 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.
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 The MHRA has issued class 2 drug alerts for Wockhardt and Pinewood Laboratories following manufacturing site inspections.
Pharmacies will need to take action within the next 48 hours and should note the large number of products affected this time. 16 different prescription only medicines in a variety of strengths made by Wockhardt Ltd are affected following manufacturing deficiencies identified by the MHRA at Wockhardt’s Waluj site in India. The medicines affected by the precautionary recall include those used for the treatment of infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson’s disease, dementia in Alzheimer’s patients and thyroid conditions. Full Details of the recalls 1. Class 2 Drug Alert (Action within 48 Hours): Multiple products - Wockhardt UK Limited (EL (13)A/19) - This includes a list of all the medicines that are affected by the precautionary recall. 2. Class 2 Medicines recall (Action within 48 Hours): Erythromycin Oral Suspension - Pinewood Laboratories Limited (EL (13)A/20) Patients do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall in the UK are defective. Therefore, it’s important that people continue to take their medicines as prescribed. This is not a patient level recall because although the medicines that are affected have not been manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK. However, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue. The deficiencies identified by the MHRA during a routine inspection in March included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten. The MHRA is working with Wockhardt and other international regulators to resolve these issues. Gerald Heddell, the MHRA’s Director of Inspection, Enforcement and Standards, said: “This is a precautionary recall. People can be reassured that there is no evidence that medicines made by Wockhardt are defective so it’s important people continue to take their medicines as prescribed. “All batches of medicines manufactured outside the European Union are tested on importation to the UK before they reach patients. However, we have taken this precautionary action because the medicines have not been manufactured to the right regulatory standards. “We are working with the Department of Health to ensure that people have access to the medicines they need. Anyone who has questions should speak to their pharmacist or GP.” The medicines that are involved in the recall are available for patients from alternative manufacturers in most cases, either in equivalent strengths or varying strengths. Where there are no alternative manufacturers of the same medicines, substitutes are available and these should be selected by a healthcare professional. The Department of Health is working closely with the companies concerned to help ensure that patients are able to get their medicines when they need them. |
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