Objective The objective of the present communication is to give an overview of the Spanish legal situation with regard to drug detection in drivers. In addition, protocols for roadside drug controls and confirmation analysis in our country will be given. Methods The Spanish participation in RoadSide Test Assessments (ROSITA) and Driving Under the Influence of Drugs, alcohol and medicines (DRUID) European projects had the direct consequence of the Penal Code modification in 2010 in order to reflect the obligation of Spanish drivers to participate in on-site drug controls if required by the police. Confirmation analysis should be done using a methodology that allows drug identification with a high degree of confidence, and enough sensitivity to detect expected drug concentrations in oral fluid and blood. We developed and validated a LC-MS/MS method for the simultaneous determination of 23 drugs of abuse and medicines including opiates, amphetamines, cocaine, methadone, benzodiazepines, z-drugs, one antidepressant and one antihistamine in oral fluid and blood. This method has been applied to thousands of real specimens since the beginning of DRUID project in 2008. Results In Spain, on-site drug controls are performed in oral fluid and, if a positive result is obtained, a second oral fluid specimen is collected and sent to homologate laboratories for confirmation. In addition, drivers have the right to ask for blood confirmation. The LC-MS/MS methodology developed in our laboratory requires a solid phase extraction procedure for sample clean-up, using 0.5 mL of oral fluid or blood. Limits of quantification (LOQ) are 1 ng/mL for all the analytes, lower than those required in the DRUID project, and the linearity ranges are 1–200 ng/mL and 1–500 ng/mL in oral fluid and blood, respectively. The methods were validated, achieving satisfactory results for all the evaluated parameters. Since 2011, on-site drug controls in Spain have significantly increased over the years. We received 64 oral fluid specimens in 2011 for on-site results confirmation, 1083 in 2012, 1284 in 2013, 8722 in 2014, and 2066 until February 2015. On-site results were confirmed in 98.5% of the oral fluid specimens received in our laboratory from 2014. Poly-drug use was observed in 42.7% of the positive cases. Confirmed drugs of abuse, consumed alone or in combination, were cannabis (83.7%), cocaine (42.8%), followed by amphetamine and derivatives (14.4%) and opioids (8.2%). Other drugs detected were ketamine (2.2%), methadone (5%), benzodiazepines (3.9%), codeine (0.6%) and zolpidem (0.1%). False positive results (1.5%) were due to cocaine (44.4%), amphetamine (24.8%), cannabis (19.6%), methamphetamine (18.3%) and opioids (12.4%). Blood specimens sent to the laboratory for on-site results confirmation are incidental compared to oral fluid specimens, although increasing over the last years. Thus, we received 4 blood specimens in 2013, 52 in 2014 and 247 in 2015. Conclusions On-site drug controls in Spain have dramatically increased since 2011. Positive on-site results are confirmed by LC-MS/MS using a second oral fluid specimen, or/and blood in exceptional cases. Results for specimens analyzed since 2014 shows a high degree of agreement between on-site and oral fluid confirmation results.
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