Healthy Skepticism Library item: 9274

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

van Puijenbroek EP, Hepburn PA, Herd TM, van Grootheest AC.
Post Launch Monitoring of food products: what can be learned from pharmacovigilance.
Regul Toxicol Pharmacol 2007 Mar; 47:(2):213-20
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WPT-4MR7DDJ-1&_user=10&_coverDate=03%2F31%2F2007&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=cf73d538f80c06117081ac69046af508

Abstract:

Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever’s Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of ‘signals’ of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

Keywords:
MeSH Terms: Adverse Drug Reaction Reporting Systems Data Collection Food/adverse effects* Food Industry/methods* Food Industry/standards Humans Netherlands Product Surveillance, Postmarketing/methods* Public Health Risk Assessment/methods Risk Management/methods