The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for Menjugate Kit vaccine, a meningococcal group C conjugate vaccine.
The recall applies to two batches (235012A and 236011) and is a precautionary measure following the failure of one of the vaccines ingredients to pass a sterility test.
Information provided by the MHRA indicates that both of the above batches of vaccine have passed all tests, including the sterility test however these batches are being recalled as a precautionary measure to ensure that there are no grounds for anyone to be concerned.
Parents who are concerned about this recall are advised to contact their doctor. Different vaccines and different batches of Menjugate are not affected by this recall.
Action: Clinicians should be aware of this recall and ensure that appropriate action is undertaken. Worried parents can be reassured if it is found that a different batch of Menjugate has been used.
The National Institute of Health and Clinical Excellence has published new guidance for the month of February.
There is one guideline that may impact on primary care, a clinical guideline on rheumatoid arthritis. This guideline recommends that treatment is started early during active disease in order to minimise damage to joints.
A combination of disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate and one other DMARD are recommended to be started within 3 months of the onset of persistent symptoms. In addition, a short course of a steroid is recommended to provide symptomatic relief during a flare.
The guideline also details the place in therapy for analgesics (including non-steroidal anti-inflammatory drugs), long-term steroids and biological agents.
Finally, the guideline recommends that people with rheumatoid arthritis are offered access to a multi-disciplinary team (MDT) including:
- specialist occupational therapy if they have trouble with daily activities or hand function
- specialist physiotherapy to improve general fitness, flexibility and strength
- a podiatrist if they have particular foot problems
Action: Primary care clinicians should be aware of these new guidelines. Clinicians who see patients with rheumatoid arthritis will find this information useful.
Deafness Research UK has published a leaflet that aims to give parents practical tips and guidance on ear infections and glue ear in children.
According to the BBC, the charity are concerned that overuse of antibiotics is not treating the root cause of recurrent ear infections. In the long term this can result in problems with speech development and perhaps hearing loss.
The leaflet aims to improve knowledge among parents about what to do if their child has recurring or persistent ear problems. This includes advice that antibiotics only help a small proportion of children with ear infections despite the commonly held belief that antibiotics offer a cure.
Orders for up to 10 leaflets are free (but donations are welcome) with order for more incurring a nominal charge to cover production and postal costs.
Action: Clinicians may find this leaflet useful when discussing treatment options for recurrent childhood ear infections with parents.
The National Institute for Health and Clinical Excellence (NICE) has been forced to reconsider the guidelines issued for osteoporosis after a successful high court challenge from one of the affected drug manufacturers.
The legal challenge was based on several points including:
- Lack of transparency around the economic model
- Misinterpretation of the clinical data
- Infringement of rights under EU and UK discrimination law
The ruling upheld the allegation regarding the economic model that was used in producing the guidelines but the other grounds were ruled in favour of NICE. The guidelines will now need to be reviewed but they may not change.
Action: Clinicians should be aware of the review status of these guidelines. The existing advice should continue to be implemented until the review is completed.
The British Medical Journal has published the results of a systematic review and meta-analysis that aimed to investigate the association between treatment-induced change in high density lipoprotein (HDL) cholesterol and cardiovascular morbidity and mortality.
HDL levels are already recognised as an independent predictor of cardiovascular risk but it remains unclear whether medical intervention in addition to established treatments provides incremental benefit.
This study reviewed data from 108 randomised controlled trials including 299,310 participants. After the data were corrected for changes in low density lipoprotein (LDL) cholesterol measured differences in HDL were not associated with the risk of cardiovascular events, cardiovascular deaths or total deaths. When statistically modelling the data, a model using HDL and LDL variables was no better than a model using LDL alone.
The authors conclude that, "simply increasing the amount of circulating high density lipoprotein cholesterol does not reduce the risk of coronary heart disease events, coronary heart disease deaths, or total deaths".
An accompanying editorial notes that these findings are "relatively simple and consistent with clinical practice guidelines". However they also state that these results have some inherent limitations as they are based on mean HDL levels and therefore increasing HDL in selected patients with low HDL cholesterol may still be beneficial.
Action: Clinicians should continue to focus lipid modifying interventions to reduce cardiovascular risk on reducing LDL levels.
Thanks to Kevin Ashworth for spotting this article