Test 1 - Lecture 1 Flashcards
Pharmacotherapeutics
- The use of drugs to diagnose, prevent, or treat disease
- the desired therapeutic effect of the drug
- The medical use/purpose/indication of the drug.
Mystical Period
Primitive and prehistoric cultures
Treatments were magical, mystical, potions
Superstitious
Empirical period
~ 3000 BC
Animal extracts, plants: didn’t understand ‘how’ it worked just knew they worked.
Treatment based on observations w/o scientific basis.
Sumerians: 1st written prescriptions
Chinese: inventory of mixtures; natural healing; 1st Pharm Books
Egyptians: standardized drug prep, 1st to use polypharmacy, Mosaic Health Code (hygienic methods)
Medieval Period
1200-1400 AD
Galen: Father of Pharmacy; extensive records on treating gladiators; 1st to have stock of pharmaceuticals.
- Apothecary System
- Withering: Digitalis “Foxglove”- treat CHF
- Jenner: Father of Vaccinations (cow utters)
London Pharmacopoeia
1618
Became Mecca of medicine
Published PDR (book of drug inserts)
Contemporary System
Began Early 1800s
Period of Research
John Jacob Abel- Father of Pharm in US
Advances: relation tween pancreas and DM; development of antimicrobial drugs; develop new drugs, hormones and vac.
Pharmacology Today
Research done in rain forests
Genetic engineering, chem sythesis
Immunochemistry: Study antibody and antigens
Designer Drugs
Drugs made to match a persons DNA. Better efficacy, reduced side effects.
T or F
The advantage of genetically engineered drugs over those made from animals is less drug reactions?
TRUE
Generic Name
- only one name
- Always written lower case
- *Orders written in Generic Name**
Trade Name
Multiple
always written upper case
Proprietary name
Drugs ending in -olol
Beta Blocker
Drugs ending in -pril
Ace Inhibitor
Drugs ending in sartan
ARBS
What are the 3 big differences between generic and trade?
- Bioavailability
- Cost
- Pharmacist needs approval from provider.
Bioavailability
Rate and extent to which the active ingredients are absorbed and made available at the site of action.
Main difference between generic and trade
Drug classifications - Chemical Composition
classify molecule by chemical base. Ex: Morphine (Opium) class is Opiate.
Drug classifications - Physiologic effect
Based on what is does. Ex: Morphine is a CNS depressent
Drug classifications- Therapeutic use or action
What its used for. Ex: Morphine- narcotic used for pain.
Prototype
One representative drug from each class
usually first drug in its class
can be combination of traditional and new drugs
helps with learning pharmacology
Ex: metropolol: Prototype for beta blocker
Phases of Clinical Development: Preclinical Testing
Lasts 6-7 years
Chemists have an idea and test on animals
Toxic?, Useful?, Effects, Any new use?
Only 1:1000 move on from this phase
Phases of Clinical Development: IND (Investigational New Drug)
FDA Review
Phases of Clinical Development: clinical Trials Phase I
1-2 yrs; small # (20-80)
Volunteers are healthy; paid to participate
Looking for: how does work in body, how does body metabolize, safety concerns?
Phases of Clinical Development: clinical Trials Phase II
2 yrs; ~100-300 pts.
Pt have the disease
Determining dosage, any side effects?
Phases of Clinical Development: clinical Trials Phase III
3-4 yrs; ~1000 - 3000 pt
Looking for any long term side effects. This is completely blind test; some pt receive placebo.
Phases of Clinical Development: FDA reporting/NDA (New Drug Application)
This process can take 1-2 years to be reviewed. Once they receive acceptance the company can start marketing
Phases of Clinical Development: clinical Trials Phase IV
On the market but can be pulled if too many reported issues (ex celebrex).
Dr. can write prescription but will be monitoring pt closely.
Orphan Drugs
Abandoned; too expensive and company won’t recoup costs.
orphan Drug Act
Tax incentive to get co to continue clinical development of an orphan drug
Off label prescribing
relating to the prescription of a drug for a condition other than that for which it has been officially approved.
Legend Drugs
Drugs that require a prescription.
What is in the Black Box Warning (BBW)?
- highlight most serious warning
- usually found on drug label in black box
- indicates adverse reactions
- Patients that should NOT take drug
- side effects
Pure Food and Drug Act of 1906
Requires co to put a label on drug. Protect people in how food or drug is processed.
Sherley Amendment to Pure Food and Drug Act
Setup to prohibit false thraputic claims.
Federal food, drug, and cosmetic Act 1938
Prevent the sale of drugs not tested. Result of this act was the FDA.
Durham Humphrey Amendment to Federal food, drug, and cosmetic Act
1951- Labeled for prescription only
Kefauver-Harris Amendment to Federal food, drug, and cosmetic Act
1962- Co must prove effective before can market. Plus must have informed consent to test meds. Ex- sleep aid taken by pregnant women in Europe that caused malformed babies.
GINA 2008
Prohibits discrimination in health coverage and employment based on genetic information.
Works with HIPPA.
Controlled Substances Act (1970)
Schedule 1 includes?
Abuse Potential - High Dependance - severe Drugs with no medical use Street Drugs Heroin, LSD, hashish
Controlled Substances Act (1970)
Schedule II includes?
Abuse Potential - High
Dependance - severe
Narcotics - morphine, vicatin, amphetamines
No refills
Controlled Substances Act (1970)
Schedule III includes?
Abuse Potential - moderate
Dependance - moderate
Written order accepted. May be refilled 5x w/i 6 mo, new script after 6mo
Codeine, hydrocodone, some CNS stimulants, anabolic steroids
Controlled Substances Act (1970)
Schedule IV includes?
Abuse Potential - Low
Dependance - Limited
Same rules as schedule III
benzodiazepine, muscle relaxants, sedatives, some opioid narcotics
Controlled Substances Act (1970)
Schedule V includes?
Abuse Potential - Limited
Dependance - Lowest
May be obtained w/o prescription
antidiarrheal, loperamide
What is the worst FDA Pregnancy Category - A, D, or X
Category X: studies in animals or humans have demonstrated fetal abnormalities and/or there is + evidence of humanfetal risk based on adverse reaction data from investigational or marketing experience.
Pregnant women cant take at all. Ex. Acutane
Complementary and alternative medicine (CAM)
Treatment practices that are not widely accepted or practiced by mainstream clinicians in a given culture.
Herbal/vitamin supplements
**Be sure to include these in med reconciliation
