Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 83

The MedWatch program is the FDA’s national pharmacovigilance program for marketed products. It collects safety information and provides clinical information about safety issues involving prescription and OTC drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements, and infant formulas). See the MedWatch site at www.fda.gov.

The website provides “one-stop shopping” for information or links to information on medical product safety alerts, recalls, withdrawals, current new and hot topics, educational materials, and a glossary, the NIH Daily Med site (hosted by the National Library of Medicine with up-to-date drug labeling information), Medication Guides, drug-specific information (more labeling), drug shortages, and more.

There is also a set of links to receive periodic e-mail notifications and RSS feeds (which you can have automatically sent to your Internet home page, if it accepts such feeds). There are also social media broadcasts produced by FDA on Facebook, Twitter, etc.

Another little-known MedWatch function is the MedWatch to Manufacturer Program (see above), which allows drug and biologics manufacturers to receive certain serious AEs submitted directly to FDA that would not otherwise be known to the manufacturer. An applicant can subscribe at any time within 3 years after product approval; FDA will send reports for a period of about 3 years after approval.

The other key part of the MedWatch site is information on reporting serious AEs to the FDA using the MedWatch form, which comes in three very similar variations — the 3500-form for the public to voluntarily submit AEs, the 3500B-form that is more consumer-friendly than the 3500-form, and the 3500A-form for mandatory reporting. Manufacturers usually use the 3500A-form only for expedited reporting from clinical trials; structured electronic reporting is required for marketed products.

An information page for health professionals and the public describes the systems used for safety reporting, which then has links to the other pages giving further information. There are links to downloadable PDF versions of the MedWatch forms. There is also a link to an online reporting form for the public.

There is a page with information for industry on the three key serious AE reporting areas. Information and links to the appropriate regulations and forms are included:

OTC Products and Dietary Supplements;

Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers;

Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting.