Description

New Product Assessment: Biosimilar insulin glargine 100iu/ml (Abasaglar Review of prescribing guidance in response to AMCo price increases.

New Product Assessment: Insulin glargine 300iu/ml (Toujeo).

NICE Guideline NG28: Type 2 diabetes in adults – management (December 2015) - Updated guidance on the prescribing of insulin-based treatments in patients with type 2 diabetes.

New Product Assessment: Empagliflozin/metformin tablets (Synjardy).

New Product Assessment: Midodrine hydrochloride 2.5mg and 5mg tablets (Bramox).

Name Change: Lithium carbonate 250mg tablets (Camcolit).

MHRA, Drug Safety Update (November 2015): Crizotinib (Xalkori): Risk of cardiac failure; Vemurafenib (Zelboraf): Risk of potentiation of radiation toxicity.

Rivaroxaban price reduction and withdrawal of rebate scheme.

East Midlands Cardiovascular Strategic Network, Medicines and Your Kidneys Leaflet.

New Product Assessment: Tafluprost 15mcg/timolol 5mg per ml preservative free single use eye drops (Taptiqom).

Description

Updated Clinical Guidance for the Diagnosis and Management of Heart Failure (September 2015).

Changes to Controlled Drug Legislation: New mandatory requisition form for Schedule 2 and 3 controlled drugs, approved wording for instalment prescribing and reclassification of ketamine from Schedule 4 to Schedule 2.

Rapid Cost Comparison: New Lower Cost Oral Contraceptives.

Rapid Cost Comparison: Levonorgestrel 1.5mg tablet (Emerres).

MHRA, Drug Safety Update (October 2015): Mirabegron (Betmiga) – Risk of severe hypertension and associated cerebrovascular and cardiac events.

European Medicines Agency: Review of SGLT2 inhibitors for diabetes begins.

Public Health England, Updated Advisory Committee on Malaria Prevention guidelines on malaria prevention in UK travellers (September 2015).

NICE Technology Appraisal 352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy (August 2015).

NICE Technology Appraisal 353: Bevacizumab for treating relapsed, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (August 2015).

NICE Technology Appraisal 357: Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab (October 2015).

NICE Technology Appraisal 356: Ruxolitinib for treating polycythaemia vera (terminated appraisal) (September 2015).

Description

New Drug Assessment:

Dulaglutide solution for injection (Trulicity).

New Formulation Assessment:

Exenatide 2mg prolonged release suspension for injection in a pre-filled pen (Bydureon).

Change in Formulary status:

Meningococcal group B vaccine (Bexsero) Paracetamol to prevent and treat fever after meningococcal group B vaccination.

Meningitis ACWY conjugative vaccines (Menveo and Nivmenrix).

Other:

Increasing price of fusidic acid 1% modified-release eye drops.

Patient Safety Alert - Addressing antimicrobial resistance through implementation of an antimicrobial stewardship programme (August 2015).

MHRA, Drug Safety Update (September 2015):

Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus.

Pseudoephedrine and ephedrine: update on managing risk of misuse in the UK.

Simeprevir and sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone.

Description

Information:

New Trial Assessment - IMPROVE-IT.

New Lincolnshire Partnership Foundation Trust, Guidance on the use of anticonvulsants for mental health problems in women of childbearing potential.

Review of formulary status of fidaxomicin tablets (Dificlir) and other microbiologist led antibiotics for resistant infections.

Changes to guidance on the use of SGLT2 inhibitors.

Supply difficulties with naftidrofuryl 100mg capsules now resolved.

MHRA, Drug Safety Update (July 2015):

Denosumab and bisphosphonates and osteonecrosis of the jaw.

Latanoprost (Xalatan) – increased reporting of eye irritation since reformulation.

Colpermin capsules contain peanut oil: avoid in patients with peanut allergy.

NICE Technology Appraisal:

NICE Technology Appraisal 338: Pomalidomide for relapsed and refractory multiple myeloma previously treated with lenalidomide and bortezomib (March 2015).

NICE Technology Appraisal 339: Omalizumab for previously treated chronic spontaneous urticaria (June 2015).

NICE Technology Appraisal 340: Ustekinumab for treating active psoriatic arthritis (June 2015).

NICE Technology Appraisal 342: Vedolizumab for treating moderately to severely active ulcerative colitis (June 2015).

NICE Technology Appraisal 351: Cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of anti-platelet therapy (July 2015).

NICE Technology Appraisal 347: Nintedanib for previously locally advanced, metastatic or locally recurrent non-small cell lung cancer (July 2015).

NICE Technology Appraisal 348: Everolimus for preventing organ rejection in liver transplantation (July 2015).

Description

Rapid Drug Assessment:

Salmeterol and fluticasone propionate 25mcg/125mcg and 25mcg/250mcg metered dose inhaler (Sirdupla).

CosmoCol range of macrogol products

Sodium hyaluronate 1% 1.2ml pre-filled syringe (SportVis and TendoVis).

Lecicarbon C for constipation, bowel clearance and diagnostic procedures in children under 12 years.

New Drug Assessment:

Budesonide 9mg sustained release gastro-resistant tablets (Cortiment)

MHRA Drug Safety Update (June 2015):

SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin) – risk of diabetic ketoacidosis.

High-dose ibuprofen (> 2400mg/day) – small increase in cardiovascular risk.

Intrauterine contraception – Uterine perforation – updated information on risk factors.

Description

Rapid Drug Assessment:

Prednisolone 2.5mg, 5mg. 10mg, 20mg and 25mg tablets (Pevanti).

Gliclazide 30mg and 60mg modified release tablets (Vamju) for type 2 diabetes mellitus.

QIPP Opportunity:

Prednisolone – use plain, not soluble tablets.

Updated Cost Comparison:

Quetiapine sustained release tablets (Mintreleq XL).

Rapid Cost Comparison:

Felodipine 5mg and 10mg modified release tablets.

Pregabalin capsules (Lecaent and Rewisca).

NICE Technology Appraisal:

NICE Technology Appraisal 344: Ofatumumab in combination with chlorambucil or bandamustine for untreated chronic lymphocytic leukaemia (June 2015).

NICE Technology Appraisal 343: Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia (June 2015).

NICE Technology Appraisal 335: Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome (March 2015).

Description

QIPP Opportunity:

Lutein and antioxidant vitamins for prevention of age-related macular degeneration.

Lower cost branded products.

Rapid Drug Assessment:

Insulin degludec 100iu/liraglutide 3.6mg injection (Xultophy).

Glycopyrronium bromide 2% roll on applicator (unlicensed special).

Product Discontinuation:

Morphine sulphate sustained release tablets (Filnarine SR).

Product Supply Problem:

Creon 40,000 (pancreatin) gastro-resistant capsules.

NICE Technology Appraisal:

NICE Technology Appraisal 336: Empagliflozin in combination therapy for treating type 2 diabetes (March 2015).

NICE Technology Appraisal 337: Rifamixin for preventing episodes of overt hepatic encephalopathy (March 2015).

Appendix: Availability of Lower Cost Branded Products.

MHRA Drug Safety Update (April 2015):

Hydroxyzine (Atarax, Ucerax) – Risk of QT interval prologation and Torsade de Pointes.

Codeine for Cough and Cold – Restricted use in children.

High strength, fixed combination and biosimilar insulin products – Minimizing the risk of medication error.

Description

Information:

Prescribing sunscreens.

Prescribing meningococcal group B vaccine (Bexsero).

Rapid Drug Assessments:

Calcichew D3 1g/800unit Once Daily chewable tablets and TheiCal-D3 chewable tablets.

Methylphenidate 18mg and 36mg sustained release tablets (Xenidate XL).

Tolterodine 4mg sustained release capsule (Neditol XL).

Colesevelam 625mg capsules (Cholestagel) for lenalidomide induced diarrhoea.

Review:

Brimonidine 3mg/g gel (Mirvaso).

NICE Technology Appraisal:

NICE Technology Appraisal 329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (February 2015).

NICE Technology Appraisal 332: Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer (February 2015).

NICE Technology Appraisal 333: Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment (February 20015).

NICE Technology Appraisal 334: Regorafenib for metastatic colorectal cancer after treatment for metastatic disease (February 2015).

MHRA Drug Safety Update (March 2015):

Dimethyl fumarate (Tecfidera): fatal PML in a multiple sclerosis patient with severe, prolonged lymphopenia.

Description

Review:

Fluticasone propionate 5 microgram/azelastine hydrochloride 137microgram nasal spray (Dymista).

Update:

The use of intranasal corticosteroids in perennial and seasonal allergic rhinitis.

NICE Technology Appraisal:

NICE Technology Appraisal 327: Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism (December 2014).

MHRA Drug Safety Update (February 2015):

Tiotropium delivered via Respimat compared with Handihaler.

New Drugs and Driving Legislation.

Further confusion between zuclopenthixol acetate injection (Clopixol Acuphase) and zuclopenthixol decanoate injection (Clopixol).

Description

Prescribing Advice - prescribing for Chronic Open Angle Glaucoma (COAG) and Ocular Hypertension (OHT).

Lower cost generic latanoprost 50mcg per ml eye drops (2.5ml bottle) are the preferred first line option in people with glaucoma or raised intraocular pressure (IOP), particularly in those with early, mild disease. Prescribers are urged to ensure that all prescribing of latanoprost 50mcg per ml eye drops is generic.

Second line options for those who have failed to achieve the desired reduction in IOP with latanoprost or who are unable to tolerate the product are either travoprost 40mcg per ml (Travatan) or third line for new patients bimatoprost 100mcg per ml (Lumigan).

Description

Review:

NICE Clinical Guideline 184: Dyspepsia and gastro-oesophageal reflux disease or both (September 2014).

New treatments for chronic hepatitis C.

New Drug Assessment:

Simeprevir 150mg capsules (Olysio).

Sofosbuvir 400mg tablets (Sovaldi).

NICE Technology Appraisal:

NICE Technology Appraisal 331, Simeprevir in combination with peginterferon alfa and ribavirin for treating genotypes 1 and 4 chronic hepatitis C (February 2015).

NICE Technology Appraisal 330, Sofosbuvir for treating chronic hepatitis C (February 2015).

NICE Technology Appraisal 328: Idelalisib for treating follicular lymphoma that is refractory to 2 prior treatments (terminated appraisal) (December 2014).

Rapid Drug Assessment:

Zafirlukast 20mg tablets (Accolate).

MHRA Drug Safety Update (December 2014):

Ivabradine (Procoralan) in the symptomatic treatment of angina.

Isotretinoin (Roaccutane) – Reminder of possible risk of psychiatric disorders.

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.

Oral diclofenac no longer available without prescription.

Aceclofenac (Preservex)- updated cardiovascular advice.

Description

Rapid Drug Assessment:

Quetiapine modified release formulations.

Propantheline 5mg tablets (Pro-Banthine) for hyperhidrosis.

Review of formulary status of topical sodium fusidate.

NICE Technology Appraisal:

NICE Technology Appraisal 323: Erythropoiesis stimulating agents (epoetin and darbepoetin) for treating anaemia in people with cancer having chemotherapy (November 2014).

NICE Technology Appraisal 324: Dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome with atrioventricular block (November 2014).

NICE Technology Appraisal 325: Nalmefene for reducing alcohol consumption in people with alcohol dependence (November 2014).

NICE Technology Appraisal 326: Imatinib for the adjuvant treatment of gastrointestinal stromal tumours (November 2014).

NHS England, Patient Safety Alert:

Risk of death or serious harm from accidental ingestion of potassium permanganate preparations (December 2014).

Risk of death and serious harm from delays in recognising and treating ingestion of button batteries (December 2014).

Description

New Drug Assessment:

Naltrexone 50mg tablets for pruritis due to cholestasis (unlicensed gastroenterology and dermatology indication).

Discontinuation of pipothiazine palmitate 50mg/ml injection (Piportil Depot).

Other:

Supply problems with haloperidol 500 microgram capsules.

NICE Technology Appraisal:

NICE Technology Appraisal 321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma (October 2014).

NICE Technology Appraisal 322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality (September 2014).

NICE Diagnostic Guidance 14: Atrial fibrillation and heart valve disease: self‑monitoring coagulation status using point‑of‑care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) (September 2014).

MHRA Drug Safety Update (November 2014):

Agomelatine (Valdoxan) – Risk of liver toxicity.

Colobreathe (colistimethate sodium dry powder for inhalation): Risk of capsule breakage.

Boceprevir (Victrelis) and telaprevir (Incivo) – Baseline predictive factors for sepsis, worsening liver function and mortality.

Ponatinib (Iclusig) – Risk of vascular occlusive events.

Chlorhexidine solutions – Reminder of the risk of chemical burns in premature infants.

Desiccants in blister packs – Risk of ingestion.

NHS England, Patient Safety Alert:

Risk of distress and death from inappropriate doses of naloxone in patients on long-term opioid/opiate treatment (November 2014).