Drug use among different populations such as household members, students, and arrestees vary substantially and the accuracy of their self-reports may be questionable. The accuracy of prevalence estimates based on self-report data can be monitored by chemical drug testing of biological specimens such as urine, saliva, sweat, and hair. Each biological specimen is unique and offers a somewhat different pattern of information regarding drug use over time. Also, each specimen has unique strengths and weaknesses regarding the type of information obtained from drug testing. The performance characteristics of the assay methodology may also be important. The validation of self-report data by drug testing must be performed with careful consideration of the limitations imposed by the testing methodology and the biological specimen.
The demographics, drug habits, and medical complications of a cohort of 1,129 addicts treated at Lexington in the period 1971-1972 were studied. These patients, admitted from 41 different states, had a mean period of addiction of 5.4 years. Over one-third of the sample had engaged in pimping or prostitution, and there were no differences by gender in terms of involvement. Eight-eight percent had shared injection equipment, and surprisingly, 78% admitted to some effort at sterilizing their "works." Hepatitis was the most common associated medical condition: 87% had serologic markers of hepatitis B virus (HBV) infection, 60% had evidence of hepatitis A virus (HAV) exposure, and 47% had abnormal liver function parameters. Gynecomastia was evident in 2% of male subjects. Thirteen percent of the sample had a reactive VDRL assay, but 64% of these were biologically false positive. Subtle abnormalities of immune function were also observed; 18% of the patients had recent unexplained weight loss, 6% had lymphadenopathy, 8% had leukopenia, and 2% had lymphocytopenia. We conclude that both HBV and HAV were important infectious disease risks in these addicts, and that many evidenced deficiencies in immune function well before AIDS became a major public health concern.
The problem of prescription drug abuse in the United States began more than 100 years ago and became epidemic in the last decade producing many tragic consequences with incredible societal costs. Drug overdoses have doubled over the last 10 years and now surpass deaths from motor vehicle accidents (DHHS, 2013). Congress reacted to this ongoing tragedy in 2012 by mandating the Food and Drug Administration (FDA) promulgate guidelines for the development of abuse-deterrent formulations (ADFs) for prescription opioid medications as one of the approaches to reducing this problem.The FDA responded in 2013 by issuing a draft guidance to industry for assessment of ADFs (FDA, 2013). The 2013 guidance expanded initial guidance proposed in 2010 (FDA, 2010).FDA is expected to issue final guidance for industry in the latter part of 2014.
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