Reporting suspected adverse drug reactions to vaccines and biological medicines

The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.

Article date: November 2012

Biological medicines are medicines derived or manufactured from a ‘living’ biological system. They encompass a broad range of therapeutic areas, including blood products, vaccines, antibodies and advanced therapies (such as gene and tissue therapy).

Biological medicines and vaccines are fundamentally different from standard chemical medicines in terms of their complexity. Unlike most small molecule drugs, their characteristics are determined as much by the specific manufacturing process as the active ingredient itself.

A wide variety of vaccines and biological medicines are available, and for many products a range of manufacturers produce the same ‘active ingredient’. These include a range of ‘biosimilar’ medicines, several vaccines which protect against a given infection, and products such as human immunoglobulin.

Unlike most standard generic medicines, the characteristics of such products will not be identical. For this reason, it is very important that safety surveillance is carried out on a brand/product-specific basis. In addition, these products may vary from batch-to-batch and so it is important that we receive information on batch number.

As a specific example, there are more than ten different brands of influenza vaccines available in the UK each year. However, it is very often the case that suspected ADR reports refer only to ‘influenza vaccine’. Following the guidance below will allow us to accurately evaluate the safety profile of specific products.

Report suspected adverse drug reactions (ADRs)

To allow us to perform product/brand-specific pharmacovigilance, when reporting a suspected ADR to a biological medicine (such as blood products, antibodies and advanced therapies [such as gene and tissue therapy]) or vaccine, in addition to the substance please ensure that you provide the brand name (or product licence number and manufacturer), and the specific batch-number, on the report.

Additionally, when providing patients with details of the vaccine or biological medicine administered, it is good practice to give them details of the brand and batch number. This will allow patients and carers to more accurately report suspected ADRs to us.

Please report suspected ADRS to any medicine or vaccine to the YellowCard Scheme.

Further information

BNF section: General guidance
Drug Safety Update article on biosimilar products
European Medicines Agency: Questions and answers on biosimilar medicines

Article citation: Drug Safety Update November 2012, vol 6, issue 4: H1

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