The reinforcement of regulation on of post-market safety management including adverse drug reactions (ADRs) has received significant emphasiszed significantly over the last several years in Korea. Not only has there been an increase in the number of spontaneous reports on ADRs, but an amendment of to the pharmaceutical law has been passed and notifications have noticeably been accelerated noticeably. However, compared with advanced countries, the efficiency of the system and people's satisfaction withon post-market safety management was has been as low as ever. This article focuses on the state of the regulations with regard to reporting of ADRs information. In addition, the status and kinds of drug utilization review informations offered by the Korea Food and Drug Administration were are illustrated in detail.
Drug Toxicity ; Drug Utilization Review ; Jurisprudence ; Korea ; Reinforcement (Psychology) ; Safety Management ; Social Control, Formal ; United States Food and Drug Administration

Cancer is the most common cause of disease-related mortality in Korea and is the key target for the solution to promote the national health and stabilize the health insurance. Without the development of a definitive prevention or treatment method, the proportion of cancer-related mortality will further increase with the advent of aging society and transition of life pattern. Nationally-based cancer screening program has been expanded to cover a larger target population in Korea since 1999. Despite the existence of some flaw in the present cancer screening program between the participants and medical institutions, the number of people taking part in the cancer screening program has been increasing. With the reinforcement of the quality control and supervision, medical institutions participating in national cancer screening program can be expected to become well acquainted with related regulations and procedures. It is necessary for all parties involved to exercise a substantial effort to achieve health examiner's best satisfaction and the quality of the cancer screening program.
Aging ; Early Detection of Cancer ; Health Services Needs and Demand ; Insurance, Health ; Korea ; Organization and Administration ; Quality Control ; Reinforcement (Psychology) ; Social Control, Formal

OBJECTIVES: Schizophrenia patients have deficits of prediction and learning related to dopaminergic dysfunction. It is hypothesized that there would be different characteristics in associative learning of reward approach and loss aversion between controls and patients. METHODS: Participants were 23 healthy participants and 20 out-patients fulfilling criteria for schizophrenia according DSM-IV-TR. Using a monetary incentive contingency reversal task, successful learning rates, numbers of trials and errors till learning, numbers of trials of maintaining learning, response times were measured. Characteristics of learning were compared between controls and patients. RESULTS: Physical anhedonia and PANSS negative symptom scores correlated with the number of trials while loss aversion was maintained. Overall correct response rates were decreased in patient group, particularly during reward approach learning. Patients required more trials and errors to learn reward approach than controls. There were no significant differences in learning performance and reaction times between groups during loss avoidance learning. CONCLUSION: These results support previous reports of deficits in reward-driven learning in schizophrenia. However, anhedonia and negative symptoms were associated with the preserved function of loss avoidance learning.
Anhedonia ; Avoidance Learning ; Humans ; Learning ; Motivation ; Outpatients ; Reaction Time ; Reinforcement (Psychology) ; Reward ; Schizophrenia

OBJECTIVE: Bipolar disorder patients often show excessive goal-directed and pleasure-seeking behavior during manic episodes and reduced hedonic capacity during depressive episodes, indicating that bipolar disorder might involve altered reward processing. As such, bipolar disorder subjects have been reported to show impaired reward learning in situations requiring integration of reinforcements over time. In this study, we examined characteristics of reward learning in euthymic patients with bipolar disorder using a probabilistic reward task. METHODS: We recruited 23 euthymic patients with bipolar disorder and 47 healthy subjects for the probabilistic reward task. This task is a reward-based paradigm to produce a response bias, in which correct identifications of two ambiguous stimuli are differently rewarded. The other dependent measures were the discriminability, hit rate and reaction time. RESULTS: Relative to comparison subjects, bipolar patients showed a reduced acquisition of response bias toward the more frequently rewarded stimulus (p<0.01). The overall reward learning was positively correlated with state and trait anxiety levels in bipolar patients (p<0.01). No significant differences of discriminability, hit rates, and reaction time were found between bipolar patients and controls. CONCLUSION: These findings suggest that euthymic patients with bipolar disorder may have deficits in reward learning related to anxiety.
Anxiety ; Bias (Epidemiology) ; Bipolar Disorder ; Humans ; Learning ; Reaction Time ; Reinforcement (Psychology) ; Reward

Interval timing is involved in a variety of cognitive behaviors such as associative learning and decision-making. While it has been shown that time estimation is adaptive to the temporal context, it remains unclear how interval timing behavior is influenced by recent trial history. Here we found that, in mice trained to perform a licking-based interval timing task, a decrease of inter-reinforcement interval in the previous trial rapidly shifted the time of anticipatory licking earlier. Optogenetic inactivation of the anterior lateral motor cortex (ALM), but not the medial prefrontal cortex, for a short time before reward delivery caused a decrease in the peak time of anticipatory licking in the next trial. Electrophysiological recordings from the ALM showed that the response profiles preceded by short and long inter-reinforcement intervals exhibited task-engagement-dependent temporal scaling. Thus, interval timing is adaptive to recent experience of the temporal interval, and ALM activity during time estimation reflects recent experience of interval.
Animals ; Mice ; Reward ; Time Factors ; Cognition ; Learning ; Decision Making ; Reinforcement, Psychology

The number of healthcare professionals (HCPs) abusing propofol has been steadily growing, while recreational use of propofol among the general public has become a social concern. Propofol was once believed to be unsuited for the purpose of abuse because it wears off too quickly and induces unconsciousness more frequently than euphoria. However, studies have demonstrated the abuse potential of propofol. Animal studies have shown that propofol increases dopamine levels in the mesolimbic dopamine system, which is a putative mechanism of addiction for most addictive drugs. Behavior studies, not only with animals but also with human beings, have demonstrated that administration of propofol induces conditioned rewards and reinforcement. Although the incidence of propofol abuse among HCPs seems to be lower than that of abuse of common addictive substances, multiple articles and case reports have documented cases. Easy access to the drug is closely associated with its abuse among HCPs. In addition, the pharmacologic properties of propofol, specifically its short onset and offset, is one of reasons HCPs start to abuse this drug without any serious consideration and makes propofol abuse difficult to detect. To reduce propofol abuse among HCPs, we should develop a strict pharmacy control system for limiting access to propofol. Adopting radio-frequency identification system for controlled drugs could be an effective option. However, substance dependent HCPs are quite resourceful even in obtaining controlled drugs. Therefore, a multilateral approach to stem the rising tide of propofol abuse among HCPs is needed: a combination of preventative education, early identification and intervention, aggressive treatment, and consistent rehabilitation.
Animals ; Delivery of Health Care ; Dopamine ; Euphoria ; Humans ; Incidence ; Pharmacy ; Propofol ; Reinforcement (Psychology) ; Reward ; Substance-Related Disorders ; Unconsciousness

Pharmaceutical quality, management are important targets to integrate in international pharmaceutical market, raising field's prestige. The authors showed that must review and control several factors in imported and exported records of the products, such as GMP condition of supplier, TSE. Learning about inspected experiences of famous special organizations. Preparing to enhance Vietnam's GMP. To advance pharmaceutical exported program to foreign country
Adjuvants, Pharmaceutic ; Reinforcement (Psychology) ; Pharmaceutical Preparations

Nicotine, the primary psychoactive components of tobacco smoke, produce diverse neurophysiological and behavioral effects through several brain regions and neurochemical pathways. It acts as an agonist to activate and desensitize nicotinic acetylcholine receptors. Nicotinic signaling leads to activation of reward centers in the CNS, including the mesoaccumbens dopamine system, which ultimately leads to behavioral reinforcement and addiction. Indeed, the actions of nicotine on many systems, including brainstem cholinergic, GABAergic, glutaminergic, noradrenergic, and serotonergic systems, may help to mediate nicotine effects related to addiction. And many years of smoking induces neuroadaptations in acetylcholine and dopamine systems. Moreover, the long-term synaptic changes results in learned behaviors and memory which are associated with smoking. We reviewed the nicotinic synaptic mechanisms in midbrain dopaminergic areas. In summary, nicotine as obtained from tobacco interacts with multiple nicotinic acetylcholine receptor subtypes on dopamine, GABA, glutaminergic neuron to produce not only the acute positive reinforcement but also the synaptic changes associated with learning and memory.
Acetylcholine ; Brain ; Brain Stem ; Dopamine ; gamma-Aminobutyric Acid ; Learning ; Memory ; Mesencephalon ; Neurons ; Nicotine* ; Receptors, Nicotinic ; Reinforcement (Psychology) ; Reward ; Smoke ; Smoking ; Tobacco ; Tobacco Use Disorder*

Nicotine is the major substance that accounts for the addictive nature of smoking. Nicotine induces neurobiological and behavioral responses through diverse neurochemical mechanisms over the central nervous system. The brain reward system, particularly the dopaminergic pathway from the ventral tegmental area to nucleus accumbens, is central to understanding the behavioral reinforcement underlying substance addictions such as the addiction to nicotine. Nicotine acts as an agonist provoking activation or desensitization of nicotinic acetylcholine receptors in different brain areas including the brain reward system. Nicotine also indirectly influences the glutaminergic, GABAergic, noradrenergic, and serotonergic neurotransmission that lead ultimately to activation of the dopaminergic pathway in the brain reward system. Chronic exposure to nicotine activates neuroadaptation and associative learning with the nicotine-related stimulus through dopaminergic or cholinergic systems, which can lead to nicotine dependence or withdrawal. In sum, the neurobiological processes described above are deeply involved in the basis of nicotine dependence and underlie the frequent failure of attempts to quit smoking. In this review we discuss the neurobiological mechanisms of nicotine addiction focusing on the roles of the nicotinic acetylcholine receptor.
Brain ; Central Nervous System ; Dopamine ; Learning ; Nicotine ; Nucleus Accumbens ; Receptors, Nicotinic ; Reinforcement (Psychology) ; Reward ; Smoke ; Smoking ; Synaptic Transmission ; Tobacco Use Disorder ; Ventral Tegmental Area

Nicotine is the major substance that accounts for the addictive nature of smoking. Nicotine induces neurobiological and behavioral responses through diverse neurochemical mechanisms over the central nervous system. The brain reward system, particularly the dopaminergic pathway from the ventral tegmental area to nucleus accumbens, is central to understanding the behavioral reinforcement underlying substance addictions such as the addiction to nicotine. Nicotine acts as an agonist provoking activation or desensitization of nicotinic acetylcholine receptors in different brain areas including the brain reward system. Nicotine also indirectly influences the glutaminergic, GABAergic, noradrenergic, and serotonergic neurotransmission that lead ultimately to activation of the dopaminergic pathway in the brain reward system. Chronic exposure to nicotine activates neuroadaptation and associative learning with the nicotine-related stimulus through dopaminergic or cholinergic systems, which can lead to nicotine dependence or withdrawal. In sum, the neurobiological processes described above are deeply involved in the basis of nicotine dependence and underlie the frequent failure of attempts to quit smoking. In this review we discuss the neurobiological mechanisms of nicotine addiction focusing on the roles of the nicotinic acetylcholine receptor.
Brain ; Central Nervous System ; Dopamine ; Learning ; Nicotine ; Nucleus Accumbens ; Receptors, Nicotinic ; Reinforcement (Psychology) ; Reward ; Smoke ; Smoking ; Synaptic Transmission ; Tobacco Use Disorder ; Ventral Tegmental Area