The EMA has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether the effectiveness of Levonelle (containing levonorgestrel) and ellaOne (containing ulipristal acetate) was reduced with increased body weight. They concluded that based on the data available the benefits of using these emergency contraceptives remains positive and it cannot be concluded that body weight has an impact on the effectiveness of these widely used medicines.
Click Here to see the MHRA Alert that has been sent to Pharmacies.
Background
You may already be aware that on 24th January 2014 the European Medicines Agency (EMA) launched a review of oral emergency hormonal contraception (EHC) to assess whether increased body weight/BMI reduces its efficacy in preventing an unintended pregnancy. More information on the work being undertaken by the EMA is available in their press notice.
The review covers the two types of EHC available within the EU – and the UK – levonorgestrel and ulipristal acetate. It is being carried out under the provisions of Article 31 of the EU Medicines Directive (2001/83/EC) which covers referrals relating to the evaluation of data from pharmacovigilance (drug safety) activities of authorised medicinal products.
The review was triggered in response to changes in the levonorgestrel (Norlevo) licence in a number of European countries based upon evidence indicating that a high bodyweight could impact the effectiveness of EHC.
The EMA’s final decision may result in the need to make some changes to current practices within a short time frame, both for commissioners and service providers such as community pharmacies who provide EHC through a patient group direction or who sell EHC over the counter.
The Faculty of Sexual and Reproductive Healthcare of the RCOG has recently published an update on this subject aimed at healthcare professionals; it outlines existing recommendations and arrangements for EHC provision in the UK.
The document has been provided to clarify the current situation and to facilitate planning and rapid implementation of any changes to EHC availability that may result from the EMA review. A decision-making guide for community pharmacists is included as an appendix for quick reference. The guide will be easily amended to include weight criteria if this is indicated by the outcome of the EMA review and the FSRH will issue further guidance after the EMA report is published.
Click Here to see the MHRA Alert that has been sent to Pharmacies.
Background
You may already be aware that on 24th January 2014 the European Medicines Agency (EMA) launched a review of oral emergency hormonal contraception (EHC) to assess whether increased body weight/BMI reduces its efficacy in preventing an unintended pregnancy. More information on the work being undertaken by the EMA is available in their press notice.
The review covers the two types of EHC available within the EU – and the UK – levonorgestrel and ulipristal acetate. It is being carried out under the provisions of Article 31 of the EU Medicines Directive (2001/83/EC) which covers referrals relating to the evaluation of data from pharmacovigilance (drug safety) activities of authorised medicinal products.
The review was triggered in response to changes in the levonorgestrel (Norlevo) licence in a number of European countries based upon evidence indicating that a high bodyweight could impact the effectiveness of EHC.
The EMA’s final decision may result in the need to make some changes to current practices within a short time frame, both for commissioners and service providers such as community pharmacies who provide EHC through a patient group direction or who sell EHC over the counter.
The Faculty of Sexual and Reproductive Healthcare of the RCOG has recently published an update on this subject aimed at healthcare professionals; it outlines existing recommendations and arrangements for EHC provision in the UK.
The document has been provided to clarify the current situation and to facilitate planning and rapid implementation of any changes to EHC availability that may result from the EMA review. A decision-making guide for community pharmacists is included as an appendix for quick reference. The guide will be easily amended to include weight criteria if this is indicated by the outcome of the EMA review and the FSRH will issue further guidance after the EMA report is published.
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