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/322358/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-amr-information-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/2014/06/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 early-onset neonatal infection: antibiotics for the prevention and treatment of early-onset 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.pdf PAPERS OF INTEREST **Am J Cardiol Meta-Analysis of Randomized Clinical Trials Comparing Short-Term Versus Long-Term 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)60541-9/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 physician-level variability in technology use http://jamia.bmj.com/content/early/2014/06/09/amiajnl-2013-002627.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_monitoring_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-improved-guidance-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=102177 **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/Surveillance/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/ISMPCSB2014-6_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/dc14-1140.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-2013-041043 **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)60683-8/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-overcoming-disparities-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=/our-work/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.aspx?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/BobLloydWhiteboard.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-and-resources/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/comms-ic/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-2013-002484.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=9B7FD7C7069D059BBDA1003976C1E96C.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)70245-7/abstract **Lancet Inf Dis Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)70737-6/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/jun-2014/RB0685%20Fentanyl%20Transdermal%20Patch%20Final.pdf - Bivalirudin Infusion Following Angioplasty: Safety http://www.cadth.ca/media/pdf/htis/may-2014/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)60460-8/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)60614-0/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)60685-1/abstract - Hypertension management in England: a serial cross-sectional study from 1994 to 2011 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60688-7/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-variation-in-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 double-blind, placebo-controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60162-8/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 13-25, 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/311887/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/311491/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/ISMPCSB2014-5_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.114.008201.abstract - Editorial: Atrial Fibrillation Epidemic and Hospitalizations: How to Turn the Rising Tide? http://circ.ahajournals.org/content/early/2014/04/23/CIRCULATIONAHA.114.010073.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.114.008779.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)60726-1/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-and-outcomes-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 case-control 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-and-resources/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/2014/05/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.113.000817.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)70088-9/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;jsessionid=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.full.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)70068-3/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)70071-4/fulltext - Cardiovascular remodelling in coronary artery disease and heart failure http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60107-0/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/may-2014/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/may-2014/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/apr-2014/RB0669%20Aspiration%20Prior%20to%20Injection%20Final.pdf -- Short-Acting Intramuscular Olanzapine for Acute Agitation: Clinical and Cost- Effectiveness and Guidelines http://www.cadth.ca/media/pdf/htis/may-2014/RB0671%20IM%20Olanzapine%20Final.pdf -- Apixaban and Rivaroxaban for Stroke Prevention in Atrial Fibrillation: Safety http://www.cadth.ca/media/pdf/htis/apr-2014/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/OfficeofMedicalProductsandTobacco/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/307143/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-lct-140502.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 HIV-positive 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)70733-9/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/healthcare_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-day-Mortality_December2013.pdf **Grattan Institute Unlocking skills in hospitals: better jobs, more care http://grattan.edu.au/static/files/assets/cf2cf3cc/810-unlocking-skills-in-hospitals.pdf **NHMRC Talking with your patients about Complementary Medicine – a Resource for Clinicians http://www.nhmrc.gov.au/your-health/complementary-medicines/talking-your-patients-about-complementary-medicine-resource-clin **NHPA Healthcare-associated Staphylococcus aureus bloodstream infections in 2012–13 http://www.myhospitals.gov.au/Content/Reports/sab/2014-03/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_BCSH.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/2014/04/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-OralLiquid-MedicationLabels.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/ISMPCSB2014-4_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=102155 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 meta-analysis 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-2013-002757.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.113.006426.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.full **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)70036-2/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.2013-3406.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-advice-opt-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-pump-140408.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-2013-002165.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-tuberculosis-western-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/apr-2014/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/patientSafetyPublications/Documents/Making%20Care%20Safer%20From%20Hospital%20to%20Home%20Care.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-hear-communication-practices-about-medications-between-physicians-and-clients-with-chronic-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): 3-year results of an open-label randomised trial http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)70029-4/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)70328-1/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-when-medications-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/expert-commentary.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/AuditRevealsVariationUsePainReliefHipFracture.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/ESUOM30.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.114.008643.abstract - Five-Year Survival in Patients with ST-Segment Elevation Myocardial Infarction According to Modalities of Reperfusion Therapy: The French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort http://circ.ahajournals.org/content/early/2014/03/21/CIRCULATIONAHA.113.005874.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-aureus-bloodstream-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 open-label phase 3b study http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60084-2/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)62709-9/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-young-people-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-ivermectin-esuom29 MEDICATION SAFETY **ISMP Canada Advancing Opioid Safety for Children in Hospitals http://www.ismp-canada.org/download/safetyBulletins/2014/ISMPCSB2014-3_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-2013-002572.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.113.005698.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-2012-001548.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)70041-4/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-mental-health-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-on-improving-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/mar-2014/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 cancer-related 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)62343-0/fulltext **MJA - Increasing incidence of Clostridium difficile infection, Australia, 2011–2012 https://www.mja.com.au/journal/2014/200/5/increasing-incidence-clostridium-difficile-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-aureus-bloodstream-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-and-reporting-of-antimicrobial-resistance-and-antibiotic-usage-for-human-health-in-australia **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-health-settings-promethazine-hydrochloride-esuom28 **NHS England Patient Safety Alert: Addressing rising trends and outbreaks in carbapenemase- producing 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-reconciliation-getting-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/human-rights-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/SafetyAlertsforHumanMedicalProducts/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_Hospital_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_Drug_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)70030-0/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)61451-8/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/drug-monitoring/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-131122-submissions.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-furoatevilanterol-relvar-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_francis_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/SafetyAlertsforHumanMedicalProducts/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.pdf?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)62159-5/abstract **MJA - Clenbuterol toxicity: a NSW Poisons Information Centre experience https://www.mja.com.au/journal/2014/200/4/clenbuterol-toxicity-nsw-poisons-information-centre-experience - Renal replacement therapy associated with lithium nephrotoxicity in Australia https://www.mja.com.au/journal/2014/200/4/renal-replacement-therapy-associated-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/feb-2014/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%20Non-drugs%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-sulfoxide-bladder-instillation-esuom26 -- ESUOM27 Chronic pain: oral ketamine http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESUOM27.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 methysergide-containing 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/2014/02/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=102114 **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 Adverse-Drug-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)62298-9/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)62159-5/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)62062-0/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-and-reporting-of-antimicrobial-resistance-and-antibiotic-usage-for-human-health-in-australia/ - NIMC Audit System User Guide http://www.safetyandquality.gov.au/publications/national-inpatient-medication-chart-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-and-events/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 disease- A 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/Medication-Safety-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)61451-8/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_associated_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%2buc0vde7AwcfSmpYQ72Jx4HoCapJ7g%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/ESUOM25.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 beta-lactam 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;jsessionid=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/art00001

**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)70609-0/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-the-Effect-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&utm_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/feb-2014/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/feb-2014/RB0641%20Intranasal%20Administration%20Final.pdf - Smart Infusion Pump use in Hospitalized Patients: Clinical Safety and Guidelines http://www.cadth.ca/media/pdf/htis/feb-2014/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/2014/01/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/SafetyAlertsforHumanMedicalProducts/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/275060/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=102106 **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%2900434-0/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-2013-204522.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=744F9D96B7AB49FDD92B879266545F8C.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-2013-002556.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.113.004777.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.113.004834.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)70212-2/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-standardised-medicine-syringe-labels-in-interventional-cardiac-catheter-and-radiology-laboratories/ - Labelling Recommendations Issues Register http://www.safetyandquality.gov.au/publications/labelling-recommendations-issues-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/latest-issue/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-for-helicobacter-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 non-calcium-based phosphate binders https://www.evidence.nhs.uk/document?ci=http%3A%2F%2Farms.evidence.nhs.uk%2Fresources%2FHub%2F1032210&q=medicines%20evidence%20commentary&ReturnUrl=%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-improve-quality/ 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/Safetywarningsandmessagesformedicines/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/art00005

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-report-pdf-1-63mb/ - NIMC 2012 National Audit Report http://www.safetyandquality.gov.au/publications/nimc-2012-national-audit-report-pdf-2-10kb/ - NIMC 2011 National Audit Report http://www.safetyandquality.gov.au/publications/nimc-2011-national-audit-report-pdf-1-02mb/ - NIMC 2010 National Audit Report http://www.safetyandquality.gov.au/publications/nimc-2010-national-audit-report-pdf-1-09mb/ - NIMC 2009 National Audit Report http://www.safetyandquality.gov.au/publications/nimc-2009-national-audit-report-pdf-1-02mb/ - Electronic Medication Management Systems: Specialist Functions http://www.safetyandquality.gov.au/publications/electronic-medication-management-systems-specialist-functions-pdf-856kb/ - NIMC Local Management Guidelines

http://www.safetyandquality.gov.au/publications/nimc-local-management-guidelines-pdf-133kb/ - NIMC and Psychiatric Acute Services Survey Report http://www.safetyandquality.gov.au/publications/nimc-and-psychiatric-acute-services-survey-report-pdf-780-kb/ - Antimicrobial Stewardship in small health service organisations http://www.safetyandquality.gov.au/publications/antimicrobial-stewardship-in-small-health-service-organisations/ - Cessation of flexible transition arrangements for the NSQHS Standards http://www.safetyandquality.gov.au/publications/advisory-a1308-cessation-of-flexible-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_campaign=NHMRC%20Health%20Tracker%20-%20December%202013&utm_content=NHMRC%20Health%20Tracker%20-%20December%202013+CID_d38b0d2f8edef604468c8a16e8bf95a2&utm_source=Mailbuild&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-risks-in-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/nps-direct/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 Health-Related Evidence http://www.ahrq.gov/research/findings/evidence-based-reports/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%20and%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%20film-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.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20140107005842&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/2013/12/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/2013/12/news_detail_002000.jsp&mid=WC0b01ac058004d5c1 **FDA Rivaroxaban labelling revision http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022406Orig1s007ltr.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-contraception-nomegestrolestradiol-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-vascular-disease-intravenous-iloprost-esuom24 -- ESUOM23 Transient ischaemic attack: clopidogrel http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESUOM23.jsp - Evidence Update: -- Post-traumatic stress disorder (PTSD) http://www.evidence.nhs.uk/document?ci=http%3A%2F%2Farms.evidence.nhs.uk%2Fresources%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/2014/01/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/SafetyAlertsforHumanMedicalProducts/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 cost-related 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/1471-2288-12-190.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.full.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-Information-Workforce-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/ESUOM25.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%20Tablets **FDA Drug Safety Communication: Methylphenidate ADHD Medications - Risk of Long-lasting Erections http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/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-man-lettering/ 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.abstract **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_Electronic_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_Adverse_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