Post Launch Monitoring of food products: what can be learned from pharmacovigilance.
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.
van Puijenbroek
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Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands. e.vanpuijenbroek@lareb.nl <e.vanpuijenbroek@lareb.nl>
Hepburn
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Herd
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van Grootheest
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D016907:Adverse Drug Reaction Reporting Systems; D003625:Data Collection; D005502:Food / Q000009:adverse effects*; D019649:Food Industry / Q000379:methods* / Q000592:standards; D006801:Humans; D009426:Netherlands; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011634:Public Health; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods