Intro + Basic Principles

generel why pharmacology

when you know what the drugs does, you know…

-Diagnosis (based on meds taking)

-Severity of Diagnosis (how many of the same kind of drug is the patient taking?)

return to optimal health: how drugs can help

-Healthy life-style ancillary services

-Surgery, removal, repair

-Drugs

• Mimic (what wrong), inhibit (too much), stimulate

• Right does, Right target site

• Too much=toxic, too little=ineffective, nonspecific=wrong target (SE ADR; effects whole body besides should=side effects)

Drug definition + intended use options + what excludes

-Drug is any substance causing physiological effect other than nutrition

-Intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease

-Explicitly excludes tobacco, caffeine, alcoholic beverages & dietary supplements (are OTC drug)

drug classification + carvedilol example

-have different classifications

Therapeutic

-Physiological change induced by drug: Antihypertensive

Pharmacological

-Mechanism of action: Betablocker

DEA schedule classification system

-ranking

-marijuana

-examples

-Ranked I-V by highest degrees of potential abuse to lowest

-Marijuana schedule 1 but trying to move to 3

•Schedule 2 have accepted medical uses despite high abuse potential, oxycodone

•Schedule 3 – less than 90 mg of codeine like Tylenol with codeine

•Schedule 4 – examples are Xanax, Ambien Tramadol

Drug naming (nomenclature)

Chemical name: specific compound structure

-Ex. N-acetyl-p-aminophenol

-only 1 per drug, specific compound structure

Generic name: nonproprietary name/ official name

-only 1 generic name per drug

-Ex. acetaminophen

Trade/Brand name: brand name by a pharmaceutical company

-Can have multiple names

-Ex. Tylenol

Trade/Brand Names patent

-New drugs - protected by 20-year patent

-After 20 years, drug can be produced as a chemical copy

o*Bioequivalence of original*

• Must be within 20% of original drug

• Must have same active ingredients including quality, strength, purity, and stability

• Must have same indications, same side effects

• Inactive ingredients can vary [fillers, color, shape, size, coating etc]

FDA 3 major acts

-Pure Food and Drug Act: Founded in 1906

oNo quality control

-Food, Drug and Cosmetic Act of 1938

oAntibiotic/flavor - toxic  (*bc kids died)

-Dietary Supplement Health and Education Act of 1994 (DSHEA)

oSafety/labeling; minor oversight

drug development

Pre-Clinical Testing: Animal studies

-Preliminary information regarding

-Pharmacokinetics: ADME and dosage and toxicity

Clinical Trials: Human studies

-Phase I: Safety Assessment: Small healthy population

*ex=asthma med given to those without asthma

-Phase II: Drug Effectiveness: Small population w/ DISEASE

-Phase III: Therapeutic effects and toxicity: Large population w/ DISEASE + RCT: double-blind, placebo control

-Phase IV: Drug approved for public use; monitor for any problems or toxicity

*if problems take out of public

Prescription vs Over the Counter

Prescription

-Requires provider prescription

-Under FDA approval

-Comes with list of adverse effects

Over the Counter

-Doesn’t require prescription

-Under Dietary Supplement Health and Education Act of 1994 (DSHEA)

-Treat minor problems

-Vitamins, minerals, herbs, metabolites, extracts

-**Can interact with prescription medications

off-label prescribing

-medications use for purpose different than original purpose

-Example: Gabapentin anti-seizure, also used for neuropathic pain