JULY 2013 Summary of Changes to the Queensland Health List of Approved Medicines (LAM) as recommended by the Queensland Health Medicines Advisory Committee (QHMAC) ITEM # 13/061 13/057 MEDICINE DUTASTERIDE WITH TAMSULOSIN CAPSULE 500microgram with 400microgram IVABRADINE TABLET 5mg DECISION & DATE EFFECTIVE ADDED 01-Oct-13 Urologists for use as per the PBS indications ADDED 01-Oct-13 Cardiologists and Radiologists to reduce heart rate in patients in sinus rhythm undergoing CT coronary angiography who do not respond to maximal doses of betablockers or are unable to tolerate beta blockers (or when a beta-blocker is contraindicated). Specialist Staff for (a) Patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications; (b) For use in postoperative nausea and vomiting (PONV) (i) in adult patients not responsive to alternative oral antiemetic therapy and who cannot use other forms of ondansetron; and (ii) in children (c) Use within Emergency Departments for acute gastroenteritis in children up to age sixteen years when frequent vomiting is interfering with oral rehydration therapy. It is recommended that the Royal Children's Hospital (Brisbane) Emergency Department Flowchart for Management of Acute Gastroenteritis be consulted and followed. Where medicines are used outside their TGA approved indications, patients should be made fully aware of the status of the medicine and appropriate consent obtained. Specialist Staff for patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications 13/T01 ONDANSETRON ORAL DISINTEGRATING TABLET 4mg ADDED 01-Sep-13 (to be reflected in 1 Oct LAM) 13/T01 ONDANSETRON ORAL DISINTEGRATING TABLET 8mg 13/058 PRASUGREL TABLET 5mg, 10mg ADDED 01-Sep-13 (to be reflected in 1 Oct LAM) ADDED 01-Oct-13 13/062 PROGESTERONE PESSARY 200mg RESTRICTION ADDED 01-Oct-13 Cardiologists in PCI capable hospitals as per the PBS indications Specialist Obstetricians for women in preterm labour with shortened cervix and those with short cervices in singleton pregnancies. Where medicines are used outside their TGA approved indications, patients should be made fully aware of the status of the medicine and appropriate consent obtained. ITEM # MEDICINE 13/053 PROSTAGLANDIN 13/076 F2 ALPHA (DINOPROST) INJECTION 5mg in 1mL (Prostin F2 alpha) APIXABAN Tablet 2.5mg DECISION & DATE EFFECTIVE ADDED 01-Oct-13 AMENDED 01-Sep-13 (to be reflected in 1 Oct LAM) AMENDED 01-Oct-13 13/055 A BCG VACCINE, DRIED LIVING Injection 1.5mg 13/056 CLOPIDOGREL TABLET 75mg AMENDED 01-Oct-13 13/055 B CYCLOSERINE Capsule 250mg AMENDED 01-Oct-13 13/T01 GRANISETRON INJECTION 3mg in 3mL AMENDED 01-Sep-13 (to be reflected in 1 Oct LAM) RESTRICTION Specialist Obstetricians and Gynaecologists and Rural Generalist General Practitioners with an Advanced Skill in Obstetrics and Gynaecology, for second line management of severe life-threatening primary postpartum haemorrhage within the guidance of the Queensland Maternal and Neonatal Clinical Guideline “Primary Postpartum Haemorrhage”. Where medicines are used outside their TGA approved indications, patients should be made fully aware of the status of the medicine and, where appropriate informed consent cannot be obtained, full details should be recorded in the patient chart. For orthopaedic prophylaxis of venous thromboembolism in total hip and knee replacement. For vaccination after approval by the Medical Advisor Tuberculosis, CHRISP and TB Control, Communicable Diseases Unit or delegate OR Director Regional Tuberculosis Control Unit. The Medical Advisor Tuberculosis, CHRISP and TB Control should be contacted for any multi-drug or extremely drug resistant cases and can be contacted during business hours via (07) 3328 9755 or email at: CHRISP_TB@health.qld.gov.au Contact information for Regional TB Control Units is available at: www.health.qld.gov.au/chrisp/tuberculosis/appointments.asp Specialist Staff for use as per the PBS indications; and for use in patients undergoing arterial stenting for up to a maximum of three months. For treatment after approval by the Medical Advisor Tuberculosis, CHRISP and TB Control, Communicable Diseases Unit or delegate OR Director Regional Tuberculosis Control Unit. The Medical Advisor Tuberculosis, CHRISP and TB Control should be contacted for any multi-drug or extremely drug resistant cases and can be contacted during business hours via (07) 3328 9755 or email at: CHRISP_TB@health.qld.gov.au Contact information for Regional TB Control Units is available at: www.health.qld.gov.au/chrisp/tuberculosis/appointments.asp Specialist Staff for patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications Page 2 of 6 ITEM # MEDICINE 13/055 E MOXIFLOXACIN Solution for IV infusion 400mg in 250mL; Tablet 400mg 13/T01 ONDANSETRON INJECTION 4mg in 2mL 13/T01 ONDANSETRON INJECTION 8mg in 4mL 13/T01 ONDANSETRON SYRUP 4mg in 5mL 50mL 13/T01 ONDANSETRON TABLET 4mg DECISION & DATE EFFECTIVE AMENDED 01-Oct-13 AMENDED 01-Sep-13 (to be reflected in 1 Oct LAM) AMENDED 01-Sep-13 (to be reflected in 1 Oct LAM) AMENDED 01-Sep-13 (to be reflected in 1 Oct LAM) AMENDED 01-Sep-13 (to be reflected in RESTRICTION For use after approval by an Infectious diseases Physician or a Clinical Microbiologist or in accord with an Infectious Diseases approved protocol: (a) For empirical therapy of patients with community acquired pneumonia or acute bacterial meningitis who have immediate hypersensitivity to penicillin and cannot be given cephalosporin; b) For patients with an infection caused by an organism with proven resistance to antibiotic agents apart from moxifloxacin, or who have severe allergy to standard agents where moxifloxacin is the most appropriate therapy available; OR For treatment after approval by the Medical Advisor Tuberculosis, CHRISP and TB Control, Communicable Diseases Unit or delegate OR Director Regional Tuberculosis Control Unit. The Medical Advisor Tuberculosis, CHRISP and TB Control should be contacted for any multi-drug or extremely drug resistant cases and can be contacted during business hours via (07) 3328 9755 or email at: CHRISP_TB@health.qld.gov.au Contact information for Regional TB Control Units is available at: www.health.qld.gov.au/chrisp/tuberculosis/appointments.asp Specialist Staff for (a) Patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications; (b) Use for postoperative nausea and vomiting (PONV) Specialist Staff for (a) Patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications; (b) Use for postoperative nausea and vomiting (PONV) Specialist Staff for use in children who cannot use any other forms of ondansetron. Where medicines are used outside their TGA approved indications, patients should be made fully aware of the status of the medicine and appropriate consent obtained Specialist Staff for (a) Patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications; (b) For use in postoperative nausea and vomiting (PONV) (i) in adult patients not responsive to alternative oral antiemetic therapy; and (ii) in children. Page 3 of 6 ITEM # MEDICINE 13/T01 ONDANSETRON TABLET 8mg 13/055 C PARAAMINOSALICYLIC ACID Sachet 4g 13/055 D PROTHIONAMIDE 13/028 CINACALCET TABLET 30mg, 60mg, 90mg SODIUM CHLORIDE COMPOUND (Ringers solution lactated with glucose) Powder for reconstitution – sachet (4) plus bottle with 13/048 Tablet 250mg DECISION & DATE EFFECTIVE 1 Oct LAM) AMENDED 01-Sep-13 (to be reflected in 1 Oct LAM) AMENDED 01-Oct-13 AMENDED 01-Oct-13 RESTRICTION Where medicines are used outside their TGA approved indications, patients should be made fully aware of the status of the medicine and appropriate consent obtained. Specialist Staff for patients on cytotoxic chemotherapy or radiotherapy as per the PBS indications. For treatment after approval by the Medical Advisor Tuberculosis, CHRISP and TB Control, Communicable Diseases Unit or delegate OR Director Regional Tuberculosis Control Unit. The Medical Advisor Tuberculosis, CHRISP and TB Control should be contacted for any multi-drug or extremely drug resistant cases and can be contacted during business hours via (07) 3328 9755 or email at: CHRISP_TB@health.qld.gov.au Contact information for Regional TB Control Units is available at: www.health.qld.gov.au/chrisp/tuberculosis/appointments.asp For treatment after approval by the Medical Advisor Tuberculosis, CHRISP and TB Control, Communicable Diseases Unit or delegate OR Director Regional Tuberculosis Control Unit. The Medical Advisor Tuberculosis, CHRISP and TB Control should be contacted for any multi-drug or extremely drug resistant cases and can be contacted during business hours via (07) 3328 9755 or email at: CHRISP_TB@health.qld.gov.au Contact information for Regional TB Control Units is available at: www.health.qld.gov.au/chrisp/tuberculosis/appointments.asp DEFERRED DEFERRED Page 4 of 6 ITEM # 13/049 13/051 13/T03 MEDICINE paediatric tip (FLO Kids Sinus Care®) SODIUM CHLORIDE COMPOUND (sterile, isotonic), paediatric nasal spray,15mL (FLO Baby VITAMIN, FAT SOLUBLE COMPOUND in tocopherol PEG suspension, chewable tablet, soft gel capsule, paediatric liquid 60mL ANIDULAFUNGIN INJECTION 100mg 13/T01 GRANISETRON INJ’N 1mg in 1mL 13/T01 ONDANSETRON WAFER 4mg DECISION & DATE EFFECTIVE RESTRICTION DEFERRED DEFERRED DELETED 01-Sep-13 (to be reflected in 1 Oct LAM) DELETED 01-Sep-13 (to be reflected in 1 Oct LAM) DELETED 01-Sep-13 (to be reflected in 1 Oct LAM) Page 5 of 6 ITEM # MEDICINE 13/T01 ONDANSETRON WAFER 8mg 13/052 PROSTAGLANDIN 13/T02 F2 ALPHA (CARBOPROST) 250microgram in 1mL SIMVASTATIN TABLET 80mg 13/057 IVABRADINE TABLET 7.5mg 13/054 LIGNOCAINE PATCH 5% DECISION & DATE EFFECTIVE DELETED 01-Sep-13 (to be reflected in 1 Oct LAM) DELETED 01-Oct-13 RESTRICTION DELETED 01-Sep-13 (to be reflected in 1 Oct LAM) NOT ADDED NOT ADDED Page 6 of 6