Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 86

The CBER website contains less information regarding product safety than the CDER site because the regulatory responsibility for approval and post-marketing evaluation of many CBER products was transferred to CDER in 2003. The products remaining in CBER include cellular products (e.g., pancreatic islet cells for transplantation, whole cells, cell fragments, or other components intended for use as preventative or therapeutic vaccines); allergenic extracts used for diagnosing and treating allergic diseases and allergen patch tests; antitoxins; antivenins/antivenoms; venoms; blood; blood components; plasma-derived products (e.g., albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase inhibitors), including recombinant and transgenic versions of plasma derivatives (e.g., clotting factors); blood substitutes; plasma volume expanders; human or animal polyclonal antibody preparations, including radio-labeled or conjugated forms; certain fibrinolytics, such as plasma-derived plasmin; and red cell reagents.

More extensive information on this subject can be found at the CBER website. In regard to safety, there is information covering recalls, shortages, biological product deviation reporting (i.e., errors and accidents in manufacturing), AE reporting, and specific information about safety issues on various products, such as flu vaccines, HIV test kits, tissue products, and blood products. As noted, most AEs are reported via MedWatch using the 3500-voluntary reporting form. One exception is vaccine AEs (e.g., Adverse Events Following Immunization (AEFI)). These are reported to the Vaccine Adverse Event Reporting System (VAERS), which is sponsored by the FDA and the CDC. As with drugs, the goal is to collect and analyze safety signals and vaccine AEs. In particular, compared with drug products, vaccines are given to large numbers of children (FDA notes on its website that more than 10 million vaccinations are given yearly to children younger than 1 year old). As with all other products, the full safety picture is not known at the time of vaccine approval. Most of the VAERS reports are mild and include fever and injection site reactions, but some 15% are more severe AEs.

The VAERS website has sections for consumer and healthcare professional reporting of AEs online, by fax, or by mail.

The VAERS database, unlike the drug database, FAERS, has a system called CDC WONDER for obtaining data and producing tables, maps, charts, and various extracts regarding the incidence of vaccine AEs. For example, one can produce a report grouped by symptoms or medical problems (e.g., gastroenteritis) and various other criteria, such as age, gender, manufacturer, US location, date vaccinated, onset interval, seriousness, and outcome. The data are immediately available and are largely up to date. Data downloads are also available. This is a very useful tool. However, many discrepancies have been introduced by the application of SMQs to add an extrapolated diagnosis to the database when a diagnosis was not provided by the reporter. SMQs were not designed or tested for this and, e.g., sometimes age-inappropriate diagnoses are added. Use caution.

See also Chapter 41.