The National Institute of Health and Clinical Excellence has published new guidance for the month of February 2011. This month there are two clinical guidelines that impact upon primary care.
The alcohol dependence and harmful alcohol use clinical guideline (PDF) provides information regarding the diagnosis, assessment and management of harmful drinking and alcohol dependence in adults and in young people aged 10–17 years.
The food allergy in children and young people clinical guideline (PDF) discusses the diagnosis and assessment of food allergy in children and young people in primary care settings. It specifically covers individuals with symptoms or signs that could suggest a food allergy and those at higher risk (for example those with other atopic illnesses like asthma and eczema). It does not cover reactions to a food that is not caused by the immune system such as lactose intolerance. This guideline was reported in the general media and there may be increased demand for consultations relating to presumed allergy symptoms.
Action: Clinicians should be aware of these recommendations and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Capsaicin cutaneous patches (Qutenza®) have been accepted for restricted use for the treatment of peripheral neuropathic pain in non-diabetic adults who have not achieved adequate pain relief from, or who have not tolerated, conventional first and second-line treatments. Treatment should be under the supervision of a specialist in pain management.
Fenticonazole (Ginoxin®) has been rejected for use in the treatment of vulvovaginal candidiasis. The manufacturer failed to make a submission.
Ivabradine (Procoralan®) has been rejected for the treatment of symptomatic chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm, in combination with beta-blockers, in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm. The manufacturer failed to make a submission.
Miconazole buccal tablets (Loramyc®) have been rejected, following a resubmission, for the treatment of oropharyngeal candidiasis in immunocompromised patients. The manufacturer failed to provide a sufficiently robust clinical and economic analysis to gain acceptance.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The National Prescribing Centre (NPC) has published a MeReC Bulletin (PDF) that reviews the prescribing of generic medicines in primary care.
This review describes the nature of branded and generic medicines and the regulatory process that is required for a generic medicine to be granted a product license. "Branded Generics" are also discussed; these are generic medicines which are given a brand name and generally priced below the Drug Tariff price.
It is recognised that some medications should rightly be prescribed by the branded name, for example to ensure stable blood levels of drugs with a narrow therapeutic index. However, it is also noted that there is no official list of medicines that should not be prescribed generically. Readers are directed to a document developed by the Health and Social Care Board of Northern Ireland that is an excellent starting resource.
Generic substitution has been proposed as a method to reduce NHS drug costs but these plans have been suspended. However, the Department of Health still supports generic prescribing especially when 5% of medicines were prescribed by brand name in 2008 when a generic alternative was available.
Action: Clinicians should already be aware of the potential for cost savings from using generic medicines. This review is a useful reminder that there are still savings to be made in this area.
The National Prescribing Centre has published MeReC Extra 48 (PDF) which discusses recently published SEARCH study and a meta-analysis that included the SEARCH results.
The SEARCH study compared simvastatin 20mg to simvastatin 80mg over a period of 6.7 years for secondary prevention of cardiovascular events. This study found no significant difference in major vascular events but a higher risk of side effects including myopathy and rhabdomyolysis with the higher dose.
The meta-analysis reviewed the benefits of statin therapy and included the SEARCH results. The review concluded that reductions in LDL cholesterol of 1mmol/L result in a reduction in major cardiovascular events of approximately 20%. They also note that more intensive statin therapy in selected high-risk populations might bring additional benefits.
Action: This new evidence supports the current NICE Lipid Modification guideline. Simvastatin 40mg daily remains the first line choice in the majority of people with higher intensity treatment reserved for consideration in those at higher risk after assessment of risks and benefits.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2011 (PDF).
This issue contains drug safety information on several drugs including dronadarone (Multaq®) and omalizumab (Xolair®).
The anti-arrhythmic dronadarone has been linked with liver toxicity and increased monitoring has been recommended. It is also associated with an increased risk of new onset heart failure and worsening of symptoms of pre-existing heart failure. Patients should be advised to report signs of developing or worsening heart failure such as weight gain, oedema and dyspnoea.
Omalizumab, a sub-cutaneous monoclonal antibody for moderate to severe asthma, has been associated with arterial thrombotic events. This product is a sub-cutaneous injection and may be self administered, as such local supply arrangements may differ. Prescribers are asked to be vigilant for such events and report these through the Yellow Card system.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.