Exam 1 Flashcards by ashlie harder

What was the 1st attempt to protect consumers in the manufacture of food and drugs?

Food and drug act 1906

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What did the food and drug act require?

All drugs meet minimal standards of strength, purity and quality
MUST label container if drug contains dangerous ingredients

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What are the 2 references the food and drug act established?

USP- United States pharmacopeia

NF- national formulary

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What are the 3 published drug references?

USP/NF
PDR
AHFS- American hospital formulary service

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What are the 4 internet drug and supplement references?

Medscape
Natural medicine databases
Medline plus
WebMD

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What are the 4 definitions of a drug according to the food, drug and cosmetic act?

1 a substance recognized in an official pharmacopeia of formulary
2 a substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease
3 a substance other than food intended to affect the structure or function of the body
4 a substance intended for use as a component of a medicine

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Which amendment established that drugs need a prescription from a licensed practitioner?

FD & C Durham Humphrey- 1951

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What established that new food additives be approved and determined for safety before being marketed?

FD&C food additives amendment- 1958

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What are the 2 food additives amendment exceptions?

GRAS- generally recognized as safe

Substances which FDA or USDA approved as safe prior to amendment

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What was used as a sleep aid and for morning sickness that caused birth defects in 1960?

Thalidomide

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What is the official name for the controlled substances act?

Comprehensive drug abuse prevent and control act- 1970

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What was created to regulate the dispensing of drugs with potential for abuse and created the 5 schedules to classify drugs?

Comprehensive drug abuse prevent and control act AKA

Controlled substances act

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What schedule has high potential for abuse and no medical use?

Schedule 1- heroine, LSD, marijuana, ecstasy, methaqualone and peyote

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Which schedule has high abuse potential but has a medical use?

Schedule 2- Vicodin, cocaine, dilaudid, Demerol, OxyContin, Dexedrine, adderall, Ritalin

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Which schedule has moderate abuse potential and accepted medical use?

Schedule 3- Tylenol with codeine, ketamine, anabolic steroids, testosterone

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Which schedule has low abuse potential and accepted medical use?

Schedule 4- xanax, soma, darvocet, Valium, Ativan, ambien, tramadol

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Which schedule has limited abuse potential and accepted medical use?

Schedule 5- robitussin AC, lomotil, motofen, lyrica

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What established that the FDA is responsible for taking action against any unsafe dietary supplement after it reaches market?

Dietary supplements health and education act- 1994

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Which act reinvestigated pesticide tolerance levels and developed stricter standards especially for children?

Food quality protection act- 1996

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Who regulates agricultural and industrial chemicals and water?

EPA

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Who recalls unsafe consumer products?

CPSC- consumer products safety commission

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Who regulates workplace chemical exposure?

OSHA- occupational safety and health admin.

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What are the 2 requirements for FDA to approve a drug for use in humans?

Efficacy

Safety

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What is the pharmaceutical development and approval process?

1 discovery and development- 1-2 years
2 pre-clinical research and development- institutional review boards, testing etc. 3-6 years
3 clinical trials- 3 phases; 6-7 years
4 FDA review NDA (new drug application) 1-2 years
5 manufacturing

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What is the therapeutic index

TI= LD50/ED50 Used to establish dosage levels in animal trials

What is the highest dose without any adverse effect?

NOAEL- no observed adverse effect level

What is the lowest dose found by experiment or observation at which there was a statistically significant observed adverse effect?

LOAEL- lowest observed adverse effect level

What is unique about supplements?

There is no FDA approval required to market it is only the FDA's job to prove it is unsafe

Adverse side effects are typically

Dose dependent

What are the 6 pregnancy FDA categories?

A- no study has been able to measure risk B- no studies done in humans, but animals show no risk C- no studies on humans or animals or if there were on animals, there is some teratogenic potential D- drug has revealed adverse effect to effect, benefit to risk ratio must be assessed X- studies have shown teratogenic effect in animals and women; contraindicated in pregnancy NR- not yet rated by FDA

What are the common drugs that have shown teratogenic effect on fetus?

``` Androgens Carbamazepine (anti-seizure) Diethylstillbesterol (estrogen) Estrogen Lithium Phenytoin (Dilantin)- anti-seizure Retinoic acid Thalidomide (immune modulator; leprosy and MM) Warfarin Depakote (anti-seizure) ```

What are the 4 unexpected adverse drug effects?

Idiosyncrasy Tolerance Paradoxical Dependence

What is the term to describe an unusual, unique or unexpected response to a drug that can cause genetic variations in enzymes or alter metabolism?

Idiosyncrasy

What is the term to describe an adverse effect with the opposite effect of what was intended?

Paradoxical

What is a decreased response that develops from a drug after repeated doses given?

Tolerance

What are the 5 types of toxic responses?

``` 1 direct toxic action- tissue lesions 2 pharmacological, physiological and biochemical effects 3 teratogenesis 4 immunotoxicity 5 mutagenesis 6 carcinogenesis ```

What direct toxicity- tissue lesion what happens and what is targeted?

Cell death- reversible or irreversible Target organ toxicity- any organ but some are more susceptible most susceptible: Liver, Lung, Kidneys

What % of adverse drug effects the liver?

What percent of CO does the liver receive?

25%

What are the types of liver toxicity?

``` Steatosis Cytotoxic damage Cholestatic damage Cirrhosis Vascular lesions Tumors Proliferation of peroxisomes ```

What does liver damage look like on blood work?

Increased: AST, ALT Decreased: bilirubin

What % CO for kidneys?

25%

What does blood work show with kidney damage?

Increased: BUN, creatinine Urine volume, pH and specific damage abnormal with damage Y-glutamyltransferase/ N-acetylglucosaminidase present in urine with damage

What are the types of lung damage?

``` Irritation Allergic response Cell damage Fibrosis Pulmonary cancer ```

No biochemical tests with lungs but what do we look at?

Decreased FEV- forced expiratory volume/ forced VC

A pharmokinetic based toxic effect is an increase in?

Concentration of the compound or active metabolite

A pharmodynamic based toxic effect is?

An altered responsiveness to target site

When is a fetus most susceptible to gross anatomical abnormalities?

Organogenesis 18-55 days

When drug interacts directly with DNA and causes damage?

Mutagenesis

What is clastogenesis?

Chromosomal damage

What is an acquisition or loss of complete chromosomes?

Aneugenesis

What is unrestrained cell replication and what are the steps?

Carcinogenesis Initiation- DNA mutation Promotion- altered gene expression and regulation Progression- another mutation leading to proliferation

Chemical carcinogens may cause?

Unusual tumors or increased incidence of typical tumors

What are the 3 phases of drug activity?

Pharmaceutic Pharmokinetic Pharmodynamic

What phase involves disintegration and dissolution of the dosage form?

Pharmaceutic phase

What is the pharmaceutic phase affected by?

Form of drug and route of administration

Which phase is described as what happens to the drug as it moves through the body?

Pharmokinetic- ADME Absorption Distribution Metabolism Excretion

What are the 4 ways drugs can be absorbed?

Passive diffusion Active transport Pinocytosis Filtration

Ionized molecules do not readily cross membranes so what needs to be done?

Needs to be un-ionized for absorption to occur Acid drugs in acidic fluid Basic drugs in alkaline fluid

What can we do in cases of toxicity to increase excretion?

Change pH of urine

Most drugs are water soluble what is an example of lipid soluble?

Anesthesia, marijuana

GI tract and lung absorption occurs mostly as?

Passive diffusion Both have large surface area

What limits absorption of foreign compounds through skin?

Keratin rich epidermis

Passive diffusion may occur with skin absorption but only certain compounds, what are they?

Lipophilic- often use carriers

The % of a dose that reaches the bloodstream is called?

Bioavailability

How much of oral meds typically reach blood?

20-40%

How much drug reaches an organ or area depends on?

Plasma protein binding Blood flow Specific tissue barriers Selective distribution

With plasma binding only ______ drug molecules can exert a pharmacological effect

Unbound, free; | some drugs are in competition and if one displaces another concentration of free drug increases and can lead to overdose

What are the 2 tissue barriers?

BBB | Placental barriers

What is the affinity or attraction of a drug to specific organ or cells?

Selective distribution Ex. Amphetamines have selective distribution to CSF

What is the time required for blood/plasma concentration of drug to fall to 50% of original level?

Half life t1/2

What are the metabolism AKAs?

Biotransformation and detoxification

Whenever a drug or other foreign substance enters the body, it tries to eliminate it. This chemical alteration is known as?

Metabolism, biotransformation, detoxification

Why do we metabolize?

Make more polar/ water soluble for excretion Decrease half-life Prevent accumulation Change bio activity

What is cytochrome P450 referred to as?

Drug microsomal metabolizing system

When a drug is taken repeatedly, the DMMS increases and leads to faster rate of drug metabolism and drug action is decreased. What is this phenomenon called?

Enzyme induction

What happens when the DMMS enzymes are inhibited thus increasing the duration and intensity of a drug?

Enzyme inhibition

What is first pass metabolism?

After oral administration all drugs are absorbed into the portal circulation; some metabolized significantly as they pass the 1st time

First pass metabolism can significantly reduce what?

Bioavailability and amount of drug that reaches general circulation

What are the major excretion sites?

Urine, bile, lungs, GI, breast milk

What are the minor excretion sites?

Sweat, tears, saliva, semen

What are the 3 methods of urinary excretion?

Filtration from blood through pores in glomerulus Diffusion from blood to tubules Active transport into tubular fluid

What are the 2 methods of biliary excretion?

Active transport into bile- can be saturated; liver toxicity Gut bacteria metabolize compounds- increase liver toxicity

What is the cycle of enterohepatic circulation?

Blood -> liver -> bile -> intestines ->

Where does passive diffusion of volatile metabolites from blood occur?

Lungs

Where does passive diffusion of weak bases into intestinal lumen occur?

GI tract

Where does passive diffusion of fat-soluble compounds occur?

Breastmilk

What is the action of the drugs on living tissue?

Pharmacodynamic phase- affected by form and route of administration

Drug concentration -> Pharmacological effect -> clinical response -> toxicity or effectiveness

Pharmacodynamics

Dose administered -> absorption or distribution -> concentration in systemic circulation or elimination-> concentration at site of action

Pharmacokinetics

Number of patients who leave doc with at least 1 prescription

2/3

Percent of population that have 4 or more prescriptions

40%

When does the rate of adverse drug reactions increase dramatically?

After 4 or more prescribed

What drug reacts with NSAIDS, sulfa drugs, macrolides, quinolones, phenytoin, statins and thyroid meds?

Warfarin

What drug reacts with potassium and spironolactone?

ACE inhibitors

What drug recommends you check with doctor if taking tranquilizers, sedatives, HBP meds or antidepressants?

Antihistamines

What percent of adults use dietary supplements?

50% or more

What supplement is an inducer of CP450 and can reduce concentration of drugs in blood?

St. John's wort

What can interfere with bleeding effects of Coumadin, heparin, aspirin and NSAIDs?

Ginseng

What can decrease effectiveness of anticonvulsant therapy (tegretol, depakote)

Ginkgo biloba

What may reduce effects of BP drugs and diuretics and increase risk of lanoxin toxicity?

Licorice

MAO inhibitors shouldn't be consumed with excessive amounts of?

Chocolate

Calcium fortified orange juice interacts with

Fluoroquinolones (cipro)

Cranberry juice interacts with

Warfarin

Grapes with

Cyclosporine (immunosuppressant)

Pomegranate with

Carbamazepine (anticonvulsant)

Grapefruit, apple or orange juice with

Fexofenadine (Allegra)

What food increases effect of diabetes meds?

Carrot

Broccoli, cauliflower, watercress, spinach, tomato and avocado effect?

Warfarin

Patients taking MAOIs need to avoid

High tyramine foods

High tyramine foods also need to be avoided with

St. John's wort

What foods induce CYP?

``` Alcohol Caffeine Garlic Grape seed Licorice St. John's wort Tobacco ```

What foods inhibit CYP?

``` Black cohosh Echinacea Feverfew Ginkgo Ginseng Goldenseal Grapefruit Milk thistle Peppermint ```

What depletes C, B12, D, Calcium, iron, zinc and folic acid?

Antacids

What depletes Vit K?

Antibiotics

What depletes B12, folic acid, thiamin, magnesium and COQ10?

Antidiabetics

What depletes zinc, COQ10, melatonin, copper, B6?

Antihypertensives

What depletes folate, iron, C, K and melatonin?

NSAIDs

What depletes sodium and melatonin?

SSRIs

What depletes COQ10?

Statins

What is an example of an absorbent?

Activated charcoal

What is the term for pumping the stomach?

Gastric lavage

What are the contraindications for inducing vomiting?

Ingestion of corrosive substances, volatile petroleum products, convulsants If patient is semi-conscious, inebriated, in shock, convulsing or has no gag reflex Patients less than 1 year Patients with cardiac or vascular disease

History of poisoning/toxicity

1906- pure food and drug act, paved way for modern FDA 1910- radium, advertised as health cure 1918- Charles Norris appointed chief medical examiner 1920- prohibition 1924- lead added to gas, caused dementia, DC in 1996 1953- first poison control center in Chicago

What is the lethal amount of methanol?

2-8 oz

What does methanol poisoning lead to?

Liver ->formaldehyde ->formic acid -> leads to metabolic acidosis and tissue injury

Sx of methanol poisoning

``` Difficult breathing Blurred vision, blindness Agitation Coma Severe abdominal pain ```

What was sold as rejuvenating tonics and dial painters ingested large amounts leading to death?

Radium

Sx of radium poisoning

Anemia Jaw necrosis Osteogenic carcinoma Malignancies Deposits in bone similar to calcium

Handling of this substance lead to severe mental deterioration and some deaths, developed by GM as anti-Knock formula

Leaded gas

Stings by bees, wasps, scorpion or fire ant may require

Epinephrine or corticosteroids Cleanse, remove stinger, apply ice

With a snake bite what must you not do?

Apply tourniquet or ice

Exam 1 Flashcards

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