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This article examines rates of nonmedical use and diversion of extended-release amphetamine and extended-release oral methylphenidate in the United States. Prescription dispensing data were sourced from retail pharmacies. Nonmedical use data were collected from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Drug Diversion Program and Poison Center Program. Drug diversion trends nearly overlapped for extended-release amphetamine and extended-release oral methylphenidate. Calls to poison centers were generally similar; however, calls regarding extended-release amphetamine trended slightly lower than those for extended-release oral methylphenidate. Data suggest similar diversion and poison center call rates for extended-release amphetamine and extended-release oral methylphenidate.

Pharmaceutical risk management can be considered to be any strategies for minimizing risks and enabling the realization of the benefits of medications. Historically, risk management has been achieved through the drug label, which includes the US Controlled Substances Act (CSA) drug scheduling placement if abuse and dependence are considered sufficiently serious to warrant special restrictions. Since the late 1990s, additional strategies for addressing abuse- and dependence-related risks have been developed, including various postmarketing requirements for surveillance and reporting to the Food and Drug Administration. These strategies have been described in guidance documents and include risk assessment, risk management, and postmarketing surveillance. Preclinical abuse potential assessment provides early signals of potential risks and scheduling. Such studies are also considered in the premarket risk evaluation that guides recommendations concerning risk management strategies that go beyond drug scheduling along with the evaluation of abuse-deterrent drug products and how such evaluation might be informed by preclinical studies.

Multidrug use is well documented among nonmedical users of prescription stimulants. We sought to provide insight into the drug use patterns of those reporting nonmedical use of prescription attention-deficit hyperactivity disorder (ADHD) stimulants in an attempt to discern whether such use is a first step in a pattern of drug-abusing behavior or, conversely, is a later development accompanied or preceded by a history of drug abuse. A cross-sectional, population-based survey of the U.S. civilian, non-institutionalized population aged 12 years and older was analyzed for lifetime nonmedical use of prescription ADHD stimulants, lifetime nonmedical use of another prescription drug, illicit drug use, and drug use initiation patterns. This included 443,041 respondents from the 2002–2009 National Survey on Drug Use and Health. Lifetime nonmedical use of prescription ADHD stimulants was reported by 3.4% of those aged 12 years and older. Of these, 95.3% also reported use of an illicit drug (i.e., marijuana, cocaine/crack, heroin, hallucinogens, inhalants) or nonmedical use of another prescription drug (i.e., tranquilizers, pain relievers, or sedatives), and such use preceded nonmedical use of prescription ADHD stimulants in 77.6% of cases. On average, 2.40 drugs were used prior to the first nonmedical use of prescription ADHD stimulants. These data suggest that nonmedical use of prescription ADHD stimulants is not commonly an initiating factor leading to the nonmedical use of other prescription medications or abuse of illicit drugs. Rather, nonmedical use of prescription ADHD stimulants appears to be adopted by individuals already engaged in broader patterns of drug abuse and misuse.

The prescription drugs regulated in the most restrictive controlled substance schedule for those with an approved therapeutic use vary widely in their real world risk of abuse and harm. Opioid analgesics have the highest rates of abuse, overdose death, drug abuse treatment needs and societal costs in comparison to other Schedule II drugs. Stimulants for attention-deficit/hyperactivity disorders (ADHD) account for substantially lower rates of abuse, harm, and public health impact. The scheduling of drugs is determined by the World Health Organization, the United States Food and Drug Administration, and other regulatory agencies, through a quasi-public process that relies heavily on pre-marketing studies that are conducted in highly controlled clinical settings. We propose that it is increasingly in the interest of science-based regulation and public health to recognize and communicate differences among drugs based on their real-world abuse and public health harm using surveillance data. Appropriate differentiation through labeling of drugs that will likely remain in the same schedule could provide powerful incentives for drug development and research, would aid prescriber/patient decision making by informing them of real differences across drugs within a schedule, and may also contribute to public health efforts to reduce drug abuse. There are risks of course, that include inadvertent perceptions that drugs labeled to be lower in risk are not taken as seriously as others in the same category. Challenges such as these, however, can be overcome and should not serve as barriers to objective communications regarding a drug's actual risks.

To examine time trends in amount of media coverage on tobacco cessation versus weight loss and test whether the 2 topics compete for limited media attention.Monthly print and broadcast media coverage from 1995 to 2003 was estimated.Tobacco and weight coverage were uncorrelated. Tobacco coverage peaked in 1997-98, whereas coverage of weight increased linearly between 1995 and 2003.Tobacco and weight topics do not appear to compete for media coverage. Interest in weight topics is rising, consistent with its growing public health importance. Coverage of tobacco is declining, suggesting a need to keep tobacco and cessation in the public eye.

Background Over-the-counter (OTC) topical corticosteroids, such as hydrocortisone cream (HC), are commonly used for the treatment of minor dermatological conditions. The safety and efficacy of such products are well documented, but details on patterns of use and self-treatment with HC in the OTC environment remain scarce. Objective We sought to determine compliance with label directions of OTC HCs by examining self-reported patterns of OTC HC use in adults and children. Methods A random digit-dialed telephone survey was conducted with 2000 US adults. Following identification of users of OTC HC in the last 6 months, respondents were asked questions about the conditions being treated with OTC HC and the frequency and duration of use in both adults and children. Results Of adults completing the survey, 20% (n=396) had used OTC HC. In 83% of cases, the conditions treated were consistent with the OTC label. Use was limited; HC was applied ≤4 times daily in 98% of adult users and lasted ≤7 days in 92%. Patterns of pediatric use were similar and almost always consistent with the labeling. Of households with children, 25% (n=168) had used OTC HC to treat pediatric dermatological conditions. Of child users, 93% were 2 years of age or older, treatment was limited (97% applied HC ≤4 times daily and 94% of treatments lasted ≤7 days), and the conditions treated were appropriate in 86% of cases. Limitations This telephone survey relied on respondents' recall and self-reporting. Our data on pediatric use of OTC HC are skewed toward treatment of younger children. Conclusion The data suggest that OTC HC products are used for self-treatment in a limited and appropriate fashion that is likely to be safe in both adults and children.

ObjectiveTo examine rates of nonmedical use (NMU) of prescription extended-release (ER) amphetamines and ER methylphenidate, relative to availability.MethodsPrescribing data were acquired from IMS Health. Data relevant to ER amphetamine and ER methylphenidate were collected from two studies in the RADARS® (Researched Abuse, Diversion and Addiction-Related Surveillance) System (Q3 2007-Q2 2009). First, the Drug Diversion System provides a law enforcement perspective based on surveys of diversion investigators throughout the US. Second, the Poison Center System provides data on exposures to prescription drugs based on spontaneous calls. RADARS System data are presented as rates per 1,000 Unique Recipients of Dispensed Drug (URDD) to account for drug availability.ResultsFrom July 2007-June 2009, 18,315,404 prescriptions were filled for ER amphetamines, 26,674,152 for ER methylphenidate. RADARS System Drug Diversion trends nearly overlap for ER amphetamine and ER methylphenidate, relative to URDD (running average of 0.042 vs. 0.024 drug diversion reports per 1,000 URDD). Similarly, trends in RADARS System Poison Center calls are generally similar for ER amphetamine and ER methylphenidate, although ER amphetamine trends slightly lower (running average of 0.15 vs. 0.22 intentional exposures per 1,000 URDD).ConclusionsTrends from the US RADARS System, which controls for utilization rates, suggest diversion and poison center call rates are similar for ER amphetamine and ER methylphenidate.Supported by funding from Shire Development Inc.