There have been some complaints related to the reintroduction of the cylindrical Oestrogel bottles.
Besins Healthcare continues to conduct further investigations of reported product quality complaints, patient returned samples, market samples and samples held at manufacturing sites. The analyses performed did not identify a root cause that confirms concerns regarding the efficacy of the gel, or sub-optimal dosages dispensed from the Oestrogel bottles in question. The testing methods used adhere to the required quality standards.
To ensure a continuous supply, we have prioritised providing Oestrogel in the cylindrical bottle (white lid), and at present the supply is limited to the cylindrical bottle. Both conical and cylindrical bottles contain the same gel manufactured with the same ingredients from the same suppliers. The gel formulation has not been changed.
Advice for healthcare professionals
• Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Follow your company’s returns procedure through your wholesaler to arrange a credit note or contact Besins (see Further Information below for contact details).
• If a patient presents with a defective pump from these batches a replacement product will be required, particularly as continuity of treatment is important for HRT products.
The Department of Health and Social Care (DHSC) has confirmed that, as this is a prescription-only medicine, a new prescription will be required for the dispensing of a replacement product.
• The majority of patients who have received this product will be entitled to free prescriptions and/or have arrangements in place for an HRT pre-payment certificate and therefore a new prescription will not incur any additional costs. Where patients pay for NHS prescriptions, a charge for the new prescription will apply; patients may contact the Defective Medicines Reporting Centre if further information is required.
Besins Healthcare (UK) Ltd has confirmed that all other batches are unaffected and that there is no impact on supply.
BHUK/2024/083r
March 2024
Further Information
For medical information enquiries please contact the Besins Healthcare UK Ltd Medical Information via email besins@eu.propharmagroup.com or by calling +44 (0)1748 828 789.
For stock control enquiries please contact Besins Healthcare UK Ltd Supply Chain via email supplychain-bhuk@besins-healthcare.com.
If your patient has experienced a recurrence of symptoms, this should be reported via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard in the United Kingdom or to www.hpra.ie in the Republic of Ireland as well as to pharmacovigilance@besins-healthcare.com.
We are committed to our ongoing investigations and will continue to collect samples for further examination. Once we have received the final outcomes from the investigation, we will provide updates to those who have lodged complaints.
If you have further questions, please contact besins@eu.propharmagroup.com.
Thank you for your understanding.
