TAG Mail 2015 (January - June) Cumulative Listing of Reports, Publications, Medication Safety Information and Papers of Interest ________________________________________________________________ TAG Mail 24 June 2015 TAG MEETINGS Nil TAG ACTIVITIES - Surveys -- Life-Saving Drugs Register Antidote Survey 2015 (closes 30 June 2015) - Email discussions -- Guiding principles for the governance of biological and biosimilar medicines (closes 30 June 2015) -- Benzodiazepine prescribing to inpatients at high risk of falls (closes 2 July 2015) -- Tapentadol addition to formulary (closes 9 July 2015) TAG WEBSITE Nil REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW -National Bowel Cancer Screening Program: monitoring report 2013-14 http://www.aihw.gov.au/publication-detail/?id=60129551421 -Alcohol and other drug treatment services in Australia 2013-14 http://www.aihw.gov.au/publication-detail/?id=60129551120 http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/gardasil-safety-update **TGA Update to Prescribing Medicines in Pregnancy database for ledipasavir, asunaprevir, clonazepam, carmustine http://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database REPORTS AND PUBLICATIONS – INTERNATIONAL **Asthma UK Patient safety failures in asthma care: the scale of unsafe prescribing in the UK http://www.asthma.org.uk/patient-safety **Canadian Agency for Drugs and Technologies in Health (CADTH) --Rapid Responses: Sedation and Anesthesia Options for Diagnostic Procedures: A Review of Clinical Effectiveness and Guidelines https://www.cadth.ca/sedation-and-anesthesia-options-diagnostic-proceduresreview-clinical-effectiveness-and-guidelines --Reports: Large Volume Crystalloid Fluid Infusion for Adults with Moderate to Severe Sepsis: Clinical Effectiveness and Guidelines https://www.cadth.ca/large-volume-crystalloid-fluid-infusion-adults-moderatesevere-sepsis-clinical-effectiveness-and --Neonatal Vitamin K Administration for the Prevention of Hemorrhagic Disease: A Review of the Clinical Effectiveness, Comparative Effectiveness, and Guidelines https://www.cadth.ca/neonatal-vitamin-k-administration-prevention-hemorrhagicdisease-review-clinical-effectiveness **Cochrane -Primary prophylaxis for venous thromboembolism in patients undergoing cardiac or thoracic surgery http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD009658.pub2 -Culturally appropriate health education for people in ethnic minority groups with type 2 diabetes mellitus http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006424.pub3/abstract;jse ssionid=1B61C5B51AA1B40CE9EF4D021BB7F87C.f04t01 -Interventions for improving the adoption of shared decision making by healthcare professionals http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006732.pub3/abstract **FDA FDA approves IV antiplatelet drug, cangrelor ‘Kangreal’ used during percutaneous coronary intervention (PCI) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452172.htm **IHI -Pursuing the Triple Aim: The first seven years. Milbank Quarterly. 2015;93(2):263300. http://www.ihi.org/resources/Pages/Publications/PursuingTripleAimFirstSevenYear s.aspx **MHRA PPRS Dispute Resolution Panel decisions 2015 https://www.gov.uk/government/publications/pprs-dispute-resolution-paneldecisions-2015 **NICE Clinical Guidelines -- Anaemia management in people with chronic kidney disease http://www.nice.org.uk/guidance/ng8 MEDICATION SAFETY **New Zealand Health Quality and Safety Commission -Medication Safety Watch Newsletter http://www.hqsc.govt.nz/our-programmes/medication-safety/publications-andresources/publication/1751/ **ISMP Medication Safety Alert- Acute Care Accidental overdoses involving fluorouracil infusions http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=111 **AHRQ Results of survey on pediatric medication safety—more is needed to protect hospitalized children from medication errors http://www.psnet.ahrq.gov/resource.aspx?resourceID=28936 **Health Canada/ Canadian Adverse Reaction Newsletter --Febuxostat and international reports of agranulocytosis and drug rash with eosinophilia and systemic symptoms (DRESS). http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/hpiw-ivps_2015-05-eng.php#s2a PAPERS OF INTEREST **Am J Health Syst Pharm -Medication management for left ventricular assist device thrombosis http://www.ajhp.org/content/72/13/1104.abstract -ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration—2014 http://www.ajhp.org/content/72/13/1119.abstract -Using lean principles to improve outpatient adult infusion clinic chemotherapy preparation turnaround times http://www.ajhp.org/content/72/13/1138.abstract **Annals of Internal Medicine Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome http://annals.org/article.aspx?articleid=2322801 **Australian Health Review -Community representation in hospital decision making: a literature review http://www.publish.csiro.au/?act=view_file&file_id=AH14016.pdf -Implementing antimicrobial stewardship in the Australian private hospital system: a qualitative study http://www.publish.csiro.au/nid/270/paper/AH14111.htm -Funding issues and options for pharmacists providing sessional services to rural hospitals in Australia http://www.publish.csiro.au/view/journals/dsp_journal_fulltext.cfm?nid=270&f=A H14081 **BMJ -Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis http://www.bmj.com/content/350/bmj.h3163 -Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18 168 people with type 1 diabetes: observational study http://www.bmj.com/content/350/bmj.h3234 -PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with non-traumatic abdominal pain: randomised trial http://www.bmj.com/content/350/bmj.h3147 - Safety of lamotrigine in paediatrics: a systematic review http://bmjopen.bmj.com/content/5/6/e007711.short?g=w_open_current_tab **BMJ Safety and Quality -Teamwork, communication and safety climate: a systematic review of interventions to improve surgical culture http://qualitysafety.bmj.com/content/24/7/458.abstract -The association of hospital prevention processes and patient risk factors with the risk of Clostridium difficile infection: a population-based cohort study http://qualitysafety.bmj.com/content/24/7/435.abstract **British Journal of Clin Pharmacology Meid AD, Lampert A, Burnett A, et al. The impact of pharmaceutical care interventions for medication underuse in older people: a systematic review and meta-analysis http://onlinelibrary.wiley.com/doi/10.1111/bcp.12657/abstract **Cleveland Clinic – Center for Continuing Education -Improving medication safety during hospital-based transitions of care http://www.clevelandclinicmeded.com/online/journal/06_June-2015/0531375/ **Clinical Pediatrics -Opioid Prescribing and Potential Overdose Errors Among Children 0 to 36 Months Old http://cpj.sagepub.com/content/54/8/738 **European Journal of Hospital Pharmacy -Medication discrepancies revealed by medication reconciliation and their potential short-term and long-term effects: a Norwegian multicentre study carried out on internal medicine wards http://ejhp.bmj.com/content/early/2015/06/19/ejhpharm-2015-000686.abstract **New England Journal of Medicine -Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation http://www.nejm.org/doi/full/10.1056/NEJMoa1501035?query=featured_home -Idarucizumab for Dabigatran Reversal http://www.nejm.org/doi/full/10.1056/NEJMoa1502000?query=featured_home CONSULTATIONS **TGA Open consultations and reviews for OTC monograph for ranitidine, mebendazole, gauifenesin and loperamide; and proposed advisory statements for esomeprazole. Closing date 10th October, 2014 http://www.tga.gov.au/newsroom/consult-open.htm OTHER NEWS Nil UPCOMING EVENTS (new additions in bold) **SHPA Antimicrobial Stewardship Pharmacist Seminar, 23-24 July 2015, Peter Doherty Institute, Melbourne http://cpd.shpa.org.au/lib/pdf/conferences/AMS_Pharmacist_Seminar_2015.pdf **VMIA Human Factors in Healthcare Forum, 5th August 2015 9.00am-1.00pm, The Alfred, AMREP Lecture Theatre, 75 Commercial Road, Melbourne https://www.vmia.vic.gov.au/learn/training-and-development/upcomingprograms/2015/08/05/Human-Factors-in-Healthcare-Forum Change Champions Medication Safety and Mental Health, 20 August, Melbourne. Abstracts close 30 June 2015 http://www.changechampions.com.au/call-for-papers **The Alfred TC-IFEM The Alfred's 4th Annual International Emergency Care Conference, 26-28 Aug 2015 http://alfredetc-professional-development.cvent.com/events/internationalemergency-care-conference-2015/event-summarydbde3298352b47ffac653eab18bad52e.aspx **AHRQ Agency for Healthcare Research and Quality (AHRQ) research conference, 4–6 October, 2015, Crystal City, Virginia USA Health care research and policy sessions on improving quality, safety, access and value in health care http://www.ahrq.gov/news/events/conference/index.html **ISQUA 'Building Quality and Safety into the Healthcare System', 4-7 October 2015, Doha, Qatar. Early bird registrations close 15th July 2015 http://www.isqua.org/conference/doha-2015/registration2015?utm_source=Conference+-+Registration+Open++March+2015&utm_campaign=Conference+-+Reg+Open+- +March+2015&utm_medium=email *SHPA Medicines Management 2015, 3-6 December 2015, Melbourne Convention Centre. Call for abstracts now open - closes Friday 17 July 2015 http://mm2015shpa.com/ TAG Mail 2015 (January - June) Cumulative Listing of Reports, Publications, Medication Safety Information and Papers of Interest TAG Mail 10th June 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **ACSQHC National Antimicrobial Resistance Strategy 2015-2019 http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-amr.htm **AIHW - Access to health services by Australians with disability 2012 http://www.aihw.gov.au/publication-detail/?id=60129551404 - The health and welfare of Australia’s Aboriginal and Torres Strait Islander peoples: 2015 http://www.aihw.gov.au/publication-detail/?id=60129550168 - Maternal deaths in Australia 2008–2012 http://www.aihw.gov.au/publication-detail/?id=60129551119 **TGA New oral anticoagulants - apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto) - No evidence to support routine blood monitoring at this time http://www.tga.gov.au/alert/new-oral-anticoagulants-apixaban-eliquis-dabigatranpradaxa-and-rivaroxaban-xarelto REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH - Rapid Response -- Filtered versus Non-Filtered Needles for Withdrawing Medication from Glass Ampoules: Comparative Clinical Effectiveness, Cost-Effectiveness, and Guidelines https://www.cadth.ca/filtered-versus-non-filtered-needles-withdrawingmedication-glass-ampoules-comparative-clinical -- Deep Sedation and General Anaesthesia in Young Children: Safety and Guidelines https://www.cadth.ca/deep-sedation-and-general-anaesthesia-young-childrensafety-and-guidelines **NICE - Clinical Guidelines -- Anaemia management in people with chronic kidney disease http://www.nice.org.uk/guidance/ng8 -- Lower urinary tract symptoms in men: assessment and management http://www.nice.org.uk/guidance/cg97 -- Bronchiolitis in children http://www.nice.org.uk/guidance/ng9 - Technology appraisal -- Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism http://www.nice.org.uk/guidance/ta341 -- Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia http://www.nice.org.uk/guidance/ta343 -- Ofatumumab in combination with chlorambucil or bendamustine for untreated chronic lymphocytic leukaemia http://www.nice.org.uk/guidance/ta344 -- Omalizumab for previously treated chronic spontaneous urticaria http://www.nice.org.uk/guidance/ta339 -- Ustekinumab for treating active psoriatic arthritis (rapid review of technology appraisal guidance 313) http://www.nice.org.uk/guidance/ta340 -- Vedolizumab for treating moderately to severely active ulcerative colitis http://www.nice.org.uk/guidance/ta342 **SIGN Management of chronic heart failure; Consultation - draft guidelines http://www.sign.ac.uk/consultation/index.html **The Joint Commission Joint Commission Joins White House Effort to Reduce Antibiotic Overuse http://www.jointcommission.org/joint_commission_joins_white_house_effort_to_r educe_antibiotic_overuse/ MEDICATION SAFETY **ISMP Part 1: Results of Survey on Pediatric Medication Safety; More is needed to protect hospitalized children from medication errors http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=110 PAPERS OF INTEREST **BMJ - Association between tumour necrosis factor-α inhibitors and risk of serious infections in people with inflammatory bowel disease: nationwide Danish cohort study http://www.bmj.com/content/350/bmj.h2809 - Outcome of delirium in critically ill patients: systematic review and meta-analysis http://www.bmj.com/content/350/bmj.h2538 **Circulation Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome http://dx.doi.org/10.1161/CIRCULATIONAHA.114.013451 **Eur J Hosp Pharm Chapter 10: Mentoring and teaching of evidence-based pharmacy http://ejhp.bmj.com/content/early/2015/06/03/ejhpharm-2015-000713?papetoc **Infection Control and Hospital Epidemiology Diagnostic Errors that Lead to Inappropriate Antimicrobial Use http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=97044 23&fileId=S0899823X15001130 **Internal Med J - Proton pump inhibitors utilisation in older people in New Zealand from 2005 to 2013 http://onlinelibrary.wiley.com/doi/10.1111/imj.12757/abstract - Medical education and law: withholding/withdrawing treatment from adults without capacity http://onlinelibrary.wiley.com/doi/10.1111/imj.12759/abstract - Is excessive acetaminophen intake associated with transaminitis in adult patients with dengue fever? http://onlinelibrary.wiley.com/doi/10.1111/imj.12756/abstract **NEJM - Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes http://www.nejm.org/doi/full/10.1056/NEJMoa1501352?query=featured_home - Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)619437/abstract **Pediatrics A trigger tool to detect harm in pediatric inpatient settings http://dx.doi.org/10.1542/peds.2014-2152 TAG Mail 3rd June 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **TGA - The Poisons Standard (the SUSMP) No.7 released http://www.tga.gov.au/publication/poisons-standard-susmp - AusPARS added Elosulfase alfa (rch) (Vimizim) and Fentanyl citrate (Fentora) http://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars REPORTS AND PUBLICATIONS – INTERNATIONAL **FDA - FDA approves Rapamune (sirolimus) to treat LAM, a very rare lung disease http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448523.htm - FDA approves two therapies to treat IBS-D, Viberzi (eluxadoline) and Xifaxan (rifaximin) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm MEDICATION SAFETY **Health Canada Febuxostat and international reports of agranulocytosis and drug rash with eosinophilia and systemic symptoms (DRESS) http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/hpiw-ivps_2015-05-eng.php#s2a **HQSCNZ Medication Safety Watch newsletter, May 2015 includes: Human factors or ergonomics and medication safety | One steps for medication safety | Opioids collaborative update | Decimal points and other error prone abbreviations in electronic systems | Insulin 500 units/mL (Humulin R® U-500 units/mL) http://www.hqsc.govt.nz/our-programmes/medication-safety/publications-andresources/publication/2176/ **TGA - Medicines Safety Update June 2015 includes: Methotrexate and hepatitis B reactivation | Ivabradine and cardiovascular events in patients with angina | Ethinylestradiol/etonogestrel vaginal ring and thromboembolic risk http://www.tga.gov.au/publication-issue/medicines-safety-update-volume-6number-3-june-2015 - Medicines and vaccines post-market vigilance - statistics for 2014 http://www.tga.gov.au/medicines-and-vaccines-post-market-vigilance-statistics2014 - Medtronic Australasia - US consent decree on SynchroMed drug infusion system https://www.tga.gov.au/media-release/medtronic-australasia-us-consent-decreesynchromed-drug-infusion-system PAPERS OF INTEREST **Am J Health-Syst Pharm - Clostridium difficile infection: A brief update on emerging therapies http://www.ajhp.org/content/72/12/1007.abstract - Role of intravenous immune globulin in streptococcal toxic shock syndrome and Clostridium difficile infection http://www.ajhp.org/content/72/12/1013.abstract - Clinical outcomes and treatment cost comparison of levalbuterol versus albuterol in hospitalized adults with chronic obstructive pulmonary disease or asthma http://www.ajhp.org/content/72/12/1026.abstract **Aust Prescriber Prescribing azithromycin http://www.australianprescriber.com/magazine/38/3/87/9 **BMJ Varenicline and risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents and offences: population based cohort study http://www.bmj.com/content/350/bmj.h2388 **BMJ Open Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review http://bmjopen.bmj.com/content/5/5/e006539 **BMJ Qual Saf A unit-based intervention aimed at improving patient adherence to pharmacological thromboprophylaxis http://qualitysafety.bmj.com/content/early/2015/06/02/bmjqs-2015003992.short?g=w_qs_ahead_tab **Br J Clin Pharmacol - Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system http://onlinelibrary.wiley.com/doi/10.1111/bcp.12611/abstract - A population-based study of the drug interaction between clopidogrel and angiotensin converting enzyme inhibitors http://onlinelibrary.wiley.com/doi/10.1111/bcp.12682/abstract **Cochrane Incentives for smoking cessation http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD004307.pub5 Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus addition of long-acting beta2-agonists (LABA) for adults with asthma http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD011438.pub2 **JAMA Antidepressant Use Late in Pregnancy and Risk of Persistent Pulmonary Hypertension of the Newborn http://jama.jamanetwork.com/article.aspx?articleid=2300602 **JAMA Intern Med Efficacy and Safety of Single-Dose Zoledronic Acid for Osteoporosis in Frail Elderly Women: A Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=2247163 Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene http://archinte.jamanetwork.com/article.aspx?articleid=2276923 Treatment With Multiple Blood Pressure Medications, Achieved Blood Pressure, and Mortality in Older Nursing Home Residents: The PARTAGE Study http://archinte.jamanetwork.com/article.aspx?articleid=2110995 **Pharmacoepidemiol Drug Saf Are ECG monitoring recommendations before prescription of QT-prolonging drugs applied in daily practice? The example of haloperidol http://onlinelibrary.wiley.com/doi/10.1002/pds.3792/abstract **Prescrire International Dabigatran (Pradaxa°) in deep vein thrombosis and pulmonary embolism http://english.prescrire.org/en/81/168/49953/0/NewsDetails.aspx TAG Mail 27th May 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW Development of a national education and training data standards strategy and implementation plan http://www.aihw.gov.au/publication-detail/?id=60129551063 **TGA - TGA presentation given at the Sydney Children's Hospital Network Research Governance, 31 March 2015 - an overview of the TGA's role in controlling access to unapproved therapeutic goods, including in clinical trials http://www.tga.gov.au/tga-presentation-given-sydney-childrens-hospital-networkresearch-governance-31-march-2015 - Information for registered users of the Australian Adverse Drug Reaction Reporting System http://www.tga.gov.au/information-registered-users-australian-adverse-drugreaction-reporting-system - Natalizumab and melanoma; Final update - no definite link established http://www.tga.gov.au/monitoring-communication/natalizumab-and-melanoma REPORTS AND PUBLICATIONS – INTERNATIONAL **EMA - First-in-class treatment to lower cholesterol; EMA has recommended authorising Repatha (evolocumab) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002336.jsp&mid=WC0b01ac058004d5c1 - New treatment option recommended for patients with advanced melanoma, Keytruda (pembrolizumab) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002334.jsp&mid=WC0b01ac058004d5c1 - New treatment option for patients with advanced lung cancer, Nivolumab BMS (nivolumab) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002335.jsp&mid=WC0b01ac058004d5c1 - EMA recommends treatment for rare cancer in children, Unituxin (dinutuximab) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002333.jsp&mid=WC0b01ac058004d5c1 - EMA recommends Imbruvica (ibrutinib) for the treatment of Waldenstrӧm’s macroglobulinaemia, Imbruvica (ibrutinib) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002332.jsp&mid=WC0b01ac058004d5c1 **Health Improvement Scotland-NHS boards and Area DTCs Biosimilar medicines: A national prescribing framework http://www.healthcareimprovementscotland.org/our_work/technologies_and_med icines/programme_resources/biosimilar_medicines_framework.aspx MEDICATION SAFETY **EMA Updated advice on use of high-dose ibuprofen http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002337.jsp&mid=WC0b01ac058004d5c1 **FDA - FDA Drug Safety Communication: FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam) http://www.fda.gov/Drugs/DrugSafety/ucm445919.htm - FDA Drug Safety Podcast: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm447651.htm **ISMP The absence of a drug-disease interaction alert leads to a child’s death http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=109 **MHRA -Drug Safety Update, May 2015 -- Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone https://www.gov.uk/drug-safety-update/sofosbuvir-with-daclatasvir-sofosbuvirand-ledipasvir-risks-of-severe-bradycardia-and-heart-block-when-taken-withamiodarone -- Pomalidomide (Imnovid▼): risks of cardiac failure, interstitial lung disease and hepatotoxicity https://www.gov.uk/drug-safety-update/pomalidomide-imnovid-risks-of-cardiacfailure-interstitial-lung-disease-and-hepatotoxicity -- Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants cannot be excluded https://www.gov.uk/drug-safety-update/epoetin-beta-neorecormon-increasedrisk-of-retinopathy-in-preterm-infants-cannot-be-excluded -- Fingolimod (▼Gilenya): first reported case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient taking fingolimod https://assets.digital.cabinetoffice.gov.uk/media/555c338ced915d7ae5000007/Gilenya_DHPC_sent_29_April.pdf -- Topical ketoprofen and risk of photosensitivity reactions: reminder of risk minimisation measures https://assets.digital.cabinetoffice.gov.uk/media/555c335ce5274a74ca000009/Ketoprofen_DHPC_sent_20-042015.pdf **NPS-MedicineWise Reducing paracetamol misuse http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/reducing-paracetamol-misuse PAPERS OF INTEREST **Ann Intern Med - Longer Versus Shorter Duration Dual-Antiplatelet Therapy After Drug-Eluting Stent Placement: A Systematic Review and Meta-analysis http://annals.org/article.aspx?articleid=2297227 - Development of an "infusion pump safety score" http://dx.doi.org/10.2146/ajhp140421 **BMJ Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases http://www.bmj.com/content/350/bmj.h2135 **Circulation Efficacy and Harms of Direct Oral Anticoagulants in the Elderly for Stroke Prevention in Atrial Fibrillation and Secondary Prevention of Venous Thromboembolism: Systematic Review and Meta-Analysis http://circ.ahajournals.org/content/early/2015/05/15/CIRCULATIONAHA.114.0132 67.abstract **Clin Transplant Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart-transplant patients http://www.ncbi.nlm.nih.gov/pubmed/25981927 **Eur J Hosp Pharm - A 2-year retrospective review of vial sharing options for the compounding of cytotoxics http://ejhp.bmj.com/content/22/3/161.abstract - Evaluation of eight drug interaction databases commonly used in the German healthcare system http://ejhp.bmj.com/content/22/3/165.abstract **JAMA Stroke Prevention in Atrial Fibrillation: A Systematic Review http://jama.jamanetwork.com/article.aspx?articleid=2293300 **JAMA Internal Medicine Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review http://archinte.jamanetwork.com/article.aspx?articleid=2294238 **JAMA Opthalmology Risk of Substantial Intraocular Bleeding With Novel Oral Anticoagulants: Systematic Review and Meta-analysis http://archinte.jamanetwork.com/article.aspx?articleid=2294238 **J Thromb Thrombolysis Chemical prophylaxis to prevent venous thromboembolism in morbid obesity: literature review and dosing recommendations http://www.ncbi.nlm.nih.gov/pubmed/25982217 **Lancet - Comparative efficacy and safety of blood pressure-lowering agents in adults with diabetes and kidney disease: a network meta-analysis http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624594/abstract - Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study http://www.thelancet.com/journals/lancet/issue/current - Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial http://www.thelancet.com/journals/lancet/issue/current - Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial http://www.thelancet.com/journals/lancet/issue/current **Lancet –Haematology Fiix-prothrombin time versus standard prothrombin time for monitoring of warfarin anticoagulation: a single centre, double-blind, randomised, non-inferiority trial http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)000733/abstract **NEJM Trial of Short-Course Antimicrobial Therapy for Intraabdominal Infection http://www.nejm.org/doi/full/10.1056/NEJMoa1411162?query=featured_home TAG Mail 20th May 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW - Incidence of type 1 diabetes in Australia 2000–2013 http://www.aihw.gov.au/publication-detail/?id=60129550890 - The nKPI data collection: data quality issues working paper http://www.aihw.gov.au/publication-detail/?id=60129551074 - Back problems: musculoskeletal fact sheet http://www.aihw.gov.au/publication-detail/?id=60129551044 - Osteoarthritis: musculoskeletal fact sheet http://www.aihw.gov.au/publication-detail/?id=60129551049 **NHMRC NHMRC Statement and Information Paper: Evidence on the Effects of Lead on Human Health http://www.nhmrc.gov.au/guidelines-publications/eh58 REPORTS AND PUBLICATIONS – INTERNATIONAL **NICE - Eyes on Evidence (NB Links bring up a PDF) -- Intermittent versus continuous administration of proton pump inhibitors after treatment of bleeding ulcers -http://arms.evidence.nhs.uk/resources/hub/1044001/attachment -- Nicotine replacement therapy for people trying to cut down cigarette use http://arms.evidence.nhs.uk/resources/hub/1044003/attachment -- Patients’ expectations of the benefits and harms of treatments and tests http://arms.evidence.nhs.uk/resources/hub/1044011/attachment **SIGN SIGN 143: Diagnosis and management of epilepsy in adults http://www.sign.ac.uk/pdf/SIGN143.pdf **WHO World Health Statistics 2015 http://www.who.int/publications/en/ MEDICATION SAFETY **AHRQ Patient Safety Primers - guide you through key concepts in patient safety http://psnet.ahrq.gov/primerHome.aspx **FDA FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) for diabetes may result in a serious condition of too much acid in the blood (ketoacidosis) http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm **TGA - Gardasil (quadrivalent human papillomavirus vaccine), update 2 http://www.tga.gov.au/alert/gardasil-quadrivalent-human-papillomavirus-vaccineupdate-2 - Enhanced school-based surveillance of acute adverse events following immunisation with human papillomavirus vaccine in males and females, 2013 http://www.tga.gov.au/enhanced-school-based-surveillance-acute-adverse-eventsfollowing-immunisation-human-papillomavirus-vaccine-males-and-females-2013 PAPERS OF INTEREST **Am J Health-Syst Pharm - Role of obinutuzumab in the treatment of chronic lymphocytic leukemia http://www.ajhp.org/content/72/11/933.abstract - Potential cytochrome P-450 drug–drug interactions in adults with metastatic solid tumors and effect on eligibility for Phase I clinical trials http://www.ajhp.org/content/72/11/958.abstract **BMJ - Primary prevention with lipid lowering drugs and long term risk of vascular events in older people: population based cohort study http://www.bmj.com/content/350/bmj.h2335 - Trimethoprim-sulfamethoxazole versus vancomycin for severe infections caused by meticillin resistant Staphylococcus aureus: randomised controlled trial http://www.bmj.com/content/350/bmj.h2219 - Exposure to prescription opioid analgesics in utero and risk of neonatal abstinence syndrome: population based cohort study http://www.bmj.com/content/350/bmj.h2102 - Antipsychotic drug use in pregnancy: high dimensional, propensity matched, population based cohort study http://www.bmj.com/content/350/bmj.h2298 **Eur J Hosp Pharm Drug-related problems in a clinical setting: a literature review and cross-sectional study evaluating factors to identify patients at risk http://ejhp.bmj.com/content/early/2015/05/15/ejhpharm-2014-000605?papetoc ** JAMA - Oral steroids for Acute Radiculopathy Due to a Herniated Lumbar Disk http://jama.jamanetwork.com/article.aspx?articleid=2293294 **JAMA Internal Medicine - Exercise and Vitamin D in Fall Prevention Among Older Women A Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=2204033 **J Clin Endocrinol Metab Comparative Resistance to Teriparatide-Induced Bone Resorption with Denosumab or Alendronate http://www.ncbi.nlm.nih.gov/pubmed/25933031 **J Patient Saf The trigger tool as a method to measure harmful medication errors in children http://www.ncbi.nlm.nih.gov/pubmed/25853805 **Lancet - Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)617049/abstract - Does antiretroviral therapy reduce HIV-associated tuberculosis incidence to background rates? A national observational cohort study from England, Wales, and Northern Ireland http://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(15)000636/abstract - Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)622200/abstract - Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)619425/abstract - Worldwide access to treatment for end-stage kidney disease: a systematic review http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)616019/abstract **MJA - Asthma control in Australia: a cross-sectional web-based survey in a nationally representative population https://www.mja.com.au/system/files/issues/red01564.pdf **Pediatrics - Effectiveness of Pediatric Pill Swallowing Interventions: A Systematic Review http://pediatrics.aappublications.org/content/135/5/883.abstract - Nicotine Replacement Therapy in Pregnancy and Major Congenital Anomalies in Offspring http://pediatrics.aappublications.org/content/135/5/859.abstract - Prescription Opioid Epidemic and Infant Outcomes http://pediatrics.aappublications.org/content/135/5/842.abstract - Cost-Effectiveness of Treatment of Acute Otorrhea in Children With Tympanostomy Tubes http://pediatrics.aappublications.org/content/135/5/e1182.abstract TAG Mail 13th May 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **TGA - Orphan drugs added: Pegaspargase (ONCASPAR) http://www.tga.gov.au/updates-list-designated-orphan-drugs - Updates to the prescribing medicines in pregnancy database http://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH - Continuous versus Intermittent Intravenous Pantoprazole for Acute Gastrointestinal Bleeding: A Review of the Clinical Effectiveness and Guidelines https://www.cadth.ca/continuous-versus-intermittent-intravenous-pantoprazoleacute-gastrointestinal-bleeding-review - Compounded Diclofenac Cream for Topical Anti-Inflammatory Treatment: Clinical and Cost-Effectiveness, and Guidelines https://www.cadth.ca/compounded-diclofenac-cream-topical-anti-inflammatorytreatment-clinical-and-cost-effectiveness-and - Treatment of Older Adults with Insomnia, Agitation, or Delirium with Benzodiazepines: Clinical Effectiveness and Guidelines https://www.cadth.ca/treatment-older-adults-insomnia-agitation-or-deliriumbenzodiazepines-clinical-effectiveness-and - Bisphosphonate Use in Patients with Osteopenia and Low Risk of Fractures: Clinical Effectiveness and Guidelines https://www.cadth.ca/bisphosphonate-use-patients-osteopenia-and-low-riskfractures-clinical-effectiveness-and-guidelines **FDA FDA approves additional antibacterial treatment for plague, Avelox (moxifloxacin) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm446283.htm **GOV.UK A number of government policy reports were collated on the day of the British election last week covering dementia, patient safety, cancer research and treatment, mental health servcie reform, children's health, longterm health conditions https://www.gov.uk/government/publications?keywords=&publication_filter_optio n=all&topics%5B%5D=national-health-service&departments%5B%5D=department-ofhealth&official_document_status=all&world_locations%5B%5D=all&from_date=&to_ date=&commit=Refresh+results MEDICATION SAFETY **EMA - Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002325.jsp&mid=WC0b01ac058004d5c1 - Reviews of Tysabri (natalizumab) and inhaled corticosteroids used to treat chronic obstructive pulmonary disease started http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/05/news_detail_002323.jsp&mid=WC0b01ac058004d5c1 **ISMP QuarterWatch™ 2014 Quarter 2: Zolpidem and canagliflozin safety signals, thousands of incomplete rosiglitazone reports http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=108 PAPERS OF INTEREST **BMJ Qual Saf - Intended and unintended effects of large-scale adverse event disclosure: a controlled before-after analysis of five large-scale notifications http://qualitysafety.bmj.com/content/24/5/295.full - Developing person-centred analysis of harm in a paediatric hospital: a quality improvement report http://qualitysafety.bmj.com/content/24/5/337.full **Cochrane Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the prevention of tension-type headache in adults http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD011681/ **Int J Pharm Prac The four or more medicines (FOMM) support service: results from an evaluation of a new community pharmacy service aimed at over-65s http://onlinelibrary.wiley.com/doi/10.1111/ijpp.12196/abstract **Intern Med J - Comparison of the management and in-hospital outcomes of acute coronary syndrome patients in Australia and New Zealand: results from the binational SNAPSHOT acute coronary syndrome 2012 audit http://onlinelibrary.wiley.com/doi/10.1111/imj.12739/abstract - Safety of coadministration of ezetimibe and statins in patients with hypercholesterolaemia: a meta-analysis http://onlinelibrary.wiley.com/doi/10.1111/imj.12706/abstract - Consensus guidelines for the investigation and management of encephalitis in adults and children in Australia and New Zealand http://onlinelibrary.wiley.com/doi/10.1111/imj.12749/abstract **JAMIA - Towards creating the perfect electronic prescription http://jamia.oxfordjournals.org/content/22/e1/e7 - Comparative outcome studies of clinical decision support software: limitations to the practice of evidence-based system acquisition http://jamia.oxfordjournals.org/content/22/e1/e13 - Impact of clinical decision support preventing the use of QT-prolonging medications for patients at risk for torsade de pointes http://jamia.oxfordjournals.org/content/22/e1/e21 - Medical student awareness of and interest in clinical informatics http://jamia.oxfordjournals.org/content/22/e1/e42 **Joint Commission Journal on Patient Safety and Quality Methods for Reducing Sepsis Mortality in Emergency Departments and Inpatient Units http://www.ingentaconnect.com/content/jcaho/jcjqs/2015/00000041/00000005/a rt00003 **Lancet Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)601659/abstract **NEJM Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction http://www.nejm.org/doi/full/10.1056/NEJMoa1500857 **Western Journal of Nursing Rresearch Nurses’ Use of Computerized Clinical Guidelines to Improve Patient Safety in Hospitals http://wjn.sagepub.com/content/early/2015/03/26/0193945915577430 TAG Mail 6th May 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW Respiratory medication use in Australia 2003–2013: treatment of asthma and COPD http://www.aihw.gov.au/publication-detail/?id=60129550778 **NPS-MedicineWise Antihypertensives in pregnancy http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/antihypertensives-in-pregnancy **NSW Health Updated Application Forms for Authority to Prescribe Pharmacotherapies http://www0.health.nsw.gov.au/policies/ib/2015/IB2015_018.html **TGA - Recall: -- DBL Methotrexate 2.5mg tablets in bottles of 30 - bottles supplied without childresistant caps http://www.tga.gov.au/alert/methotrexate-dbl-methotrexate-tablets-25-mgtablets-bottles-30 - Medicine shortages: -- Ampicillin injection and Amoxycillin injection http://www.tga.gov.au/alert/ampicillin-injection-and-amoxycillin-injectionmedicine-shortages -- IMMUCYST® BCG and ONCOTICE® (Bacillus Calmette and Guerin) http://www.tga.gov.au/alert/immucystr-bcg-and-oncoticer-bacillus-calmette-andguerin-medicine-shortages REPORTS AND PUBLICATIONS – INTERNATIONAL **GOV.UK EAGA guidance on HIV post-exposure prophylaxis https://www.gov.uk/government/publications/eaga-guidance-on-hiv-postexposure-prophylaxis **FDA FDA approves treatment, Kybella (deoxycholic acid), for fat below the chin http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444978.htm MEDICATION SAFETY **Health Canada Health Product InfoWatch - April 2015 includes: Goldenseal and cytochrome P450 inhibition; Attention Deficit Hyperactivity Disorder (ADHD) Drugs http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/hpiw-ivps_2015-04-eng.php#s1c **MHRA - Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes https://www.gov.uk/drug-safety-update/hydroxyzine-atarax-ucerax-risk-of-qtinterval-prolongation-and-torsade-de-pointes - Codeine for cough and cold: restricted use in children https://www.gov.uk/drug-safety-update/codeine-for-cough-and-cold-restricteduse-in-children - High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error https://www.gov.uk/drug-safety-update/high-strength-fixed-combination-andbiosimilar-insulin-products-minimising-the-risk-of-medication-error - Ketoconazole HRA: information about the risk of hepatotoxicity https://assets.digital.cabinetoffice.gov.uk/media/5537a3d740f0b6158900002f/Ketoconazole_DHPC_sent_24_Mar ch_2015.pdf PAPERS OF INTEREST **Acta Psychiatr Scand Clozapine-induced myocarditis, a widely overlooked adverse reaction http://www.ncbi.nlm.nih.gov/pubmed/25865238 **Am J Health-Syst Pharm - Development of an “infusion pump safety score” http://www.ajhp.org/content/72/10/777.full - Assessing pharmacologic and nonpharmacologic risks in candidates for kidney transplantation http://www.ajhp.org/content/72/10/781.abstract **JAMA Intern Med - Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Veterans of the Iraq and Afghanistan Conflicts: A Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=2174941 - Safety and Benefit of Discontinuing Statin Therapy in the Setting of Advanced, Life-Limiting Illness: A Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=2204034 - Effect of Vitamin D Supplementation on Blood Pressure: A Systematic Review and Meta-analysis Incorporating Individual Patient Data http://archinte.jamanetwork.com/article.aspx?articleid=2195120 - Continuous Proton Pump Inhibitor Therapy and the Associated Risk of Recurrent Clostridium difficile Infection http://archinte.jamanetwork.com/article.aspx?articleid=2173095 **JAMIA Tailoring of alerts substantially reduces the alert burden in computerized clinical decision support for drugs that should be avoided in patients with renal disease http://jamia.oxfordjournals.org/content/early/2015/04/21/jamia.ocv027 **Lancet - Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624491/abstract - Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drugresistant pulmonary tuberculosis http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)62002X/abstract - Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)622844/abstract **MJA A prospective cohort study of trends in self-poisoning, Newcastle, Australia, 1987– 2012: plus ça change, plus c’est la même chose https://www.mja.com.au/journal/2015/202/8/prospective-cohort-study-trendsself-poisoning-newcastle-australia-1987-2012-plus TAG Mail 29th April 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **ACSQHC Guide to the National Safety and Quality Health Service Standards for health service organisation boards, April 2015 http://www.safetyandquality.gov.au/publications/guide-to-the-national-safetyand-quality-health-service-standards-for-health-service-organisation-boards-april2015/ **AIHW Alcohol and Other Drug Treatment Services in Australia 2013-14 collection and reporting http://www.aihw.gov.au/media-release-detail/?id=60129550783 **TGA - AusPARS added: Remestemcel-L, ex vivo adult human mesenchymal stem cells (Prochymal)S http://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars - Accu-Chek Spirit Combo and Accu-Chek Spirit insulin pumps http://www.tga.gov.au/alert/accu-chek-spirit-combo-and-accu-chek-spirit-insulinpumps REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH Gabapentin for Adults with Neuropathic Pain: A Review of the Clinical Efficacy and Safety https://www.cadth.ca/gabapentin-adults-neuropathic-pain-review-clinicalefficacy-and-safety-0 - Combination Benzodiazepine-Opioid Use: Clinical Evidence and Guidelines https://www.cadth.ca/combination-benzodiazepine-opioid-use-clinical-evidenceand-guidelines-0 - Angiotensin Converting Enzyme Inhibitor and Angiotensin II Receptor Blocker Combination Therapy: Harms and Guidelines https://www.cadth.ca/angiotensin-converting-enzyme-inhibitor-and-angiotensin-iireceptor-blocker-combination-therapy - Non-Steroidal Anti-Inflammatory Drugs in Patients with Hypertension, Chronic Kidney Disease, or Heart Failure: Benefits, Harms, and Guidelines https://www.cadth.ca/non-steroidal-anti-inflammatory-drugs-patientshypertension-chronic-kidney-disease-or-heart-failure **EMA New treatment for advanced melanoma: Opdivo (nivolumab) offers treatment option for patients with poor prognosis http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/04/news_detail_002314.jsp&mid=WC0b01ac058004d5c1 **FDA FDA approves first generic Abilify (aripiprazole) to treat mental illnesses http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444862.htm **NICE Chronic obstructive pulmonary disease: aclidinium/formoterol [ESNM57] http://www.nice.org.uk/advice/esnm57 MEDICATION SAFETY **EMA - EMA recommends avoidance of certain hepatitis C medicines and amiodarone together: Concomitant use may increase risk of slow heart rate and related problems http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/04/news_detail_002313.jsp&mid=WC0b01ac058004d5c1 - Codeine not to be used in children below 12 years for cough and cold http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/04/news_detail_002316.jsp&mid=WC0b01ac058004d5c1 **GOV.UK Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia https://www.gov.uk/drug-safety-update/dimethyl-fumarate-tecfidera-fatal-pml-ina-ms-patient-with-severe-prolonged-lymphopenia **ISMP - Life-threatening errors with flecainide suspension in children http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=107 - You are invited to take part in a Measurement Survey to Create a Meaningful Medication Safety Dashboard http://surveys.ismp.org/s3/Measurement-Matters-ISMP PAPERS OF INTEREST **Am J Health-Syst Pharm ASHP Guidelines on Preventing Medication Errors with Chemotherapy and Biotherapy http://www.ajhp.org/content/72/8/e6?hw-tma-check=true **Ann Intern Med Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis http://annals.org/article.aspx?articleid=2279798 **BMJ - Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study http://www.bmj.com/content/350/bmj.h1857 - with Editorial: Safety of new oral anticoagulants http://www.bmj.com/content/350/bmj.h1679 - Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study http://www.bmj.com/content/350/bmj.h1585 **Cochrane Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the prevention of migraine in adults http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002919.pub3/abstract **Eur J Hosp Pharm - Is a POMMP approach the way to move the medication safety agenda forward in your organisation http://ejhp.bmj.com/content/22/3/127.full - A cohort study investigating medication management by pharmacists to prevent drug-related problems in pain therapy http://ejhp.bmj.com/content/22/3/156.full - Impact of educational interventions on the physicians for early switchover of parenteral drugs to oral therapy http://ejhp.bmj.com/content/22/3/176.abstract - Safety and effectiveness of the combination acetazolamide and bicarbonates to induce alkaline diuresis in patients with rhabdomyolysis http://ejhp.bmj.com/content/early/2015/04/26/ejhpharm-2014000577.short?g=w_ejhp_ahead_tab **Health Policy How to make medication error reporting systems work—factors associated with their successful development and implementation http://dx.doi.org/10.1016/j.healthpol.2015.03.002 **JAMA - Effect of a Retrievable Inferior Vena Cava Filter Plus Anticoagulation vs Anticoagulation Alone on Risk of Recurrent Pulmonary Embolism: A Randomized Clinical Trial http://jama.jamanetwork.com/article.aspx?articleid=2279714 - Emergency Department–Initiated Buprenorphine/Naloxone Treatment for Opioid Dependence: A Randomized Clinical Trial http://jama.jamanetwork.com/article.aspx?articleid=2279713 **JAMA Intern Med Long-term Nicotine Replacement Therapy: A Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=2167116 **Lancet Rituximab as second-line treatment for adult immune thrombocytopenia (the RITP trial): a multicentre, randomised, double-blind, placebo-controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)614951/abstract **NEJM Prednisolone or Pentoxifylline for Alcoholic Hepatitis http://www.nejm.org/doi/full/10.1056/NEJMoa1412278 **Neurology Evidence-based guideline: Management of an unprovoked first seizure in adults http://www.neurology.org/content/84/16/1705.full.pdf+html TAG Mail 22nd April 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW National opioid pharmacotherapy statistics (NOPSAD) http://www.aihw.gov.au/alcohol-and-other-drugs/nopsad/ **NHMRC NHMRC CEO Statement: Electronic cigarettes (e-cigarettes) http://www.nhmrc.gov.au/guidelinespublications/ds13?utm_medium=email&utm_campaign=NHMRC%20Health%20Tracker %20-%20April%202015&utm_content=NHMRC%20Health%20Tracker%20%20April%202015+CID_74cc15005da49da4722ef405e5004ed5&utm_source=Mailbuild &utm_term=NHMRC%20website **National Asthma Council Australia Australian Asthma Handbook, updated version released http://www.nationalasthma.org.au/news-media/d/2015-04-16/updated-asthmahandbook-released **NPS-MedicineWise - NPS RADAR April 2015 includes -- Ranibizumab (Lucentis) and aflibercept (Eylea) for ocular indications -- Aripiprazole modified release (Abilify Maintena) for schizophrenia -- Dapagliflozin (Forxiga) with insulin, an option for type 2 diabetes add-on treatment -- Sensipar (cinacalcet) PBS listing to be deleted http://www.nps.org.au/publications/health-professional/nps-radar - NPS Direct, April 2015 includes: -- 'Mirror, mirror': a blood test to reflect how best to quit smoking? -- Antihypertensive medicine in pregnancy -- Flu vaccination recommendations for 2015 http://www.nps.org.au/health-professionals/e-newsletters/nps-direct/2015/april **TGA - ASTRAZENECA suxamethonium chloride 100mg/2mL injection BP ampoule medicine shortage http://www.tga.gov.au/alert/astrazeneca-suxamethonium-chloride-100mg2mlinjection-bp-ampoule-medicine-shortage - Prostin F2 Alpha (dinoprost trometamol): discontinuation of supply of medicine http://www.tga.gov.au/alert/prostin-f2-alpha-dinoprost-trometamoldiscontinuation-supply-medicine - Zovirax Ophthalmic ointment; 2nd alternative product now available http://www.tga.gov.au/alert/zovirax-ophthalmic-ointment REPORTS AND PUBLICATIONS – INTERNATIONAL **FDA - FDA approves first generic Copaxone (glatiramer acetate injection) to treat multiple sclerosis http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm443143.htm - FDA approves Corlanor (ivabradine) to treat heart failure http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm442978.htm **NICE - Evidence summaries: Unlicensed or off-label medicines -- Interstitial cystitis: oral pentosan polysulfate sodium [ESUOM43] http://www.nice.org.uk/advice/esuom43 **RCOG Reducing the Risk of Venous Thromboembolism during Pregnancy and the Puerperium https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf MEDICATION SAFETY **AHRQ New Interactive Training on Safe Opioid Use http://health.gov/hcq/training.asp#pathways **HQSNZ Health Quality & Safety Commission | Safe use of opioids national collaborative newsletter – Issue 1 http://www.hqsc.govt.nz/our-programmes/medication-safety/news-andevents/news/2107/ **ISMP ENFit enteral devices are on their way...Important safety considerations for hospitals http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=105 **UKMi -What are the differences between US and UK drug names? http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=796665 - What is the risk of interaction between opioids and monoamine oxidase inhibitors (MAOIs)? http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=796667 PAPERS OF INTEREST **Am J Health-Syst Pharm National trends in prescription drug expenditures and projections for 2015 http://www.ajhp.org/content/72/9/717.abstract **Ann Intern Med - Cost-Effectiveness and Population Impact of Statins for Primary Prevention in Adults Aged 75 Years or Older in the United StatesStatins for Primary Prevention in U.S. Adults Aged 75 Years or Older http://annals.org/article.aspx?articleid=2275384 - Metformin Prescription for Insured Adults With Prediabetes From 2010 to 2012: A Retrospective Cohort StudyMetformin Prescription for Insured Adults With Prediabetes http://annals.org/article.aspx?articleid=2275385 - Routine Iron Supplementation and Screening for Iron Deficiency Anemia in Pregnancy: A Systematic Review for the U.S. Preventive Services Task ForceIron Supplementation and Screening for Iron Deficiency Anemia in Pregnancy http://annals.org/article.aspx?articleid=2212247 **BMJ - Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials http://www.bmj.com/content/350/bmj.h1618 - Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design http://www.bmj.com/content/350/bmj.h1798 - Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study http://www.bmj.com/content/350/bmj.h1748 - New drug for hepatitis C contributes to 13% rise in spending on prescription drugs in US http://www.bmj.com/content/350/bmj.h2055 **Cochrane Lipid-lowering efficacy of atorvastatin http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008226.pub3/abstract **JAMA Intern Med Effects of Low Blood Pressure in Cognitively Impaired Elderly Patients Treated With Antihypertensive Drugs http://archinte.jamanetwork.com/article.aspx?articleid=2173093 **JAMIA - Novel user interface design for medication reconciliation: an evaluation of Twinlist http://jamia.oxfordjournals.org/content/22/2/340.abstract - Optimization of drug–drug interaction alert rules in a pediatric hospital's electronic health record system using a visual analytics dashboard http://jamia.oxfordjournals.org/content/22/2/361 - The long-term financial impact of electronic health record implementation http://jamia.oxfordjournals.org/content/22/2/443 **Lancet Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624478/abstract **MJA Polypharmacy among inpatients aged 70 years or older in Australia https://www.mja.com.au/journal/2015/202/7/polypharmacy-among-inpatientsaged-70-years-or-olderaustralia?utm_source=MJA+news+alerts&utm_campaign=99686633a9MJA_news_vol_202_Issue_7_20_Apr_20154_16_2015&utm_medium=email&utm_ter m=0_8c7e70a099-99686633a9-41328121 **Pediatrics - Antidepressant Use During Pregnancy and Asthma in the Offspring http://pediatrics.aappublications.org/content/135/4/e911.abstract - Off-Label Use of Inhaled Nitric Oxide After Release of NIH Consensus Statement http://pediatrics.aappublications.org/content/135/4/643.abstract - Etiology of Childhood Bacteremia and Timely Antibiotics Administration in the Emergency Department http://pediatrics.aappublications.org/content/135/4/635.abstract TAG Mail 15th April 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW -National opioid pharmacotherapy statistics (NOPSAD) http://www.aihw.gov.au/alcohol-and-other-drugs/nopsad/ -Australian Burden of Disease Study: fatal burden of disease in Aboriginal and Torres Strait Islander people 2010 http://www.aihw.gov.au/publication-detail/?id=60129550618 **NPS-MedicineWise -Heartburn and reflux http://www.nps.org.au/conditions/digestive-system-problems/indigestion-refluxand-stomach-ulcers/heartburn-and-reflux **TGA - Dianeal peritoneal dialysis solution and various irrigation solutions - recall https://www.tga.gov.au/alert/dianeal-peritoneal-dialysis-solution-and-variousirrigation-solutions - TGA Reforms: A blueprint for TGA’s future: Progress report as at 31 December 2014 https://www.tga.gov.au/publication/tga-reforms-blueprint-tgas-future-progressreport-31-december-2014 REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH - What's on the 2015 Canadian Top 10 List of Game-Changing Health Technologies? (includes andexanet alfa for bleeding episodes associated with the NOACs) https://www.cadth.ca/whats-2015-canadian-top-10-list-game-changing-healthtechnologies -Factor V Leiden and Prothrombin Mutation Testing in Patients With Unprovoked Thromboembolism https://www.cadth.ca/factor-v-leiden-and-prothrombin-mutation-testing-patientsunprovoked-thromboembolism **Health Canada - Summary Safety Review - PRADAXA (dabigatran) and MULTAQ (dronedarone) or CORDARONE (amiodarone) - Drug-Drug Interaction http://www.hc-sc.gc.ca/dhp-mps/medeff/reviewsexamens/dabigatran_dronedarone_amiodarone-eng.php **NICE - Savings and Productivity and Local Practice Collections: Stopping perioperative antibiotics for post-tonsillectomy morbidity http://www.nice.org.uk/savingsandproductivityandlocalpracticeresource?ci=http%3 A%2F%2Farms.evidence.nhs.uk%2Fresources%2FQIPP%2F1043205%3Fniceorg%3Dtrue **Centre for Disease Control and Prevention - National Action Plan for Combating Antibiotic-Resistant Bacteria http://www.cdc.gov/drugresistance/solutions-initiative/index.html **The Health Foundation - Evaluation: what to consider. Commonly asked questions about how to approach evaluation of quality improvement in health care http://www.health.org.uk/publications/evaluation-what-to-consider/ - Using communications approaches to spread improvement http://www.health.org.uk/publications/using-communications-approaches-tospread-improvement/ MEDICATION SAFETY **AHRQ Automated communication tools and computer-based medication reconciliation to decrease hospital discharge medication errors. http://www.psnet.ahrq.gov/resource.aspx?resourceID=28835 **EMA -Pharmacovigilance Risk Assessment Committee recommends updating advice on use of high-dose ibuprofen http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/04/news_detail_002306.jsp&mid=WC0b01ac058004d5c1 **FDA - Abuse-Deterrent Opioids — Evaluation and Labeling Guidance http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation /Guidances/UCM334743.pdf PAPERS OF INTEREST ** Ann Intern Med -Screening for Type 2 Diabetes Mellitus: A Systematic Review for the U.S. Preventive Services Task Force Screening for Type 2 Diabetes Mellitus http://annals.org/article.aspx?articleID=2246121 **BMJ - Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis http://www.bmj.com/content/350/bmj.h1389-0 ** BMJ Quality and Safety - Preventing device-associated infections in US hospitals: national surveys from 2005 to 2013 http://qualitysafety.bmj.com/content/early/2015/04/10/bmjqs-2014003870.short?g=w_qs_ahead_tab **Drug Safety -Initiatives to Identify and Mitigate Medication Errors in England https://dx.doi.org/10.1007/s40264-015-0270-3 **Eur J Hosp Pharm - Pharmacist prescribing within a UK NHS hospital trust: nature and extent of prescribing, and prevalence of errors http://ejhp.bmj.com/content/22/2/79.full - Integrated medicines management to medicines optimisation in Northern Ireland (2000–2014): a review http://ejhp.bmj.com/content/early/2015/04/13/ejhpharm-2014000512.short?g=w_ejhp_ahead_tab **Health Affairs -Efficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs http://content.healthaffairs.org/content/34/4/681.abstract ** Heart -Prevalence and antithrombotic management of atrial fibrillation in hospitalised patients http://heart.bmj.com/content/early/2015/04/14/heartjnl-2014-307059.full ** Heart, Lung and Circulation - Indications for Omega-3 Long Chain Polyunsaturated Fatty Acid in the Prevention and Treatment of Cardiovascular Disease http://www.heartlungcirc.org/article/S1443-9506(15)00167-5/pdf **Intern Med Journal - Council of Australian Therapeutic Advisory Groups: supporting the Quality Use of Medicines across the acute-care sector http://onlinelibrary.wiley.com/doi/10.1111/imj.12709/abstract - Understanding and improving the use of allopurinol in a teaching hospital http://onlinelibrary.wiley.com/doi/10.1111/imj.12701/abstract - Association between vitamin B12 deficiency and long-term use of acid-lowering agents: a systematic review and meta-analysis http://onlinelibrary.wiley.com/doi/10.1111/imj.12697/abstract - Venous thromboembolism rates in patients undergoing major hip and knee joint surgery at Waitemata District Health Board: a retrospective audit http://onlinelibrary.wiley.com/doi/10.1111/imj.12702/abstract ** JAMA -Site-Level Variation in and Practices Associated With Dabigatran Adherence http://jama.jamanetwork.com/article.aspx?articleid=2247144 **JAMA Int Med -Effects of Low Blood Pressure in Cognitively Impaired Elderly Patients Treated With Antihypertensive Drugs http://archinte.jamanetwork.com/article.aspx?articleid=2173093 -Prescription Opioid Duration of Action and the Risk of Unintentional Overdose Among Patients Receiving Opioid Therapy http://archinte.jamanetwork.com/article.aspx?articleid=2110997 **JAMIA -Nature and management of duplicate medication alerts http://jamia.oxfordjournals.org/content/early/2015/04/09/jamia.ocv021 **Journal of Hospital Medicine -The July effect: an analysis of never events in the nationwide inpatient sample http://psnet.ahrq.gov/resource.aspx?resourceID=28892 **Journal of Patient Safety -Impact of inpatient harms on hospital finances and patient clinical outcomes. http://psnet.ahrq.gov/resource.aspx?resourceID=28884 **The Lancet - Crohn's disease management after intestinal resection: a randomised trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)619085/abstract **The Lancet Neurology -Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)000186/abstract ** Pediatrics -Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial http://pediatrics.aappublications.org/content/135/4/597.abstract -Antipsychotic Medication Prescribing in Children Enrolled in Medicaid http://pediatrics.aappublications.org/content/135/4/648.abstract TAG Mail 1st April 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NSW Health - Privacy Manual for Health Information http://www.health.nsw.gov.au/policies/manuals/Pages/privacy-manual-forhealth-information.aspx - The Hospital Drug and Alcohol Consultation Liaison Model of Care http://www.health.nsw.gov.au/mhdao/programs/da/Pages/Hosp-DA-consultmoc.aspx **TGA AusPARS added: Bevacizumab (Avastin), Tofacitinib (as citrate) (Xeljanz) https://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars REPORTS AND PUBLICATIONS – INTERNATIONAL **FDA FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439838.htm ** The Joint Commission Sentinel Event Alert 54: Safe use of health information technology http://www.jointcommission.org/assets/1/18/SEA_54.pdf **MHRA Corticosteroids e-learning module launched - new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids https://www.gov.uk/drug-safety-update/corticosteroids-e-learning-modulelaunched **NICE - Evidence Update -- Fertility http://arms.evidence.nhs.uk/resources/hub/1043055/attachment -- Psychosis and schizophrenia in children and young people http://arms.evidence.nhs.uk/resources/hub/1043085/attachment **SIGN - Sign 142 Management of osteoporosis and the prevention of fragility fractures http://www.sign.ac.uk/guidelines/fulltext/142/index.html - SIGN 144 Glaucoma referral and safe discharge http://www.sign.ac.uk/guidelines/fulltext/144/index.html MEDICATION SAFETY **EMA New restrictions to minimise the risks of effects on heart rhythm with hydroxyzinecontaining medicines http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/03/news_detail_002296.jsp&mid=WC0b01ac058004d5c1 **FDA - FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol) http://www.fda.gov/Drugs/DrugSafety/ucm440138.htm - FDA Drug Safety Podcast: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another Direct Acting Antiviral drug http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm440475.htm - FDA Drug Safety Podcast: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm440024.htm **MHRA Drug Safety Update: Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia https://www.gov.uk/drug-safety-update/dimethyl-fumarate-tecfidera-fatal-pml-ina-ms-patient-with-severe-prolonged-lymphopenia **TGA Medicines Safety Update, April 2015 includes: 2015 seasonal influenza vaccines; Agomelatine (Valdoxan) - monitoring of liver function; Non-steroidal antiinflammatory drugs and diclofenac reviews https://www.tga.gov.au/publication-issue/medicines-safety-update-volume-6number-2-april-2015 PAPERS OF INTEREST **Am Health-Syst Pharm - Comparison of warfarin time in the therapeutic range at a pharmacist-run anticoagulation clinic and the RE-LY trial http://www.ajhp.org/content/72/7/557.abstract - Outpatient management of febrile neutropenia associated with cancer chemotherapy: Risk stratification and treatment review http://www.ajhp.org/content/72/8/619.abstract - ASHP Guidelines on Preventing Medication Errors with Chemotherapy and Biotherapy http://www.ajhp.org/content/72/8/e6.full?hw-tma-check=true **Ann Intern Med - Routine Iron Supplementation and Screening for Iron Deficiency Anemia in Pregnancy: A Systematic Review for the U.S. Preventive Services Task ForceIron Supplementation and Screening for Iron Deficiency Anemia in Pregnancy http://annals.org/article.aspx?articleid=2212247 - The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 InfectionSofosbuvir-Based Regimens for Treatment of HCV Genotype 2 or 3 Infection http://annals.org/article.aspx?articleid=2212248 **BMJ Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials http://www.bmj.com/content/350/bmj.h1225 ** BMJ Quality and Safety How to study improvement interventions: a brief overview of possible study types http://qualitysafety.bmj.com/content/early/2015/03/24/bmjqs-2014-003620.long ** Br J Anaesthiol - Development and measurement of perioperative patient safety indicators http://bja.oxfordjournals.org/content/early/2015/02/10/bja.aeu561 **Eur J Heart The effect of statin therapy on heart failure events: a collaborative meta-analysis of unpublished data from major randomized trials http://eurheartj.oxfordjournals.org/content/early/2015/03/16/eurheartj.ehv072.a bstract **Eur J Hosp Pharm The medication therapy management pyramid shifting medication review to an integrated medication therapy management process http://ejhp.bmj.com/content/early/2015/03/24/ejhpharm-2014000502.short?g=w_ejhp_ahead_tab **JAMA - Virologic Response Following Combined Ledipasvir and Sofosbuvir Administration in Patients With HCV Genotype 1 and HIV Co-infection http://jama.jamanetwork.com/article.aspx?articleid=2173266 - Ombitasvir, Paritaprevir Co-dosed With Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected With HIV-1: A Randomized Trial http://jama.jamanetwork.com/article.aspx?articleid=2173265 **JAMA Intern Med Reducing Inappropriate Polypharmacy: The Process of Deprescribing http://archinte.jamanetwork.com/article.aspx?articleid=2204035 **JAMIA - Recommendations to Improve the Usability of Drug-Drug Interaction Clinical Decision Support Alerts http://jamia.oxfordjournals.org/content/early/2015/03/30/jamia.ocv011 **Lancet 140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(14)61459-8.pdf **NEJM Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema http://www.nejm.org/doi/full/10.1056/NEJMoa1414264 TAG Mail 25th March 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **ACSQHC A better way to care: Dementia and delirium posters http://www.safetyandquality.gov.au/publications/a-better-way-to-care-dementiaand-delirium-posters/ **AIHW - Cardiovascular disease, diabetes and chronic kidney disease - Australian facts: risk factors http://www.aihw.gov.au/publication-detail/?id=60129550538 - COPD snapshot http://www.aihw.gov.au/copd/ - Admitted patient care 2013-14: Australian hospital statistics http://www.aihw.gov.au/publication-detail/?id=60129550483 - Mental health services in Australia http://mhsa.aihw.gov.au/home/ **HETI Biannual Report, January 2015 http://www.heti.nsw.gov.au/about/heti-reports/ **NHMRC A statement summarising the evidence on the safety, quality and efficacy of ecigarettes http://www.nhmrc.gov.au/media/releases/2015/nhmrc-ceo-releases-statement-ecigarettes **NPS-MedicineWise Vaccination recommendations for the 2015 influenza season http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/2015-fluvax-recommendations **NSW Health Infants and Children: Acute Management of Community Acquired Pneumonia Clinical Practice Guideline http://www0.health.nsw.gov.au/policies/gl/2015/GL2015_005.html **TGA - AusPARS added: Influenza Virus Haemagglutinin H1N1, H3N2, B Victoria lineage, B Yamagata lineage (FluQuadri, FluQuadri Junior), Peginterferon beta 1a (rch) (Plegridy) https://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars - Reasons for the medicines scheduling delegates final decisions, March 2015 https://www.tga.gov.au/scheduling-decision-final/reasons-medicines-schedulingdelegates-final-decisions-march-2015-medicines REPORTS AND PUBLICATIONS – INTERNATIONAL **HQSCNZ - Attributes of a health literate organisation http://www.hqsc.govt.nz/our-programmes/consumer-engagement/publicationsand-resources/publication/2048/ - Enliven organisational health literacy self-assessment resource http://www.hqsc.govt.nz/our-programmes/consumer-engagement/publicationsand-resources/publication/2047/ - Three steps to better health literacy – a guide for health care professionals http://www.hqsc.govt.nz/publications-and-resources/publication/2046/ **NICE - Evidence summaries: medicines and prescribing briefings -- Clostridium difficile infection: risk with broad-spectrum antibiotics [ESMPB1] http://www.nice.org.uk/advice/esmpb1 - Evidence summary: new medicine -- Glaucoma: brinzolamide/brimonidine combination eye drops [ESNM56] http://www.nice.org.uk/advice/esnm56 -- Asthma: tiotropium (Spiriva Respimat) [ESNM55] http://www.nice.org.uk/advice/esnm55 - Evidence summary: unlicensed or off-label medicine -- Digital ulcers: sildenafil [ESUOM42] http://www.nice.org.uk/advice/esuom42 - Quality Standards -- Alcohol: preventing harmful alcohol use in the community [QS83] http://www.nice.org.uk/guidance/qs83 -- Falls in older people: assessment after a fall and preventing further falls [QS86] http://www.nice.org.uk/guidance/qs86 -- Managing medicines in care homes [QS85] http://www.nice.org.uk/guidance/qs85 - Technology appraisals -- Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome [TA335] http://www.nice.org.uk/guidance/ta335 -- Rifaximin for preventing episodes of overt hepatic encephalopathy [TA337] http://www.nice.org.uk/guidance/ta337 -- Pomalidomide for relapsed and refractory multiple myeloma previously treated with lenalidomide and bortezomib [TA338] http://www.nice.org.uk/guidance/ta338 -- Empagliflozin in combination therapy for treating type 2 diabetes [TA336] http://www.nice.org.uk/guidance/ta336 **The Joint Commission Accelerating the Adoption of a Safety Culture http://www.jointcommission.org/assets/1/18/Healthcare_Executive_McKee_03201 5.pdf **The King’s Fund Acute hospitals and integrated care: From hospitals to health systems http://www.kingsfund.org.uk/publications/acute-hospitals-and-integrated-care MEDICATION SAFETY **FDA - FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug http://www.fda.gov/Drugs/DrugSafety/ucm439484.htm - FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) http://www.fda.gov/Drugs/DrugSafety/ucm439147.htm PAPERS OF INTEREST **Am J Health-Syst Pharm - Comparative efficacy and safety of insulin analogs in hospitalized adults http://www.ajhp.org/content/72/7/525 - Development of recommendations for dosing of commonly prescribed medications in critically ill obese children http://www.ajhp.org/content/72/7/542 - ASHP Guidelines on the Pharmacist’s Role in Providing Drug Information http://www.ajhp.org/content/72/7/573 **Cochrane Library Corticosteroid therapy for nephrotic syndrome in children http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD001533.pub5 **JAMA IntMed - Cumulative Use of Strong Anticholinergics and Incident Dementia: A Prospective Cohort Study http://archinte.jamanetwork.com/article.aspx?articleid=2091745 - Out-of-Hospital Mortality Among Patients Receiving Methadone for Noncancer Pain http://archinte.jamanetwork.com/article.aspx?articleid=2091400 **Lancet Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)601659/abstract **MJA - Evolving views and practices of antiretroviral treatment prescribers in Australia https://www.mja.com.au/journal/2015/202/5/evolving-views-and-practicesantiretroviral-treatment-prescribers-australia - Facing the challenge of multidrug-resistant gram-negative bacilli in Australia https://www.mja.com.au/journal/2015/202/5/facing-challenge-multidrugresistant-gram-negative-bacilli-australia TAG Mail 18th March 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW - Asthma snapshot, January 2015 http://www.aihw.gov.au/asthma/ - Arthritis, osteoporosis and other musculoskeletal conditions http://www.aihw.gov.au/arthritis-and-musculoskeletal-conditions/ **CEC - Continuity of Medication Management Toolkit http://www.cec.health.nsw.gov.au/programs/continuity-of-medicationmanagement#toolkit - MSQ Connect, March 2015 includes: Tall Man Lettering | Medication Safety Self Assessment http://www.cec.health.nsw.gov.au/__documents/programs/insafehands/2015/msq _-connect_-newsletter_-march_-2015.pdf **NHMRC NHMRC releases statement and advice on homeopathy http://www.nhmrc.gov.au/media/releases/2015/nhmrc-releases-statement-andadvice-homeopathy **NPS MedicineWise NPS Direct – March 2015 includes: Diabetes drugs for weight management? | Highrisk younger people missing out on flu vaccine | Accidental fentanyl exposure can be fatal | Warfarin safety update | Fast five: Improving asthma control http://www.nps.org.au/health-professionals/e-newsletters/nps-direct/2015/march **NSW Health - Safety Alert: Suxamethonium Chloride Injection BP 100mg / 2mL Disruption to Supply http://www.health.nsw.gov.au/sabs/Documents/2015-sn-001.pdf - Policy Directive: Tuberculosis Management of People Knowingly Placing Others at Risk of Infection http://www0.health.nsw.gov.au/policies/pd/2015/PD2015_012.html **TGA AusPARS added: Empagliflozin (Jardiance) https://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars REPORTS AND PUBLICATIONS – INTERNATIONAL **AHRQ Public Reporting of Cost Measures in Health http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-andreports/?pageaction=displayproduct&productID=2053 **FDA FDA approves Cholbam to treat rare bile acid synthesis disorders (cholic acid) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm438572.htm **HQSCNZ Three-fold opioid variation a cue to look at prescribing, says Commission http://www.hqsc.govt.nz/news-and-events/media/2042/ **NICE - Evidence summary: unlicensed or off-label medicine -- Management of aggression, agitation and behavioural disturbances in dementia: carbamazepine [ESUOM40] http://www.nice.org.uk/advice/esuom40 -- Management of aggression, agitation and behavioural disturbances in dementia: valproate preparations [ESUOM41] http://www.nice.org.uk/advice/esuom41 - Eyes on Evidence -- Allopurinol for chronic gout http://nice.us8.listmanage1.com/track/click?u=7864f766b10b8edd18f19aa56&id=1a8a180079&e=9c2fd 5fb40 - Medicines Evidence Commentary -- MHRA drug safety advice: drugs and driving http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=795618 - Public health guidelines -- Maintaining a healthy weight and preventing excess weight gain among adults and children [NG7] http://www.nice.org.uk/guidance/ng7 **WHO Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection http://www.who.int/hiv/pub/hepatitis/hepatitis-b-guidelines/en/ MEDICATION SAFETY **EMA - PRAC recommends restrictions on the use of codeine for cough and cold in children - PRAC recommends further measures to minimise known risk of osteonecrosis of the jaw associated with bisphosphonate medicine http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/03/news_detail_002285.jsp&mid=WC0b01ac058004d5c1 **FDA FDA warns health care professionals not to use Treanda Injection (solution bendamustine hydrochloride) with closed system transfer devices, adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene http://www.fda.gov/Drugs/DrugSafety/ucm437469.htm **ISMP Delayed administration and contraindicated drugs place hospitalized Parkinson’s disease patients at risk http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=103 **TGA Medicines supplied without child-resistant caps - multiple brands recalled https://www.tga.gov.au/alert/medicines-supplied-without-child-resistant-capsmultiple-brands PAPERS OF INTEREST **Ann Intern Med - Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United StatesCost-Effectiveness of HCV Treatment With Sofosbuvir and Ledipasvir http://annals.org/article.aspx?articleid=2197176 - Cost-Effectiveness of Novel Regimens for the Treatment of Hepatitis C VirusCostEffectiveness of New Regimens for Hepatitis C Virus http://annals.org/article.aspx?articleid=2197177 **BMJ - Methotrexate use and risk of lung disease in psoriasis, psoriatic arthritis, and inflammatory bowel disease: systematic literature review and meta-analysis of randomised controlled trials http://www.bmj.com/content/350/bmj.h1269 - Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis http://www.bmj.com/content/350/bmj.h1109 - Statins and congenital malformations: cohort study http://www.bmj.com/content/350/bmj.h1035 - Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines http://www.bmj.com/content/350/bmj.h949 - Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial http://www.bmj.com/content/350/bmj.h1046 **Cochrane Hormone therapy for preventing cardiovascular disease in post-menopausal women http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD002229.pub4 **JAMA Antiplatelet Therapy Duration Following Bare Metal or Drug-Eluting Coronary Stents: The Dual Antiplatelet Therapy Randomized Clinical Trial http://jama.jamanetwork.com/article.aspx?articleid=2203799 **Lancet Glucose-lowering drugs or strategies and cardiovascular outcomes in patients with or at risk for type 2 diabetes: a meta-analysis of randomised controlled trials http://www.thelancet.com/journals/landia/article/PIIS2213-8587(15)000443/abstract **MJA Effectiveness of a care bundle to reduce central line-associated bloodstream infections https://www.mja.com.au/journal/2015/202/5/effectiveness-care-bundle-reducecentral-line-associated-bloodstream-infections **Pediatrics - Medication-Related Emergency Department Visits in Pediatrics: a Prospective Observational Study http://pediatrics.aappublications.org/content/135/3/435.abstract - Azithromycin in Early Infancy and Pyloric Stenosis http://pediatrics.aappublications.org/content/135/3/483.abstract TAG Mail 11th March 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NPS-MedicineWise Diabetes drugs for weight management? http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/diabetes-drugs-for-weight-management **TGA - TGA key performance indicators: July to December 2014 https://www.tga.gov.au/publication/tga-key-performance-indicators-julydecember-2014 - Zovirax Ophthalmic ointment - Update 2 - alternative product now available https://www.tga.gov.au/alert/zovirax-ophthalmic-ointment - AusPARS added: Brimonidine (as tartrate) (Mirvaso), Efraloctocog alfa (rhu) (Eloctate), Ezetimibe / Rosuvastatin (as calcium) (Ezalo, Rosuzet) and Sucroferric oxyhydroxide (Velphoro) https://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars - Updates to the list of designated orphan drugs: Amikacin Sulfate https://www.tga.gov.au/updates-list-designated-orphan-drugs REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH Rapid response: Switching from Innovator to Biosimilar (Subsequent Entry) Infliximab: A Review of the Clinical Effectiveness, Cost-Effectiveness, and Guidelines http://www.cadth.ca/media/pdf/htis/mar2015/RC0635%20Infliximab%20Switching%20Final.pdf **FDA - FDA approves first therapy for high-risk neuroblastoma, Unituxin (dinutuximab) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm - FDA approves first biosimilar product Zarxio (filgrastim-sndz) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm - FDA approves new antifungal drug Cresemba, (isavuconazonium sulfate) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437106.htm **NICE Guideline: Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes http://www.nice.org.uk/guidance/ng5 **The Joint Commission Quick Safety - Issue Ten February 2015: Preventing copy-and-paste errors in EHRs http://www.jointcommission.org/issues/article.aspx?Article=bj%2b%2f2w37MuZrou WveszI1weWZ7ufX%2fP4tLrLI85oCi0%3d&j=2434516&e=nswtag@stvincents.com.au&l =9552_HTML&u=43350978&mid=1064717&jb=0 MEDICATION SAFETY **FDA - FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking http://www.fda.gov/Drugs/DrugSafety/ucm436494.htm - FDA Drug Safety Podcast: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm436688.htm **Health Canada Health Product InfoWatch, February 2015 includes Summary Safety Reviews of Aricept (donepezil), Atypical Antipsychotics, Domperidone, Metoclopramide, Prolia (denosumab), Vascular Endothelial Growth Factor Receptor Inhibitors http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/hpiw-ivps_2015-02-eng.php#a2 PAPERS OF INTEREST **Clin Ther Impact of Switching From High-Efficacy Lipid-Lowering Therapies to Generic Simvastatin on LDL-C Levels and LDL-C Goal Attainment Among High-Risk Primary and Secondary Prevention Populations in the United Kingdom http://www.ncbi.nlm.nih.gov/pubmed/25626487 **Cochrane Interventions for reducing medication errors in children in hospital http://onlinelibrary.wiley.com/enhanced/doi/10.1002/14651858.CD006208.pub3 **Diabetes Care Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes http://care.diabetesjournals.org/content/38/1/140.long **Intern Med J - Thromboprophylaxis in patients undergoing total hip and knee arthroplasty: a review of current practices in an Australian teaching hospital http://onlinelibrary.wiley.com/doi/10.1111/imj.12675/abstract - Assessment of aminoglycoside dosing and estimated glomerular filtration rate in determining gentamicin and tobramycin area under the curve and clearance http://onlinelibrary.wiley.com/doi/10.1111/imj.12684/abstract **JAMA Intern Med Continuous Proton Pump Inhibitor Therapy and the Associated Risk of Recurrent Clostridium difficile Infection http://archinte.jamanetwork.com/article.aspx?articleid=2173095 **Lancet - Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)619942/abstract - Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)619437/abstract - Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624107/abstract TAG Mail 4th March 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **TGA AusPARS added: Bendamustine hydrochloride (Ribomustin), Febuxostat (FBX) (Adenuric) and Tocilizumab (rch) (Actemra) https://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH - Rapid responses: - Dehydroepiandrosterone for the Treatment of Menopausal or Andropausal Symptoms: Clinical Effectiveness and Safety http://www.cadth.ca/media/pdf/htis/feb2015/RB0795%20DHEA%20for%20Menopause%20Final.pdf - Dehydroepiandrosterone for the Treatment of Infertility: Clinical Effectiveness and Safety http://www.cadth.ca/media/pdf/htis/feb2015/RB0796%20DHEA%20for%20Infertility%20Final.pdf - Enemas for the Treatment of Constipation in the Emergency Department: Clinical Effectiveness and Guidelines http://www.cadth.ca/media/pdf/htis/feb2015/RB0791%20Enemas%20for%20Fecal%20Impaction%20Final.pdf - Long-term Use of Cyclobenzaprine for Pain: A Review of the Clinical Effectiveness http://www.cadth.ca/media/pdf/htis/feb2015/RC0634%20Cyclobenzaprine%20Final.pdf - The Timing of Prophylactic Antibiotics for Surgery: Clinical Evidence http://www.cadth.ca/media/pdf/htis/feb2015/RA0735%20Preop%20Antibiotics%20Final.pdf -- Topical Nitroglycerin for Peripheral Circulation and Wound Healing in the Elderly: Clinical Effectiveness and Guidelines http://www.cadth.ca/media/pdf/htis/feb2015/RB0792%20Nitroglycerin%20for%20Circulation%20Final.pdf **EMA - Jinarc (tolvaptan) recommended for approval in rare kidney disease http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/02/news_detail_002280.jsp&mid=WC0b01ac058004d5c1 - Zykadia (ceritinib) recommended for approval in advanced non small cell lung cancer http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/02/news_detail_002279.jsp&mid=WC0b01ac058004d5c1 **FDA FDA approves new antibacterial drug Avycaz (ceftazidime-avibactam) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435629.htm **NICE - Clinical guidelines: Depression in children and young people: Identification and management in primary, community and secondary care [CG28] http://www.nice.org.uk/guidance/cg28 - Quality Standard: Inflammatory bowel disease [QS81] http://www.nice.org.uk/guidance/qs81 - Evidence summaries New medicines: Asthma: tiotropium (Spiriva Respimat) [ESNM55] http://www.nice.org.uk/advice/esnm55 MEDICATION SAFETY **EMA Ambroxol and bromhexine expectorants: safety information to be updated (Risk of allergy and skin reactions to be included) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/02/news_detail_002276.jsp&mid=WC0b01ac058004d5c1 **FDA - FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labelling change to inform of possible increased risk of heart attack and stroke with use http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm - FDA Drug Safety Podcast: FDA requires label warnings to prohibit sharing of multidose diabetes pen devices among patients http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm436028.htm **NHS-UKMi In-use product safety assessment report: Remsima® and inflectra® (infliximab biosimilars) http://www.ukmi.nhs.uk/filestore/ukmiaps/ProductsafetyassessmentforinfliximabF eb-2015.pdf **ISMP EPINEPHrine for anaphylaxis: Autoinjector or 1 mg vial or ampul? http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=102 PAPERS OF INTEREST **Cochrane - Oxycodone for cancer-related pain http://www.cochrane.org/CD003870/SYMPT_oxycodone-for-cancer-related-pain - Antiplatelet agents for preventing failure of peripheral arterial grafts http://www.cochrane.org/CD000535/PVD_antiplatelet-agents-for-preventingfailure-of-peripheral-arterial-grafts **Eur J Hosp Pharm - Pharmacist intervention in a psychiatric setting http://ejhp.bmj.com/content/early/2015/03/02/ejhpharm-2014000564.short?g=w_ejhp_ahead_tab - Clinical impact of the hospital pharmacy drug information service: how does information on drug–drug interaction enquiries translate into clinical decisions? http://ejhp.bmj.com/content/22/2/83.abstract **International Journal of Medical Informatics Clinical safety of England's national programme for IT: A retrospective analysis of all reported safety events 2005 to 2011 http://www.sciencedirect.com/science/article/pii/S1386505614002482 **International Journal of Pharmacy Practice Reducing unacceptable missed doses: pharmacy assistant-supported medicine administration http://onlinelibrary.wiley.com/doi/10.1111/ijpp.12172/abstract;jsessionid=ABBB3 F6BCCE883F94D1E1D8AEE3DEC29.f02t02?systemMessage=Wiley+Online+Library+will+ be+disrupted+on+7th+March+from+10%3A00-13%3A00+GMT+%2805%3A0008%3A00+EST%29+for+essential+maintenance.++Apologies+for+the+inconvenience **Intern Med J Assessment of aminoglycoside dosing and estimated glomerular filtration rate in determining gentamicin and tobramycin area under the curve and clearance (pages 319–329) http://onlinelibrary.wiley.com/enhanced/doi/10.1111/imj.12684/ **JAMA Intern Med Potential Overtreatment of Diabetes Mellitus in Older Adults With Tight Glycemic Control http://archinte.jamanetwork.com/article.aspx?articleid=2089233 **Lancet - Co-trimoxazole prophylaxis in adults, including pregnant women, with HIV: a systematic review and meta-analysis http://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(15)000053/abstract - Extended duration dual antiplatelet therapy and mortality: a systematic review and meta-analysis http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)620523/abstract **Pediatrics Medication-Related Emergency Department Visits in Pediatrics: a Prospective Observational Study http://pediatrics.aappublications.org/content/135/3/435.abstract TAG Mail 25th February 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NSW Health - Alert notice: Any Glutathione Batch No: SY51.898-20141209 originating from Zhejiang Senyo Biotech Co Ltd, China, or from Cheung Wing Pharmchem, China must be quarantined and NSW Ministry of Health, Pharmaceutical Services must be informed about any recipients of medicines compounded from it - Policy Directive: Pharmaceuticals - Preparation in NSW Public Health Facility Pharmacy Services http://www0.health.nsw.gov.au/policies/pd/2015/PD2015_007.html **NPS-MedicineWise - High-risk younger people missing out on flu vaccine http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/young-missing-flu-vaccine - NPS Direct Feb 2015 includes: Obesity: simple solutions for a complex problem | LDL cholesterol: a surrogate supported | Biosimilars: what's in a name? | Fast five: Type 2 diabetes – upskill with these resources http://www.nps.org.au/health-professionals/e-newsletters/npsdirect/2015/february REPORTS AND PUBLICATIONS – INTERNATIONAL **FDA FDA approves Farydak (panobinostat) for treatment of multiple myeloma http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435296.htm **Health Canada Risperidone - Restriction of the Dementia Indication http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43797a-eng.php **NICE - Medicines Evidence Commentary includes: Risk of fall injuries in older people with commonly prescribed medicines https://www.nice.org.uk/Media/Default/newsletter/Eyes%20on%20Evidence%20Feb ruary%202015.pdf - Clinical guidlines -- Bladder cancer: diagnosis and management of bladder cancer [NG2] http://www.nice.org.uk/guidance/ng2 -- Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period [NG3] http://www.nice.org.uk/guidance/ng3 - Technology appraisals -- Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262) [TA329] http://www.nice.org.uk/guidance/ta329 -- Sofosbuvir for treating chronic hepatitis C [TA330] http://www.nice.org.uk/guidance/ta330 -- Simeprevir in combination with peginterferon alfa and ribavirin for treating genotypes 1 and 4 chronic hepatitis C [TA331] http://www.nice.org.uk/guidance/ta331 -- Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer [TA332] http://www.nice.org.uk/guidance/ta332 -- Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment [TA333] http://www.nice.org.uk/guidance/ta333 **Public Health England-Dept of Health Antibiotic prescribing and behaviour change in healthcare settings https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/4 05031/Behaviour_Change_for_Antibiotic_Prescribing_-_FINAL.pdf MEDICATION SAFETY **HQSCNZ Medication Safety Watch Issue 13 includes: Error prevention strategies | One steps for medication safety | Azithromycin/Azathioprine (confusion) http://www.hqsc.govt.nz/our-programmes/medication-safety/publications-andresources/publication/2014/ **ISMP Free webinar 'Improving Medication Safety in the Perioperative Setting' for a target audience of pharmacists, pharmacy technician and nurses http://s3.proce.com/res/flash/Periop/story.html PAPERS OF INTEREST **BMJ - Antidepressant use and risk of suicide and attempted suicide or self harm in people aged 20 to 64: cohort study using a primary care database http://www.bmj.com/content/350/bmj.h517 - Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial http://www.bmj.com/content/350/bmj.h846 **Eur J Hosp POharm Medicines wastage evaluation and prescription management in homecare medicines in Nottingham University Hospitals NHS Trust http://ejhp.bmj.com/content/early/2015/02/05/ejhpharm-2014000594.short?g=w_ejhp_ahead_tab **Intern Med J - Does the availability of therapeutic drug monitoring, computerised dose recommendation and prescribing decision support services promote compliance with national gentamicin prescribing guidelines? http://onlinelibrary.wiley.com/enhanced/doi/10.1111/imj.12627/ - Transition from hospital to primary care: an audit of discharge summary – medication changes and follow-up expectations http://onlinelibrary.wiley.com/enhanced/doi/10.1111/imj.12581/ **JAMA - Association of NSAID Use With Risk of Bleeding and Cardiovascular Events in Patients Receiving Antithrombotic Therapy After Myocardial Infarction http://jama.jamanetwork.com/article.aspx?articleid=2130316 - Anticoagulant Reversal, Blood Pressure Levels, and Anticoagulant Resumption in Patients With Anticoagulation-Related Intracerebral Hemorrhage http://jama.jamanetwork.com/article.aspx?articleid=2130317 - Ombitasvir, Paritaprevir Co-dosed With Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected With HIV-1: A Randomized Trial http://jama.jamanetwork.com/article.aspx?articleid=2173265 **JAMA Intern Med - Long-term Nicotine Replacement Therapy: A Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=2167116 - Hospital Ward Antibiotic Prescribing and the Risks of Clostridium difficile Infection http://archinte.jamanetwork.com/article.aspx?articleid=2130725 **JAMIA Visualizing collaborative electronic health record usage for hospitalized patients with heart failure http://jamia.oxfordjournals.org/content/early/2015/02/20/jamia.ocu017 ** Mayo Clin Proc The Safety of Intravenous Iron Preparations: Systematic Review and Meta-analysis http://www.ncbi.nlm.nih.gov/pubmed/25572192 **MJA Knowing when to stop antibiotic therapy https://www.mja.com.au/journal/2015/202/3/knowing-when-stop-antibiotictherapy **NEJM Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer http://www.nejm.org/doi/full/10.1056/NEJMoa1413513 TAG Mail 18th February 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NPS-MedicineWise Obesity: finding simple solutions to a global problem http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/obesity-solutions **NSW Health NSW Healthy Eating Active Living Strategy Status Report Year1 2014 http://www.health.nsw.gov.au/heal/Pages/Strategy-Status-Report-Yr1-2014.aspx **TGA - Warfarin review https://www.tga.gov.au/alert/warfarin-review - with ACSOM advice https://www.tga.gov.au/committee-meeting-info/acsom-meeting-statementmeeting-22-9-may-2014 - Orphan drug added: Para-aminosalicylic acid (PASER) https://www.tga.gov.au/updates-list-designated-orphan-drugs REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH Rapid response: Multidisciplinary Chronic Non-Cancer Pain Programs for Adults: Guidelines for Referral, Treatment Management and Program Duration http://www.cadth.ca/media/pdf/htis/feb2015/RB0786%20Chronic%20Pain%20Programs%20Final.pdf **FDA - FDA approves Lenvima (lenvatinib) for a type of thyroid cancer http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434288.htm - FDA issues new draft documents related to compounding of human drugs http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434270.htm **NHS Seven steps to managing polypharmacy http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=794907 **NICE Quality standard: Psychosis and schizophrenia in adults [QS80] http://www.nice.org.uk/guidance/qs80 **HQSCNZ Poster: Communicating so people will understand http://www.open.hqsc.govt.nz/medication/publications-andresources/publication/1984/ MEDICATION SAFETY **EMA PRAC recommends new measures to minimise known heart risks of hydroxyzinecontaining medicines http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/H ydroxyzine_31/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment _Committee/WC500182461.pdf **GOV.UK-MHRA - Drugs and driving: blood concentration limits set for certain drugs https://www.gov.uk/drug-safety-update/drugs-and-driving-blood-concentrationlimits-set-for-certain-drugs - Letters sent to healthcare professionals since November 2014: vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel), and telavancin (Vibativ▼) https://www.gov.uk/drug-safety-update/letters-sent-to-healthcare-professionalssince-november-2014 **HDIS Fact sheet: Can 5–HT3 antagonists (e.g., ondansetron etc.) really contribute to serotonin toxicity? http://www.ciap.health.nsw.gov.au/nswtag/members/other-topics-interest.html **ISMP Getting closer to the bull’s eye: 2014-2015 Targeted Medication Safety Best Practices (Follow-up survey results) http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=101 PAPERS OF INTEREST **Annals of Emergency Medicine Intercepting Wrong-Patient Orders in a Computerized Provider Order Entry System http://www.annemergmed.com/article/S0196-0644(14)01558-3/abstract **JAMA - Effect of Corticosteroids on Treatment Failure Among Hospitalized Patients With Severe Community-Acquired Pneumonia and High Inflammatory Response: A Randomized Clinical Trial http://jama.jamanetwork.com/article.aspx?articleid=2110967 - Association Between the Use of Fondaparinux vs Low-Molecular-Weight Heparin and Clinical Outcomes in Patients With Non–ST-Segment Elevation Myocardial Infarction http://jama.jamanetwork.com/article.aspx?articleid=2110970 **JAMA Intern Med - Treatment With Multiple Blood Pressure Medications, Achieved Blood Pressure, and Mortality in Older Nursing Home Residents: The PARTAGE Study http://archinte.jamanetwork.com/article.aspx?articleid=2110995 - Prescription Opioid Duration of Action and the Risk of Unintentional Overdose Among Patients Receiving Opioid Therapy http://archinte.jamanetwork.com/article.aspx?articleid=2110997 **JAMIA - Cost-effectiveness analysis of a hospital electronic medication management system http://jamia.oxfordjournals.org/content/early/2015/02/09/jamia.ocu014 - Novel user interface design for medication reconciliation: an evaluation of Twinlist http://jamia.oxfordjournals.org/content/early/2015/02/07/jamia.ocu021 **Lancet - Prescribing safety: ensuring that new graduates are prepared http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)623394/abstract - Efficacy of nitric oxide, with or without continuing antihypertensive treatment, for management of high blood pressure in acute stroke (ENOS): a partial-factorial randomised controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)611211/abstract **MJA Antimicrobial stewardship resources and activities for children in tertiary hospitals in Australasia: a comprehensive survey https://www.mja.com.au/journal/2015/202/3/antimicrobial-stewardshipresources-and-activities-children-tertiaryhospitals?utm_source=MJA+news+alerts&utm_campaign=43a79e7e6dMJA_news_vol_202_Issue_3_16_Feb_20152_12_2015&utm_medium=email&utm_ter m=0_8c7e70a099-43a79e7e6d-41328121 TAG Mail 11th February 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NPS MedicineWise Accidental fentanyl exposure in children can be fatal http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/child-fentanyl-exposure **TGA Decisions have been made on rescheduling of naproxen and paracetamol combination products https://www.tga.gov.au/book/interim-decisions-matters-referred-expert-advisorycommittee-acms-february-2015-11-16 These are aligned with recommendations made in NSW TAG's submission last year http://www.ciap.health.nsw.gov.au/nswtag/members/docs/submissionsconsultations/2014/tga-acms-rescheduling-naproxen-sept-2014.pdf REPORTS AND PUBLICATIONS – INTERNATIONAL ** CADTH Development of Antibiotic Resistance to Norfloxacin in the Treatment of Urinary Tract Infections: Clinical Evidence http://www.cadth.ca/media/pdf/htis/feb2015/RA0732%20Norfloxacin%20for%20UTI%20Final.pdf **FDA FDA approves Lucentis (ranibizumab injection) to treat diabetic retinopathy in patients with diabetic macular edema http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm433392.htm **NICE - Evidence summary: unlicensed or off-label medicine -- Autoimmune haemolytic anaemia: rituximab [ESUOM39] http://www.nice.org.uk/advice/esuom39 **Public Health England Influenza: treatment and prophylaxis using anti-viral agents https://www.gov.uk/government/publications/influenza-treatment-andprophylaxis-using-anti-viral-agents MEDICATION SAFETY **Health Canada Safety Information: TECFIDERA (dimethyl fumarate) - Risk of Rare Brain Condition Known as Progressive Multifocal Leukoencephalopathy (PML) http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43625a-eng.php PAPERS OF INTEREST **Circulation Secondary Prevention After Coronary Artery Bypass Graft Surgery: A Scientific Statement From the American Heart Association http://circ.ahajournals.org/content/early/2015/02/09/CIR.0000000000000182?pap etoc **CMAJ - Trimethoprim-sulfamethoxazole and risk of sudden death among patients taking spironolactone http://www.cmaj.ca/content/early/2015/02/02/cmaj.140816 - with UKMi comment http://www.medicinesresources.nhs.uk/en/Medicines-Awareness/PrimaryResearch/Other-primary-research/Trimethoprim-sulfamethoxazole-and-risk-ofsudden-death-among-patients-taking-spironolactone/ **Cochrane - First-line drugs inhibiting the renin angiotensin system versus other first-line antihypertensive drug classes for hypertension http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008170.pub2/full - Rituximab for rheumatoid arthritis http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007356.pub2/full - Effects of RAS inhibitors on diabetic retinopathy: a systematic review and metaanalysis http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)702566/abstract **Eur J Clin Pharmacol Identifying high-risk medication: a systematic literature review http://www.ncbi.nlm.nih.gov/pubmed/24671697 **JAMA Oral Iron Supplementation After Blood Donation: A Randomized Clinical Trial http://jama.jamanetwork.com/article.aspx?articleid=2108889 Effect of Creatine Monohydrate on Clinical Progression in Patients With Parkinson Disease: A Randomized Clinical Trial http://jama.jamanetwork.com/article.aspx?articleid=2108890 Treating Hypertension in Patients With Diabetes: When to Start and How Low to Go? http://jama.jamanetwork.com/article.aspx?articleid=2108870 **JAMA Intern Med - Statin Therapy and Risk of Fracture: Results From the JUPITER Randomized Clinical Trial http://archinte.jamanetwork.com/article.aspx?articleid=1936580 - Tramadol Use and the Risk of Hospitalization for Hypoglycemia in Patients With Noncancer Pain http://archinte.jamanetwork.com/article.aspx?articleid=1984249 **Joint Commission Journal on Quality and Patient Safety Rethinking Critical Care: Decreasing Sedation, Increasing Delirium Monitoring, and Increasing Patient Mobility http://www.ingentaconnect.com/content/jcaho/jcjqs/2015/00000041/00000002/a rt00003 **NEJM Prehospital Use of Magnesium Sulfate as Neuroprotection in Acute Stroke http://www.nejm.org/doi/full/10.1056/NEJMoa1408827 **Therapeutics Initiative The limitations and potential hazards of using surrogate markers http://www.ti.ubc.ca/letter92 TAG Mail 4th February 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW Australian Burden of Disease Study: fatal burden of disease 2010 http://www.aihw.gov.au/publication-detail/?id=60129550176 **NSW Health - Policy Directive -- Human Immunodeficiency Virus (HIV) - Management of Non-Occupational Exposure http://www0.health.nsw.gov.au/policies/pd/2015/PD2015_005.html -- Principles for Safe Management of Disturbed and /or Aggressive Behaviour and the Use of Restraint http://www0.health.nsw.gov.au/policies/pd/2015/PD2015_004.html **NPS MedicineWise LDL cholesterol: a surrogate supported http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/ldl-surrogates REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH - Discontinuation Strategies for Patients with Long-term Z-drug Use: Clinical Evidence and Guidelines http://www.cadth.ca/media/pdf/htis/jan-2015/RA0727%20Zdrug%20Discontinuation%20Strategies%20Final.pdf - Rituximab for Granulomatosis with Polyangiitis or Microscopic Polyangiitis: A Review of the Clinical and Cost-effectiveness http://www.cadth.ca/media/pdf/htis/feb2015/RC0631%20Rituximab%20for%20GPA%20or%20MPA%20Final.pdf **EMA EU report provides basis for effective fight against development of resistant bacteria http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/01/news_detail_002260.jsp&mid=WC0b01ac058004d5c1 **FDA - FDA approves Ibrance (palbociclib) for postmenopausal women with advanced breast cancer http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432871.htm - FDA expands uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432543.htm **NICE - Evidence summary: new medicine -- Chronic obstructive pulmonary disease: olodaterol [ESNM54] http://www.nice.org.uk/advice/esnm54 -- Asthma in adults: beclometasone/formoterol dry powder inhaler (Fostair NEXThaler) [ESNM53] http://www.nice.org.uk/advice/esnm53 - Quality standard -- Sarcoma [QS78] http://www.nice.org.uk/guidance/qs78 -- Idiopathic pulmonary fibrosis [QS79] http://www.nice.org.uk/guidance/qs79 **Tufts University Cost to develop an approved new drug http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study **UK Dept of Health Improving care for people with dementia (updated, includes toolkit) https://www.gov.uk/government/policies/improving-care-for-people-withdementia **WHO Global status report on noncommunicable diseases 2014 http://www.who.int/nmh/publications/ncd-status-report-2014/en/ MEDICATION SAFETY **Health Canada Cisplatin and venous thromboembolism http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/hpiw-ivps_2015-01eng.php#cisplatin **ISMP A critique of FDA’s key drug safety reporting system http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=100 **TGA Medicines Safety Update, February 2015 includes: Combined oral contraceptives and hormone replacement therapy - inflammatory bowel disease; Metoclopramide and neurological adverse events; Publication changes for Medicines Safety Update https://www.tga.gov.au/publication-issue/medicines-safety-update-volume-6number-1-february-2015 PAPERS OF INTEREST **BMJ The association between kidney function and major bleeding in older adults with atrial fibrillation starting warfarin treatment: population based observational study http://www.bmj.com/content/350/bmj.h246.full.pdf+html **Circ Cardiovasc Qual Outcomes Quantifying the Utility of Taking Pills for Cardiovascular Prevention http://circoutcomes.ahajournals.org/content/early/2015/02/03/CIRCOUTCOMES.1 14.001240.abstract?papetoc **JAMA Diagnosis and Treatment of Clostridium difficile in Adults: A Systematic Review http://jama.jamanetwork.com/article.aspx?articleid=2091993 **JAMIA - Temporal and other factors that influence the time doctors take to prescribe using an electronic prescribing system http://jamia.oxfordjournals.org/content/22/1/206 - Electronic health records improve clinical note quality http://jamia.oxfordjournals.org/content/22/1/199 **J Clin Endocrinol Metab Drugs Commonly Associated With Weight Change: A Systematic Review and Metaanalysis http://www.ncbi.nlm.nih.gov/pubmed/25590213 **Lancet Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624491/abstract **NEJM - Adjuvant Ovarian Suppression in Premenopausal Breast Cancer http://www.nejm.org/doi/full/10.1056/NEJMoa1412379 - Cost-Effectiveness of Hypertension Therapy According to 2014 Guidelines http://www.nejm.org/doi/full/10.1056/NEJMsa1406751 **Pediatrics - Morphine Versus Clonidine for Neonatal Abstinence Syndrome http://pediatrics.aappublications.org/content/135/2/e383.abstract - Cardiovascular Risk Factors in Children After Repeat Doses of Antenatal Glucocorticoids: An RCT http://pediatrics.aappublications.org/content/135/2/e405.abstract - Morphine or Ibuprofen for Post-Tonsillectomy Analgesia: A Randomized Trial http://pediatrics.aappublications.org/content/135/2/307.abstract TAG Mail 28th January 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NPS MedicineWise Biosimilars: what's in a name? http://www.nps.org.au/publications/health-professional/health-newsevidence/2015/naming-biosimilars **NSW Health - Safety information 00/15: E – Cigarettes, Oxygen Therapy, Burns and Fire Risk http://www.health.nsw.gov.au/sabs/Documents/2015-si-001.pdf - Policy Directive: Preventing and Managing Violence in the NSW Health Workplace A Zero Tolerance Approach http://www0.health.nsw.gov.au/policies/pd/2015/pdf/PD2015_001.pdf **TGA - Orphan drugs added: Fomepizole https://www.tga.gov.au/updates-list-designated-orphan-drugs - Safety advisory: Lieel Icos Cialis tadalafil 80mg and 100mg and 'Top Gun for Men' tablets pose a serious risk to your health https://www.tga.gov.au/alert/lieel-icos-cialis-tadalafil-80mg-and-100mg-tablets https://www.tga.gov.au/alert/top-gun-men-tablets REPORTS AND PUBLICATIONS – INTERNATIONAL **AHRQ AHRQ Safety Program for End-Stage Renal Disease Facilities Toolkit (to help prevent infection in people with end-stage renal disease) http://www.ahrq.gov/professionals/quality-patient-safety/patient-safetyresources/resources/esrd/index.html **CADTH - Discontinuation Strategies for Patients with Long-Term Benzodiazepine Use: Clinical Evidence and Guidelines http://www.cadth.ca/media/pdf/htis/jan2015/RA0726%20BZD%20Discontinuation%20Strategies%20Final%20ABS.pdf - Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C: A Review of the Clinical Evidence http://www.cadth.ca/media/pdf/htis/jan2015/RC0632%20Holkira%20and%20Harvoni%20Final.pdf **EMA Saxenda recommended for approval in weight management in adults http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/01/news_detail_002255.jsp&mid=WC0b01ac058004d5c1 **FDA - FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431358.htm - FDA approves first generic version of Nexium (esomeprazole magnesium delayedrelease capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431648.htm - FDA approves new psoriasis drug Cosentyx (secukinumab) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm **NICE - Quality standards -- Urinary incontinence in women [QS77] http://www.nice.org.uk/guidance/qs77 MEDICATION SAFETY **EMA - Central repository to facilitate assessment of medicines safety reports http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/01/news_detail_002257.jsp&mid=WC0b01ac058004d5c1 - New international standard to improve safety of medicines http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/01/news_detail_002252.jsp&mid=WC0b01ac058004d5c1 **HQSCNZ - Reducing harm from falls downloadable resources: Ask, assess, act pocket card http://www.hqsc.govt.nz/our-programmes/reducing-harm-from-falls/publicationsand-resources/publication/1025/ - Safe use of opioids national collaborative: Library of potential opioid-related harms and measures http://www.hqsc.govt.nz/assets/Medication-Safety/collaborative/PR/expertfaculty-measures-Jan-2015.pdf **MHRA - Stronger advice on the use of valproate medicines in women http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON502625 - Drug Safety Update, January 2015 includes: Medicines related to valproate: risk of abnormal pregnancy outcomes | Ustekinumab (Stelara): risk of exfoliative dermatitis | Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis | Aceclofenac (Preservex): updated cardiovascular advice in line with diclofenac and COX-2 inhibitors https://www.gov.uk/drug-safety-update PAPERS OF INTEREST **BMJ Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis http://www.bmj.com/content/350/bmj.h102 **Cochrane - Are shorter courses of systemic steroids as effective as conventional longer courses in the treatment of patients with flare-ups of COPD? http://summaries.cochrane.org/CD006897/AIRWAYS_are-shorter-courses-ofsystemic-steroids-as-effective-as-conventional-longer-courses-in-the-treatment-ofpatients-with-flare-ups-of-copd - The relative safety and effectiveness of different epoetin drugs for treating anaemia in people with chronic kidney disease http://summaries.cochrane.org/CD010590/RENAL_the-relative-safety-andeffectiveness-of-different-epoetin-drugs-for-treating-anaemia-in-people-withchronic-kidney-disease **JAMA Intern Med Cumulative Use of Strong Anticholinergics and Incident Dementia: A Prospective Cohort Study http://archinte.jamanetwork.com/article.aspx?articleid=2091745 **JAMIA - A novel method of adverse event detection can accurately identify venous thromboembolisms (VTEs) from narrative electronic health record data http://jamia.oxfordjournals.org/content/22/1/155 - Effects of electronic health record use on the exam room communication skills of resident physicians: a randomized within-subjects study http://jamia.oxfordjournals.org/content/22/1/192 **Lancet - Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)619425/abstract - HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)611831/abstract **Pediatrics - Potential Drug−Drug Interactions in Infant, Child, and Adolescent Patients in Children’s Hospitals http://pediatrics.aappublications.org/content/135/1/e99.abstract - Anaerobic Antimicrobial Therapy After Necrotizing Enterocolitis in VLBW Infants http://pediatrics.aappublications.org/content/135/1/e117.abstract TAG Mail 21st January 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **NPS-MedicineWise NPS Direct, January 2015 includes: Antibiotics in infancy linked to childhood obesity | Oxycodone deaths: abuse not the only cause http://www.nps.org.au/health-professionals/e-newsletters/nps-direct **TGA - AusPARS added: Aripiprazole monohydrate (Abilify maintena), Canakinumab (Ilaris), Enzalutamide (Xtandi), Fenofibrate (Lipidil) https://www.tga.gov.au/australian-public-assessment-reports-prescriptionmedicines-auspars - Submissions received: Medicine labelling https://www.tga.gov.au/submissions-received-medicine-labelling - Evaluation (and naming conventions) of biosimilars https://www.tga.gov.au/evaluation-biosimilars REPORTS AND PUBLICATIONS – INTERNATIONAL **MHRA Diclofenac tablets now only available as a prescription medicine http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON500341 **NHS Exploring the costs of unsafe care in the NHS. A report prepared for the Department of Health http://www.frontier-economics.com/documents/2014/10/exploring-the-costs-ofunsafe-care-in-the-nhs-frontier-report-2-2-2-2.pdf **NICE - Evidence summary: new medicine -- Chronic obstructive pulmonary disease: umeclidinium inhaler (Incruse) [ESNM52] http://www.nice.org.uk/advice/esnm52 - Key therapeutic topics updated and include: -- Antibiotic prescribing – especially broad spectrum antibiotics [KTT9] http://www.nice.org.uk/advice/ktt9 -- First-choice antidepressant use in adults with depression or generalised anxiety disorder [KTT8] http://www.nice.org.uk/advice/ktt8 http://www.nice.org.uk/advice MEDICATION SAFETY **Health Canada MedEffect notice: Domperidone Maleate - Association with Serious Abnormal Heart Rhythms and Sudden Death (Cardiac Arrest) http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43423a-eng.php **ISMP Technology and error-prevention strategies: Why are we still overlooking the IV room? http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=98 **TGA Safety advisory: Power 1 tablets pose a serious risk to your health and should not be taken https://www.tga.gov.au/alert/power-1-tablets PAPERS OF INTEREST **Am J Health-Syst Pharm - Development of an inpatient operational pharmacy productivity model http://www.ajhp.org/content/72/3/206.abstract - Impact of incorporating pharmacy claims data into electronic medication reconciliation http://www.ajhp.org/content/72/3/212.abstract **BMJ Open Prescriber barriers and enablers to minimising potentially inappropriate medications in adults: a systematic review and thematic synthesis http://bmjopen.bmj.com/content/4/12/e006544.abstract **BMJ Qual Saf Computerised physician order entry-related medication errors: analysis of reported errors and vulnerability testing of current systems http://qualitysafety.bmj.com/content/early/2015/01/16/bmjqs-2014-003555 **Cochrane - Use of rapid point-of-care testing for infection to guide doctors prescribing antibiotics for acute respiratory infections in primary care settings http://summaries.cochrane.org/CD010130/ARI_use-of-rapid-point-of-care-testingfor-infection-to-guide-doctors-prescribing-antibiotics-for-acute-respiratoryinfections-in-primary-care-settings - Can electronic cigarettes help people stop smoking or reduce the amount they smoke, and are they safe to use for this purpose? http://summaries.cochrane.org/CD010216/TOBACCO_can-electronic-cigaretteshelp-people-stop-smoking-or-reduce-the-amount-they-smoke-and-are-they-safe-touse-for-this-purpose **International Journal for Quality in Health Care - What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system http://intqhc.oxfordjournals.org/content/early/2015/01/12/intqhc.mzu098 - Multicentre study to develop a medication safety package for decreasing inpatient harm from omission of time-critical medications http://intqhc.oxfordjournals.org/content/early/2014/12/22/intqhc.mzu099 **JAMA Intern Med - Out-of-Hospital Mortality Among Patients Receiving Methadone for Noncancer Pain http://archinte.jamanetwork.com/article.aspx?articleid=2091400 - Dietary Sodium Content, Mortality, and Risk for Cardiovascular Events in Older Adults: The Health, Aging, and Body Composition (Health ABC) Study http://archinte.jamanetwork.com/article.aspx?articleid=2091399 - Association of Amiodarone Use With Acute Pancreatitis in Patients With Atrial Fibrillation: A Nested Case-Control Study http://archinte.jamanetwork.com/article.aspx?articleid=2091397 - Orders for Intravenous Proton Pump Inhibitors After Implementation of an Electronic Alert http://archinte.jamanetwork.com/article.aspx?articleid=2091396 - Falls and Fractures With Atypical Antipsychotic Medication Use: A PopulationBased Cohort Study http://archinte.jamanetwork.com/article.aspx?articleid=2089230 **J Clin Endocrinol Metab Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline http://press.endocrine.org/doi/pdf/10.1210/jc.2014-3415 **Lancet - The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised openlabel masked endpoint clinical trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624569/abstract - Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)624478/abstract - Efficacy and safety of LDL-lowering therapy among men and women: metaanalysis of individual data from 174 000 participants in 27 randomised trials http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)613684/abstract **Lancet Neurol Pharmacotherapy for neuropathic pain in adults: a systematic review and metaanalysis http://www.thelancet.com/journals/laneur/article/PIIS1474-4422%2814%29702510/abstract **NEJM Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis http://www.nejm.org/doi/full/10.1056/NEJMoa1405760 TAG Mail 14th January 2015 REPORTS AND PUBLICATIONS - AUSTRALIA Nil REPORTS AND PUBLICATIONS – INTERNATIONAL **British Government-Wellcome Trust Review on Antimicrobial Resistance http://amr-review.org/ **EMA EMA approves Lynparza (olaparib), Vargatef (nintedanib) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicin es/003726/human_med_001831.jsp&mid=WC0b01ac058001d124 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicin es/002569/human_med_001822.jsp&mid=WC0b01ac058001d124 **FDA FDA approves anti-clotting drug Savaysa (edoxaban tablets) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm **RAND Corporation Estimating the economic costs of antimicrobial resistance http://www.rand.org/pubs/research_reports/RR911.html **KPMG The global economic impact of anti-microbial resistance https://www.kpmg.com/UK/en/IssuesAndInsights/ArticlesPublications/Documents/ PDF/Issues%20and%20Insights/amr-report-final.pdf **NICE Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people [NG1] http://www.nice.org.uk/guidance/ng1 MEDICATION SAFETY **EMA PRAC considers risk of severe allergic reactions with ambroxol- and bromhexinecontaining medicines to be small http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 15/01/news_detail_002248.jsp&mid=WC0b01ac058004d5c1 **FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm with Podcast http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm430053.htm PAPERS OF INTEREST **Am J Clin Oncol Interaction of Salicylates and the Other Nonsteroidal Anti-Inflammatory Agents With Breast Cancer Endocrine Treatment: Systematic Review http://www.ncbi.nlm.nih.gov/pubmed/25503435 **Ann Intern Med - The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop http://annals.org/article.aspx?articleID=2089370 - Position paper: National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic PainThe Role of Opioids in the Treatment of Chronic Pain http://annals.org/article.aspx?articleID=2089371 **BMJ Qual Saf Systematic review: Key characteristics of successful quality improvement curricula in physician education: a realist review http://qualitysafety.bmj.com/content/24/1/77.short?g=w_qs_current_tab TAG Mail 7th January 2015 REPORTS AND PUBLICATIONS - AUSTRALIA **AIHW - Staphylococcus aureus bacteraemia in Australian public hospitals 2013–14: Australian hospital statistics http://www.aihw.gov.au/publication-detail/?id=60129550044 - Cardiovascular disease, diabetes and chronic kidney disease: Australian facts: morbidity—hospital care http://www.aihw.gov.au/publication-detail/?id=60129550063 - Health expenditure Australia 2012–13: analysis by sector http://www.aihw.gov.au/publication-detail/?id=60129550083 **NPS-MedicineWise Antibiotics in infancy linked to childhood obesity http://www.nps.org.au/publications/health-professional/health-newsevidence/2014/infancy-antibiotics-obesity **NSW Health - 2014 Policy Directives & Guidelines -- Guidelines for the Management of Substance Use During Pregnancy Birth and the Postnatal Period -- Infants and Children: Management of Acute Gastroenteritis, Fourth Edition -- Principles for the Management of Tuberculosis in New South Wales http://www0.health.nsw.gov.au/policies/date/2014.asp - Building a sustainable health workforce for rural NSW http://www.health.nsw.gov.au/rural/Pages/building-sustainable-workforce.aspx **TGA Orphan drugs added Factor XI Concentrate (human coagulation factor XI) http://www.tga.gov.au/updates-list-designated-orphan-drugs REPORTS AND PUBLICATIONS – INTERNATIONAL **CADTH - Rapid responses -- Dexmedetomidine for Sedation in the ICU or PICU: A Review of Cost-Effectiveness and Guidelines -- Intravenous Administration of Medications in Home Care Settings: Clinical Evidence and Guidelines http://www.cadth.ca/en/products/rapid-response **FDA - FDA approvals: -- weight-management drug Saxenda (liraglutide [rDNA origin] injection) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm -- Opdivo (nivolumab) for advanced melanoma http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427716.htm -- Rapivab (peramivir) to treat flu infection http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427755.htm -- Lynparza (olaparib) to treat advanced ovarian cancer http://www.fda.gov/Drugs/NewsEvents/ucm130958.htm -- new antibacterial drug Zerbaxa (ceftolozane/tazobactam) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427534.htm **NICE - Evidence Update -- Hyperphosphataemia in chronic kidney disease, December 2014 http://arms.evidence.nhs.uk/resources/hub/1041123/attachment - Evidence summary: new medicine -- Hyperphosphataemia in adults with chronic kidney disease on dialysis: sucroferric oxyhydroxide [ESNM51] http://www.nice.org.uk/advice/esnm51 - Quality standards -- Antibiotics for neonatal infection [QS75] http://www.nice.org.uk/guidance/qs75 -- Acute kidney injury [QS76] http://www.nice.org.uk/guidance/qs76 MEDICATION SAFETY **ISMP Tragic error with neuromuscular blocker should prompt risk assessment by all hospitals http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=97 **MHRA Drug safety update, December 2014 includes: Ivabradine (Procoralan) in the symptomatic treatment of angina: risk of cardiac side effects—new advice to minimise risk | Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders—warn patients and family; monitor patients for signs of depression | Hydroxyethyl starch intravenous infusions to be used only in patients with acute blood loss and when crystalloids alone are not sufficient http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htm PAPERS OF INTEREST **Am J Health-Syst Pharm - Effect of computerized prescriber order entry on pharmacy: Experience of one health system http://www.ajhp.org/content/72/2/133.abstract **Ann Intern Med - Valganciclovir for the Prevention of Complications of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Cell Transplantation: A Randomized TrialLate CMV Prevention After HCT http://annals.org/article.aspx?articleid=2088543 - Comparative Effectiveness of Pharmacologic Interventions for Knee Osteoarthritis: A Systematic Review and Network Meta-analysisPharmacologic Interventions for Knee OA http://annals.org/article.aspx?articleid=2088548 - Effects of Blood Pressure Reduction in Mild Hypertension: A Systematic Review and Meta-analysis http://annals.org/article.aspx?articleid=2085847 **BMJ Qual Saf Adverse events in patients with return emergency department visits http://qualitysafety.bmj.com/content/early/2014/12/24/bmjqs-2014003194.short?g=w_qs_ahead_tab **Cochrane Collaboration - Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006897.pub3/abstract;jse ssionid=B89364C93CAAF59E71F14C84F72F37C4.f04t01 - Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010590.pub2/abstract **JAMA Intern Med - Secondary Prevention of Cardiovascular Disease With Vorapaxar: A New Era of 3Drug Antiplatelet Therapy? http://archinte.jamanetwork.com/article.aspx?articleid=1921757 - Risk of Bleeding With Dabigatran in Atrial Fibrillation http://archinte.jamanetwork.com/article.aspx?articleid=1921753 - Medication Therapy Management Interventions in Outpatient Settings: A Systematic Review and Meta-analysis http://archinte.jamanetwork.com/article.aspx?articleid=1935933 **MJA Australia-wide point prevalence survey of the use and appropriateness of antimicrobial prescribing for children in hospital https://www.mja.com.au/journal/2014/201/11/australia-wide-point-prevalencesurvey-use-and-appropriateness-antimicrobial **Pediatrics - Anaerobic Antimicrobial Therapy After Necrotizing Enterocolitis in VLBW Infants http://pediatrics.aappublications.org/content/135/1/e117.abstract - Antimicrobial Stewardship Programs in Freestanding Children’s Hospitals http://pediatrics.aappublications.org/content/135/1/33.abstract - Off-Label Prescribing in Pediatric Outpatients http://pediatrics.aappublications.org/content/135/1/49.abstract