CREATEDATE 4/30/09 7:04 PM Alcohol and other drug abuse Chapter 3: Drug products and their regulations The Beginnings Reformism Issues leading to legislation -morphine= a narcotic, the primary active chemical in opium. Heroin is made from morphine -by start of 20th century, most physicians were aware of the dangers of morphine over use, but many patients had developed morphine dependence under their doctor?s care and relied upon their physicians and pharmacists for a regular supply -unique disorder and needed to continue treatment, or weak-willed, simply seeking pleasure in the drug?s effect (moral model of dependence) --patent medicines= medicines sold directly to the public --opium and the Chinese --cocaine= a stimulant; the primary active chemical in coca -became available in mid 1800s, and use increased over time 1906 pure food and drug act -prohibited interstate commerce in adulterated or misbranded foods and drugs Harrison act of 1914 -an act to impose tax on people who produced, imported, manufactured, compounded, dealt with, dispensed, or gave away opium or coca leaves, salts, derivatives, or preparations Two bureaus, two types of regulation Regulation of pharmaceuticals Purity -FDA= US food and drug administration Safety -?sulfa? drugs- effective antibiotics, causes kidney poisoning -in 1938 law, before a new drug could be marketed its manufacturer had to test it for toxicity -company was to submit a new drug application NDA -NDA= new drug application, must be approved before drug is sold Effectiveness -thalidomide, a sedative and sleeping pill, was first marketed in W Germany in 1957 -drug was used by pregnant women because reduced morning sickness -an American company submitted an NDA in 1960 to market thalidomide, but the FDA physician didn?t approve it quickly, and in 61 and 62, became clear that thalidomide was responsible for birth defects -1962 Kefauver-Harris amendments added several important provisions, including requirement that companies seek approval of any testing to be done with humans before clinical trials are done -advertisements for prescription drugs need to contain summary of info about adverse reactions to the drugs -every new drug be demonstrated effective for the illnesses mentioned on the label Marketing a new drug -IND= application to investigate a new drug in human clinical trials -phase 1- studies with low doses of drug on limited number of healthy people -phase 2- patients who have the condition the candidate drug is designed to treat, involve a few hundred patients who are chosen because new drug might help -phase 3- administers the drug to larger number of people 1000-5000 with the disease or symptom for which the drug is intended, if compound proves effective in phase 3, FDA balances dangers against benefits before releasing it to public Dietary supplements -treated more as foods, don?t need to be proved to be effective for a specific intended purpose Controlled substances After the Harrison act -1919 prohibition unit?18th amendment --arresting physicians and pharmacists -new method of enforcing the Harrison act resulted in growth of illicit drug trade, charged users up to 50 times more than legal retail drug price -opioid dependence increasingly viewed as police rather than medical problem --stiffer penalties -1924 another act prohibited importing opium for manufacture of heroin -1925 Linder case- US supreme court declared it could be legal for a physician to prescribe opioids for a dependent user if it were a part of a curing program and didn?t transcend limits of professional conduct -but, most physicians would have nothing to do with drug dependent patients --prison versus treatment -by 1928, individuals sentenced for drug violations made up 1/3 of total population in federal prisons -in 1929, congress viewed enormous expenditure for drug offenders as indicator that something was wrong and decided they needed to be cured rather than repeatedly jailed -voted to establish 2 ?narcotic farms? for treatment of people dependent on habit forming drugs- who had been convicted of violating federal law --the bureau of narcotics -WWII caused decrease in importation of both legal and illegal drugs -1951 Boggs amendment to Harrison act established mandatory minimum sentences for drug offenses -1956 Narcotic Drug Control Act- any offense except first offense possession had to result in a jail term, and no suspension, probation, or parole was allowed -anyone caught selling heroin to a person younger than 18 could receive the death penalty Drug abuse control amendments of 1965 -early 1960s saw increase in illegal drug use and shift in type of drugs beign used illegally -new drug users better educated and emphasize drugs that alter mood and consciousness, such as amphetamines, barbiturates, and hallucinogens -1965 drug abuse control amendments referred to these as dangerous drugs and included hallucinogens, such as LSD -bureau of narcotics became bureau of narcotics and dangerous drugs Comprehensive drug abuse prevention and control act of 1970 -aka: controlled substance act updated all previous laws concerned with both narcotic and dangerous drugs --prevention and treatment -controlled substance act dealt with prevention and treatment of drug abuse by appropriating funds to expand role of community mental health centers and public health service hospitals in the treatment of those who misuse drugs -authorized development of educational material and drug education workshops for professional workers and in public schools --control issues resolved -control aspects of this act were most debated parts -this was a law to control drugs directly rather than through taxes -enforcement was moved from treasury to drug enforcement administration -DEA= drug enforcement administration, branch of the department of justice -separation of enforcement of the law from the scientific evaluation of the drugs considered for control --schedules -law established 5 schedules of drugs that must be updated and published regularly --penalties for possession -a first offense of illegal possession of a controlled drug or distributing a small amount of marijuana for no remuneration can be punished by up to 1 years imprisonment and or a fine of $1000-$5000 -court can place person on probation for up to a year, if there is no violation of the conditions of probation, charge is dismissed and conviction is erased except that a nonpublic record of the action is kept to prevent a person from being a first offender more than once --penalties for selling -1970- max first offense penalty for distributing schedule 1 or 2 ?narcotic? was 15 yrs and $25000 -1986- penalties became more complex depending on individual drug and amount sold -mandatory minimum sentences -provision prevents a judge from considering such things as the defendants character, work history, and requires prison terms 5yrs or 10 yrs be imposed depending on offense -helped contribute to huge growth in prison populations --Omnibus drug act -the 1988 law removes from public housing the entire family of anyone who engages in criminal activity, including drug related activity, on or near public housing premises --drug precursors -controlled substance act provides that the attorney general may include on the schedules any immediate precursor of a controlled substance --drug paraphernalia -1988 revision of controlled substances act prohibited sales of drug paraphernalia (equipment used in conjunction with any activity) --office of national drug control policy -1988 omnibus drug act established the cabinet level position of director of national drug control policy -prepares national drug control strategy and an annual consolidated drug control budget for all federal agencies involved -office of national drug control policy was reauthorized and given additional authority in 1998 State and local regulations -there are several current instances of individuals being charged under federal law for conduct that is protected by state laws Federal support for drug screening Military and federal employees -navy followed by army was first to use random urine screening on large scale -1986 Reagan 1st declared random urine tests be performed on all federal employees in sensitive jobs -in 2004 new guidelines were proposed that would allow federal agencies to use urine, sweat, saliva, or hair samples to test for drugs -THC= delta-9-tetrahydrocannabinol, the most important psychoactive chemical in marijuana transportation workers private employers public schools testing methods -hair testing has increased in popularity recently -general idea of screens seems to be discourage illicit drug use more than to detect impairment of performance The impact of drug enforcement -2004 the defense department spent ~$500 million on drug interdiction activities Budget International programs Other federal agencies Other costs -paying to house large number of prisoners Effectiveness of control -laws work at one level, estimated that 10-15% of illegal drug supply is seixed by federal agencies each year -
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