Post-marketing surveillance van stoffen

On behalf of the Ministry of Health a survey was prepared of possibilities for setting up a 'post-marketing surveillance' (PMS)-system for chemical substances in consumer products, including food. With such a system, (long-term) health effects of substances which are already on the market may be identified. Setting up such a system was advised by the Health Council of The Netherlands (GR) based on a report from 2014. In this report, GR concluded that PMS of chemicals is warranted given that certain health effects in humans may not become visible in animal studies used for risk assessment. First, a preliminary overview of current PMS related activities in different areas of legislation, such as food, drugs and consumer products, was prepared. Existing experience in different legislative frameworks can feed into a new system. Relevant national stakeholders have contributed to the overview, and have discussed short and long-term opportunities for further development of PMS. Possible short-term options included sharing existing information, to connect different existing databases and to share new information about health effects of chemicals on an ad hoc basis. For the longer term, exposure assessment directly in humans or for example in blood samples stored in biobanks were considered. In addition, more extensive registration of the use of compounds in consumer products was advised, as well as international harmonization of PMS data collection. It was advised to establish a working group with stakeholders to expand this initiative and to exchange ad hoc information on a regular basis. stakeholders regulatory framework signalingIn opdracht van VWS heeft het RIVM een eerste inventarisatie gemaakt van mogelijkheden om een 'post marketing surveillance'-systeem (PMS) voor chemische stoffen in consumentenproducten, inclusief voeding, op te zetten. Met een dergelijk systeem worden signalen over schadelijke (langetermijn)effecten van stoffen in kaart gebracht, nadat ze op de markt zijn gebracht. Aanleiding hiervoor is een voorstel van de Gezondheidsraad om een PMS in te richten. De raad concludeerde namelijk in 2014 dat mogelijk niet alle relevante effecten van stoffen op de volksgezondheid uit (proefdier)onderzoek worden opgepikt, waardoor ze niet vooraf in de risicobeoordeling worden meegenomen. Voor de inventarisatie is eerst een globaal overzicht opgesteld welke post-marketing-surveillance activiteiten op het gebied van onder andere voeding, geneesmiddelen en consumentenproducten al worden uitgevoerd. Van de ervaringen uit deze 'kaders' kan immers gebruik worden gemaakt. Verschillende stakeholders binnen de overheid hebben het overzicht vervolgens aangevuld en hebben mogelijkheden voor aanpassingen op de korte en lange termijn besproken. Voor de korte termijn raden zij aan kennis uit verschillende kaders met elkaar te delen, bestaande databases aan elkaar te koppelen en elkaar te informeren over effecten van chemische stoffen die ad hoc worden gesignaleerd. Voor de toekomst wordt meer aansluiting gezocht bij metingen van blootstelling direct in de mens, dan wel via metingen in bijvoorbeeld bloedmonsters die in biobanken zijn opgeslagen. Ook wordt een intensievere registratie van het gebruik van stoffen in consumentenproducten voorgesteld, en een methode om PMS-data internationaal op uniforme manier te verzamelen. Geadviseerd wordt om de input met de stakeholders te structureren in de vorm van een werkgroepMinisterie van VW

Brainstorming opportunities for postmarketing surveillance of chemicals : Workshop report

On behalf of the Ministry of Health a survey was prepared of possibilities for setting up a 'post-marketing surveillance' (PMS)-system for chemical substances in consumer products, including food. With such a system, (long-term) health effects of substances which are already on the market may be identified. Setting up such a system was advised by the Health Council of The Netherlands (GR) based on a report from 2014. In this report, GR concluded that PMS of chemicals is warranted given that certain health effects in humans may not become visible in animal studies used for risk assessment. First, a preliminary overview of current PMS related activities in different areas of legislation, such as food, drugs and consumer products, was prepared. Existing experience in different legislative frameworks can feed into a new system. Relevant national stakeholders have contributed to the overview, and have discussed short and long-term opportunities for further development of PMS. Possible short-term options included sharing existing information, to connect different existing databases and to share new information about health effects of chemicals on an ad hoc basis. For the longer term, exposure assessment directly in humans or for example in blood samples stored in biobanks were considered. In addition, more extensive registration of the use of compounds in consumer products was advised, as well as international harmonization of PMS data collection. It was advised to establish a working group with stakeholders to expand this initiative and to exchange ad hoc information on a regular basis. stakeholders regulatory framework signalin

Delta-9-Tetrahydrocannabinol and Cannabidiol produce dissociable effects on prefrontal cortical executive function and regulation of affective behaviors

The use of cannabis for therapeutic and recreational purposes is growing exponentially. Nevertheless, substantial questions remain concerning the potential cognitive and affective side-effects associated with cannabis exposure. In particular, the effects of specific marijuana-derived phytocannabinoids on neural regions such as the prefrontal cortex (PFC) are of concern, given the role of the PFC in both executive cognitive function and affective processing. The main biologically active phytocannabinoids, Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with multiple neurotransmitter systems important for these processes directly within the PFC. Considerable evidence has demonstrated that acute or chronic THC exposure may induce psychotomimetic effects, whereas CBD has been shown to produce potentially therapeutic effects for both psychosis and/or anxiety-related symptoms. Using an integrative combination of cognitive and affective behavioral pharmacological assays in rats, we report that acute intra-PFC infusions of THC produce anxiogenic effects while producing no impairments in executive function. In contrast, acute infusions of intra-PFC CBD impaired attentional set-shifting and spatial working memory, without interfering with anxiety or sociability behaviors. In contrast, intra-PFC CBD reversed the cognitive impairments induced by acute glutamatergic antagonism within the PFC, and blocked the anxiogenic properties of THC, suggesting that the therapeutic properties of CBD within the PFC may be present only during pathologically aberrant states within the PFC. Interestingly, the effects of PFC THC vs. CBD were found to be mediated through dissociable CB1 vs. 5-HT1A-dependent receptor signaling mechanisms, directly in the PFC