DREXEL PSY 310 - Drug Policy (5 pages)

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Drug Policy



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Drug Policy

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Pages:
5
School:
Drexel University
Course:
Psy 310 - Drugs & Human Behavior
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Drug Policy Two Classes of Drug Laws Regulation of legal drugs pharmaceutical companies pharmacists physicians all others who manufacture and dispense Criminalization of certain drugs use possession sales Beginnings of Regulation Issues leading to legislation Fraud patent medicines Morality and race drugs of abuse 3 pieces of legislation inform current drug laws 1906 Pure Food and Drugs Act 1914 Harrison Act 18th Amendment Alcohol Prohibition 1918 Issues Leading to Legislation Fraud in patent medicines sold directly to the public False therapeutic claims Habit forming drug content Opium Opium smoking brought to U S by Chinese workers U S was involved in international drug trade Laws passed against the importation manufacture and use of opium Role of racism Cocaine Present in products o Patent medicines o Coca Cola Viewed as a cause of increasing crime Role of racism 1906 Pure Food and Drug Act Purpose of the legislation Prohibited interstate commerce in misbranded and adulterated food and drugs Misbranding referred only to labeling not advertising Later amendments for Testing for safety Testing for effectiveness Harrison Act of 1914 Purpose of the legislation required those who produce import manufacture compound deal in dispense or give away certain drugs to register and pay a special tax Initially controlled opium and cocaine Later expanded to include other federal controlled substance regulations Two Types of Regulation The Pure Food and Drugs Act 1906 U S Department of Agriculture Goal drugs are pure and honestly labeled Harrison Act 1914 U S Treasury Department Goal taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians pharmacists and legitimate manufacturers Regulation of Pharmaceuticals Purity 1906 Pure Food and Drug Act o Product contents must be accurately listed on the label Initially FDA encouraged voluntary cooperation and compliance 1912 Sherley Amendment outlawed false and fraudulent therapeutic claims on labels Safety 1906 Pure Food and Drug Act o No legal requirement that medications be safe 1938 Food Drug and Cosmetic Act o FDA became a gatekeeper and expanded greatly o Required pre market testing for toxicity o Companies required to submit a New Drug Application NDA Directions must be included o Adequate instructions for consumer or o Drug can be used only with physician prescription Effectiveness 1938 Food Drug and Cosmetic Act o No legal requirement that medications be effective 1962 Kefauver Harris Amendments o Pre approval required before human testing o Advertising for prescription drugs must include information about adverse reactions o Every new drug must be demonstrated to be effective for the illnesses mentioned on label Process for Introducing a New Drug Preclinical research and development Company submits Notice of Claimed Investigational Exemption for a New Drug IND Clinical research and development Phas Testing Who is tested e 1 2 3 How the drug is absorbed and excreted Initial effectiveness testing Broader effectiveness testing low doses 20 80 healthy volunteers A few hundred patients who could benefit typically 1 000 5 000 patients Additional FDA Legislation Orphan Drug Act 1983 Developing drugs for rare disorders Tax and other financial incentives Prescription Drug Marketing Act of 1988 Regulation of free samples to physicians 1997 FDA Modernization Act Guidelines for o postmarketing reporting of adverse effects o distribution of information on off label uses Dietary Supplements 1994 Dietary Supplement Health and Marketing Act Labels must be accurate Products can t make unsubstantiated direct claims Products can make general health claims Products can be marketed without first proving safety Legislation of Controlled Substances Early enforcement 1914 Harrison Act o Narcotics Division s interpretation of Act led to criminalization of drug use o Physicians and pharmacists arrested 18th Amendment Alcohol Prohibition 1918 Jones Miller Act of 1922 Doubled the penalties for dealing in illegal drugs Prison vs rehabilitation Congress deemed punishment ineffective Established Narcotic farms for rehabilitation 1935 Bureau of Narcotics Formed in 1930 in the Treasury Department Harry Anslinger first Drug Czar Instrumental in passing the Marijuana Tax Act 1937 1956 Narcotic Drug Control Act Toughest penalties to date Drug Abuse Control Act Amendments of 1965 Added new classes of drugs Comprehensive Drug Abuse Prevention and Control Act of 1970 Replaced or updated all previous laws Drugs controlled by the Act are under federal jurisdiction o In some cases state and federal laws conflict Increased funding for Prevention and treatment Department of Heath and Human Services Direct control of drugs Drug Enforcement Agency o Taxation was no longer a strategy Enforcement separated from scientific and medical decisions Amendments to Comprehensive Drug Abuse Prevention and Control Act of 1970 1986 o Stiffened possession and selling penalties o Crack vs powder cocaine sentencing 1988 o Control of drug precursors o Control of drug paraphernalia o Established the Office of National Drug Control Policy Controlled Substances Schedules Schedul e I II III IV V Criteria Examples a High potential for abuse b No accepted medical use c Lack of accepted safety a High potential for abuse b Currently accepted medical use c Abuse may lead to severe dependence Heroin marijuana MDMA Ecstasy Morphine cocaine methamphetamin e Anabolic steroids most barbiturates Dronabinol THC in pill form Xanax barbital chloral hydrate fenfluramine a Potential for abuse less than I and II b Currently accepted medical use c Abuse may lead to moderate physical dependence or high psychological dependence a Low potential for abuse relative to III b Currently accepted medical use c Abuse may lead to limited physical or psychological dependence relative to III a Low potential for abuse relative to IV b Currently accepted medical use c Abuse may lead to limited physical or psychological dependence relative to IV State and Local Regulations Penalties differ from state to state Federal law overrides state law Significant growth in number of Americans in prison U S has greatest proportion of citizens in prison compared to other countries Federal Support for Drug Screening Examples of tested populations Military and federal employees Transportation workers Employees at private companies Public schools employees Testing method issues Mixture with small amounts of codeine or opium


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