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Archive for the ‘drug abuse’ Category

FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids

April 3, 2015 Comments off

FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.

Audit of VA’s Drug-Free Workplace Program

March 31, 2015 Comments off

Audit of VA’s Drug-Free Workplace Program
Source: U.S. Department of Veterans Affairs, Office of Inspector General

We conducted this audit to assess how effectively VA’s Drug-Free Workplace Program identifies and addresses illegal drug use among VA employees. VA needs to improve management of its Drug-Free Workplace Program. VA selected about 3 of every 10 applicants for pre employment drug testing before hiring these individuals into Testing Designated Positions (TDPs) in fiscal year (FY) 2013. We estimate that of the nearly 22,600 individuals VA reported hiring into TDPs in FY 2013, about 15,800 were hired without a pre-employment drug test. VA facilities tested about 68 percent of the 3,420 employees selected for random drug testing in FY 2013. We identified at least 19,100 employees in TDPs who were not subject to the possibility of monthly random drug testing.

In addition, VA erroneously designated as many as 13,200 employees in non-TDPs for drug testing in FY 2014. Further, only 17 (33 percent) of the 51 employees who tested positive for drugs as a result of reasonable suspicion of on-the-job drug use or after a workplace accident or injury were referred to VA’s Employee Assistance Program.

These issues occurred because VA does not support that all tentative selectees for TDPs need to be drug tested before being hired. VA also does not effectively monitor local facility compliance with random employee drug testing requirements. Furthermore, VA lacks adequate oversight to ensure the accuracy of drug testing data and that consistent personnel actions are taken when employees test positive for drugs. As a result, VA has little assurance that this program is performing as intended to identify and eliminate illegal drug use in its workforce.

Since VA’s workforce is expected to grow significantly with the passage of the Veterans Access, Choice, and Accountability Act of 2014, VA needs to take actions to address weaknesses in its Drug-Free Workplace Program immediately. We recommended the Deputy Assistant Secretary for Human Resources Management implement processes to ensure full compliance with VA’s pre-employment applicant drug testing and random employee drug testing requirements, and improve program integrity by ensuring the accurate coding of employees in TDPs.

The Acting Deputy Assistant Secretary for Human Resources Management concurred with our recommendations and provided an acceptable action plan. We will follow up on the implementation of the corrective actions.

Monitoring Health Concerns Related to Marijuana in Colorado: 2014

March 30, 2015 Comments off

Monitoring Health Concerns Related to Marijuana in Colorado: 2014 (PDF)
Source: Colorado Department of Public Health and Environment

As one of the first two states in the nation to legalize retail marijuana, the Colorado Legislature mandated that the Colorado Department of Public Health and Environment (CDPHE) study the potential public health impacts of marijuana. Though medical marijuana has been legal in Colorado since 2000, it was largely viewed as an individual doctor/patient decision outside the scope of public health policy. However, the legalization of retail (non- medical) marijuana and the potential for greater availability of marijuana in the community, prompted a closer look at potential health impacts on the population at large.

Legalized retail marijuana presents a paradigm shift, grouping marijuana with other legal substances like alcohol, tobacco and prescription drugs, as opposed to illicit drugs like cocaine and heroin. As with alcohol, tobacco, or prescription drugs, misuse of marijuana can have serious health consequences. Standard public health approaches to alcohol, tobacco and prescription drugs is to monitor use patterns and behaviors, health care utilization and potential health impacts, and emerging scientific literature to guide the development of policies or consumer education strategies to prevent serious health consequences. This report presents initial efforts toward monitoring the changes in marijuana use patterns, potential health effects of marijuana use, and the most recent scientific findings associated with marijuana use to help facilitate evidence-based policy decisions and science-based public education campaigns.

CRS — International Drug Control Policy: Background and U.S. Responses (March 16, 2015)

March 25, 2015 Comments off

International Drug Control Policy: Background and U.S. Responses (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

The global illegal drug trade represents a multi-dimensional challenge that has implications for U.S. national interests as well as the international community. Common illegal drugs trafficked internationally include cocaine, heroin, and methamphetamine. According to the U.S. intelligence community, international drug trafficking can undermine political and regional stability and bolster the role and capabilities of transnational criminal organizations in the drug trade. Key regions of concern include Latin America and Afghanistan, which are focal points in U.S. efforts to combat the production and transit of cocaine and heroin, respectively. Drug use and addiction have the potential to negatively affect the social fabric of communities, hinder economic development, and place an additional burden on national public health infrastructures.

Drug Courts

February 17, 2015 Comments off

Drug Courts (PDF)
Source: U.S. Department of Justice, Office of Justice Programs

Drug courts are specialized court docket programs that target criminal defendants and offenders, juvenile offenders, and parents with pending child welfare cases who have alcohol and other drug dependency problems. Although drug courts vary in target populations and resources, programs are generally managed by a multidisciplinary team including judges, prosecutors, defense attorneys, community corrections, social workers and treatment service professionals. Support from stakeholders representing law enforcement, the family and the community is encouraged throu

New From the GAO

February 10, 2015 Comments off

New GAO Reports
Source: Government Accountability Office

1. Prenatal Drug Use and Newborn Health: Federal Efforts Need Better Planning and Coordination. GAO-15-203, February 10.
http://www.gao.gov/products/GAO-15-203
Highlights – http://www.gao.gov/assets/670/668386.pdf

2. Medicaid: Additional Federal Action Needed to Further Improve Third-Party Liability Efforts. GAO-15-208, January 28.
http://www.gao.gov/products/GAO-15-208
Highlights – http://www.gao.gov/assets/670/668135.pdf

3. Critical Technologies: Agency Initiatives Address Some Weaknesses, but Additional Interagency Collaboration Is Needed. GAO-15-288, February 10.
http://www.gao.gov/products/GAO-15-288
Highlights – http://www.gao.gov/assets/670/668383.pdf

Drunk driving declines, while drug use behind the wheel rises

February 9, 2015 Comments off

Drunk driving declines, while drug use behind the wheel rises
Source: National Highway Traffic Safety Administration

The nation’s decades-long campaign to combat drunk driving continues to make our roads safer, but use of marijuana and prescription drugs is increasingly prominent on the highways, creating new safety questions, according to a pair of ground-breaking studies released today by the Department of Transportation’s National Highway Traffic Safety Administration.

One study, the latest version of NHTSA’s Roadside Survey of Alcohol and Drug Use by Drivers, found that the number of drivers with alcohol in their system has declined by nearly one-third since 2007, and by more than three-quarters since the first Roadside Survey in 1973. But that same survey found a large increase in the number of drivers using marijuana or other illegal drugs. In the 2014 survey, nearly one in four drivers tested positive for at least one drug that could affect safety.

A second survey, the largest of its kind ever conducted, assessed whether marijuana use by drivers is associated with greater risk of crashes. The survey found that marijuana users are more likely to be involved in accidents, but that the increased risk may be due in part because marijuana users are more likely to be in groups at higher risk of crashes. In particular, marijuana users are more likely to be young men – a group already at high risk.

This was the most precisely controlled study of its kind yet conducted, but it measured the risk associated with marijuana at the levels found among drivers in a large community. Other studies using driving simulators and test tracks have found that marijuana at sufficient dosage levels will affect driver risk.

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