NPC Archive Item: April Drug Safety Update from MHRA/CHM

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13th April 2011

The MHRA and CHM have published the April edition of Drug Safety Update. This edition advises healthcare professionals of the following:

  • In patients taking atypical (second-generation) antipsychotics, weight, glucose, and lipid levels should be monitored and managed
  • Tigecycline▼ has been shown to be associated with increased mortality in clinical trials and should be prescribed only when other antibiotics are unsuitable
  • Stavudine should be used only when there are no appropriate alternatives, and then only for the shortest possible time. This is due to an increased risk of potentially severe adverse effects compared with alternative HIV treatments.
  • Prescribers of Vivaglobin® are asked to be vigilant for signs of arterial or venous thromboembolism due to the rare risk of associated thromboembolic events. Where possible, prescribers are advised to use alternative appropriate therapy for patients with risk factors for thromboembolism.

More details are available in Drug Safety Update (DSU), which also includes links to further useful sources of information. This publication is an essential read for everyone whose professional practice involves medicines.

Atypical (second generation) antipsychotics: important monitoring reminder

People with schizophrenia are around three times more likely to die prematurely, largely of cardiovascular (CV) disease, compared to those without mental health disorders. While many people with schizophrenia have higher rates of certain CV risk factors (e.g. smoking, poor diet etc), some atypical antipsychotics are associated with significant weight gain (>7% of baseline), dyslipidaemia, and hyperglycaemia (metabolic adverse effects). Individual atypical antipsychotics differ in their propensity for metabolic adverse effects: available data suggest that clozapine, olanzapine, and quetiapine are especially implicated.

In support of the NICE guidance on schizophrenia, the DSU reminds of the need for the following when atypical antipsychotics are used in people with schizophrenia:

  • early identification of modifiable risk factors
  • monitoring for further development of metabolic adverse effects
  • management of metabolic adverse effects.

As NICE recommend, accompanied by an audit standard, GPs and primary healthcare professionals should monitor the physical health of all people with schizophrenia at least once a year. Bearing in mind their increased CV risk profile compared with the general population, their care should be managed according to the relevant NICE guidance (e.g. CG 67 – lipid modification,  CG34 for hypertension, CG43 for obesity, CG15 for type 1 diabetes, CG66 for type 2 diabetes).

Furthermore, the MHRA/CHM advises healthcare professionals managing people with schizophrenia to:

  • Encourage and educate patients as appropriate to maintain a healthy diet and regular exercise
  • Base any decision to change antipsychotic drugs on a careful assessment of the potential benefits versus the risks of destabilising the person’s mental state.

Audit data from 2006 suggested that CV assessment and monitoring of patients taking antipsychotics was sub-optimal. For example, only 26% had a recorded blood pressure measurement within the previous year, while obesity in 17%, blood glucose (or HbA1c) in 28% and plasma lipids in 22% were also sub-optimally recorded. All 4 measures were documented in only 11% of patients. More recent data from Humberside using the NICE audit standards as a measure, indicate there is some progress to be made before people with schizophrenia are given the requisite standards of care.

NICE guidance on schizophrenia gives further information about physical health screening for people with schizophrenia. More information on schizophrenia can be found in the NPC e-learning materials.

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