The National Prescribing Centre has published "Prescribing Specials – Five guiding principles for prescribers" (PDF). This resource discusses the prescribing of special-order unlicensed medicines (or Specials) made to meet the needs of an individual patient.
Prescribing Specials is associated with more risk than when prescribing a licensed medication. This document introduces five principles to support prescribers in the safe and appropriate use of Specials. The five principles are:
- Establish a clinical need - Can the clinical need of the patient only be met by a Special?
- Identify medicines and preparations - Consider the safety, effectiveness, quality and cost of all the options available
- Make a shared decision with the patient (or carer)
- Ensure effective prescribing governance - Understand the rationale for using a Special and the practical implications before prescribing
- Monitor and review on an ongoing basis - the need for the Special should be regularly reviewed in terms of the Special and the medicine it contains
Action: This document is a valuable resource to any clinician who may need to prescribe a Special product.
The British Medical Journal has published the results of a meta-analysis that aimed to assess the effect of intensive blood glucose lowering on cardiovascular outcomes and microvascular events in patients with type 2 diabetes.
The analysis included 13 studies involving 34,533 participants (18,315 in the intensive treatment group and 16,218 in the standard treatment group). The primary outcomes for the study were all cause mortality and cardiovascular death with secondary outcomes of severe hypoglycaemia, macrovascular and microvascular events. The studies all involved patients over the age of 18 years (mean age of 62 years) and with a diagnosis of type 2 diabetes. The mean follow up for the studies was 5 years.
There was no difference noted in the primary outcomes. In the secondary outcomes, intensive glucose lowering was associated with a reduced risk of non-fatal myocardial infarction and new onset microalbuminuria but an increased risk of severe hypoglycaemia.
The results of this analysis indicate that intensively lowering blood glucose in 600 patients for 5 years would:
- Prevent 4 or 5 non-fatal myocardial infarctions
- Present 4 to 20 cases of new onset microalbuminuria
- Cause 12 to 40 cases of severe hypoglycaemia
The authors conclude that, "the overall results of this meta-analysis show limited benefits of intensive glucose lowering treatment". They note that the risk:benefit ratio of intensive glucose lowering remains uncertain and that more randomised controlled trials are needed.
This study adds yet more weight to using an holistic approach to treat type 2 diabetes with due consideration of preventing macrovascular and microvascular complications. Lifestyle interventions, blood pressure and lipid management should be prioritised ahead of intensive glucose management.
Action: Clinicians should be aware of this analysis. Intensive glucose lowering should only be a consideration once all other interventions are effectively implemented.
The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of July 2011. This month there are two technology appraisals that impact upon primary care.
Retigabine (Trobalt®) is recommended (QRG) for the adjuvant treatment of partial onset seizures in epilepsy. NICE has recommended that this treatment as an option for individuals aged 18 years and older in whom existing treatments have proven ineffective or have been poorly tolerated. Treatment changes would normally be recommended by a specialist.
Agomelatine (Valdoxan®) has not been recommended (QRG) for the treatment of major depressive episodes. The appraisal was terminated when the manufacturer advised that they would not be making an evidence submission as the current evidence would not allow an economic case to be made. NICE has noted that NHS organisations should take into consideration the reasons why an evidence submission was not made when deciding whether or not to recommend local use of agomelatine.
Action: Clinicians should be aware of these recommendations and implement any necessary changes to practice.
The Joint Committee on Vaccination and Immunisation (JCVI) has issued revised advice (PDF) regarding the routine pneumococcal vaccination programme for adults aged 65 years and older using pneumococcal polysaccharide vaccine (PPV).
In March this year, advice was issued that the programme should be discontinued because there have been no discernible reduction in the rate of invasive pneumococcal disease since the introduction of the vaccine. The DH sought the views of professional and patient groups and the vaccine manufacturers before making a final decision. Following a review of all the submissions and a new analysis the JCVI have concluded that, "whilst uncertainty remains about the effectiveness of PPV, there is better evidence from the UK experience of the vaccine suggesting that PPV provides some moderate short-term protection to those aged 65 years and older, although protection may be less and wane faster in older age groups and for some clinical risk groups".
The JCVI have therefore recommended continuing the current programme with routine use recommended in individuals aged 65 years and older. It is also suggested that the efficacy of the programme is reviewed again in 2 years time.
This revised advice is the subject of a Department of Health (DH) letter (PDF) that states that the new analysis indicates that the programme remains cost effective despite the limited effectiveness of the vaccine.
Action: Clinicians should be aware of this review and final decision. Clinicians should continue to implement the advice in the Green Book.
The European Medicines Agency (EMA) has recommended (PDF) several new contra-indications and warnings for pioglitazone (Actos®) to minimise the impact of a small increased risk of bladder cancer.
The review concluded that "these medicines remain a valid treatment option for certain patients with type 2 diabetes" but that "the small increased risk could be reduced by appropriate patient selection and exclusion".
Clinicians are advised to not use pioglitazone in:
- Patients with bladder cancer
- Patients with a history of bladder cancer
- Patients with uninvestigated macroscopic haematuria
Risk factors for bladder cancer should be assessed before starting treatment, especially in older patients and treatment should be regularly reviewed and only continued when treatment continues to provide a benefit.
The relative risk of bladder cancer from three recent observational studies ranges from 1.12 to 1.33. A meta-analysis of randomised controlled trials indicated an absolute risk increase of 0.08% (7 cases in 10,212 patients or 0.07% risk in the placebo group versus 19 cases in 12,506 patients or 0.15% in the treatment group).
The EMA has also requested that a pan-European epidemiological study is conducted to provide more robust information about the risk.
Action: Clinicians should be aware of this review and the additional warnings and contra-indications for pioglitazone. The figures quoted in the review may be helpful when explaining the risks to patients.
UPDATE: A summary is now available from the Medicines and Healthcare products Regulatory Agency (MHRA).