Description

Aspirin for the primary prevention of cardiovascular disease

Prescribing generic clopidogrel

New Drug Assessment:

Estradiol valerate/dienogest combined oral contraceptive pill (Qlaira) classified RED-RED

Caphosol solution Dry mouth, particularly oral mucositis, hyposalivation or xerostomia.classified RED

Rapid Drug Assessment:

Betamethasone valerate adhesive plaster (Betesil) Steroid responsive dermatoses classified RED-RED

Fentanyl transdermal reservoir patch (Fentalis) Severe chronic pain classified RED-RED

Trospium chloride sustained release capsules 60mg (Regurin XL) Urge incontinence, increased urinary frequency and urgency in patients with overactive bladder Classified GREEN

Influenza A (H1N1)v swine flu vaccines (Pandemrix and Celvapan) classified GREEN

New Trials in Brief: Prophylactic paracetamol at the time of vaccination may affect antibody response; ACE Inhibitors and Angiotensin Receptor Blockers in patients with ischaemic heart disease; Antidepressant prescribing continues to rise

NICE TA182: Prasugrel for the treatment of acute coronary syndromes with percutaneous coronary intervention (October 2009)

NICE TA183: Topotecan for the treatment of recurrent and stage IVB cervical cancer (October 2009)

MHRA, Drug Safety Update (November 2009): Bisphosphonates and osteonecrosis of the jaw; Vigabatrin for infantile spasms; Planned withdrawal of orciprenaline sulphate syrup (Alupent); Updated product information on statins.

Description

New Drug Assessment: Liraglutide injection 6mg/ml (Victoza)

New Trials in Brief: Vitamin D and Falls

NICE TA179: Sunitinib for the treatment of Gastrointestinal Stromal Tumours (September 2009)

NICE TA180: Ustekinumab for the treatment of adults with moderate to severe psoriasis (September 2009)

NICE TA181: Pemetrexed for the first-line treatment of non-small-cell lung cancer (September 2009)

NICE CG88: Low back pain – Early management of persistent non-specific low back pain (May 2009)

Guidelines for the Treatment of Commonly Occurring Infections in Primary Care: Winter 2009/10

Description

New Drug Assessment:

Buprenorphine patches (BuTrans) Licensed for the treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Classified GREEN

Agomelatine 25mg tablets (Valdoxan) Major depressive disorder in adults Classified RED

Rapid Drug Assessment:

Prasugrel 5mg and 10mg tablets (Efient) Licensed in combination with aspirin for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).Classified RED-RED

Amlodipine/olmesartan tablets 5/20mg, 10/20mg and 10/40mg (Sevikar) for hypertension classified GREEN

C1-esterase inhibitor human injection (Berinert) Licensed for the treatment of acute episodes of hereditary angioedema type I and II classified RED

New Trials in Brief: Antibiotic Prescribing – Respiratory Tract Infections in Children; Amoxicillin in Acute Otitis Media; Tiotropium and the UPLIFT Study; Risk of Falls Associated With Medicines

NICE TA173: Tenofovir disoproxil for the treatment of chronic hepatitis B (July 2009)

NICE TA174: Rituximab for the first-line treatment of chronic lymphocytic leukaemia (July 2009)

NICE TA175: Gefitinib for the second-line treatment of locally advanced or metastatic non-small-cell lung cancer (terminated appraisal) (July 2009)

NICE TA176: Cetuximab for the first-line treatment of metastatic colorectal cancer (August 2009)

NICE TA177: Alitretinoin for the treatment of severe chronic hand eczema (August 2009)

NICE TA178: Bevacizumab (first-line), sorafenib (first-and-second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and or metastatic renal cell carcinoma (August 2009)

NICE CG85: Glaucoma – Diagnosis and management of chronic open angle glaucoma and ocular hypertension (April 2009)

NICE CG86: Coeliac disease – Recognition and assessment of coeliac disease (May 2009)

MHRA: Drug Safety Update (August/September 2009): Safety information: oseltamivir (Tamiflu) and zanamivir (Relenza); Herbal products – safety update; Insulin glargine – possible cancer link

Description

Launch of Generic Clopidogrel

Rapid Drug Assessment:

Hydrogen peroxide 1% cream (Crystacide) Licensed for the treatment of primary and secondary superficial skin infections. Classified RED-RED

Ibandronic acid 150mg tablets (Bonviva) Treatment of postmenopausal osteoporosis.Classified RED-RED

Aspirin prolonged release 162.5mg capsule (Flamasacard) Licensed for secondary prophylaxis after a first coronary or cerebrovascular ischaemic event and following coronary angioplasty or coronary artery bypass surgery where rapid onset of action is not required Classified RED-RED

Metformin 500mg and 1000mg powder for oral solution (Glucophage Powder) Type 2 diabetes , particularly in overweight patients, when diet and exercise provide inadequate control. Classified GREEN

New Trials in Brief: Increased hospital-acquired pneumonia risk in patients taking acid suppressive medication; Cost-effectiveness of prescribing PPIs with NSAIDs or Cox-II inhibitors

Aspirin for primary prevention of cardiovascular disease

NICE TA171; Lenalidomide for the treatment of multiple myeloma in people who have received at least one prior therapy (June 2009)

NICE TA172: Cetuximab for the treatment of recurrent and/or metastatic squamous cell cancer of the head and neck (June 2009)

NICE CG84: Diarrhoea and vomiting in children: Diarrhoea and vomiting caused by gastroenteritis – diagnosis, assessment and management in children younger than 5 years (April 2009)

MHRA: Drug Safety Update (July 2009): Clopidogrel and proton pump inhibitors; Long acting beta-agonists and chronic obstructive pulmonary disease; Mycophenolate mofetil and pure red cell aplasia; ACE inhibitors and Angiotensin II receptor antagonists in breast feeding

Legal Advice: Patient consent to changes in medication

Description

NICE CG87: Type 2 diabetes – the management of type 2 diabetes (May 2009)

Sitagliptin (Januvia) has been re-classified as GREEN subject to NICE initiation criteria

Pioglitazone (Actos) and rosiglitazone (Avandia) remain GREEN, although it is recommended that new patients requiring glitazone therapy should be initiated on pioglitazone

Exenatide (Byetta) remains GREEN and is now indicated for a wider range of patients

Description

PACEF: Key Principles of Working

Rapid Drug Assessment:

Oxycodone/Naloxone prolonged release tablets (Targinact) Licensed for the treatment of severe pain.Classified RED-RED

Nicorette Invisipatch Nicotine replacement as an aid to smoking cessation Classified GREEN

New Trials in Brief: Antibiotic prescribing for lower respiratory tract infections; Aspirin for primary prevention of cardiovascular events; Blood glucose and cardiovascular outcomes; Rosiglitazone and cardiovascular outcomes

NICE CG82: Schizophrenia (May 2009)

MHRA: Drug Safety Update (June 2009): Antipsychotics and risk of venous thromboembolic events; Chloral hydrate and Triclofos; Topical ketoprofen and photosensitivity reactions; Clopidogrel and proton pump inhibitors

Description

Launch of NHS Evidence

Rapid Drug Assessment: Fluticasone furoate nasal spray (Avamys) Licensed for the treatment of allergic rhinitis in adults, adolescents and children over 6 Classified RED-RED

New Drug Assessment Appeal: Ethinylestradiol/etonogestrel vaginal ring (NuvaRing) Classified REDApproved for use by Sexual Health Services within restricted criteria only

New Formulation Assessment: Budesonide CFC-free Metered Dose Inhalers 100mcg and 200mcg (Pulmicort Inhaler CFC Free) Licensed for the treatment of bronchial asthma Classified GREEN

Review: Standardised Grass Pollen Allergen From Timothy Grass (Grazax) Licensed for grass pollen induced rhinitis and conjunctivitis diagnosed with a positive skin prick test and/or specific IgE test in adults and children aged 5 and over Classified RED-RED

New Trials in Brief: Hypoglycaemic episodes and possible risk of dementia; Naftidrofuryl and intermittent claudication

NICE TA170: Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults (April 2009)

NICE CG80: Early and locally advanced breast cancer: Diagnosis and treatment (February 2009)

NICE CG81: Advanced breast cancer: Diagnosis and treatment (February 2009)

MHRA Drug Safety Update May 2009: Aliskiren - Risk of Angioedema and Renal Dysfunction; ACE Inhibitors and Angiotensin II Receptor Antagonists - Recommendations on use during breast feeding; Non-Steroidal Anti-Inflammatory Drugs - Renal failure and impairment; New advice on oral salicylate gels for those younger than 16 years; Fortodol: Risk of serious liver damage

Description

NATIONAL PATIENT SAFETY AGENCY (NPSA) RAPID RESPONSE REPORT 011 – REDUCING RISK OF OVERDOSE WITH MIDAZOLAM INJECTION IN ADULTS (DECEMBER 2008)

Description

New Drug Assessment:

Alitretinoin capsules (Toctino) Licensed for the treatment of severe, chronic hand eczema unresponsive to treatment with potent topical corticosteroids.Classified RED

Aripiprazole IM injection (Abilify) Licensed for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate. Classified RED

Rapid Assessments: Fentanyl buccal tablets (Effentora) and Fentanyl sublingual tablets (Abstral) Classified GREEN

New Trial Assessment: The Veterans Affairs Diabetes Trial (VADT)

New Trials in Brief: Efficacy and Safety of Insulin Analogues; Atrial Fibrillation and Atrial Flutter with Bisphosphonates; Self Monitoring of Blood Glucose

NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma (March 2009)

NICE CG77: Antisocial personality disorder – Treatment, management and prevention (January 2009)

NICE CG78: Borderline personality disorder – Treatment and management (January 2009)

NICE CG79: Rheumatoid arthritis – The management of rheumatoid arthritis in adults (February 2009)

MHRA Drug Safety Update April 2009: Antiepileptics; Off-Label Use or Unlicensed medicines – Prescribers’ Responsibilities; Over-the-Counter Cough and Cold Medicines for Children

Description

New Drug Assessment:

Methylnaltrexone bromide injection (Relistor) Opioid induced constipation in patients receiving palliative care when response to usual laxative therapy is inadequate classified AMBER

Ethinylestradiol/ etonogestrel vaginal ring (NuvaRing) Licensed as a form of contraception in women of fertile age Classified RED-RED

Rapid Assessment:

Calcipotriol/ betamethasone gel (Xamiol) Topical treatment for scalp psoriasis Classified GREEN

Tadalafil 2.5mg and 5mg tablets (Cialis Once-A-Day) Licensed for once daily use in the treatment of erectile dysfunction (ED) classified GREEN

Review: Zoledronic acid intravenous infusion (Aclasta) Once yearly IV infusion bisphosphonate licensed for the treatment of post menopausal osteoporosis classified RED

New Trials in Brief

NICE TA168: Amantadine, oseltamivir and zanamivir for the treatment of influenza (February 2009)

NICE CG73: Chronic kidney disease: Early identification and management of chronic kidney disease in adults in primary and secondary care (September 2008)

NICE CG76: Medicines adherence: Involving patients in decisions about prescribed medicines and supporting adherence (January 2009)

MHRA Safety Update: Methylphenidate; Atomoxetine; Antipsychotics in Dementia; Exenatide and pancreatitis; Bisphosphonates and stress fractures

National Patient Safety Agency (NPSA) Rapid Response Report – Reducing Risk of Harm from Oral Bowel Cleansing Solutions (February 2009)

Description

PRESCRIBING RECOMMENDATIONS FOR HAY FEVER: SPRING / SUMMER 2009

Description

Rapid Drug Assessment: Midazolam Buccal Liquid (Epistatus) Unlicensed product used for the emergency treatment of status epilepticus as a second line alternative to rectal diazepam Classified AMBER

New Drug Assessment:

Icatibant injection (Firazyr) Licensed for the symptomatic treatment of acute attacks of hereditary angioedema Classified RED-RED

Ivabradine tablets (Procoralan) Licensed for the symptomatic treatment of chronic stable angina in patients in normal sinus rhythm who are unable to take beta-blockers due to contra-indication or intolerance Classified RED-RED

New Trial Assessment: Population-based study of the drug interaction between proton pump inhibitors and clopidogrel

NICE TA163: Infliximab for acute exacerbations of ulcerative colitis (December 2008)

NICE TA164: Febuxostat for the management of hyperuricaemia in people with gout (December 2008)

National Patient Safety Agency Rapid Response Report – Reducing Risk of Overdose with Midazolam Injection in Adults (December 2008)

Description

Influenza Season 2008/09 – Use of Antivirals

Rapid Drug Assessment:

Sodium Valproate (Epilim Chronosphere) modified release granules Licensed for the treatment of general, partial or other epilepsy Classified RED-RED

Sodium Valproate (Episenta) prolonged release granules Licensed for all forms of epilepsy Classifoed GREEN

Quetiapine prolonged release tablets (Seroquel XL) Licensed for schizophrenia and manic episodes associated with bipolar disorder Classified AMBER

Thalidomide Pharmion capsules Licensed for use in combination with melphalan and prednisone as first line treatment of untreated multiple myeloma in patients aged 65 and over or ineligible for high-dose chemotherapy Classified RED

New Drug Assessment:

Rasagiline tablets (Azilect) Licensed for the treatment of Parkinson’s disease, used alone or as an adjunct to levodopa with dopa-decarboxylase inhibitor Classified RED-RED

Rivaroxaban tablets (Xarelto) Licensed for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip replacement surgery or elective total knee replacement surgery Classified RED

Patent Expiries: Risperidone and Bicalutamide

New Trial Assessment: Prevention of Progression of Arterial Disease and Diabetes Trial (POPADAD)

NICE TA162: Erlotinib for the treatment of non-small-cell lung cancer (November 2008)