This guideline makes recommendations on the diagnosis, assessment and management of harmful drinking and alcohol dependence in adults and in young people aged 10–17 years.
This is one of three pieces of NICE guidance addressing alcohol-related problems and should be read in conjunction with:

• Alcohol-use disorders: preventing the development of hazardous and harmful drinking. NICE public health guidance 24 (2010). Available from www.nice.org.uk/guidance/PH24 – public health guidance on the price, advertising and availability of alcohol, how best to detect alcohol misuse in and outside primary care, and brief interventions to manage it in these settings.
• Alcohol-use disorders: diagnosis and clinical management of alcohol-related physical complications. NICE clinical guideline 100 (2010). Available from www.nice.org.uk/guidance/CG100 – a clinical guideline covering acute unplanned alcohol withdrawal including delirium tremens, alcohol-related liver damage, alcohol-related pancreatitis and management of Wernicke’s encephalopathy.

Harmful drinking is defined as a pattern of alcohol consumption causing health problems directly related to alcohol. This could include psychological problems such as depression, alcohol-related accidents or physical illness such as acute pancreatitis. In the longer term, harmful drinkers may go on to develop high blood pressure, cirrhosis, heart disease and some types of cancer, such as mouth, liver, bowel or breast cancer.
Alcohol dependence is characterised by craving, tolerance, a preoccupation with alcohol and continued drinking in spite of harmful consequences (for example, liver disease or depression caused by drinking). Alcohol dependence is also associated with increased criminal activity and domestic violence, and an increased rate of significant mental and physical disorders. Although alcohol dependence is defined in ICD-10 and DSM-IV in categorical

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)). Examples of products that are addressed in this guidance include new molecular entities and new dosage forms of drug substances already controlled under the Controlled Substances Act (21 U.S.C. 812(c)). Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.2

Specifically, the guidance discusses the following:

• The definition of abuse potential

• Information on submitting an abuse potential assessment, including a proposal for scheduling

• A description of what constitutes an adequate abuse potential assessment

• Information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”