Out-patient drug policy by clinical assessment rather than financial constraints? The gate-keeping function of the out-patient drug reimbursement system in The Netherlands

Since 1991, the Dutch Price Reference System (DPRS) has aimed at a growth reduction of out-patient drug costs without loss of medical quality. New drugs are excluded unless they pass legally anchored clinical criteria, i.e. substitutability with accepted drugs (DPRS-list 1a, implies a reimbursement maximum), 'unique and valuable' (DPRS-list 1b, liberal price setting), or lack of value (rejected). We analysed the performance (transparency, judgement stability) of the gate-keeping function during July 1999-July 2002. For drugs applied for DPRS-list 1b status, we relate the satisfaction of existing and implicit criteria to being accepted or rejected. Of 85 DPRS-list 1b applicants, 20 were shifted to DPRS-list 1a, 52 were accepted, and 13 were rejected with different roles of therapeutic value, budget impact, and burden of disease, the latter emerging as a decisive yet non-legal criterion. The gate-keeping function of the DPRS offers a non-opportunistic balance between clinical and economic demands, provided the burden of disease criterion is implemented, and provides influential tools for financial constraint

Synthetic turf pitches with rubber granulate infill: are there health risks for people playing sports on such pitches?

The presence of carcinogenic substances in rubber granulate made from old car tyres raised concerns that the use of this granulate as infill on synthetic turf pitches may cause leukaemia and lymphoma in young football players and goalkeepers. Limitations in a number of prior studies on the topic casted doubts on their conclusion that it was safe to play sports on such pitches. Rubber granulate samples from 100 Dutch synthetic turf pitches were analysed for 45 (all samples) or 79 substances (a subset). A subset of samples was additionally analysed for migration of polycyclic aromatic hydrocarbons (PAHs), phthalates and metals into sweat and the gastrointestinal tract, and for evaporation of volatile substances into air. Exposure scenarios were developed to estimate the exposure of amateur football players via the oral, dermal and inhalation route to the most hazardous substances in rubber granulate. Risks to human health were assessed by comparing toxicological reference values for these substances with the exposure estimates. A number of carcinogenic, mutagenic and reprotoxic substances were present in rubber granulate used on Dutch pitches. No concern was, however, identified for phthalates, benzothiazoles, bisphenol A and the metals cadmium, cobalt and lead, as their exposures were below the levels associated with adverse effects on health. PAHs appeared to be the substances of highest concern, but even they present no appreciable health risk with exposures resulting in additional cancer risks at or below the negligible risk level of one in a million. Our findings for a representative number of Dutch pitches are consistent with those of prior and contemporary studies observing no elevated health risk from playing sports on synthetic turf pitches with recycled rubber granulate. Based on current evidence, there is no reason to advise people against playing sports on such pitches