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Biomedical subjects

Sidney H Schnoll

Publications and source records attributed to Sidney H Schnoll.

14 recordsLinked to original sources
PubMed2006

Impact of formulation on the abuse liability, safety and regulation of medications: the expert panel report.

A scientific meeting was held in April 2005 to consider how the formulation of medications might impact on their potential for abuse. The background papers prepared for this meeting, as well as abstracts of volunteered presentations, are published in this supplemental issue of Drug and Alcohol Dependence. This paper is the Expert Panel Report summarizing the discussions held following the formal presentations and including the suggested recommendations for additional research that emerged from these discussions. There was overwhelming consensus that formulation does play a role in prescription drug abuse, i.e., a formulation of an abused substance can be developed that will decrease its abuse potential, and several examples were cited. Nevertheless, it is imperative that new formulations have similar efficacy and in no way compromise medication access to doctors and patients. However, there was also consensus that a great deal of research and discussion was needed to fully implement a program of risk management through reformulation of existing products or tailoring the formulation of new products to retain clinical efficacy and safety while minimizing potential for abuse. Those who need to take part in this discussion include scientific groups, pharmaceutical companies, as well as governmental and regulatory agencies. The areas where more research is needed include development of standards for assessing tamper-resistance, improved animal models that can address formulation-related variables (e.g., onset, duration), the redesign of human laboratory studies providing appropriate models for comparing formulations, and improved post-marketing surveillance. Finally, knowledge and experience are needed to translate scientific work into a predictable, transparent and reliable regulatory process.

Chemistry, Pharmaceutical↗
PubMed2006

A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain.

Concern about abuse/dependence in chronic pain patients taking opioid analgesics may lead to undertreatment of pain, yet little is known about the prevalence of abuse/dependence in these patients and how it differs among analgesic agents. The objective of this study was to assess the prevalence of tramadol abuse compared to nonsteroidal anti-inflammatory drugs (NSAIDs) and hydrocodone-containing analgesics in patients with chronic noncancer pain (CNP). The study had three arms. The first arm consisted of subjects prescribed tramadol alone; the second of subjects randomized to either NSAIDs or tramadol; and the third of subjects randomized to hydrocodone or tramadol. Each investigator received two boxes of prescriptions randomized so that one in every four prescriptions was for tramadol. Upon deciding on the therapeutically appropriate arm, the physician selected the appropriate box, opened the next envelope and completed the enclosed prescription. After the initial randomization, physicians could prescribe whatever medication was therapeutically appropriate. A total of 11,352 subjects were enrolled. Up to nine interviews using a structured questionnaire were conducted over a 12-month period. An algorithm called the "Abuse Index" was developed to identify subjects who were abusing the drug. The primary components of the index were increasing dose without physician approval, use for purposes other than intended, inability to stop its use, and withdrawal. The percent of subjects who scored positive for abuse at least once during the 12-month follow-up were 2.5% for NSAIDs, 2.7% for tramadol, and 4.9% for hydrocodone. When more than one hit on the algorithm was used as a measure of persistence, abuse rates were 0.5% for NSAIDs, 0.7% for tramadol, and 1.2% for hydrocodone. Thus, the results of this study suggest that the prevalence of abuse/dependence over a 12-month period in a CNP population that was primarily female was equivalent for tramadol and NSAIDs, with both significantly less than the rate for hydrocodone.

Adolescent↗
PubMed2005

A systems approach to identifying inappropriate use of controlled substances: the need for balance.

BACKGROUND: The diversion, abuse, and inappropriate use of controlled substances remain of concern among health care practitioners, insurers, and policy makers in the United States. The principle of "balance" represents a need to establish a system of control to prevent abuse, trafficking, and diversion of controlled substances, while ensuring their medical availability for legitimate patients. ADMINISTRATIVE DATABASES TO STUDY OUTCOMES AND QUALITY OF CARE: Some models employ pattern recognition within administrative health databases, for example, to examine outcomes and quality of medical care and monitor fraudulent behaviors and inappropriate medical care. Patients' use of resources or variations in practitioners' practice patterns can be examined. A SYSTEMS APPROACH TO ADDRESS INAPPROPRIATE USE OF CONTROLLED SUBSTANCES: A systems approach would require collaboration with medical and pharmacy directors, systems analysts, coding experts, legal experts, and clinicians to develop the claims-based model. Once a patient and/or practitioner with possible diversion or abuse are identified, a second step is required to distinguish inappropriate and appropriate behaviors and medical care. CONCLUSION: Programs to detect misuse of controlled substances must be validated through clinical research, and a consensus should be reached as to what constitutes a breach of accepted medical practice.

Databases as Topic↗
PubMed2004

Psychopathology and treatment outcome of drug dependent women in a perinatal program.

One hundred and five drug-dependent women in outpatient perinatal addiction treatment were classified by cluster analysis of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) profiles into high and low psychopathology (HP and LP) groups that differed on three validation measures. The HP group (n=29, 27.6%) had elevations on MMPI-2 Scales F, 2, 4, 6, 7, and 8, while the LP group (n=76, 72.4%) generated a normal range profile with elevations on Scales F and 4. Psychological outcomes differed by group. HP participants showed reduced alcohol, family, and psychiatric severity, and reduced depressive symptoms, while LP subjects showed reduced drug, self-debasing, and acting-out problems. Data suggest the need for lower intensity services for the majority of the perinatal drug dependent population with LP.

Alcohol Drinking↗
PubMed2003

Incorporating the assessment of abuse liability into the drug discovery and development process.

Evaluation of abuse liability is one of many obligations incurred by industrial sponsors in the development of medications acting on substrates in the central nervous system. In addition to providing the information necessary for a scheduling recommendation in the marketing application, the abuse liability assessment allows sponsors to estimate safety and commercial risks associated with scheduling, as well as to tailor their pre- and post-approval programs to collect information relevant to product misuse, illicit diversion and physical dependence. There are several important factors to consider before embarking on an abuse liability assessment, including the compound's primary and secondary biochemical activities, its absorption and metabolism, its final formulation, and its intended clinical population. Each of these factors will temper the timing and extent of the abuse liability program in animals and humans. Although every drug development program is unique in some way, a decision-making process may be applied to abuse liability assessment that will serve to better utilize limited resources and inform decisions regarding subsequent steps in the process. The emerging properties of the product will define the unique procedures best applied to assess it.

Algorithms↗
PubMed2003

Physical dependence on Ultram (tramadol hydrochloride): both opioid-like and atypical withdrawal symptoms occur.

In 1994, the Drug Abuse Advisory Committee (DAAC) of the Food and Drug Administration (FDA) concluded that Ultram (tramadol hydrochloride) could be marketed as an analgesic drug without scheduling under the Controlled Substances Act based upon extensive pre-clinical, clinical and European epidemiological data. However, to guard against unexpectedly high levels of abuse in the United States, the DAAC recommended that an independent steering committee (ISC) be appointed to proactively monitor abuse/dependence. In the event that high rates of abuse were found, this ISC was given the authority to immediately recommend to the FDA that Ultram be scheduled. In the course of the surveillance project, the ISC received reports of withdrawal following abrupt discontinuation of Ultram and in some instances, following dose reductions. In most cases, the withdrawal symptoms consisted of classical opioid withdrawal, but in some cases were accompanied by withdrawal symptoms not normally observed in opiate withdrawal, such as hallucinations, paranoia, extreme anxiety, panic attacks, confusion and unusual sensory experiences such as numbness and tingling in one or more extremities. Withdrawal symptoms of either type were one of the more prevalent adverse events associated with chronic Ultram use, comprising nearly 40% of all adverse events reported with Ultram. Most of these consisted of typical opiate withdrawal symptoms, but 1 in 8 cases presented as atypical. These results indicate that physicians and other healthcare professionals need to be aware of the potential of Ultram to induce withdrawal of the classical opioid type, and that atypical withdrawal may also occur.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

Definitions related to the medical use of opioids: evolution towards universal agreement.

Misunderstandings regarding the nature and occurrence of addiction have historically been barriers to the appropriate treatment of pain and have stigmatized the medical use of opioids. This article reviews the evolution of nomenclature related to addiction, presents current scientific understanding of addiction that may help shape universally acceptable terminology, and discusses an integrated effort of pain and addiction professionals to reach consensus on addiction-related terms. The article suggests key principles that may clarify terminology including: clear differentiation of the concepts of addiction and physical dependence, conceptualization of addiction as a multidimensional disease, and use of a label for the phenomenon of addiction that does not include the ambiguous term "dependence." More universal agreement on terminology related to addiction is expected to improve the treatment of both pain and addictive disorders; improve communication between health care providers, regulators, and enforcement agencies; and reduce health care and other societal costs.

Analgesics, Opioid↗
PubMed2003

Addiction and pain.

The use of opioid medications for analgesia is associated with concerns about adverse side effects and the potential for development of physical dependence, tolerance, or addiction. Pain often is undertreated, which may provoke drug-seeking behavior by patients. Physicians must assess requests for more pain medication as stemming from either undertreatment of pain, development of physical tolerance, or addiction. Important tools for addiction screening include the use of questionnaires, patient interviews, and lab tests. In this study, the physiological and behavioral consequences of chronic pain and its treatment with opioids, along with guidelines for prescribing opioid pain medication, are presented.

Analgesics↗
PubMed2002

Tramadol post-marketing surveillance in health care professionals.

Tramadol has been marketed in the US since 1995. The US Food and Drug Administration agreed to release tramadol as a non-scheduled drug if proactive post-marketing surveillance studies would be conducted. This study was one of two phase IV protocols that were part of the overall surveillance program. It focused on impaired health professionals who are a high risk/high access population for drug abuse. All active participants in four state monitoring programs between November 1, 1995 and August 15, 1998 (n = 1,601) were recruited for the study. With the exceptions of implementing a standardized intake interview and urine testing for tramadol metabolites, all states operated their programs in the usual fashion. The programs were alerted to persistent non-prescribed tramadol use so that appropriate interventions could be employed. Despite availability of tramadol and the conditions that might lead to its abuse, the incidence rate for tramadol use in the study population was only 69 per thousand persons per year and the incidence rate for tramadol abuse or dependence was 6.9 per thousand persons per year.

Adult↗
PubMed2002

Opioid treatment of chronic pain in patients with addiction.

Patients with a history of drug or alcohol addiction may present to physicians with pain complaints. The medical literature is weak on the treatment of pain with opioids in patients in recovery or active addiction. This is because inconsistent criteria were used to define addiction and the types of chronic pain. There are clear differences between physical dependence, tolerance, and addiction. Addiction is different from pseudoaddiction and must be determined by the patient's behavior after appropriate pain management. Long-acting opioids are often the medications of choice for moderate to severe pain control. Short-acting opioids can be used for breakthrough pain. There are many other medications that can enhance pain control as adjunctive analgesics. Drug-seeking behavior may be seen with either active addiction or pseudoaddiction, or as part of deviant behavior such as drug diversion. A way to distinguish between these conditions is by giving the patient appropriate pain medication and observing the pattern of behavior to determine which is causing the drug-seeking behavior. Safe prescribing of medications with abuse potential includes use of a medication agreement, setting goals with the patient, giving appropriate amounts of pain medication, monitoring with pill counts and drug screens, and careful documentation. Even patients with a history of addiction can benefit from opioid pain medications if monitored appropriately.

Analgesics, Opioid↗
PubMed1986

Maternal-neonatal incest.

Among all the forms of child abuse, sexual abuse during infancy is the least often discovered. Three cases of mother-child incest initiated during the neonatal period are described in this paper. The mothers all were estranged from their sexual partners, had demonstrated some confusion regarding sexual identity, and had sought assistance with chemical dependency during pregnancy.

Adult↗
PubMedDate not supplied

Treatment of pain in pregnancy.

BACKGROUND: The treatment of pain during pregnancy other than that of labor is a clinical issue that has not been addressed in a systematic manner. MATERIALS AND METHODS: To assess current knowledge, a review of the human and animal literatures was undertaken using MEDLINE. In addition, the dynamics of three pharmacological compartments, the mother, the placenta, and the fetus, and fate of drugs given in pregnancy, was reviewed. RESULTS: The literature review yielded little information except for a few case studies in which opiates, nonsteroidal anti-inflammatory drugs, antidepressants, mu agonists, and anticonvulsants were used in the treatment of pain in pregnancy. In contrast, there is extensive information in the addiction medicine literature concerning the use of opioids in recovering pregnant addicts. Methadone, buprenorphine, and morphine have been used to treat women seeking recovery from opioids, and neonatal outcomes have been closely monitored with no evidence of harm to the newborn. CONCLUSIONS: Experience in women seeking recovery from opioids and their newborns illustrates that opioids are an effective and safe pharmacological option for the treatment of pain during pregnancy. Controlled studies are needed to expand knowledge in this clinical area.

Analgesics, Opioid↗