Chapter 1: Chapter 1: Drugs: Mind, Body, and Society

Drug: any chemical entity or mixture, other than those required for the maintenance of normal health (such as food), which alters biological function or structure where administered.

  • In 2017, 5% of the world's adult population (250 million people) report using an illicit drug at least once.
  • The United States has 4.4% of the world's population, but consumes 65% of the world's supply of illicit drugs and a 1/4 of drug related deaths.
  • Substance Abuse and Mental Health Administration Survey
  1. Age: 18-20 years old have the highest rate of illicit drug use.
  2. Gender: men are more likely to use illicit drugs than are women.
  3. Race: Rate's are highest in Hispanics, and whites tend to fall in-between for Middle and high school. For adults, Asians have the lowest rate.
  4. Education: those without a high school diploma showed the lowest rates of current illicit drug use, followed by college graduates, and then high school graduates. Drug use was highest among those who attended but did not finish college.
  • Nearly 70% percent of Americans are on at least one prescription drugs, and more than 50% take two.
  • Reasons for Fluctuations in Drug Use
  1. Penalties for use
  2. Perceived Risk and Accessibility
  3. Social activities and lifestyle

  • Why Do People Use Drugs?
  1. To feel pleasure and to avoid feeling pain
  2. To change the state of consciousness
  3. To enhance spiritual, religious, or mystical experiences
  4. To facilitate and enhance social interactions
  5. To alter and improve the body

  • How Does Drug Use Affect Individuals and Society?
  1. Individual Problems with Acute Use
  2. Individual Problems with Chronic Use
  3. Societal Problems Associated with Drug Use

Illegal drugs: restricted at some level of government or authority

Illicit drugs: Forbidden by laws, rules, or customs.

Recreational drugs: Drugs that are taken for nonmedical purposes

Endogenous: produced or originated from within an organism.

Synthetic Drugs: Taking a purified form of a natural drug and changing its chemical structure.

Drug Naming: is given it's chemical name/formula, then a generic name (official name), then its brand or trade name (used by company that filed patent)

  • Drugs sold with generic names are cheaper than sold with the brand patent name.
  • Drugs marketed to men have tougher letters, while women's have more softer letters

Drug Schedules: The five categories that drugs are classified into based upon the drug's accepted medical use and it's potential for abuse and addiction. 1 being the most dangerous and 5 being the least.

  1. Schedule I - lack of accepted safety and not currently medically used in the US.
  2. Schedule II - Abuse may lead to dependence with some accepted medical use.
  3. Schedule III - Less potential for abuse and is accepted medically in the US
  4. Schedule IV - limited potential for abuse and dependence and is accepted medically in the US
  5. Schedule V - limited potential for abuse and dependence and is accepted medically in the US
  • People who schedule drugs are with the FDA and the Secretary of the Department of Health and Human Services and the Drug Enforcement Agency.
  • FDA provides the Secretary of Health with scientific/medical evaluations to decide where it belongs, DEA determines the schedule and enforces the penalties.

  • How are new drugs developed?
  1. The rediscovery of traditional uses of various naturally occurring products
  2. The accidental observation of an unexpected drug effect
  3. The synthesis of known or novel compounds

The FDA: responsible for regulating the safety of food, prescription and over-the-counter pharmaceuticals, tobacco, dietary supplements, vaccines, and medical devices.

  • When a compound is believed to have clinical value, it's tested on animals, then limited study on healthy human volunteers and clinical patients. Then if benefits outweigh risks, it can be approved for liscencing/marketing.

Preclinical Stage: first stage of drug development. Lasts for 2-10 years and includes initial synthesis and development of the drugs and preclinical trials. Tested on two animal species (at least).

Clinical Stage: Can last 6-7 years and costs an avg. of 40 million.

  1. Phase 1: clinical trials establish the drug's safety. human reaction's to drug are tested. toxicity is evaluated, side effects.
  2. Phase 2: clinical trials emphasize effectiveness. Tested on people with targeted disease.
  3. Phase 3: clinical trials are typically double-blinded, placebo-controlled studies.

FDA Review: If drug is safe, can submit a New Drug Application to the FDA. Performs a standard review (10 months) or an accelerated review (6 months). Typically takes two years.

Postmarketing Analysis: After the drug is on the market, its effectiveness, side effects, adverse effects are all still monitored. If concerns arise, can be pulled from the market.

Direct-to-consumer Advertising: Pharmaceutical companies market their products directly to patients rather than to healthcare professionals.

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