Pharmacology final

• Regulation


  law (federal, state) establishes a uniform standard for the interpretation of safety, legally enforceable by an agency, consequences will vary based on situation/agency but could include: fines and/or incarceration
• Guidance


  an agency's opinion based on the current scientific knowledge and is not enforceable.

  Gives an agency flexibility and allows them to address issues quickly (document put out)
• Tolerance


  defined regulatory limit (concentration) considered to be safe (above concentration can result in noncompliance)

  Publically available information & can be viewed on-line by visiting the agency's website
• Regulatory toxicology


  sub-specialty of toxicology that describes branch legally mandated to approve/permit substances to be used (pesticides, drugs, food additives), establish "safe" thresholds (concentrations), enforce regulations (laws) relevant to product public safety
• 4


  how many primary agencies in the US are responsible for ensuring public safety on the federal level?
• FDA (US Food and Drug Administration)


  regulatory agency in charge of monitoring food additives, drugs, cosmetics and medical devices
• EPA (Environmental Protection Agency)


  regulatory federal agency responsible for pesticides, drinking water and air quality
• OSHA (occupational safety and health administration)


  regulatory federal agency responsible for worker safety
• CPSC (Consumer product safety commission)


  regulatory federal agency responsible for miscellaneous products not regulated by FDA/EPA
• effective communication in both directions (done so a limit that cannot be achieved scientifically isn't established)


  What is needed to help advance science and public safety between researchers are regulatory agencies?
• have different "personalities" and operate independently while trying to collaborate/ coordinate efforts


  How are regulatory agencies described?
• Congress


  where is all direction for research and regulatory agencies taken from?
• Food, drug & cosmetics (FD&C) Act 1938


  gave FDA legal authority to oversee product areas (i.e. drugs, food..) due to catastrophic event that killed 100s of patients due to diethylene glycol used as solvent for sulfanilamide. (vehicle caused morbidity when it shouldn't have)
• Food Additives Amendment 1958


  a substance must be proven to be safe (based on experimental/ scientific data) before humans can be exposed (NO RISK)
• Delaney clause (in 1958 food additives amendment)


  substance can not be considered safe if shown to cause cancer in laboratory animals or humans
• Risk assessment


  most agencies use this progressive approach to manage non-carcinogenic chemicals/ substances
• Post 1958 Amendments to the FD&C act


  allows FDA to adapt regulation as the science/technology continues to evolve

  •Provisions applicable to pesticide residues on food and adopted tolerance levels for carcinogenic pesticides if estimated risk is very low (i.e. 1 in 1 million)

  •Shift from NO RISK to NEGLIBLE RISK
• food for humans and animals, human & veterinary drugs, medical devices (anything that one touches in a hospital), cosmetics


  What products does the FDA have jurisdiction over?
• Risk Assessment


  what do most agencies use as a progressive approach to manage non-carcinogenic chemicals/substances?
• Substance ingested for caloric value and/or nutritional support to sustain life


  What is food?
• oral and


  What types of exposure (route/duration) is food considered to be?
• Direct food additives


  intentional ingredient (i.e. salt, sucrose, wheat flour)
• Indirect food additives


  food packaging and chemicals that migrate into food
• health effects, ability to measure (quantify) the contaminant, price and availability of food


  What three factors should be considered (but not necessarily in order of importance) for authorized establishment of tolerances for added poisonous substances that cannot be avoided by GMPs?
• T (this includes defined regulatory process & testing requirements as well as considering pre- and post market activities)


  T or F: all food additives must be approved for use prior to marketing in the US
• Added poisonous or deleterious substances which may render it injurious to health

  Non-added toxicants that make them 'ordinarily injurious to health


  The FD&C forbids marketing of any foods containing what?
• natural elements in soil (arsenic in rice)


  What are examples of non-added toxicants that can make foods ordinarily injurious to health?
• T


  T or F: Authorized establishment of tolerances for "added poisonous substances" that can't be avoided by good manufacturing practices (GMPs)
• Drug


  articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals [FD&C Act, sec. 201 (g)(1)]
• The definition of a drug

  What is dependent on the country as are regulations?
• reduces risk of dangerous drugs being introduced to the market


  What does the pre-market approval process do?
• safety and efficacy testing requirements (Orange book) and tiered testing approach (includes laboratory animal studies before human clinical trials)


  What testing is required for pre-market approval?
• In multiple phases before a drug is reviewed for approval


  how is toxicology testing done?
• discovery/synthesis, preclinical, ongoing safety survelliance, phase 1, phase 2, phase 3, FDA Review, phase 4


  Land markers in drug development and approval
• phase 1


  part of timeline for drug development and approval 1st time drug is in humans and includes health volunteers and where toxicity is first tested (long term effects of drug not known)
• preclinical trials


  part in drug development and approval timeline where laboratory animals are used to test drugs
• phase 2


  part of timeline for drug development where small group of patients are tested. look for signs of efficacy
• phase 3


  part of timeline for drug development where large group of patients (scale up from small group)
• phase 4


  post marketing survey in the general population (where drugs get recalled and FDA continues to monitor for ongoing safety surveillance)
• Medical device


  an instrument, apparatus, implement, machine, contrivance, implant, in vitro, reagent, or other similar or related article, including a component part, or