The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of August 2013. This month there are two clinical guidelines and one technology appraisal that impact upon primary care.
The Acute kidney injury guideline provides evidence-based advice on the prevention, detection and management of acute kidney injury. It recommends assessment for kidney injury in acutely ill individuals with risk factors such ask chronic kidney disease, heart failure, diabetes and those using nephrotoxic drugs.
The Autism - management of autism in children and young people guideline provides evidence-based advice on the care and management of children and young people with autism. Effective communication is encouraged and should include families and carers. The guideline includes recommendations on anticipating and preventing behaviour that challenges as well as treatment interventions.
The Breast cancer - everolimus technology appraisal does not recommend the use of this drug in combination with exemestane for treating advanced HER2-negative hormone-receptor-positive breast cancer after endocrine therapy. The review concluded that it does not provide enough benefit to patients to justify its high cost.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
MTRAC issued a new Commissioning Support review in August 2013. The review covers mirabegron.
The Mirabegron (Betmiga®) summary advises that this drug is suitable for prescribing in primary care. The committee considered the drug to have a lower place in therapy and relatively weak evidence due to limited comparative data with anti-muscarinics and limited long-term efficacy data. The committee also noted that NICE has recommended this treatment as an option for treating overactive bladder (OAB) only for people in whom anti-muscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Abatacept (Orencia®) has been accepted for restricted use in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a TNF-alpha inhibitor. Use is only recommended in individuals with a disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.
Elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild) has been accepted for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to the three antiretroviral agents in this product. It is noted that this advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness.
Pirfenidone (Esbriet®) has been accepted for restricted use in the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Use is only recommended in patients with a predicted forced vital capacity (FVC) less than or equal to 80%.
Ursodeoxycholic acid (Ursofalk®) has been accepted for use in the dissolution of cholesterol gallstones in the gall bladder. The product licence limits use to when the gallstones do not show as shadows on X-ray images and do not exceed 15mm in diameter and the gall bladder must be functioning despite the gallstone(s).
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2013 (PDF).
This issue contains drug safety advice reminding clinicians that nitrofurantoin is contraindicated in patients with a creatinine clearance of less than 60ml/min. It is recommended that clinicians are aware of the current renal function when prescribing nitrofurantoin, especially for elderly patients.
The hot topic section reminds clinicians should not prescribe oral ketoconazole for fungal infections because the risk of liver injury outweighs benefits. Topical formulations are unaffected by this advice. Any patient currently taking ketoconazole orally for fungal infections should be reviewed and treatment stopped or an appropriate alternative issued. This section also contains a summary of the recently issued European Medicines Agency advice recommending that the dose and duration of use for metoclopramide is restricted because of neurological side effects.
This issue also contains information that the SSRI Learning Module has been updated to include information about QT interval risk and that a public consultation has been opened into the continued availability of oral diclofenac for purchase in pharmacies as a Pharmacy (P) medicine. This consultation will not affect topical products or the availability of diclofenac on prescription.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute for Care Excellence (NICE) has published good practice guidance for those involved in providing medicines to patients without a prescription under a Patient Group Direction (PGD).
It recommends that PGDs are used when only when there is a clear benefit to the patient, safety is not compromised and provided there are transparent processes and line of accountability.
The guidance further recommends that organisations explore all the available options for supplying and/or administering medicines before developing a PGD including consideration of investing in training more non-medical prescribers to enable service redesign. It is also recommended that PGDs are not used to treat long term conditions or to provide medication with frequent dose changes (e.g. insulin and anticoagulants).
Action: Clinicians who use PGDs or who are involved in the preparation and review of PGDs will find this guide to be a useful resource.