodiazepine use in older people: meta-analysis of
randomised controlled trials
http://bjp.rcpsych.org/content/204/2/98.abstract
**Can J Diabetes
Safe and Appropriate Use of Insulin and Other Antihyperglycemic Agents in Hospital
http://www.sciencedirect.com/science/article/pii/S1499267114000033
**Circulation
- Periprocedural Stroke and Bleeding Complications in Patients undergoing Catheter
Ablation of Atrial Fibrillation with Different Anticoagulation Management: Results
from the "COMPARE" Randomized Trial
http://circ.ahajournals.org/content/early/2014/04/17/CIRCULATIONAHA.113.0064
26.abstract
- Periprocedural Management of New Oral Anticoagulants in Patients Undergoing
Atrial Fibrillation Ablation
http://circ.ahajournals.org/content/129/16/1688.full
**Eur Heart J
Expert position paper on the management of antiplatelet therapy in patients
undergoing coronary artery bypass graft surgery
http://eurheartj.oxfordjournals.org/content/early/2014/04/18/eurheartj.ehu158.f
ull
**Eur J Hosp Pharm
- Potential drug interactions and side effects in an outpatient oncology clinic: a
retrospective descriptive study
http://ejhp.bmj.com/content/early/2014/04/28/ejhpharm-2014-000449?papetoc
- Teicoplanin usage in adult patients with haematological malignancy in the UK and
Ireland: Is there scope for improvement?
http://ejhp.bmj.com/content/early/2014/04/15/ejhpharm-2013-000412.abstract
**Lancet Inf Dis
Individualised antibiotic dosing for patients who are critically ill: challenges and
potential solutions
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)700362/abstract
**JAMA
- Effect of the Use of Ambulance-Based Thrombolysis on Time to Thrombolysis in
Acute Ischemic Stroke: A Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1861800
- Door-to-Needle Times for Tissue Plasminogen Activator Administration and Clinical
Outcomes in Acute Ischemic Stroke Before and After a Quality Improvement
Initiative
http://jama.jamanetwork.com/article.aspx?articleid=1861802
- Editorial: tPA for Stroke: Important Progress in Achieving Faster Treatment
http://jama.jamanetwork.com/article.aspx?articleid=1861774
- Lorazepam vs Diazepam for Pediatric Status Epilepticus: A Randomized Clinical
Trial
http://jama.jamanetwork.com/article.aspx?articleid=1861799
- Pharmacological Treatment of Parkinson Disease: A Review
http://jama.jamanetwork.com/article.aspx?articleid=1861807
**JAMA Intern Med
Antihypertensive Medications and Serious Fall Injuries in a Nationally
Representative Sample of Older Adults
http://archinte.jamanetwork.com/article.aspx?articleid=1832197
**Pediatrics
Prenatal SSRI Use and Offspring With Autism Spectrum Disorder or Developmental
Delay
http://pediatrics.aappublications.org/content/early/2014/04/09/peds.20133406.abstract
TAG Mail 16th April 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**NHMRC
- Ethical Considerations in Quality Assurance and Evaluation Activities
http://www.nhmrc.gov.au/guidelines/publications/e111
- Inclusion of advice on an opt-out approach, in the National Statement on Ethical
Conduct in Human Research, 2007 (Chapter 2.3)
http://www.nhmrc.gov.au/health-ethics/human-research-ethics/inclusion-adviceopt-out-approach-national-statement-ethical-con
**TGA
- Canesten 6 day cream 35 g: Recall - potential problem with plastic applicator
http://www.tga.gov.au/safety/alerts-medicine-canesten-140414.htm
- AusPARs added: Crizotinib (Xalkori); Ezetimibe and rosuvastatin (as calcium)
(Ezalo Composite Pack / Rosuzet Composite Pack)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**BNF
BNF/BNFC Update April 2014, includes:
- Oral doses of amoxicillin and ampicillin for children updated
- Changes to recommendations on interchangeability of oral mesalazine
preparations
- Doses of naloxone for opioid overdosage revised
- Reminder on cytokine modulators and tuberculosis
- Phosphate-containing eye drops and corneal calcification
http://www.pharmpress.com/mailouts/bnf/apr14/BNF_enewsletter.html
**NHS Evidence
Eyes on Evidence April 2014, includes:
- E-cigarette awareness and use to quit smoking
- Beta-2 agonists and exercise-induced asthma Blood pressure control with home
telemonitoring and pharmacist management
- Antidepressant use late in pregnancy and risk of postpartum haemorrhage
https://www.evidence.nhs.uk/eyes-on-evidence-april-2014.pdf
**NICE
Quality Standard QS58: Sickle cell acute painful episode
http://guidance.nice.org.uk/QS58
** WHO
WHO guidelines for the screening, care and treatment of persons with hepatitis C
infection
http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/
MEDICATION SAFETY
**TGA
Medtronic paradigm insulin pump: Safety advisory - risk of over-infusion
http://www.tga.gov.au/safety/alerts-device-medtronic-paradigm-insulin-pump140408.htm
**EMA
Pharmacovigilance Risk Assessment Committee (PRAC) recommends against
combined use of medicines affecting the renin-angiotensin (RAS) system
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/04
/WC500165197.pdf
**Health Canada
Neupogen (filgrastim) and Neulasta (pegfilgrastim) - Risk of Capillary Leak
Syndrome
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38893a-eng.php
**MHRA
Drug Safety Update April 2014, includes:
- Tumour necrosis factor alpha inhibitors: risk of tuberculosis—screen all patients
before starting treatment and monitor them closely
- Yellow Card Scheme update: Reporting suspected adverse reactions experienced
by the woman or child associated with medicines taken during pregnancy
- Dispensing errors: please ensure appropriate precautions are in place
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/
**NHS England
- Patient Safety Alert, Stage One - Warning: Residual anaesthetic drugs in cannulae
and intravenous lines
http://www.england.nhs.uk/2014/04/14/pat-safety-alert/
- Patient Safety Alert, Stage One - Warning: Minimising risks of omitted and delayed
medicines for patients receiving homecare services
http://www.england.nhs.uk/2014/04/10/psa-min-risks/
PAPERS OF INTEREST
**Arthritis Rheum
Methotrexate and Lung Disease in Rheumatoid Arthritis: A Meta-Analysis of
Randomized Controlled Trials
http://onlinelibrary.wiley.com/doi/10.1002/art.38322/abstract
**BMJ
- Zanamivir for influenza in adults and children: systematic review of clinical study
reports and summary of regulatory comments
http://www.bmj.com/content/348/bmj.g2547
- Oseltamivir for influenza in adults and children: systematic review of clinical
study reports and summary of regulatory comments
http://www.bmj.com/content/348/bmj.g2545
- Editorial: Neuraminidase inhibitors for influenza
http://www.bmj.com/content/348/bmj.g2548
**BMJ Open
Non-steroidal anti-inflammatory drugs and the risk of atrial fibrillation: a
population-based follow-up study
http://bmjopen.bmj.com/content/4/4/e004059
**BMJ Qual Saf
- Are interventions to reduce interruptions and errors during medication
administration effective? a systematic review
http://qualitysafety.bmj.com/content/23/5/414?etoc
- Computerised provider order entry combined with clinical decision support
systems to improve medication safety: a narrative review
http://qualitysafety.bmj.com/content/early/2014/04/12/bmjqs-2013002165.abstract
**Eur Heart J
Balancing stroke and bleeding risks in patients with atrial fibrillation and renal
failure: the Swedish Atrial Fibrillation Cohort study
http://eurheartj.oxfordjournals.org/content/early/2014/04/09/eurheartj.ehu139.
abstract
**Circulation
- Antiplatelet Therapy for Stable Coronary Artery Disease in Atrial Fibrillation
Patients Taking an Oral Anticoagulant. A Nationwide Cohort Study
http://circ.ahajournals.org/content/129/15/1577.abstract?etoc
- Variations in Cause and Management of Atrial Fibrillation in a Prospective Registry
of 15 400 Emergency Department Patients in 46 Countries: The RE-LY Atrial
Fibrillation Registry
http://circ.ahajournals.org/content/129/15/1568.abstract?etoc
**Diabetes Care
The Efficacy and Safety of Imeglimin as Add-on Therapy in Patients With Type 2
Diabetes Inadequately Controlled With Sitagliptin Monotherapy
http://care.diabetesjournals.org/content/early/2014/04/07/dc13-2349.abstract
**Int J Qual Healthcare
Standardization in patient safety: the WHO High 5s project
http://intqhc.oxfordjournals.org/content/26/2/109.full.pdf+html
**JAMA
- Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors vs Conventional
Chemotherapy in Non–Small Cell Lung Cancer Harboring Wild-Type Epidermal
Growth Factor Receptor: A Meta-analysis
http://jama.jamanetwork.com/article.aspx?articleid=1857337
- Effect of Metformin on Left Ventricular Function After Acute Myocardial Infarction
in Patients Without Diabetes: The GIPS-III Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1853892
**JAMA Intern Med
- Bleeding Risk of Patients With Acute Venous Thromboembolism Taking
Nonsteroidal Anti-Inflammatory Drugs or Aspirin
http://archinte.jamanetwork.com/article.aspx?articleid=1860497
- Reduction of Inappropriate Benzodiazepine Prescriptions Among Older Adults
Through Direct Patient Education: The EMPOWER Cluster Randomized Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1860498
- Sildenafil Use and Increased Risk of Incident Melanoma in US Men: A Prospective
Cohort Study
http://archinte.jamanetwork.com/article.aspx?articleid=1857095
**J Clin Onc
Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in
Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice
Guideline
http://jco.ascopubs.org/content/early/2014/04/09/JCO.2013.54.0914.abstract
Screening, Assessment, and Care of Anxiety and Depressive Symptoms in Adults
With Cancer: An American Society of Clinical Oncology Guideline Adaptation
http://jco.ascopubs.org/content/early/2014/04/09/JCO.2013.52.4611.abstract
Screening, Assessment, and Management of Fatigue in Adult Survivors of Cancer: An
American Society of Clinical Oncology Clinical Practice Guideline Adaptation
http://jco.ascopubs.org/content/early/2014/04/09/JCO.2013.53.4495.abstract
**MJA
Multidrug-resistant tuberculosis in Western Australia, 1998–2012
https://www.mja.com.au/journal/2014/200/6/multidrug-resistant-tuberculosiswestern-australia-1998-2012
**NEJM
- Spironolactone for Heart Failure with Preserved Ejection Fraction
http://www.nejm.org/doi/full/10.1056/NEJMoa1313731
- Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism
http://www.nejm.org/doi/full/10.1056/NEJMoa1302097
**Pediatrics
- American Academy of Pediatrics Policy Statement: Off-Label Use of Drugs in
Children
http://pediatrics.aappublications.org/content/133/3/563.full.pdf+html
TAG Mail 9th April 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
National Aged Care Data Clearinghouse now available: an independent and
centralised repository of national aged care data, which provides access to aged
care information or custom aged care data on request.
http://www.aihw.gov.au/national-aged-care-data-clearinghouse/
**TGA
- EMA and Australian regulatory authority strengthen collaboration in the area of
orphan medicines
http://www.tga.gov.au/newsroom/media-2014-ema-orphan-medicines-140407.htm
- AusPARs added: Aminolevulinic acid HCl (Gliolan) and Deferasirox (Exjade)
http://www.tga.gov.au/industry/pm-auspar.htm
**NPS
NPS RADAR: Glycopyrronium (Seebri) for chronic obstructive pulmonary disease
http://www.nps.org.au/publications/health-professional/nps-radar/latest-
issue/glycopyrronium
REPORTS AND PUBLICATIONS - INTERNATIONAL
**CADTH
- Issues in Emerging Health Technologies: Laquinimod for Relapsing-Remitting
Multiple Sclerosis
http://www.cadth.ca/media/pdf/EH0010_Laquinimod_for_MS_e.pdf
- Rapid Response report: Vitamin Supplementation for Hospitalized Adults: Clinical
Evidence and Guidelines
http://www.cadth.ca/media/pdf/htis/apr2014/RB0664%20Vitamin%20Supplementation%20for%20Inpatients%20Final.pdf
**CDC
Healthcare-associated Infections (HAI) Progress Report, March 2014 (2102 data)
http://www.cdc.gov/hai/progress-report/index.html
**CPSI
Making Care Safer, From Hospital to Home Care: A collaborative report from
Accreditation Canada and the Canadian Patient Safety Institute
http://www.patientsafetyinstitute.ca/English/toolsResources/patientSafetyPublica
tions/Documents/Making%20Care%20Safer%20From%20Hospital%20to%20Home%20Ca
re.pdf
**FDA
FDA approves new hand-held auto-injector to reverse opioid overdose -first
naloxone treatment specifically designed to be given by family members or
caregivers
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm
MEDICATION SAFETY
**TGA
- Hydroxyethyl starch (Voluven and Volulyte): Safety advisory - increased risk of
mortality and the need for dialysis in patients with sepsis
http://www.tga.gov.au/safety/alerts-medicine-hydroxyethyl-starch-140404.htm
- Bexsero meningococcal B vaccine: Monitoring communication - consumers and
health professionals are advised that the TGA is undertaking intensive monitoring of
the safety and risk profile of Bexsero meningococcal B vaccine following its
introduction to the Australian market.
http://www.tga.gov.au/safety/ews-medicine-bexsero-140402.htm
- Domperidone (Motilium) and effects on the heart: Monitoring communication- the
TGA is reviewing new information regarding domperidone (Motilium) and its
potential effects on the patient's heart, particularly with doses above 30 mg daily.
http://www.tga.gov.au/safety/ews-medicine-domperidone-140402.htm
**Health Canada
Association of vemurafenib (ZELBORAF®) Use with Drug Induced Liver Injury
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38867a-eng.php
PAPERS OF INTEREST
**Ann Intern Med
- Low-Dose Aspirin for Prevention of Morbidity and Mortality From Preeclampsia: A
Systematic Evidence Review for the U.S. Preventive Services Task Force
http://annals.org/article.aspx?articleid=1859300
- The Incidence and Determinants of Primary Nonadherence With Prescribed
Medication in Primary Care: A Cohort Study
http://annals.org/article.aspx?articleid=1852865
- Effectiveness of Combination Therapy With Statin and Another Lipid-Modifying
Agent Compared With Intensified Statin Monotherapy: A Systematic Review
http://annals.org/article.aspx?articleid=1828554
**BMJ
- Vitamin D and multiple health outcomes: umbrella review of systematic reviews
and meta-analyses of observational studies and randomised trials
http://www.bmj.com/content/348/bmj.g2035
- Vitamin D and risk of cause specific death: systematic review and meta-analysis of
observational cohort and randomised intervention studies
http://www.bmj.com/content/348/bmj.g1903
- Selective digestive or oropharyngeal decontamination and topical oropharyngeal
chlorhexidine for prevention of death in general intensive care: systematic review
and network meta-analysis
http://www.bmj.com/content/348/bmj.g2197
- Causes and patterns of readmissions in patients with common comorbidities:
retrospective cohort study
http://www.bmj.com/content/347/bmj.f7171
**Cochrane
- Combined oral contraceptives: venous thrombosis
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010813.pub2/full
- Combined oral contraceptives: the risk of myocardial infarction and ischemic
stroke
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011054/abstract
- Antidepressants for the treatment of depression in patients with cancer
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011006/abstract
- Darbepoetin for the anaemia of chronic kidney disease
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009297.pub2/abstract
- Direct thrombin inhibitors versus vitamin K antagonists for preventing cerebral or
systemic embolism in people with non-valvular atrial fibrillation
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009893.pub2/abstract
- Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for
COPD: a network meta-analysis
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010844.pub2/abstract
- Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010115.pub2/full
- Pharmacotherapies for sleep disturbances in Alzheimer's disease
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009178.pub2/abstract
- Antibiotic prophylaxis for preventing post solid organ transplant tuberculosis
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008597.pub2/full
- Paroxetine versus other anti-depressive agents for depression
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006531.pub2/abstract
**Eur J Hosp Pharm
- The rate and nature of medication errors among elderly upon admission to
hospital after implementation of clinical pharmacist-led medication reconciliation
http://ejhp.bmj.com/content/early/2014/04/04/ejhpharm-2013-000403?papetoc
- Physicochemical compatibility of commonly used analgesics and sedatives in the
intensive care medicine
http://ejhp.bmj.com/content/early/2014/04/04/ejhpharm-2014-000444.abstract
- Improving the efficiency of a hospital pharmacy service: the journey of one
hospital pharmacy
http://ejhp.bmj.com/content/early/2014/04/04/ejhpharm-2013-000429.abstract
**Int J Clin Pharm
Drug related problems identified by community pharmacists on hospital discharge
prescriptions in New Zealand
http://link.springer.com/article/10.1007/s11096-014-9935-8
**JAMA Intern Med
- Histamine-2 Receptor Antagonists vs Proton Pump Inhibitors on Gastrointestinal
Tract Hemorrhage and Infectious Complications in the Intensive Care Unit
http://archinte.jamanetwork.com/article.aspx?articleid=1830021
- Antihypertensive Medications and Serious Fall Injuries in a Nationally
Representative Sample of Older Adults
http://archinte.jamanetwork.com/article.aspx?articleid=1832197
- Outbreak of Bacteremia Due to Burkholderia contaminans Linked to Intravenous
Fentanyl From an Institutional Compounding Pharmacy
http://archinte.jamanetwork.com/article.aspx?articleid=1819575
- National estimates of insulin-related hypoglycemia and errors leading to
emergency department visits and hospitalizations
http://archinte.jamanetwork.com/article.aspx?articleid=1835360
**J Am Med Inform Assoc
- Appropriateness of commercially available and partially customized medication
dosing alerts among pediatric patients
http://jamia.bmj.com/content/21/e1/e35
**J Particip Med
Do You Hear What I Hear? Communication Practices about Medications Between
Physicians and Clients with Chronic Illness in Canada
http://www.jopm.org/evidence/research/2014/01/15/do-you-hear-what-i-hearcommunication-practices-about-medications-between-physicians-and-clients-withchronic-illness-in-canada/
**J Pain Symptom Manag
Variation of Opioid Use in Pediatric Inpatients Across Hospitals in the United States
http://www.sciencedirect.com/science/article/pii/S0885392414001511
**Lancet Diabetes Endocrin
Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3year results of an open-label randomised trial
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)700294/abstract
**Lancet Infect Dis
New antituberculosis drugs, regimens, and adjunct therapies: needs, advances, and
future prospects
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(13)703281/fulltext
**MJA
Case Report: Impact of drug interactions when medications are stopped: the often
forgotten risks
https://www.mja.com.au/journal/2014/200/6/impact-drug-interactions-whenmedications-are-stopped-often-forgotten-risks
TAG Mail 2nd April 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**TGA
- TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2013
http://www.tga.gov.au/about/tga-reforms-blueprint-progress-131231.htm
- AusPARs added: Abiraterone acetate (Zytiga), Adalimumab (Humira), Besifloxacin
hydrochloride (Besivance), Canagliflozin (as hemihydrate), Invokana (Prominad),
Denosumab (Prolia), Imatinib (Glivec), Influenza virus haemagglutinin inactivated
split influenza vaccine (Fluarix Tetra) and Japanese Encephalitis Vaccine (live,
attenuated) (Imojev)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**AHRQ
Medication Administration Errors in Hospitals — Challenges and Recommendations
for Their Measurement
http://www.qualitymeasures.ahrq.gov/expert/expertcommentary.aspx?f=rss&id=47856
**FDA
- FDA approves topiramate (Topamax) for migraine prevention in adolescents
(First approved treatment for ages 12 to 17)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391026.htm
- FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary
Arterial Hypertension
http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm
**NICE
- Audit reveals variation in use of pain relief for hip fracture
http://www.nice.org.uk/newsroom/news/AuditRevealsVariationUsePainReliefHipFr
acture.jsp
- Evidence Summaries: New Medicines:
-- ESNM39 Schizophrenia: aripiprazole prolonged-release suspension for injection
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM39.jsp
-- ESNM38 Induction of labour: misoprostol vaginal delivery system
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM38.jsp
- Evidence summary: unlicensed or off-label medicine:
-- ESUOM30 Pouchitis: rifaximin
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESU
OM30.jsp
- Technology Appraisals:
-- TA307 Aflibercept in combination with irinotecan and fluorouracil-based therapy
for treating metastatic colorectal cancer that has progressed following prior
oxaliplatin-based chemotherapy
http://guidance.nice.org.uk/TA307
-- TA308 Rituximab in combination with glucocorticoids for treating anti-neutrophil
cytoplasmic antibody-associated vasculitis
http://guidance.nice.org.uk/TA308
MEDICATION SAFETY
**TGA
Medicines Safety Update, April 2014. Includes:
- Olmesartan and sprue-like enteropathy
- Codeine use in children after tonsillectomy and/or adenoidectomy
- Methoxyflurane and occupational exposure
http://www.tga.gov.au/hp/msu-2014-04.htm
**Health Canada
- Association of mirtazapine with QT Prolongation/Torsades de Pointes
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38709a-eng.php
- Association of azathioprine or mercaptopurine with Hepatosplenic T-Cell
Lymphoma (HSTCL)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38691a-eng.php
**ISMP
Still outside the bull’s eye: 2014-2015 Targeted Medication Safety Best Practices
(baseline survey results)
http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=76
PAPERS OF INTEREST
**Am J Health Syst Pharm
Variations in pharmacy-based transition-of-care activities in the United
States: A national survey
http://www.ajhp.org/cgi/content/abstract/71/8/648?etoc
**BMC Medicine
Unintended effects of statins from observational studies in the general population:
systematic review and meta-analysis
http://www.biomedcentral.com/1741-7015/12/51
**Can J Cardiol
Recent Advances in Antidotes for Direct Oral Anticoagulants: Their Arrival Is
Imminent
http://www.sciencedirect.com/science/article/pii/S0828282X14000476
**Circulation
- 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial
Fibrillation
http://circ.ahajournals.org/content/early/2014/03/27/CIR.0000000000000041.full.
pdf%20html
- National Assessment of Warfarin Anticoagulation Therapy for Stroke Prevention in
Atrial Fibrillation
http://circ.ahajournals.org/content/129/13/1407.abstract
- Lack of Concordance between Empirical Scores and Physician Assessments of
Stroke and Bleeding Risk in Atrial Fibrillation: Results from the Outcomes Registry
for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry
http://circ.ahajournals.org/content/early/2014/03/20/CIRCULATIONAHA.114.0086
43.abstract
- Five-Year Survival in Patients with ST-Segment Elevation Myocardial Infarction
According to Modalities of Reperfusion Therapy: The French Registry on Acute STElevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort
http://circ.ahajournals.org/content/early/2014/03/21/CIRCULATIONAHA.113.0058
74.abstract
**Int J Med Informatics
E-prescribing errors in community pharmacies: Exploring consequences and
contributing factors
http://www.sciencedirect.com/science/article/pii/S1386505614000434
**JAMA
- Validation of the Atherosclerotic Cardiovascular Disease Pooled Cohort Risk
Equations
http://jama.jamanetwork.com/article.aspx?articleid=1853203
- Effect of Metformin on Left Ventricular Function After Acute Myocardial
Infarction in Patients Without Diabetes: The GIPS-III Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1853892
- Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients
in Australia and New Zealand, 2000-2012
http://jama.jamanetwork.com/article.aspx?articleid=1850096
- Comparison of Application of the ACC/AHA Guidelines, Adult Treatment Panel III
Guidelines, and European Society of Cardiology Guidelines for Cardiovascular
Disease Prevention in a European Cohort
http://jama.jamanetwork.com/article.aspx?articleid=1853204
**JAMA Intern Med
Effect of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor
Blockers on All-Cause Mortality, Cardiovascular Deaths, and Cardiovascular Events
in Patients with Diabetes Mellitus: A Meta-analysis
http://archinte.jamanetwork.com/article.aspx?articleid=1847572
**MJA
Staphylococcus aureus bloodstream infection in Australian hospitals: findings from a
Victorian surveillance system.
https://www.mja.com.au/journal/2014/200/5/staphylococcus-aureusbloodstream-infection-australian-hospitals-findings
**NEJM
- Aspirin in Patients Undergoing Noncardiac Surgery
http://www.nejm.org/doi/full/10.1056/NEJMoa1401105?query=featured_home
- Clonidine in Patients Undergoing Noncardiac Surgery
http://www.nejm.org/doi/full/10.1056/NEJMoa1401106
- Multistate Point-Prevalence Survey of Health Care–Associated Infections
http://www.nejm.org/doi/full/10.1056/NEJMoa1306801
- A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
http://www.nejm.org/doi/full/10.1056/NEJMoa1316222
**Lancet
- Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive
adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised openlabel phase 3b study
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)600842/abstract
- Efficacy and safety of colchicine for treatment of multiple recurrences of
pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised
trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)627099/abstract
**Pediatrics
Ceftriaxone and Acute Renal Failure in Children
http://pediatrics.aappublications.org/content/133/4/e917.abstract
TAG Mail 26th March 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
Health expenditure Australia 2011-12: analysis by sector
http://www.aihw.gov.au/publication-detail/?id=60129546642
**CEC
Four new Clinical Focus Reports have been published:
– Falls
- Retrieval and Inter-Hospital Transfer
- Patient Controlled Analgesia
- A Review of Acute Coronary Syndrome Incidents
http://www.cec.health.nsw.gov.au/programs/patient-safety#publications2
**NSW Health
Goods and Services Procurement Policy
http://www0.health.nsw.gov.au/policies/pd/2014/pdf/PD2014_005.pdf
REPORTS AND PUBLICATIONS - INTERNATIONAL
**FDA
FDA approves Otezla (apremilast) to treat adults with active psoriatic arthritis
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390091.htm
**NICE
- Evidence Summaries: New Medicines
-- ESNM37: Partial seizures in children and young people with epilepsy: zonisamide
as adjunctive therapy
http://publications.nice.org.uk/esnm37-partial-seizures-in-children-and-youngpeople-with-epilepsy-zonisamide-as-adjunctive-esnm37
-- ESNM36: Systemic juvenile idiopathic arthritis: canakinumab
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM36.jsp
- Evidence summary: unlicensed or off-label medicine
-- ESUOM29: Difficult-to-treat scabies: oral ivermectin
http://publications.nice.org.uk/esuom29-difficult-to-treat-scabies-oral-ivermectinesuom29
MEDICATION SAFETY
**ISMP Canada
Advancing Opioid Safety for Children in Hospitals
http://www.ismp-canada.org/download/safetyBulletins/2014/ISMPCSB20143_HospitalOpioidSafetyForChildren.pdf#page=1
**MHRA
Patient Safety Alert, Stage Three: Directive - Improving medication error incident
reporting and learning
http://www.england.nhs.uk/wp-content/uploads/2014/03/psa-med-error.pdf
PAPERS OF INTEREST
**Am Heart J
Physician practices regarding contraindications to oral anticoagulation in atrial
fibrillation: Findings from the Outcomes Registry for Better Informed Treatment of
Atrial Fibrillation (ORBIT-AF) registry
http://www.sciencedirect.com/science/article/pii/S0002870314000076
**BMJ
- Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards:
retrospective cohort study
http://www.bmj.com/content/348/bmj.g1996
- Antidepressant efficacy of agomelatine: meta-analysis of published and
unpublished studies
http://www.bmj.com/content/348/bmj.g1888
**BMJ Qual Saf
Identifying systems failures in the pathway to a catastrophic event: an analysis of
national incident report data relating to vinca alkaloids
http://qualitysafety.bmj.com/content/early/2014/03/18/bmjqs-2013002572.full.pdf+html
**Circulation
STARTS-2: Long-Term Survival With Oral Sildenafil Monotherapy in Treatment-Naïve
Pediatric Pulmonary Arterial Hypertension
http://circ.ahajournals.org/content/early/2014/03/17/CIRCULATIONAHA.113.0056
98.abstract
**Eur Heart J
- The association between older age and receipt of care and outcomes in patients
with acute coronary syndromes: a cohort study of the Myocardial Ischaemia
National Audit Project (MINAP)
http://eurheartj.oxfordjournals.org/content/early/2014/03/17/eurheartj.ehu039.
abstract
- Management of major bleeding events in patients treated with rivaroxaban vs.
warfarin: results from the ROCKET AF trial
http://eurheartj.oxfordjournals.org/content/early/2014/03/20/eurheartj.ehu083.
abstract.html?papetoc
**JAMA
- Ezetimibe Prescribing Fails to Keep Up With Evidence
http://jama.jamanetwork.com/article.aspx?articleid=1850961
- The perpetual challenge of antimicrobial resistance
http://jama.jamanetwork.com/article.aspx?articleid=1851734
**JAMIA
Design and usability study of an iconic user interface to ease information retrieval
of medical guidelines
http://jamia.bmj.com/content/early/2014/03/20/amiajnl-2012001548.short?g=w_jamia_ahead_tab
*Lancet Resp Med
- Effectiveness of neuraminidase inhibitors in reducing mortality in patients
admitted to hospital with influenza A H1N1pdm09 virus infection: a meta-analysis
of individual participant data
http://www.thelancet.com/journals/lancet/article/PIIS2213-2600(14)700414/fulltext
- Atorvastatin as a stable treatment in bronchiectasis: a randomised controlled trial
http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(14)70050-
5/abstract
**NEJM
Ribavirin for Chronic Hepatitis E Virus Infection in Transplant Recipients
http://www.nejm.org/doi/full/10.1056/NEJMoa1215246?query=TOC
TAG Mail 19th March 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**NSW Health
Snakebite and Spiderbite Clinical Management Guidelines 2013 - Third Edition
http://www0.health.nsw.gov.au/policies/gl/2014/GL2014_005.html
**TGA
- Review of the colouring substance tartrazine
http://www.tga.gov.au/newsroom/media-2014-tartrazine-140317.htm
- Common list of colouring substances published
http://www.tga.gov.au/newsroom/media-2014-colouring-140317.htm
- AusPARs added Tocilizumab (Actemra)
http://www.tga.gov.au/industry/pm-auspar.htm
**ACSQHC
- Accreditation Workbook for Mental Health Services
http://www.safetyandquality.gov.au/publications/accreditation-workbook-mentalhealth-services/
- National Round Table Report on Improving the Safety and Quality of Pharmacy
Dispensing Labels
http://www.safetyandquality.gov.au/publications/national-round-table-report-onimproving-the-safety-and-quality-of-pharmacy-dispensing-labels/
REPORTS AND PUBLICATIONS - INTERNATIONAL
**CADTH
Rapid Response Report: Bolused (Vice Infused) Tranexamic Acid in Adults
Experiencing Hemorrhagic Shock: Safety, Patient Benefits, and Guidelines
http://www.cadth.ca/media/pdf/htis/mar2014/RB0652%20Bolused%20Tranexamic%20Acid%20Final.pdf
**IHI
“Always Events” Getting Started Kit
http://www.ihi.org/resources/Pages/Tools/AlwaysEventsGettingStartedKit.aspx
**MHRA
Early access to medicines scheme announced: The new scheme aims to give
patients in the UK with life threatening or seriously debilitating conditions access to
medicines that do not yet have a marketing authorisation.
http://www.mhra.gov.uk/NewsCentre/CON392899
**NICE
Eyes on Evidence, March 2014. Includes:
- Oral contraceptive pills in preventing ovarian;
- Tamsulosin for benign prostatic hyperplasia and risk of severe hypotension.
https://www.evidence.nhs.uk/eyes-on-evidence-march-2014.pdf
MEDICATION SAFETY
**TGA
Monitoring communication: Natalizumab and melanoma. The TGA is monitoring
reports of melanoma in patients being treated with natalizumab and encourages
reporting of all such cases.
http://www.tga.gov.au/safety/ews-medicine-natalizumab-melanoma-140318.htm
**ISMP
Recommendations for practitioners and manufacturers to address system-based
causes of vaccine errors
http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=74
**MHRA
Drug Safety Update March 2014, includes:
- Orlistat: theoretical interaction with antiretroviral HIV medicines;
- St John’s wort: interaction with hormonal contraceptives, including implants—
reduced contraceptive effect;
- Strontium ranelate: cardiovascular risk—restricted indication and new monitoring
requirements;
- Methysergide: serious fibrotic reactions—restricted use and new monitoring
requirements;
- Combined hormonal contraceptives: risk of venous thromboembolism—clarification
of advice.
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htm
PAPERS OF INTEREST
**Am J Health Syst Pharm
- Comparison of injectable anticoagulants for thromboprophylaxis after cancerrelated surgery
http://www.ajhp.org/content/71/7/562.abstract?etoc
- Impact of shortages of injectable oncology drugs on patient care
http://www.ajhp.org/content/71/7/571.abstract?etoc
**Ann Intern Med
Association of Dietary, Circulating, and Supplement Fatty Acids With Coronary Risk:
A Systematic Review and Meta-analysis
http://annals.org/article.aspx?articleid=1846638
**BMJ
Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre
trial of efficacy
http://www.bmj.com/content/348/bmj.g1622
**Eur J Prev Cardiol
What proportion of symptomatic side effects in patients taking statins are genuinely
caused by the drug? Systematic review of randomized placebo-controlled trials to
aid individual patient choice
http://cpr.sagepub.com/content/early/2014/03/06/2047487314525531.abstract
**J Emerg Med
Adverse Drug Event Nonrecognition in Emergency Departments: An Exploratory
Study on Factors Related to Patients and Drugs
http://www.sciencedirect.com/science/article/pii/S0736467913014510
**NEJM
- A Randomized Trial of Protocol-Based Care for Early Septic Shock
http://www.nejm.org/doi/full/10.1056/NEJMoa1401602?query=featured_home
- Albumin Replacement in Patients with Severe Sepsis or Septic Shock
http://www.nejm.org/doi/full/10.1056/NEJMoa1305727?query=featured_home
- High versus Low Blood-Pressure Target in Patients with Septic Shock
http://www.nejm.org/doi/full/10.1056/NEJMoa1312173
**JAMA
Factor Xa Inhibitors vs Warfarin for Preventing Stroke and Thromboembolism in
Patients With Atrial Fibrillation
http://jama.jamanetwork.com/article.aspx?articleid=1841952
**JAMA Intern Med
- Nonleg Venous Thrombosis in Critically Ill Adults: A Nested Prospective Cohort
Study
http://archinte.jamanetwork.com/article.aspx?articleid=1835349
- National Estimates of Insulin-Related Hypoglycemia and Errors Leading to
Emergency Department Visits and Hospitalizations
http://archinte.jamanetwork.com/article.aspx?articleid=1835360
**Lancet: Cardiology
Comparison of the efficacy and safety of new oral anticoagulants with warfarin in
patients with atrial fibrillation: a meta-analysis of randomised trials
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)623430/fulltext
**MJA
- Increasing incidence of Clostridium difficile infection, Australia, 2011–2012
https://www.mja.com.au/journal/2014/200/5/increasing-incidence-clostridiumdifficile-infection-australia-2011-2012
- Staphylococcus aureus bloodstream infection in Australian hospitals: findings from
a Victorian surveillance system
https://www.mja.com.au/journal/2014/200/5/staphylococcus-aureusbloodstream-infection-australian-hospitals-findings
TAG Mail 12th March 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**ACSQHC
National surveillance and reporting of antimicrobial resistance and antibiotic usage
for human health in Australia
http://www.safetyandquality.gov.au/publications/national-surveillance-andreporting-of-antimicrobial-resistance-and-antibiotic-usage-for-human-health-inaustralia
**Grattan Institute
Controlling costly care: a billion-­dollar hospital opportunity, March 2014
http://grattan.edu.au/static/files/assets/9b40e378/806-costly-care.pdf
**TGA
Information on 2014 seasonal influenza vaccines
http://www.tga.gov.au/safety/media-2013-seasonal-flu-140311.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**CDC
Antibiotic Rx in Hospitals: Proceed with Caution
http://www.cdc.gov/vitalsigns/pdf/2014-03-vitalsigns.pdf
**NICE
- Evidence Summary: New Medicine
-- ESNM35: Type 2 diabetes: empagliflozin
http://publications.nice.org.uk/esnm35-type-2-diabetes-empagliflozin-esnm35
- Evidence summary: unlicensed or off-label medicine
-- ESUOM28: Rapid tranquillisation in mental health settings: promethazine
hydrochloride
http://publications.nice.org.uk/esuom28-rapid-tranquillisation-in-mental-healthsettings-promethazine-hydrochloride-esuom28
**NHS England
Patient Safety Alert: Addressing rising trends and outbreaks in carbapenemaseproducing Enterobacteriaceae
http://www.england.nhs.uk/2014/03/06/psa-enterobacteriaceae/
**Public Health England
Acute trust toolkit for the early detection, management and control of
carbapenemase-producing Enterobacteriaceae
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317140378646
**PSQH
Medication Reconciliation: Getting Started with IT
http://www.psqh.com/january-february-2014/1826-medication-reconciliationgetting-started-with-it
**WHO
Ensuring Human Rights in the provision of contraceptive information and services:
Guidance and recommendations
http://www.who.int/reproductivehealth/publications/family_planning/humanrights-contraception/en/
MEDICATION SAFETY
**EMA
- The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee
(PRAC) recommends restricting use of domperidone: Benefits still considered to
outweigh risks when given short-term and in low doses to treat nausea or vomiting
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/03
/WC500162558.pdf
- PRAC recommends product information of zolpidem be updated with new advice
to minimise the risk of next-morning impaired driving ability and mental alertness
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/03
/WC500162556.pdf
**FDA
Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat
Pneumonia on Ventilated Patients
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
dicalProducts/ucm388328.htm
PAPERS OF INTEREST
**BMJ
Use of macrolides in mother and child and risk of infantile hypertrophic pyloric
stenosis: nationwide cohort study
http://www.bmj.com/content/348/bmj.g1908
**Cochrane
Over-the-counter (OTC) medications to reduce cough as an adjunct to antibiotics
for acute pneumonia in children and adults
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006088.pub4/abstract
**Diabetes Care
Outcomes of Combined Cardiovascular Risk Factor Management Strategies in Type 2
Diabetes: The ACCORD Randomized Trial
http://care.diabetesjournals.org/content/early/2014/02/27/dc13-2334.abstract
**Eur Heart J
Effect of B-type natriuretic peptide-guided treatment of chronic heart failure on
total mortality and hospitalization: an individual patient meta-analysis
http://eurheartj.oxfordjournals.org/content/early/2014/03/05/eurheartj.ehu090.
abstract
**International Journal of Medical Informatics
The impact of clinical leadership on health information technology adoption:
systematic review
http://www.sciencedirect.com/science/article/pii/S1386505614000446
**J Patient Saf
- Who Do Hospital Physicians and Nurses Go to for Advice About Medications? A
Social Network Analysis and Examination of Prescribing Error Rates
http://journals.lww.com/journalpatientsafety/Abstract/publishahead/Who_Do_Ho
spital_Physicians_and_Nurses_Go_to_for.99780.aspx
- Core Drug-Drug Interaction Alerts for Inclusion in Pediatric Electronic Health
Records With Computerized Prescriber Order Entry
http://journals.lww.com/journalpatientsafety/Abstract/2014/03000/Core_Drug_Dr
ug_Interaction_Alerts_for_Inclusion_in.8.aspx
**JAMA Intern Med
- National Estimates of Insulin-Related Hypoglycemia and Errors Leading to
Emergency Department Visits and Hospitalizations
http://archinte.jamanetwork.com/article.aspx?articleid=1835360
- Warfarin Interactions With Antibiotics in the Ambulatory Care Setting
http://archinte.jamanetwork.com/article.aspx?articleid=1813223
- Blood Culture Use in the Emergency Department in Patients Hospitalized for
Community-Acquired Pneumonia
http://archinte.jamanetwork.com/article.aspx?articleid=1835358
** Lancet: Diabetes and Endocrinology
Effects of sodium restriction and hydrochlorothiazide on RAAS blockade efficacy in
diabetic nephropathy: a randomised clinical trial
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)700300/fulltext
**Lancet: Cardiology
Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment
elevation myocardial infarction with or without angiography: a secondary,
prespecified analysis of the TRILOGY ACS trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)614518/fulltext
**Ther Drug Monit
Effect of Cyclosporine on Steady-State Pharmacokinetics of MPA in Renal Transplant
Recipients Is Not Affected by the MPA Formulation: Analysis Based on Therapeutic
Drug Monitoring Data
http://journals.lww.com/drugmonitoring/Abstract/publishahead/Effect_of_Cyclosporine_on_Steady_State.99423.
aspx
TAG Mail 5th March 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**TGA
- Submissions and TGA response: Chloramphenicol, propamidine,
dibromopropamidine and sulfacetamide for ophthalmic use: proposed advisory
statements for medicines
http://www.tga.gov.au/newsroom/consult-otc-chloramphenicol-131122submissions.htm
- Monitoring communication: Levonorgestrel 1.5 mg and 0.75 mg, oral emergency
contraceptive
http://www.tga.gov.au/safety/ews-medicine-levonorgestrel-140228.htm
- AusPARs added: Alemtuzumab (rch) (Lemtrada, Remniq), Levonorgestrel (Jaydess)
and Ruxolitinib (Jakavi)
http://www.tga.gov.au/industry/pm-auspar.htm
- Orphan drugs added: Anti-H5N1
http://www.tga.gov.au/industry/pm-orphan-drugs.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**NICE
- Evidence summary: new medicine:
-- ESNM34: Asthma: fluticasone furoate/vilanterol (Relvar Ellipta) combination
inhaler
http://publications.nice.org.uk/esnm34-asthma-fluticasone-furoatevilanterolrelvar-ellipta-combination-inhaler-esnm34
- Final Appraisal Determination:
-- Lung cancer (non small cell, non squamous) - pemetrexed (maintenance following
pemetrexed & cisplatin)
http://guidance.nice.org.uk/TAG/309/FAD2
- Quality Standards:
-- QS55:Children and young people with cancer
http://guidance.nice.org.uk/QS55
-- QS56: Metastatic spinal cord compression
http://guidance.nice.org.uk/QS56
- Interventional Procedure Guideline:
-- IPG478: Electrochemotherapy for primary basal cell carcinoma and primary
squamous cell carcinoma
http://guidance.nice.org.uk/IPG478
**Nuffield Trust (UK)
The Francis Report: one year on. The response of acute trusts in England
http://www.nuffieldtrust.org.uk/sites/files/nuffield/publication/140206_the_franc
is_inquiry.pdf
MEDICATION SAFETY
**ACSQHC
Medication Safety Newsletter February 2014. Includes: Evidence briefings on
interventions to improve medication safety; New Medication Safety Program web
site; Literature Review: Medication Safety in Australia 2013; NIMC 2012 National
Audit Report
http://www.safetyandquality.gov.au/wp-content/uploads/2012/01/Medication-
Safety-Update-11-February-2014.pdf
**FDA
- Acetaminophen Prescription Combination Drug Products with more than 325 mg:
FDA Statement - Recommendation to Discontinue Prescribing and Dispensing
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
dicalProducts/ucm381650.htm
**ISMP
ISMP Canada identifies themes associated with fatal medication events in the home
http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=72
**MHRA
Press Release: Nearly one-third of parents in London fail to report drug side-effects
experienced by their children to GPs
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON390434
PAPERS OF INTEREST
**Age Aging
Aminoglycosides use in patients over 75 years old
http://ageing.oxfordjournals.org/content/early/2014/02/28/ageing.afu023.full.pd
f?papetoc
**Am J Health Syst Pharm
- Cost-minimization analysis of two fluid products for resuscitation of critically
injured trauma patients
http://www.ajhp.org/content/71/6/470.abstract
- National trends in prescription drug expenditures and projections for 2014
http://www.ajhp.org/content/71/6/482.abstract
**Ann Intern Med
Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease
Risk in Adults: Synopsis of the 2013 American College of Cardiology/American Heart
Association Cholesterol Guideline
http://annals.org/article.aspx?articleid=1818923
**BMC Health Services Research
A national survey of inpatient medication systems in English NHS hospitals
http://www.biomedcentral.com/1472-6963/14/93/abstract
**BMJ
Associations between palliative chemotherapy and adult cancer patients’ end of life
care and place of death: prospective cohort study
http://www.bmj.com/content/348/bmj.g1219
**BMJ Qual Saf
Medication errors: do they occur in isolation?
http://qualitysafety.bmj.com/content/early/2014/02/27/bmjqs-2014-002924.full
**Circulation
- 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart
Disease: A Report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines
http://circ.ahajournals.org/content/early/2014/02/27/CIR.0000000000000031.full.
pdf
- Nonsteroidal Anti-Inflammatory Drugs and the Heart
http://circ.ahajournals.org/content/129/8/907.full
**Eur Heart J
- Efficacy and safety of apixaban compared with aspirin in patients who previously
tried but failed treatment with vitamin K antagonists: results from the AVERROES
trial
http://eurheartj.oxfordjournals.org/content/early/2014/02/24/eurheartj.ehu048.
abstract
- Statin therapy and long-term adverse limb outcomes in patients with peripheral
artery disease: insights from the REACH registry
http://eurheartj.oxfordjournals.org/content/early/2014/02/27/eurheartj.ehu080.
abstract
**JAMA
Warfarin, Kidney Dysfunction, and Outcomes Following Acute Myocardial Infarction
in Patients with Atrial Fibrillation
http://jama.jamanetwork.com/article.aspx?articleid=1835505
**JAMA Intern Med
- Association of β-Blocker Therapy with Risks of Adverse Cardiovascular Events and
Deaths in Patients with Ischemic Heart Disease Undergoing Noncardiac Surgery: A
Danish Nationwide Cohort Study
http://archinte.jamanetwork.com/article.aspx?articleid=1779729
- Renoprotective Effect of Renin-Angiotensin-Aldosterone System Blockade in
Patients With Predialysis Advanced Chronic Kidney Disease, Hypertension, and
Anemia
http://archinte.jamanetwork.com/article.aspx?articleid=1787693
- Nudging Guideline-Concordant Antibiotic Prescribing: A Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1815102
- Cognitive Function and Brain Structure in Persons With Type 2 Diabetes Mellitus
After Intensive Lowering of Blood Pressure and Lipid Levels: A Randomized Clinical
Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1819574
**J Onc Pharm Prac
- Intravenous chemotherapy preparation errors: Patient safety risks identified in a
pan-Canadian exploratory study
http://opp.sagepub.com/content/20/1/40.abstract
- Medication safety and the administration of intravenous vincristine: International
survey of oncology pharmacists
http://opp.sagepub.com/content/early/2014/01/13/1078155213517729.abstract
**Lancet
Preoperative chemotherapy for non-small cell lung cancer: a systematic review and
meta-analysis of individual participant data
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)621595/abstract
**MJA
- Clenbuterol toxicity: a NSW Poisons Information Centre experience
https://www.mja.com.au/journal/2014/200/4/clenbuterol-toxicity-nsw-poisonsinformation-centre-experience
- Renal replacement therapy associated with lithium nephrotoxicity in Australia
https://www.mja.com.au/journal/2014/200/4/renal-replacement-therapyassociated-lithium-nephrotoxicity-australia
**Pediatrics
- Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement
http://pediatrics.aappublications.org/content/133/3/e716
- Pediatric Clinical Practice Guidelines for Acute Procedural Pain: A Systematic
Review
http://pediatrics.aappublications.org/content/133/3/500.abstract
- Safety of Medical Interventions in Children Versus Adults
http://pediatrics.aappublications.org/content/133/3/e666.abstract
TAG Mail 26th February 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
- Health care expenditure on cardiovascular diseases 2008-09
http://www.aihw.gov.au/publication-detail/?id=60129546381
- Type 2 diabetes in Australia's children and young people: a working paper
http://www.aihw.gov.au/publication-detail/?id=60129546361
REPORTS AND PUBLICATIONS - INTERNATIONAL
**CADTH
Rapid Response Reports:
- Trientine for Treatment of Wilson’s Disease: Clinical and Cost-Effectiveness, and
Safety
http://www.cadth.ca/media/pdf/htis/feb-2014/RA0660%20Trientine%20Final.pdf
- Drug Interventions for Chronic Non-Cancer Pain: Guidelines and Recommendations
http://www.cadth.ca/media/pdf/htis/feb2014/RA0658%20Drugs%20for%20Chronic%20Non-Cancer%20Pain%20Final.pdf
- Non-Drug Interventions for Chronic Non-Cancer Pain: Guidelines and
Recommendations
http://www.cadth.ca/media/pdf/htis/feb-2014/RA0659%20Nondrugs%20for%20Chronic%20Non-Cancer%20Pain%20Final.pdf
**NICE
- Evidence summaries: unlicensed or off-label medicines:
-- ESUOM26: Interstitial cystitis: dimethyl sulfoxide bladder instillation
http://publications.nice.org.uk/esuom26-interstitial-cystitis-dimethyl-sulfoxidebladder-instillation-esuom26
-- ESUOM27 Chronic pain: oral ketamine
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESU
OM27.jsp
- Technology Appraisals:
-- TA305 Macular oedema (central retinal vein occlusion) - aflibercept solution for
injection
http://guidance.nice.org.uk/TA305
-- TA306 Non Hodgkin's lymphoma (relapsed refractory) - pixantrone monotherapy
http://guidance.nice.org.uk/TA306
**FDA
FDA approves Myalept (metreleptin for injection) as replacement therapy to treat
the complications of leptin deficiency, in addition to diet, in patients with
congenital generalized or acquired generalized lipodystrophy
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm387060.htm
MEDICATION SAFETY
**EMA
- European Medicines Agency recommends restricting the use of methysergidecontaining medicines: New recommendations follow concerns over association with
fibrosis
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/02
/WC500161952.pdf
- European Medicines Agency recommends that Protelos/Osseor remain available
but with further restrictions
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/02
/WC500161971.pdf
- European Medicines Agency and US Food and Drug Administration strengthen
collaboration in pharmacovigilance area
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
14/02/news_detail_002028.jsp&mid=WC0b01ac058004d5c1
**Health Canada
New safety information regarding Telzir (fosamprenavir calcium) used in the
treatment of HIV
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/38061a-eng.php
**ISMP
New standards for healthcare connectors - the "Stay Connected" program"
http://www.ismp.org/tools/stayconnectedprogram.aspx
**NHS England
Patient Safety Alert: Stage Three Directive - Non-Luer spinal (intrathecal) devices
for chemotherapy
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=1021
14
**Prescrire
Nausea and vomiting: stop the use of domperidone once and for all
http://english.prescrire.org/en/81/168/49205/0/NewsDetails.aspx
PAPERS OF INTEREST
**Am J Cardiol
Meta-Analysis of Randomized Controlled Trials on the Risk of Bleeding With
Dabigatran
http://www.sciencedirect.com/science/article/pii/S000291491302448X
**Ann Intern Med
Vitamin, Mineral, and Multivitamin Supplements for the Primary Prevention of
Cardiovascular Disease and Cancer: U.S. Preventive Services Task Force
Recommendation Statement
http://annals.org/article.aspx?articleid=1832969
**Ann Pharmacother
Impact of a Clinical Pharmacy Admission Medication Reconciliation Program on
Medication Errors in “High-Risk” Patients
http://aop.sagepub.com/content/47/12/1599
**BMJ Open
Medication use in pregnancy: a cross-sectional, multinational web-based study
http://bmjopen.bmj.com/content/4/2/e004365.full
**Cochrane
- Safety of regular formoterol or salmeterol in adults with asthma: an overview of
Cochrane reviews
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010314.pub2/abstract
- Anticonvulsants for alcohol dependence
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008544.pub2/abstract
**Drug Saf
- Pharmacokinetic Drug Interaction Profiles of Proton Pump Inhibitors: An Update
http://link.springer.com/article/10.1007/s40264-014-0144-0
- Self-Medication with Over-the-Counter and Prescribed Drugs Causing AdverseDrug-Reaction-Related Hospital Admissions: Results of a Prospective, Long-Term
Multi-Centre Study
http://link.springer.com/article/10.1007/s40264-014-0141-3
**Heart
High-potency statin and ezetimibe use and mortality in survivors of an acute
myocardial infarction: a population-based study
http://heart.bmj.com/content/early/2014/02/19/heartjnl-2013-304678.abstract
**Thorax
Safety of tiotropium through the Handihaler: why did meta-analyses and database
studies appear to give a false alarm?
http://thorax.bmj.com/content/early/2014/02/18/thoraxjnl-2014-205155.full
**JAMA Intern Med
Antihypertensive Medications and Serious Fall Injuries in a Nationally
Representative Sample of Older Adults
http://archinte.jamanetwork.com/article.aspx?articleid=1832197
** Lancet
- Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3
randomised, double-blind, placebo-controlled trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)622989/abstract
- Preoperative chemotherapy for non-small cell lung cancer: a systematic review
and meta-analysis of individual participant data
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)621595/fulltext
- Reduction of adverse effects from intravenous acetylcysteine treatment for
paracetamol poisoning: a randomised controlled trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)620620/abstract
**NEJM
- Improved Survival with Bevacizumab in Advanced Cervical Cancer
http://www.nejm.org/doi/full/10.1056/NEJMoa1309748
- Bevacizumab plus Radiotherapy–Temozolomide for Newly Diagnosed Glioblastoma
http://www.nejm.org/doi/full/10.1056/NEJMoa1308345
- A Randomized Trial of Bevacizumab for Newly Diagnosed Glioblastoma
http://www.nejm.org/doi/full/10.1056/NEJMoa1308573
TAG Mail 19th February 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**ACSQHC
- National surveillance and reporting of antimicrobial resistance and antibiotic
usage for human health in Australia
http://www.safetyandquality.gov.au/publications/national-surveillance-andreporting-of-antimicrobial-resistance-and-antibiotic-usage-for-human-health-inaustralia/
- NIMC Audit System User Guide
http://www.safetyandquality.gov.au/publications/national-inpatient-medicationchart-audit-system-user-guide/
**NPS
NPS Direct February 2014
Includes: Superbug stowaways: multi-drug-resistant bacteria hitch a ride with
travellers; Anticholinergics sedatives and older people; Vitamin D: cause or effect?
**Pharmacy Guild
Changes to the arrangements for medication management programs funded under
the Community Pharmacy Agreement
http://www.guild.org.au/docs/default-source/public-documents/news-andevents/media-releases/2014/mr_cpa-changes_12-feb2014.pdf?sfvrsn=2
**TGA
AusPARs added: Mirabegron (Betmiga), Pneumococcal polysaccharide conjugate
vaccine (Prevenar 13) and Regorafenib (Stivarga)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**FDA
- FDA expands the approved use of Imbruvica (ibrutinib) for chronic lymphocytic
leukemia (CLL) patients who have received at least one previous therapy.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm385764.htm
- Northera capsules (droxidopa) approved for the treatment of neurogenic
orthostatic hypotension (NOH)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386311.htm
- FDA approves Vimizim (elosulfase alfa), the first FDA-approved treatment for
Mucopolysaccharidosis Type IVA (Morquio A syndrome)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386008.htm
**NHS Evidence
- Eyes on Evidence February 2014.
Includes: Iodine deficiency in pregnancy; Silicone cervical pessaries in women with
a multiple pregnancy; Prenatal valproate exposure and autism in children
http://www.evidence.nhs.uk/eyes-on-evidence-february-2014.pdf
- Evidence Update January 2014: Prevention of cardiovascular diseaseA summary of selected new evidence relevant to NICE public health guidance 25
‘Prevention of cardiovascular disease’ (2010)
www.evidence.nhs.uk/evidence-update-50
- Evidence Update February 2014: The epilepsies - A summary of selected new
evidence relevant to NICE clinical guideline 137 ‘The epilepsies: the diagnosis and
management of the epilepsies in adults and children in primary and secondary
care’(2012)
www.evidence.nhs.uk/evidence-update-53
MEDICATION SAFETY
**HQSCNZ
Medication Safety Watch February 2014
Key messages in this issue: Off-label use of medicines; Transdermal patches alerts;
US medication safety best practices; Incidents and cautions
http://www.hqsc.govt.nz/assets/Medication-Safety/Watch-Updates/MedicationSafety-Watch-9-Feb-2014.pdf
**ISMP
- 2014-2015 Targeted Medication Safety Best Practices for Hospitals
http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf
- NAN Alert: Potential inaccuracy of electronically transmitted medication history
information used for medication reconciliation
http://www.ismp.org/NAN/files/NAN-20140218.pdf
- Acute Care Newsletter: How FDA can help reduce dabigatran (PRADAXA) bleeding
risks
http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=71
**MHRA
Drug Safety Update February 2014. Includes: Cetuximab: importance of establishing
wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal
cancer; Combined hormonal contraceptives and venous thromboembolism: review
confirms risk is small—consider risk factors and remain vigilant for signs and
symptoms
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/
PAPERS OF INTEREST
**Am J Health Syst Pharm
Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations,
and recommendations
http://www.ajhp.org/content/71/5/373.abstract
**Ann Intern Med
Treatment of Primary Sjögren Syndrome With Rituximab: A Randomized Trial
http://annals.org/article.aspx?articleid=1829791
**Aust Pres
Intravenous paracetamol in paediatrics: cause for caution (M. Gazarian, A. Drew, A.
Bennett)
http://www.australianprescriber.com/magazine/37/1/24/5
**BMJ Qual Saf
From physician intent to the pharmacy label: prevalence and description of
discrepancies from a cross-sectional evaluation of electronic prescriptions
http://qualitysafety.bmj.com/content/23/3/223.short?g=w_qs_current_tab
**JAMA
- Effect of Citalopram on Agitation in Alzheimer Disease: The CitAD Randomized
Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1829989
- Treatment of Venous Thromboembolism
http://jama.jamanetwork.com/article.aspx?articleid=1829996
- New Oral Anticoagulants for Acute Venous Thromboembolism
http://jama.jamanetwork.com/article.aspx?articleid=1829983
**JAMA Intern Med
- Dronedarone for Atrial Fibrillation: The Limited Reliability of Clinical Practice
Guidelines
http://archinte.jamanetwork.com/article.aspx?articleid=1830022
- Histamine-2 Receptor Antagonists vs Proton Pump Inhibitors on Gastrointestinal
Tract Hemorrhage and Infectious Complications in the Intensive Care Unit
http://archinte.jamanetwork.com/article.aspx?articleid=1830021
- Multifaceted Intervention to Improve Medication Adherence and Secondary
Prevention Measures After Acute Coronary Syndrome Hospital Discharge: A
Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1779681
- Assessing Potential Glycemic Overtreatment in Persons at Hypoglycemic Risk
http://archinte.jamanetwork.com/article.aspx?articleid=1785199
**JAMIA
- A sense inventory for clinical abbreviations and acronyms created using clinical
notes and medical dictionary resources
http://jamia.bmj.com/content/21/2/299.abstract
- Mining clinical text for signals of adverse drug-drug interactions
http://jamia.bmj.com/content/21/2/353.abstract
- Sensitivity and specificity of dosing alerts for dosing errors among hospitalized
pediatric patients
http://jamia.bmj.com/content/early/2014/02/04/amiajnl-2013-002161.abstract
- Evaluation of medium-term consequences of implementing commercial
computerized physician order entry and clinical decision support prescribing
systems in two ‘early adopter’ hospitals
http://jamia.bmj.com/content/early/recent
** Lancet Cardiol
Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment
elevation myocardial infarction with or without angiography: a secondary,
prespecified analysis of the TRILOGY ACS trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)614518/fulltext
**NEJM
Comparison of Pregabalin with Pramipexole for Restless Legs Syndrome
http://www.nejm.org/doi/full/10.1056/NEJMoa1303646
**Pediatrics
Dexamethasone for Acute Asthma Exacerbations in Children: A Meta-analysis
http://pediatrics.aappublications.org/content/early/2014/02/04/peds.2013-2273
TAG Mail 12th February 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**TGA
Orphan drugs: added Olaparib
http://www.tga.gov.au/industry/pm-orphan-drugs.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**AHRQ PSNet
Multifactorial Medication Mishap - Case of a 10-fold overdose of an opioid
medication, includes commentary and key learning points.
http://webmm.ahrq.gov/case.aspx?caseID=314
**BNF Update
Recommended indications and doses of paracetamol in children have been revised
http://www.pharmpress.com/mailouts/bnf/feb14/BNF_enewsletter.html#section3
**Joint Commission
- New Toolkit Aims to Decrease Central Line-Associated Bloodstream Infections
https://www.jointcommission.org/new_toolkit_aims_to_decrease_central_line_ass
ociated_bloodstream_infections/
- Free guides help leaders and physicians develop patient safety strategies and
improve bedside care
http://www.jointcommission.org/issues/article.aspx?Article=buNJYCJ7IK7Xd%2buc0
vde7AwcfSmpYQ72Jx4HoCapJ7g%3d
**NICE
- Evidence summary new medicines:
-- ESNM33 Chronic obstructive pulmonary disease: indacaterol/glycopyrronium
(Ultibro Breezhaler)
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM33.jsp
- Evidence summary unlicensed/off-label medicine:
-- ESUOM25 Non-cystic fibrosis bronchiectasis: colistimethate sodium
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESU
OM25.jsp
- Clinical Guidelines:
-- CG177 Osteoarthritis: care and management in adults
http://guidance.nice.org.uk/CG177
-- CG178 Psychosis and schizophrenia in adults: treatment and management
http://guidance.nice.org.uk/CG178
- Quality Standards
-- QS53 Anxiety Disorders
http://guidance.nice.org.uk/QS53
**SIGN
SIGN Guideline 137: Management of lung cancer
http://www.sign.ac.uk/guidelines/fulltext/137/index.html
MEDICATION SAFETY
**TGA
Safety Advisory: Strontium ranelate (Protos) and risk of adverse events
http://www.tga.gov.au/safety/alerts-medicine-strontium-ranelate-protos-
140204.htm
**FDA
FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug
saxagliptin
http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm
**MHRA
Drug Safety Update January 2014. Includes: Prasugrel (Efient): increased risk of
bleeding—information on timing of loading dose; Ofatumumab: screen for hepatitis
B virus before treatment; Temozolomide: risk of hepatic injury, including fatal
hepatic failure—updated warnings and monitoring guidance; Capecitabine: risk of
severe skin reactions—discontinue treatment.
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htm
**Health Canada
Lithium – Risk of hypercalcemia and hyperparathyroidism
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37903a-eng.php
PAPERS OF INTEREST
**Br J Psych
Interventions for reducing benzodiazepine use in older people: meta-analysis of
randomised controlled trials
http://bjp.rcpsych.org/content/204/2/98.abstract
**Can Pharm J
A practice tool for the new oral anticoagulants
http://cph.sagepub.com/content/147/1/25.full.pdf+html
**Clin Inf Dis
DALI: Defining Antibiotic Levels in Intensive care unit patients: Are current betalactam antibiotic doses sufficient for critically ill patients?
http://cid.oxfordjournals.org/content/early/2014/01/14/cid.ciu027
**Ann Intern Med
Effectiveness of Combination Therapy With Statin and Another Lipid-Modifying
Agent Compared With Intensified Statin Monotherapy: A Systematic Review
http://annals.org/article.aspx?articleid=1828554
**BMJ
Rates and risk factors for prolonged opioid use after major surgery: population
based cohort study
http://www.bmj.com/content/348/bmj.g1251
**Cochrane Library
- Buprenorphine maintenance versus placebo or methadone maintenance for opioid
dependence
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002207.pub4/abstract;jse
ssionid=E1DE03DFFA3219521AA5ECA28AE7D00B.f01t02
- Mycophenolate mofetil for relapsing-remitting multiple sclerosis
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010242.pub2/abstract
- Pharmacological interventions for hypertension in children
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008117.pub2/abstract
**Eur J Hosp Pharm
Pharmacist contributions to ensuring safe and accurate transfer of written
medicines-related discharge information: lessons from a collaborative audit and
service evaluation involving 45 hospitals in England
http://ejhp.bmj.com/content/early/2014/02/10/ejhpharm-2013-000418?papetoc
**Eur Heart J
Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in
patients with atrial fibrillation
http://eurheartj.oxfordjournals.org/content/early/2014/02/07/eurheartj.ehu006.
abstract
**JAMA Intern Med
Nudging Guideline-Concordant Antibiotic Prescribing: A Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1815102
**Jt Comm J Qual Pat Saf
Assessing the State of Safe Medication Practices Using the ISMP Medication Safety
Self Assessment® for Hospitals: 2000 and 2011
http://www.ingentaconnect.com/content/jcaho/jcjqs/2014/00000040/00000002/a
rt00001
**Lancet Diabetes Endocrinol
Metformin for non-diabetic patients with coronary heart disease (the CAMERA
study): a randomised controlled trial
http://download.thelancet.com/pdfs/journals/landia/PIIS2213858713701529.pdf
**Lancet Onc
Second primary malignancies with lenalidomide therapy for newly diagnosed
myeloma: a meta-analysis of individual patient data
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)706090/abstract
TAG Mail 5th February 2014
REPORTS AND PUBLICATIONS – AUSTRALIA
**ACSQHC
Evaluating the Effect of the Australian List of Tall Man Names
http://www.safetyandquality.gov.au/wp-content/uploads/2014/01/Evaluating-theEffect-of-the-Australian-List-of-Tall-Man-Names.pdf
**Productivity Commission
- Report on Government Services 2014, Volume E: Health
http://www.pc.gov.au/gsp/rogs/health
**TGA
- Pilot web service for transmission of adverse event reports from medical software
to the Therapeutic Goods Administration
http://www.tga.gov.au/newsroom/media-2014-pilot-web-servce-140203.htm
- AusPARs: Added nanoparticle albumin-bound (nab) paclitaxel (Abraxane)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**AHRQ
- Factors That Influence the Scale Up and Spread of Innovations
http://www.innovations.ahrq.gov/content.aspx?id=4088&utm_source=issueanc&ut
m_medium=email&utm_campaign=20140129
- Statewide Measurement and Reporting System Stimulates Quality Improvement in
Targeted Clinical Areas
http://www.innovations.ahrq.gov/content.aspx?id=3914
**CADTH
- Flushing Intravenous Tubing Post Administration of Medications: Clinical Evidence
and Guidelines
http://www.cadth.ca/media/pdf/htis/feb2014/RA0657%20Flushing%20IV%20Lines%20Final.pdf
- Buprenorphine/Naloxone (Suboxone) Film versus Buprenorphine/Naloxone Tablets
for the Treatment of Opioid Addiction: Comparative Safety
http://www.cadth.ca/media/pdf/htis/feb-2014/RB0642%20Suboxone%20Final.pdf
- Intranasal Versus Intravenous Administration of Anxiolytic or Analgesic
Medications: Comparative Clinical Effectiveness
http://www.cadth.ca/media/pdf/htis/feb2014/RB0641%20Intranasal%20Administration%20Final.pdf
- Smart Infusion Pump use in Hospitalized Patients: Clinical Safety and Guidelines
http://www.cadth.ca/media/pdf/htis/feb2014/RB0640%20Smart%20Pumps%20Final.pdf
**EMA
Review of Emergency Contraceptives started: The European Medicines Agency has
started a review of emergency contraceptives to assess whether increased
bodyweight and body mass index (BMI) reduce the efficacy of these medicines in
preventing an unintended pregnancy following unprotected sexual intercourse or
contraceptive failure.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
14/01/news_detail_002010.jsp&mid=WC0b01ac058004d5c1
**FDA
- FDA approves Hetlioz (tasimelteon), a melatonin receptor agonist, the first
treatment for non-24 hour sleep-wake disorder in blind individuals
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm384092.htm
**NICE
- Evidence summary new medicines:
-- ESNM31 Long-acting reversible contraception: subcutaneous depot
medroxyprogesterone acetate (DMPA-SC)
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM31.jsp
-- ESNM32 Relapsed and refractory multiple myeloma: pomalidomide
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM32.jsp
-Quality Standards:
-- QS52 Peripheral arterial disease
http://guidance.nice.org.uk/QS52
-Clinical Guidelines:
-- CG175 Prostate cancer: diagnosis and treatment
http://guidance.nice.org.uk/CG175
-- CG176 Head Injury: Triage, assessment, investigation and early management of
head injury in children, young people and adults
http://guidance.nice.org.uk/CG176
-Technology Appraisal
-- TA303 Teriflunomide for treating relapsing-remitting multiple sclerosis
http://guidance.nice.org.uk/TA303
**NHS England
- National Patient Safety Alerting System (NPSAS) launched - a tool that will be used
to ensure warnings of potential risks to the safety of patients can be swiftly
developed and disseminated across the NHS.
http://www.england.nhs.uk/2014/01/31/mike-durkin-4/
- Principles for sharing the benefits associated with more efficient use of medicines
not reimbursed through national prices
http://www.england.nhs.uk/wp-content/uploads/2014/01/princ-shar-benefits.pdf
MEDICATION SAFETY
**TGA
- Medicines Safety Update, February 2014. In this issue: Quetiapine and QT
prolongation; bioCSL Fluvax - not for children under 5 years; How you can play a
vital role in medicine regulation.
http://www.tga.gov.au/hp/msu-2014-01.htm
- Hazard Alert: Medtronic SynchroMed II implantable infusion pump system: risk of
incorrect pump replacement scheduling and premature reservoir alarms
http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm
**FDA
- Testosterone Products: Drug Safety Communication - FDA Investigating Risk of
Cardiovascular Events
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
dicalProducts/ucm384225.htm
**Health Canada
Health Canada evaluating whether body weight affects the effectiveness of
emergency contraceptive pill
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37771a-eng.php
**ISMP
- A mislabeling event with batched drugs: The unintended consequences of practice
changes
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=68
PAPERS OF INTEREST
**Am J Health Syst Pharm
- Multidisciplinary initiative to improve inpatient anticoagulation and management
of venous thromboembolism
http://www.ajhp.org/content/71/4/305
- Development of an electronic patient prioritization tool for clinical pharmacist
interventions
http://www.ajhp.org/cgi/content/abstract/71/4/311?etoc
**Ann Intern Med
- Lipid Management in Chronic Kidney Disease: Synopsis of the Kidney Disease:
Improving Global Outcomes 2013 Clinical Practice Guideline
http://annals.org/article.aspx?articleid=1788220
- Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease
Risk in Adults: Synopsis of the 2013 ACC/AHA Cholesterol Guideline
http://annals.org/article.aspx?articleid=1818923
**Annals of Pharmacotherapy
Medication Reconciliation During Transitions of Care as a Patient Safety Strategy
http://annals.org/article.aspx?articleid=1656444
**BMJ
- Safety of benzodiazepines and opioids in very severe respiratory disease: national
prospective study
http://www.bmj.com/content/348/bmj.g445
**Eur J Hosp Pharm
- No evidence or evidence of no effect
http://ejhp.bmj.com/content/early/2014/01/30/ejhpharm-2014-000445.full
**Heart
- Risk of drug-induced liver injury with the new oral anticoagulants: systematic
review and meta-analysis
http://heart.bmj.com/content/early/2014/01/29/heartjnl-2013-305288.abstract
- Maintenance of statin use over 3 years following acute coronary syndromes: a
national data linkage study (ANZACS-QI-2)
http://heart.bmj.com/content/early/2014/01/16/heartjnl-2013-304960.abstract
**JAMA
Effects of Immediate Blood Pressure Reduction on Death and Major Disability in
Patients With Acute Ischemic Stroke: The CATIS Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1778674
**JAMA Intern Med
Multifaceted Intervention to Improve Medication Adherence and Secondary
Prevention Measures After Acute Coronary Syndrome Hospital Discharge: A
Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1779681
**J Clin Oncol
- Clinical Impact of Delaying Initiation of Adjuvant Chemotherapy in Patients with
Breast Cancer
http://jco.ascopubs.org/content/early/2014/01/21/JCO.2013.49.7693.abstract
**MJA
Off-label prescribing (editorial, J P Seale)
https://www.mja.com.au/journal/2014/200/2/label-prescribing
**Psychosomatics
- Use of Serotonergic Antidepressants and Bleeding Risk in Patients Undergoing
Surgery.
http://www.sciencedirect.com/science/article/pii/S0033318213001692
TAG Mail 29th January 2013
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
- Medical workforce 2012
http://www.aihw.gov.au/publication-detail/?id=60129546100
REPORTS AND PUBLICATIONS - INTERNATIONAL
**Department of Health (USA)
- Updated guidance on occupational HIV post-exposure prophylaxis (PEP) from the
UK Chief Medical Officers' Expert Advisory Group on AIDS (EAGA)
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/2
75060/EAGA_advice_on_PEP_after_exposure_to_UD_source_Dec13.pdf
**Health Canada
- ARZERRA (ofatumumab) - Recommendations to Screen, Monitor and to Manage
Hepatitis B Virus Reactivation
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37705a-eng.php
**NHS
- Combined hormonal contraceptives: Europe-wide review confirms the risk of
thromboembolism is small and agrees updated information to reflect the latest
evidence
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=1021
06
**NICE
- Teriflunomide for treating relapsing-remitting multiple sclerosis
http://www.nice.org.uk/nicemedia/live/14353/66336/66336.pdf
- Prevention of cardiovascular disease: Evidence Update January 2014
http://arms.evidence.nhs.uk/resources/hub/1032130/attachment
MEDICATION SAFETY
Nil
PAPERS OF INTEREST
**Am J Surg
- Weight-based enoxaparin dosing for venous thromboembolism prophylaxis in the
obese trauma patient
http://www.americanjournalofsurgery.com/article/S0002-9610%2813%29004340/abstract
**Ann Intern Med
- Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease
Risk in Adults: Synopsis of the 2013 ACC/AHA Cholesterol Guideline
http://annals.org/article.aspx?articleid=1818923
- Concepts and Controversies: The 2013 American College of Cardiology/American
Heart Association Risk Assessment and Cholesterol Treatment Guidelines
http://annals.org/article.aspx?articleid=1817256
**Ann Rheum Dis
- Extended report: Effects and safety of rituximab in systemic sclerosis: an analysis
from the European Scleroderma Trial and Research (EUSTAR) group
http://ard.bmj.com/content/early/2014/01/17/annrheumdis-2013204522.full.pdf+html
**BJCP
- Is polypharmacy always hazardous? A retrospective cohort analysis using linked
electronic health records from primary and secondary care
http://onlinelibrary.wiley.com/doi/10.1111/bcp.12292/abstract;jsessionid=744F9D
96B7AB49FDD92B879266545F8C.f02t02
**BMJ
- Undetermined impact of patient decision support interventions on healthcare
costs and savings: systematic review
http://www.bmj.com/content/348/bmj.g188
**BMJ Qual Saf
- Using quality improvement to optimise paediatric discharge efficiency
http://qualitysafety.bmj.com/content/early/2014/01/27/bmjqs-2013002556.abstract
**Circulation
- Optimal Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent
Implantation: A Randomized, Controlled Trial
http://circ.ahajournals.org/content/129/3/304.abstract
-Warfarin Use and the Risk for Stroke and Bleeding in Patients with Atrial
Fibrillation undergoing Dialysis
http://circ.ahajournals.org/content/early/2014/01/22/CIRCULATIONAHA.113.0047
77.abstract
- Antiplatelet Therapy for Stable Coronary Artery Disease in Atrial Fibrillation
Patients on Oral Anticoagulant: A Nationwide Cohort Study
http://circ.ahajournals.org/content/early/2014/01/27/CIRCULATIONAHA.113.0048
34.abstract
**Cochrane
- Clonidine premedication for postoperative analgesia in children
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009633.pub2/abstract
- Dihydroartemisinin-piperaquine for treating uncomplicated Plasmodium
falciparum malaria
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010927/abstract
- Implementation of treatment guidelines for specialist mental health care
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009780.pub2/abstract
**Eur J Hosp Pharm
- The tools of evidence-based medicine
http://ejhp.bmj.com/content/early/2014/01/28/ejhpharm-2014-000442.extract
**JAMA
- Evidence-Based Medicine - An Oral History
http://jama.jamanetwork.com/article.aspx?articleid=1817042
- Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents,
2005-2012
http://jama.jamanetwork.com/article.aspx?articleid=1817794
- Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial
Applications for New Drugs, 2000-2012
http://jama.jamanetwork.com/article.aspx?articleid=1817795
**JAMA Intern Med
- Nudging Guideline-Concordant Antibiotic Prescribing: A Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1815102
**Lancet Diabetes and Endocrinology
- The effect of vitamin D supplementation on skeletal, vascular, or cancer
outcomes: a trial sequential meta-analysis
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(13)702122/abstract
**NEJM
- Acute Osteomyelitis in Children
http://www.nejm.org/doi/full/10.1056/NEJMra1213956
TAG Mail 22nd January 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**ACSQHC
- Evaluation of Standardised Medicine Syringe Labels in Interventional Cardiac
Catheter and Radiology Laboratories
http://www.safetyandquality.gov.au/publications/evaluation-of-standardisedmedicine-syringe-labels-in-interventional-cardiac-catheter-and-radiologylaboratories/
- Labelling Recommendations Issues Register
http://www.safetyandquality.gov.au/publications/labelling-recommendationsissues-register/
**AIHW
- Dental workforce 2012
http://www.aihw.gov.au/publication-detail/?id=60129545961
- AIHW deaths snapshot
http://www.aihw.gov.au/deaths/
**NPS
Treating neuropathic pain with anticonvulsants — which ones work?
http://www.nps.org.au/health-professionals/health-news-evidence/latestissue/treating-neuropathic-pain
**TGA
AusPARS added: Alogliptin as benzoate (Vipidia/Nesina)
http://www.tga.gov.au/industry/pm-auspar.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**Cochrane
Summaries:
- Optimum duration of regimens for Helicobacter pylori eradication
http://summaries.cochrane.org/CD008337/ideal-length-of-treatment-forhelicobacter-pylori-h.-pylori-eradication
- Statins for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis
http://summaries.cochrane.org/CD008623/statins-for-non-alcoholic-steatohepatitis
**Health Canada
EFFIENT (prasugrel hydrochloride) - Association with Increased Risk of Bleeding in
Patients Treated in Hospital for Certain Types of Heart Attacks - For Health
Professionals
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37611a-eng.php
**NHS
A report of NHS Services, Seven Days a Week Forum that sets out set out ten new
clinical standards that describe the standard of urgent and emergency care all
patients should expect seven days a week, each supported by clinical evidence and
developed in partnership with the Academy of Medical Royal Colleges
http://www.england.nhs.uk/2013/12/15/sir-bruce-keogh-7ds/
**NICE
Medicines Evidence Commentary:Chronic kidney disease: calcium-based versus noncalcium-based phosphate binders
https://www.evidence.nhs.uk/document?ci=http%3A%2F%2Farms.evidence.nhs.uk%
2Fresources%2FHub%2F1032210&q=medicines%20evidence%20commentary&ReturnU
rl=%2Fsearch%3Fq%3Dmedicines%2Bevidence%2Bcommentary
**SIGN
- Managing chronic pain (patient booklet)
http://www.sign.ac.uk/patients/publications/136/index.html
- Prevention of stroke in patients with atrial fibrillation: A guide for primary care.
http://www.sign.ac.uk/pdf/AF_publication.pdf
**The Health Foundation, London
Using clinical communities to improve quality: Ten lessons for getting the clinical
community approach to work in practice
http://www.health.org.uk/publications/using-clinical-communities-to-improvequality/
MEDICATION SAFETY
**MHRA
Safety warnings and messages for medicines, December 2013 included:
Avoiding ponatinib in people with a history of myocardial infarction or stroke |
minimising prasugrel bleeding risk | temozolomide and hepatic failure |
capecitabine and severe skin reactions | screening for hepatitis B virus infection
before starting ofatumumab
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safety
warningsandmessagesformedicines/CON364176
PAPERS OF INTEREST
**Am J Health-Syst- Pharm
- Effect of barcode technology with electronic medication administration record
on medication accuracy rates
http://www.ajhp.org/content/71/3/209.abstract
- Alternative dosing strategies for liraglutide in patients with type 2 diabetes
mellitus
http://www.ajhp.org/content/71/3/223.abstract
**BMJ
- Prenatal exposure to antidepressants and persistent pulmonary hypertension of
the newborn: systematic review and meta-analysis
http://www.bmj.com/content/348/bmj.f6932.pdf%2Bhtml
- A unified model of patient safety (or "Who froze my cheese?")
http://www.bmj.com/content/347/bmj.f7273.pdf%2Bhtml
**Eur J Hosp Pharm
- Impact of electronic prescription alerts on medication errors related to vitamin K
antagonists in hospitalised patients
http://ejhp.bmj.com/content/21/1/29.short?g=w_ejhp_current_tab
- Management of patients with HIV-1 infection by pharmacist prescribers: an
evaluation of practice
http://ejhp.bmj.com/content/21/1/13.short?g=w_ejhp_current_tab
**JAMA
Effects of Immediate Blood Pressure Reduction on Death and Major Disability in
Patients With Acute Ischemic Stroke: The CATIS Randomized Clinical Trial
http://jama.jamanetwork.com/article.aspx?articleid=1778674
**Joint Commission Journal on Quality and Patient Safety
Medication event huddles: a tool for reducing adverse drug events
http://www.ingentaconnect.com/content/jcaho/jcjqs/2014/00000040/00000001/a
rt00005
TAG Mail 15th January 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**ACSQHC
- NIMC VTE Phase 2 Final Report
http://www.safetyandquality.gov.au/publications/nimc-vte-phase-2-final-reportpdf-1-63mb/
- NIMC 2012 National Audit Report
http://www.safetyandquality.gov.au/publications/nimc-2012-national-auditreport-pdf-2-10kb/
- NIMC 2011 National Audit Report
http://www.safetyandquality.gov.au/publications/nimc-2011-national-auditreport-pdf-1-02mb/
- NIMC 2010 National Audit Report
http://www.safetyandquality.gov.au/publications/nimc-2010-national-auditreport-pdf-1-09mb/
- NIMC 2009 National Audit Report
http://www.safetyandquality.gov.au/publications/nimc-2009-national-auditreport-pdf-1-02mb/
- Electronic Medication Management Systems: Specialist Functions
http://www.safetyandquality.gov.au/publications/electronic-medicationmanagement-systems-specialist-functions-pdf-856kb/
- NIMC Local Management Guidelines
http://www.safetyandquality.gov.au/publications/nimc-local-managementguidelines-pdf-133kb/
- NIMC and Psychiatric Acute Services Survey Report
http://www.safetyandquality.gov.au/publications/nimc-and-psychiatric-acuteservices-survey-report-pdf-780-kb/
- Antimicrobial Stewardship in small health service organisations
http://www.safetyandquality.gov.au/publications/antimicrobial-stewardship-insmall-health-service-organisations/
- Cessation of flexible transition arrangements for the NSQHS Standards
http://www.safetyandquality.gov.au/publications/advisory-a1308-cessation-offlexible-transition-arrangements-for-2013/
**AIHW
- Australian hospital statistics 2012-13: Staphylococcus aureus bacteraemia in
Australian public hospitals (released 20 December 2014)
http://www.aihw.gov.au/publication-detail/?id=60129545754
- Specialist homelessness services 2012-13
http://www.aihw.gov.au/publication-detail/?id=60129545629
**CINSW
Cancer Institute NSW Annual Report 2013
http://www.cancerinstitute.org.au/publications/i/annual-report-2012-13
**NHMRC
Summary Guide for the Management of Overweight and Obesity in Primary Care
http://www.nhmrc.gov.au/guidelines/publications/n57?utm_medium=email&utm_c
ampaign=NHMRC%20Health%20Tracker%20%20December%202013&utm_content=NHMRC%20Health%20Tracker%20%20December%202013+CID_d38b0d2f8edef604468c8a16e8bf95a2&utm_source=Mailb
uild&utm_term=NHMRC%20website
**NPS
- PPIs in older people — do you know the risks?
http://www.nps.org.au/health-professionals/health-news-evidence/2014/ppi-risksin-older-people
- NPS Direct December 2013 includes:
Vaccinate: take a shot at antibiotic resistance | Fast five: 2013 highlights
http://www.nps.org.au/publications/health-professional/npsdirect/2013/november2
**NSW Health
- Information Bulletin: Pharmaceutical Charges for Hospital Outpatients and Safety
Net Thresholds 2014
http://www0.health.nsw.gov.au/policies/ib/2013/IB2013_066.html
- Policy Directive: Infants and Children: Acute Management of Abdominal Pain
[PD2013_053]
http://www0.health.nsw.gov.au/policies/pd/2013/PD2013_053.html
**TGA
- AusPARS added: Dabrafenib mesilate (Tafinlar) and Palonosetron hydrochloride
(Aloxi)
http://www.tga.gov.au/industry/pm-auspar.htm
- Dextropropoxyphene - questions and answers
http://www.tga.gov.au/safety/alerts-medicine-dextropropoxyphene-qa.htm
REPORTS AND PUBLICATIONS - INTERNATIONAL
**AHRQ
Communication and Dissemination Strategies to Facilitate the Use of HealthRelated Evidence
http://www.ahrq.gov/research/findings/evidence-basedreports/commstrattp.html
**eMC
- Aggrastat™ (tirofiban) SPC (PI equiv) revised to extend indications to include
patients with STEMI
http://www.medicines.org.uk/emc/medicine/2478/SPC/Aggrastat%20250%20mcg%
20ml%20Concentrate%20for%20Solution%20for%20Infusion/
- Crixivan (indinavir) 200 mg and 400 mg hard capsules SPC updated to advise that
quetiapine should not be co-administered with indinavir
http://www.medicines.org.uk/emc/medicine/14292/SPC/CRIXIVAN%20200%20mg%2
0and%20400%20mg%20hard%20capsules/
- Revised SPC: Xarelto (rivaroxaban) 10mg, 15mg and 20mg film-coated tablets SPC
revised to include angioedema and allergic oedema as undesirable effects reported
during post-marketing experience
http://www.medicines.org.uk/emc/medicine/21265/SPC/Xarelto%2010%20mg%20fi
lm-coated%20tablets/
**EMA
- Abraxane® (paclitaxel formulated as albumin bound nanoparticles) approved in EU
(in combination with gemcitabine) for first-line treatment of adults with metastatic
adenocarcinoma of the pancreas. The approval was based on results of the MPACT
Phase III trial
http://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab
520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20140
107005842&newsLang=en
- European Medicines Agency recommends approval of a new medicine, Sirturo
(bedaquiline), for multidrug-resistant tuberculosis
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
13/12/news_detail_001999.jsp&mid=WC0b01ac058004d5c1
- Acipimox only to be used as additional or alternative treatment to reduce high
triglyceride levels
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
13/12/news_detail_002000.jsp&mid=WC0b01ac058004d5c1
**FDA
Rivaroxaban labelling revision
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s007
ltr.pdf
**NICE
- Evidence Summary: new medicine
-- ESNM30 Prostate cancer: triptorelin (Decapeptyl SR)
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM30.jsp
-- ESNM28: Combined oral contraception: nomegestrol/estradiol (Zoely)
http://publications.nice.org.uk/combined-oral-contraceptionnomegestrolestradiol-zoely-esnm28
- Evidence Summary: unlicensed or off-label medicine
-- ESUOM24: Critical limb ischaemia in peripheral vascular disease: intravenous
iloprost
http://publications.nice.org.uk/critical-limb-ischaemia-in-peripheral-vasculardisease-intravenous-iloprost-esuom24
-- ESUOM23 Transient ischaemic attack: clopidogrel
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESU
OM23.jsp
- Evidence Update:
-- Post-traumatic stress disorder (PTSD)
http://www.evidence.nhs.uk/document?ci=http%3A%2F%2Farms.evidence.nhs.uk%2
Fresources%2FHub%2F1031525&q=evidence%20update
MEDICATION SAFETY
**EMA
PRAC recommends suspending use of Protelos/Osseor (strontium ranelate)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20
14/01/news_detail_002005.jsp&mid=WC0b01ac058004d5c1
**FDA
Sodium Phosphate Over-the-Counter Products: Drug Safety Communication Possible Harm From Exceeding Recommended Dose
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
dicalProducts/ucm380833.htm
**Health Canada
- Jevtana (cabazitaxel) - Potential for Medication Errors During Preparation Leading
to Overdose: pharmacy staff should add the ENTIRE content of the diluent vial to
the concentrate. Reconstitution errors that led to overdoses 15% to 20% higher than
the prescribed dose reported in Europe
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37453a-eng.php
- MedEffect safety information notice: Sublinox (zolpidem tartrate) - New Dosage
Recommendations to Minimize Risk of Next-Day Impairment in Both Women and
Men. The recommended initial dose has been lowered to 5 mg for women and
either 5 or 10 mg for men, taken only once per night immediately before bedtime
with at least 7-8 hours remaining before awakening.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37415a-eng.php
**NICE
- Eyes on Evidence, January 2014 includes:
-- Antibiotics and community-associated Clostridium difficile infection
https://www.evidence.nhs.uk/eyes-on-evidence-january-2014.pdf
PAPERS OF INTEREST
**Am J Health-Syst Pharm
- Comparison of medication safety effectiveness among nine critical access
hospitals
http://www.ajhp.org/content/70/24/2218.abstract?etoc
- Standardized versus custom parenteral nutrition: Impact on clinical and costrelated outcomes
http://www.ajhp.org/cgi/content/abstract/71/2/114
- Outcomes of a new dosage regimen of amikacin based on pharmacokinetic
parameters of Korean neonates
http://www.ajhp.org/cgi/content/abstract/71/2/122
**Am J Med
Myocardial ischemic events in ‘real world’ patients with atrial fibrillation treated
with dabigatran or warfarin: A nationwide cohort study
http://www.amjmed.com/article/S0002-9343(13)01073-5/abstract
**Am J Psychiatry
Drug-Induced Long QT in Adult Psychiatric Inpatients: The 5-Year Cross-Sectional
ECG Screening Outcome in Psychiatry Study
http://ajp.psychiatryonline.org/article.aspx?articleID=1787323
**Ann Intern Med
Health Information Technology: An Updated Systematic Review with a Focus on
Meaningful Use
http://annals.org/article.aspx?articleID=1811028
**BMC Medical Research Methodology
Search strategies to identify reports on “off-label” drug use in EMBASE
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3543848/pdf/1471-2288-12190.pdf
**BMJ Qual Saf
Governing patient safety: lessons learned from a mixed methods evaluation of
implementing a ward-level medication safety scorecard in two English NHS hospitals
http://qualitysafety.bmj.com/content/23/2/136?etoc
**Cochrane
- Inotropic agents and vasodilator strategies for acute myocardial infarction
complicated by cardiogenic shock or low cardiac output syndrome
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009669.pub2/abstract
- Trifluoperazine versus placebo for schizophrenia
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010226.pub2/abstract
**Eur Heart J
Peri-interventional management of novel oral anticoagulants in daily care: results
from the prospective Dresden NOAC registry
http://eurheartj.oxfordjournals.org/content/early/2014/01/05/eurheartj.eht557.f
ull.pdf?papetoc
**JAMA
Pharmacological Treatments for Smoking Cessation
http://jama.jamanetwork.com/article.aspx?articleid=1812940
**JAMA Neurology
New Oral Anticoagulants and the Risk of Intracranial Hemorrhage: Traditional and
Bayesian Meta-analysis and Mixed Treatment Comparison of Randomized Trials of
New Oral Anticoagulants in Atrial Fibrillation
http://archneur.jamanetwork.com/article.aspx?articleid=1788609
**New Engl J Med
A Randomized Trial of Hyperglycemic Control in Pediatric Intensive Care
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1302564
**Paediatrics
Recognition and Management of Iatrogenically Induced Opioid Dependence and
Withdrawal in Children
http://pediatrics.aappublications.org/content/133/1/152.abstract
TAG Mail 7th January 2014
REPORTS AND PUBLICATIONS - AUSTRALIA
**AIHW
Australia's mothers and babies 2011
http://www.aihw.gov.au/publication-detail/?id=60129545702
**NMTAN (National Medical Training Advisory Network)
Health Information Workforce Report (October 2013)
http://www.hwa.gov.au/sites/uploads/HWA13IAP009_Health-InformationWorkforce-Report_v3.pdf
REPORTS AND PUBLICATIONS - INTERNATIONAL
**MedEffect Canada
Revlimid (lenalidomide) - Risk of Liver Problems - For Health Professionals
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/37383a-eng.php
**NICE
- Non-cystic fibrosis bronchiectasis: colistimethate sodium
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESU
OM25.jsp
- Evidence summary for a new medicine: ESNM29 Alcohol dependence:
nalmefene
http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM29.jsp
MEDICATION SAFETY
**eMC
Revised SPC: Pioglitazone 15/30/45mg tablets (Sandoz generic): Postmarketing
reports of hypersensitivity reactions in patients treated with pioglitazone have been
reported. These reactions include anaphylaxis, angioedema, and urticaria and have
been added to section 4.8
http://www.medicines.org.uk/emc/medicine/26001/SPC/Pioglitazone%2015mg%20
Tablets
**FDA
Drug Safety Communication: Methylphenidate ADHD Medications - Risk of Longlasting Erections
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
dicalProducts/ucm378876.htm
**New Zealand Health Quality and Safety Commission
- New alert gives advice on the management of transdermal patches
http://www.hqsc.govt.nz/news-and-events/news/1304/
- The New Zealand Tall Man lettering list is now available
http://www.hqsc.govt.nz/our-programmes/medication-safety/projects/tall-manlettering/
PAPERS OF INTEREST
**Am J Health Sys Pharm
Risk of hepatotoxicity associated with fluoroquinolones: A national case–control
safety study
http://www.ajhp.org/cgi/content/abstract/71/1/37
**Am J Perinatol.
Medication Use in the Neonatal Intensive Care Unit
https://www.thieme-connect.de/ejournals/abstract/10.1055/s-0033-1361933
**Arch Gerontol Geriatr
An inter-rater reliability study of the prescribing indicated medications quality
indicators of the ACOVE 3 criteria as a potentially inappropriate prescribing tool
http://www.sciencedirect.com/science/article/pii/S0167494313001982
**Bone
Update on long-term treatment with bisphosphonates for postmenopausal
osteoporosis: A systematic review
http://www.sciencedirect.com/science/article/pii/S8756328213003785
**BMJ Quality and Safety
Batalden P. Making Improvement Interventions Happen — The Work Before the
Work: Four Leaders Speak
http://qualitysafety.bmj.com/content/early/2013/09/19/bmjqs-2013-002440
**Chest
Risk of serious atrial fibrillation and stroke with use of bisphosphonates: evidence
from a meta-analysis
http://journal.publications.chestnet.org/article.aspx?articleid=1691936
**Eur Heart J
Initiation of warfarin in patients with atrial fibrillation: early effects on ischaemic
strokes
http://eurheartj.oxfordjournals.org/content/early/2013/12/15/eurheartj.eht499.a
bstract
**JAMA
- 2014 Evidence-Based Guideline for the Management of High Blood Pressure in
Adults
http://jama.jamanetwork.com/article.aspx?articleid=1791497
- Effect of Vitamin E and Memantine on Functional Decline in Alzheimer Disease
http://jama.jamanetwork.com/article.aspx?articleid=1810379
**JAMA Intern Med
- Lower Risk of Cardiovascular Events in Postmenopausal Women Taking Oral
Estradiol Compared With Oral Conjugated Equine Estrogens
http://archinte.jamanetwork.com/article.aspx?articleid=1741892
- Gabapentin Treatment for Alcohol Dependence: A Randomized Clinical Trial
http://archinte.jamanetwork.com/article.aspx?articleid=1764009
- Renoprotective Effect of Renin-Angiotensin-Aldosterone System Blockade in
Patients With Predialysis Advanced Chronic Kidney Disease, Hypertension, and
Anemia
http://archinte.jamanetwork.com/article.aspx?articleid=1787693
**Journal of Patient Safety
- Safe Use of Electronic Health Records and Health Information Technology Systems:
Trust But Verify
http://journals.lww.com/journalpatientsafety/Fulltext/2013/12000/Safe_Use_of_E
lectronic_Health_Records_and_Health.1.aspx
- Automated Adverse Event Detection Collaborative: Electronic Adverse Event
Identification, Classification, and Corrective Actions Across Academic Pediatric
Institutions
http://journals.lww.com/journalpatientsafety/Abstract/2013/12000/Automated_A
dverse_Event_Detection_Collaborative__.4.aspx
**New Engl J Med
Vaccine for Prevention of Mild and Moderate-to-Severe Influenza in Children
http://www.nejm.org/doi/full/10.1056/NEJMoa1215817?query=TOC
**Paediatrics
Comparative Effectiveness of Empiric Antibiotics for Community-Acquired
Pneumonia
http://pediatrics.aappublications.org/content/133/1/e23.abstract