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Research Quality Assurance
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
At about the same time that the GLP regulations were being formulated, the FDA also issued several reports dealing with the conduct of clinical investigations as well. Based on these reports, the FDA, on September 27, 1977, issued proposed regulations detailing the obligations of sponsors and monitors who conduct clinical investigations. In proposing these regulations, FDA noted that while inspections of several clinical trials revealed no gross violations of generally accepted clinical practices, there were numerous minor deficiencies [5]. These deficiencies centered around areas of patient consent, protocol adherence, study control, and records availability and accuracy. In the preamble to the regulations, the Commissioner also cited the General Accounting Office (GAO) report entitled, "Federal Control of New Drug Testing Is Not Adequately Protecting Human Test Subjects and the Public" [6]. In this report, dated July 15, 1976, the GAO recommended that the FDA improve regulations governing clinical investigations to protect the rights of the patients involved.
Laboratory Screening and Verification of Drug Use
Published in Frank Lynn Iber, Alcohol and Drug Abuse as Encountered in Office Practice, 2020
The assumption upon which all drug testing is tacitly based is that tolerant abusers cannot forgo use of their substance sufficiently long to allow it to clear their system completely. The validity of this assumption is examined in the section on breath tests.
Substance misuse and forensic adolescent mental health
Published in Ilana B. Crome, Richard Williams, Roger Bloor, Xenofon Sgouros, Substance Misuse and Young People, 2019
Sue Bailey, Prathiba Chitsabesan, Louise Theodosiou
The RCPCH (2013) advises that secure settings should develop a comprehensive substance misuse strategy in conjunction with the local providers and purchasers of substance misuse services. A drug testing policy should differentiate between testing for disciplinary and for therapeutic purposes. The RCPCH also recognises the requirement for young people’s access to, and support from a substance misuse team.
How the war on drugs impacts social determinants of health beyond the criminal legal system
Published in Annals of Medicine, 2022
Aliza Cohen, Sheila P. Vakharia, Julie Netherland, Kassandra Frederique
Drug testing of public benefits applicants is less discussed in the peer-reviewed literature [101]. Although the PRWORA authorised, but did not require, drug screenings of public benefits applicants, today 13 states drug test TANF applicants [102,103]. States that drug test as a condition of receiving TANF can only test if drug use is suspected. For example, some states automatically require people with felony drug convictions to take a drug test [104], while other states require all applicants to undergo a drug screening questionnaire and then require a test if there is suspicion of drug use [105]. Many TANF applicants, who are already low income, are expected to pay for their drug tests. The impact of drug testing on people with felony drug convictions is compounded since they are already disproportionately poor, unemployed, and food insecure compared to people who have never been incarcerated [106–108].
Child and adolescent benzodiazepine exposure and overdose in the United States: 16 years of poison center data
Published in Clinical Toxicology, 2020
Joseph M. Friedrich, Christie Sun, Xue Geng, Diane P. Calello, Michael Gillam, Kaelen L. Medeiros, Mark Smith, Bruce Ruck, Maryann Mazer-Amirshahi
There are limitations to this study. First, NPDS is a voluntary database, as healthcare providers and the general public have no obligation to report to poison control centers. Second, it is possible that there is an underestimation of pediatric exposure to benzodiazepines by medical professionals, which may lead to underdiagnoses and underreporting. Third, in many medical settings, the determination of benzodiazepine exposure is made by rapid drug testing, which may exclude various types of benzodiazepines and typically does not include confirmatory testing. This may generate both false negative and false positive results [18–21]. All of these factors further obscure and likely underestimate the true prevalence of benzodiazepine overdose and exposure in the pediatric population. Finally, the identity of specific co-ingestants was not analyzed in this study. It is unclear what role specific co-ingestants played affecting the results seen throughout this study.
Pharmacotherapy for opioid addiction in community corrections
Published in International Review of Psychiatry, 2018
Robert P. Schwartz, Mary M. Mitchell, Kevin E. O’Grady, Sharon M. Kelly, Jan Gryczynski, Shannon Gwin Mitchell, Michael S. Gordon, Jerome H. Jaffe
The studies that have been conducted use different definitions of criminal justice status (e.g. parole, probation, drug court, awaiting trial, arrest in the previous 12 months). Community criminal justice supervision regimes could vary from civil commitment, parole after release from prison, and probation as an alternative to incarceration, and pre-trial diversion. These types of supervision are applied with varying levels of intensity with a wide variety of caseloads, different drug testing methods and frequency, and different degrees of sanctions’ certainty and severity. Of note, there are virtually no pharmacotherapy studies for opioid addiction reported from US drug courts. The studies have different drug use outcomes (e.g. self-report and urine drug testing) and criminal justice outcomes (number of arrests, incarceration events, months of incarceration, brief incarceration vs state prison, parole or probation revocation, arrest or incarceration for new crimes in contrast to parole and probation violations). The criminal justice outcomes were obtained by different means (e.g. self-report vs official records).