The importance of recording brand and batch numbers of prescribed biologic medicines
In 2017-18, the NHS saved over £200 million by using more biosimilar medicines1. In 2018, NHS England announced plans to increase the uptake of biosimilars with the aim to save up to £300m a year by 20211.
Generic versions of small molecule medicines can be considered chemically identical to the original branded version. A biosimilar is, in principle, the biologic equivalent of a generic drug. However because these are large complex molecules, often produced by living cells, a biosimilar is not regarded as identical to the original biologic drug. The manufacturing process of a biosimilar is very complex, so a lot of regulatory scrutiny is required to approve a claim of equivalence to the original. Also there may be several biosimilars marketed by different companies as a lower cost alternative to the original biologic. It is necessary to ensure that a patient who receives a biologic or a biosimilar medicine regularly continues to receive the same product every time. If a patient experiences an adverse drug reaction (ADR) after use, for proper pharmacovigilance it is important to know exactly which product they received. Therefore, in accordance with European pharmacovigilance legislation which came into effect in July 2012, healthcare professionals are requested to record both the exact name and batch number of the biologic drug provided to the patient2.
The Dutch not-for-profit organisation, Lygature, has conducted a study in collaboration with the DSRU to investigate the extent to which the brand name and batch number are recorded when dispensing or administrating biologics in the UK hospital setting and the extent to which these details are provided in reports of ADRs submitted to the UK’s Yellow Card Scheme. The study was funded by an unrestricted research grant from ABPI and was supported by the National Institute for Health Research Clinical Research Network (NIHR CRN). Final results will be published shortly.
- Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products