PRESCRIPTION PAD. The Newsletter of the Cumbria Area Prescribing Committee. February 2012 No. 18. Click here to find more. News from the MHRA

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1 PRESCRIPTION PAD The Newsletter of the Cumbria Area Prescribing Committee February 2012 No. 18 Click here to find more Clinical policy and Formulary news Lothian changes Targeted Medication Use Reviews (MUR s) Silver dressings Paracetamol doses in children a reminder Recommendations on new medicines Degarelix News from the MHRA Dronedarone (Multaq ): cardiovascular, hepatic and pulmonary adverse events new restrictions and monitoring requirements Buccal midazolam (Buccolam ): new authorised medicine for paediatric use care needed when transferring from unlicensed formulations NICE Guidance TA235 Mifamurtide for osteosarcoma TA236 Ticagrelor for acute coronary syndromes CG130 Hyperglycaemia in acute coronary syndromes CG131 Colorectal cancer Miscellanea

2 Clinical Policy and Formulary News Lothian changes Targeted Medication Use Reviews(MUR s) Antidiabetes drugs Glitazones (thiazolidinediones) Vitamins Saxagliptin licence has changed and it can now be prescribed in patients with moderate to severe renal impairment. It should be prescribed at a reduced dose of 2.5mg daily. Saxagliptin is approved for use in combination with metformin, where the addition of a sulphonylurea is not appropriate. Sitagliptin remains first choice, as it has more SMC approved indications. Prescribing notes have been added to provide guidance on the use of pioglitazone in patients with current or history of bladder cancer. This section has been rewritten, with some new subsections added, following recent approvals at formulary committee. New subsections include: vitamin A and D in cystic fibrosis and other malabsorption syndromes vitamin E One of the eligible groups for a targeted MUR is patients recently discharged from hospital whose medicines have been changed during admission. The Local Pharmaceutical Committee (LPC) and the Pharmacy departments at the Cumberland Infirmary and Furness General are working to raise awareness of this service. The LPC have produced a leaflet which will be included in bags of discharge medicines from the Cumberland Infirmary and Furness General. If this is successful, it will be extended to other hospitals in Cumbria and community hospitals. You may get queries from patients who have been given the leaflet, please direct them to their usual community pharmacy. Medicines managers will also receive a supply of the leaflets to include when they post out an amended right hand side of a repeat prescription following receipt of a discharge medication summary in the practice. It is well recognised that the period immediately post discharge is high risk period for patients, communication about changes made to medication may not have been received by the GP practice before the patient requests further supplies with the potential for discontinued medication to be supplied or new medicines missed. This service aims to ensure that patients are taking the correct medicines during this vulnerable period, so it is important that the MUR is done as soon as possible after discharge and within 4 weeks. Silver dressings The APC has agreed to endorse the document, Best Practice Statement, the use of topical antiseptic/antimicrobial agents in wound management, 2 nd edition ( )

3 Paracetamol doses in children a reminder The doses of paracetamol have recently been changed. A reminder of the recommended doses is as follows: The APC still has some concerns about the inappropriate use of wound dressings. The Drug and Therapeutics Bulletin (2010, vol. 48, no. 4) reviewed the use of silver dressings. It concluded that: There have been few high quality clinical trials to establish whether they have advantages over other, cheaper, alternatives The routine use of silver dressings is not justified on clinical or cost effectiveness grounds as treatment for uncomplicated leg ulcers Silver dressings should not be used on acute wounds, as there is weak evidence to suggest that they delay wound healing Where silver dressings are used, the wound should be reassessed regularly Silver dressings should be stopped if the wound does not respond, or once infection is controlled (Reproduced with permission, LN ) FOR PARACETAMOL INFANT SUSPENSION (120mg/5mL) Age: 2 3 months Dose 1. Post vaccination fever 2.5mL 2. Other causes of pain and fever if your If necessary, after 4 6 hours, give a baby weighs over 4kg and was born after second 2.5mL dose 37 weeks Do not give to babies less than 2 months of age Do not give more than 2 doses Leave at least 4 hours between doses If further doses are needed, talk to your doctor or pharmacist Child s age How much How often (in 24 hours) 3 6 months 2.5mL 4 times 6 24 months 5mL 4 times 2 4 years 7.5mL 4 times 4 6 years 10mL 4 times Do not give more than 4 doses in any 24 hour period Leave at least 4 hours between doses Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

4 FOR PARACETAMOL SIX PLUS SUSPENSION (240mg/5mL OR 250mg/5mL) Child s age How much How often (in 24 hours) 6 8 years 5mL 4 times 8 10 years 7.5mL 4 times years 10mL 4 times Do not give more than 4 doses in any 24 hour period Leave at least 4 hours between doses Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist Do not give to children under the age of 6 years Dose for children age years: 10 to 15mL up to 4 times a day Dose for adults and children over 16 years: 10 to 20mL up to 4 times a day Return to page 1

5 Recommendations on New Medicines The following drugs have been recommended as suitable for use: Degarelix injection (Firmagon ) Treatment of adult male patients with advanced hormone dependent prostate cancer. Added as a prescribing note, suitable for patients at risk from testosterone flare if given LHRH agonist RED Return to page 1

6 News from the MHRA Dronedarone (Multaq ): cardiovascular, hepatic and pulmonary adverse events new restrictions and monitoring requirements Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful cardioversion in a limited population of patients with paroxysmal or persistent atrial fibrillation; however, in light of safety concerns dronedarone should only be prescribed after other treatment options have been considered. To support safer use, patients should have their treatment reviewed at the next routine appointment to ensure that they remain eligible for dronedarone treatment according to the revised prescribing information, including new restrictions on use. Regular monitoring of cardiac, liver, and renal function during treatment is recommended: Cardiovascular monitoring: Patients should receive regular cardiac examinations, including an ECG at least every 6 months, to identify those who revert to AF. Discontinuation of dronedarone should be considered for these patients Discontinue treatment if the patient develops permanent AF Patients should be carefully evaluated for symptoms of heart failure during treatment Patients should be appropriately anticoagulated as per clinical AF guidelines. International Normalised Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per the prescribing information for these products Hepatic monitoring: Liver function tests should be done: before starting treatment with dronedarone; after 1 week of treatment; after 1 month of treatment; then every month for 6 months; at month 9; at month 12; and periodically thereafter Renal monitoring: Plasma creatinine values should be measured before and 7 days after initiation of dronedarone, and renal function should be monitored periodically afterwards. Discontinue treatment in any patients with further elevations of serum creatinine Pulmonary monitoring: Cases of interstitial lung disease, including pneumonitis and pulmonary fibrosis, have been reported in

7 Buccal midazolam (Buccolam ): new authorised medicine for paediatric use care needed when transferring from unlicensed formulations association with dronedarone. Onset of dyspnoea or non productive cough may be related to pulmonary toxicity. If pulmonary toxicity is suspected during treatment, relevant lung examinations should be considered and treatment discontinued if confirmed. Buccal midazolam (Buccolam ) is a new authorised treatment for prolonged acute convulsive seizures. It is now available on the UK market. Buccal midazolam may be considered as an alternative to rectal diazepam for the treatment of prolonged seizures. Several factors should be considered when transferring patients to the authorised Buccolam product when an unlicensed medicine other than Buccolam has been used previously Buccal midazolam may be considered as an alternative to rectal diazepam for the treatment of prolonged seizures. Various buccal midazolam preparations have been used in children as unlicensed medicines, including Buccolam prior to authorisation. Several factors should be considered when transferring patients to the authorised Buccolam product when an unlicensed medicine other than Buccolam has been used previously. Buccolam is half the strength of some other unlicensed preparations. It contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. Although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorised for Buccolam. The preparations available are as follows (and are colour coded): Age Range Dose Label colour 3 to 6 months (hospital setting 2.5mg (0.5mL) Yellow >6 months to <1 year 2.5mg (0.5mL) Yellow 1 year to <5 years 5mg (1mL) Blue 5 years to <10 years 7.5mg (1.5mL) Purple 10 years to <18 years 10mg (2mL) Orange Return to page 1

8 NICE guidance These are brief summaries. The complete guidance should be consulted ( ) Drug Condition Resume TA235 Mifamurtide Osteosarcoma Mifamurtide in combination with postoperative multi agent chemotherapy is recommended within its licensed indication as an option for the treatment of high grade resectable non metastatic osteosarcoma after macroscopically complete surgical resection in children, adolescents and young. RED TA236 Ticagrelor Acute coronary syndromes At present, the position of ticagrelor in Cumbria is being considered further. Guidance will be published once it has been agreed. AMBER CG130 Hyperglycaemia in acute coronary syndrome Manage hyperglycaemia in patients admitted to hospital for an acute coronary syndrome (ACS) by keeping blood glucose levels below 11.0mmol/litre while avoiding hypoglycaemia. In the first instance, consider a dose adjusted insulin infusion with regular monitoring of blood glucose levels. Do not routinely offer intensive insulin therapy (an intravenous infusion of insulin and glucose with or without potassium) to manage hyperglycaemia (blood glucose above 11.0 mmol/litre) CG131 Colorectal cancer When offering multiple chemotherapy drugs to patients with advanced and metastatic colorectal cancer, consider one of the following sequences of chemotherapy unless they are contraindicated: FOLFOX (folinic acid plus fluorouracil plus oxaliplatin) as first line treatment then single agent irinotecan as second line treatment or FOLFOX as first line treatment then FOLFIRI (folinic acid plus fluorouracil plus irinotecan) as second line treatment or XELOX (capecitabine plus oxaliplatin) as first line treatment then FOLFIRI (folinic acid plus fluorouracil plus irinotecan) as second line treatment.

9 Miscellanea This is available at the PCT Medicines Management website at: Return to page 1

Buccal Midazolam For the treatment of prolonged epileptic seizures, clusters of epileptic seizures and status epilepticus.

Oxfordshire Clinical Commissioning Group, Oxford University Hospitals NHS Trust and Oxfordshire Health NHS Foundation Trust Shared Care Protocol and Information for GPs Buccal Midazolam For the treatment