RXRS final

• DEA


  Drug Enforcement Administration (July 1, 1973)
• DEA


  • Enforces controlled substance laws and regulations
  • Bring to the criminal and civil justice system organizations and their principal members involved in the growing, manufacture, or distribution of controlled substances
  • Recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances
  • Consolidate and coordinate the government's drug control activities
• DEA today


  • Enforces the provisions of the controlled substances and chemical diversion and trafficking laws and regulations
  • Conducts operations on a worldwide basis
  • Disrupts and dismantles these organizations by arresting their members, confiscating their drugs, and seizing their assets
  • Creates, manages, and supports enforcement-related programs - domestically and internationally - aimed at reducing the availability of and demand for illicit controlled substances
• Legalization


  The complete removal of sanctions, making a certain behavior legal, and applying no criminal or administrative penalties
• Legalization


  1. Vote

  2. Establishment of a regulatory system

  3. Emergence of retail sales outlets

  4. Development of an adequate legal supply of product

  5. Retail shops have additional regulatory hurdles - electricity, computer systems, water usage, and environmental safety
• Drug Liberalization


  The process of eliminating or reducing drug prohibition laws
• Decriminalization


  The removal of sanctions under the criminal law, with optional use of administrative sanctions
• Administrative sanctions


  • Civil fines
  • Court-ordered therapeutic responses
• In 2001, Portugal decriminalized all drugs
• Portugal legislation treated possession and use of small quantities of drugs as a public health issue, not criminal
• In Portugal, drugs remained "illegal" but getting caught with them is a small fine, potential referral to a treatment program, no jail time, and no criminal record
• A lot of good things resulted from Portugal's decriminalization, including reducing illicit drug use among problematic drug users and teens, reducing burden of drug offenders on the criminal justice system, reducing opiate-related deaths and infectious diseases, retail prices of drugs also reduced, and increased uptake of drug treatment and the amounts of drugs seized by authorities - for sales in foreign markets
• Depenalization


  The decision in practice not to criminally penalize offenders, such as non-prosecution or non-arrest
• Ethics


  The systematizing, defending, and recommending concepts and actions behind right and wrong conduct
• Bioethics


  The study of ethical issues emerging from advances in biology and medicine
• Scope of bioethics


  • Cloning
  • Gene therapy
  • Life extension
  • Human genetic engineering
  • Astroethics
  • Life in space
• Medical Ethics


  The study of moral values and judgments as they apply to medicine
• Medical ethics seeks to inform healthcare professionals and enable them to make moral decisions by providing a set of values that professionals can refer to in instances where confusion/conflict arise
• Medical ethics allows doctors, care providers, and families to create a treatment plan and work toward the same common growth
• Autonomy


  Self-determination that is free from both controlling interferences by others and personal limitations preventing meaningful choice
• Respect for persons encompasses

  • All individuals should be treated as autonomous agents
  • They can deliberate about personal choices and act upon those deliberations
  • Individuals who have diminished autonomy must be protected
• Four conditions flow directly from Respect for persons

  • Voluntary consent
  • Informed consent
  • Protection of privacy and confidentiality
  • Right to withdraw without penalty from a study
• Beneficence


  Moral obligation to act for the benefit of others
• Beneficence requires the examination of the risks and benefits of the study, the study should do no harm, benefits must be maximized while harm is minimized, and the risks are justified by the benefits of the study
• Confidentiality


  The information a patient reveals to a healthcare provider is private and has limits on how and when it can be disclosed to a third party; usually the provider must obtain permission from the patient to make such a disclosure
• Non-maleficence / do no harm

  An obligation not to inflict harm intentionally
• Equity / Justice


  Giving others what is due to them; is comprised of a group of norms for the fair distribution of benefits, risks, and costs
• Types of justice


  • Distributive
  • Criminal or punitive
  • Rectifactory
• Interventional/experimental research


  Where the participants receive an intervention, such as a new medicine, in order to evaluate the safety and efficacy
• Observational research


  A study in which a researcher simply systematically observes behavior without influencing or interfering with the behavior
• Throughout history, the role of human research subjects has been fraught with danger and suffering
• Advances in protection for human subjects have often come in response to abuses or scandal
• FDA


  Food and Drug Administration: responsible for protecting and promoting public health through the control and supervision of various products
• The FDA was empowered by the U.S. Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency
• Drug Safety


  The potential for adverse effects related to the administration of drugs
• All drugs can harm as well as help, safety is a relative term
• Drug Efficacy


  The drug's ability to produce the desired result in the body
• 1962: Thalidomide tragedy - US 17 birth defects, manufacturers had to prove drugs were effective and safe, clinical investigations including a requirement for INFORMED CONSENT had to be approved, advertising of prescription drugs was to become FDA regulated, all previously approved drugs had to be retested for safety and efficacy (1938-1962), over the counter drugs were also under requirement to be retested
• After 1962, all New Drug Applications to the FDA were required to show efficacy and safety in humans before the drug could be approved for consumer use
• Informed Consent


  A process that involved getting permission before conducting a healthcare intervention on a person