evolution of medications
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Evolution of Medicinal Drugs
Medicinal Origins
Legislation & Regulation
Drug Testing & Approval
Introduction *Historical Trends
Major Areas of Pharmacology
Pharmacology is a science that studies the effects of drugs within a living system.
Toxicology concerned with the harmful effects of drugs
Pharmacy the study of preparing and dispensing medications and a place.
Pharmacotherapeutics how drugs are used in the treatment of disease.
Pharmacodynamics Pharmacokinetics
Basic Terminology
Adverse Effect Agonist Antagonist Chemical Name Contraindications Dose Drug Drug indication
Generic name Mechanism of action OTC Pharmacology Receptor Side effect Site of action Trade name
Substance Misuse & Abuse Terms
Drug Misuse Substance Abuse Drug Abuse Physical Dependence Psychological
Dependence Addiction Illicit Drugs
Diagnostic Statistical Manual –IVfor Substance Dependence
At least three symptoms in 12 months: Tolerance Withdrawal Use beyond intention Inability to reduce usage Time-consuming Valued activities abandoned or reduced Use continues despite problems
DSM-IV Criteria for Substance Abuse
One or more of the following in 12 months: Substance use repeatedly leads to failure to
fulfull home, work, or school responsibilities Repeated substance use in physically
hazardous situations Repeated legal problems for substance use Continued use despite resulting, repeated
social or interpersonal problems.
Medicines that Changed the World
Medicines that Changed the World
Opium– Sedative/painkiller
Smallpox vaccine 19thC– 1798 vax prevent illness
Salvarsan (arsphenamine) – 1910 20th cent-cure illness– Syphillis spirochete
Insulin– 1920– Few other drugs have
helped so many so fast!
Psychopharmacology ’50s– Drugs can treat mental illness
Enovid ’60s – 1960 The’PILL’– Alter normal physio process
Thalidomide– 1950’s birth defects– Prompted radical changes in
regulation of medicines– 1990 reemerged (MS, leprosy)
Reasons for Medication Use
Prevention Vaccines Antimalaria agents Antibiotic prophylaxis
Curative Antibacterial Oncology drugs Antifungal
Control of Disease Process
Antihypertensives Antidiabetics Thyroid agents
Palliation Analgesics Oncology drugs
Reasons for Different Routes of Administration
Convenience Preferred route is unavailable Rapid onset of action is desired Target delivery of drug to specific site of action Prolong duration of action
DosageRoutes Forms
Oral (by mouth)– Swallowed, SL, Buccal
Parenteral (injection)– IV,IM,SQ, ICranial,
epidural, Intraperitoneal Topical
– Applied to surface of skin or mucous membranes- Transdermal
– Respiratory: inhaled, intra-nasal, smoke, volatile gases
Tabs, caps, sol, elix, susp, lozenges, ’take a powder!’
Solutions & suspensions Ung, crm, ltn, otic, opth,
inhalants, suppos Rectal/vaginal Nasogastral
Plants Cinchona Bark
Purple Foxglove
Poppy (Opium)
Quinidine
Digitalis
Morphine Codeine
Anti Arrthymic
Cardiotonic
Analges/Antitussive
Minerals Magnesium
Zinc
Gold/Silver
MOM
ZnOxide
Auranofin/SilverNitr
Antacid/Laxative
Skin Protectant
RA/Anti-infective
Animals Pancreas Cow/Hog
Stomach Cow/Hog
Thyroid glands
Insulin
PepsinThyroid,USP
Antidiabetic
Digestive enzyme
Hormone
Synthetic Meperidine
Diphenoxylate
Co-Trimoxazole
Omeprazole
Demerol
Lomotil
Bactrim/Septra
Prilosec
Analgesic
Anti-diarrhea
Anti-Infective
Gastric acid inhibitor
Bioengineer Erythropoietin Epogen RBC Stimulant
Legend Drugs Over-the-Counter
Prescription ONLY Legend Statement
– ‘Federal law prohibits dispensing of this drug without a prescription’
Transfer Warning– ‘State or federal law
prohibits the transfer of this drug to any person other than the person to whom it was prescribed’
Prescription is not required
– Safe,effective– Taken w/o medical
supervision– Dose low (Why?)
– Negligible abuse potential Maybe????
Atomic(molecular) composition
Chemical Name Structural Formula Nonproprietary Name
(generic)– Stems & classes
Therapeutic class …pril
Proprietary Name (brand)
NDC #
Drug Names & Classifications
Drug Legislation & Regulation
FDAFDA Food & Drug Administration
FTCFTC Federal Trade Commission
DEADEA Drug Enforcement Agency
Controlled Substances Act
Schedule I– Heroin,THC
Schedule II– Methadone
Schedule III– Valium, Vicodin
Schedule IV– Alprazolam, Darvocet
Schedule V– Lomotil
Phases of Clinical Trials
Drug Testing & ApprovalClinical Trials
10-15 years from lab to US patients Only 1 in 5000 cmpds make it to human testing Only 1 in 5 tested in humans is approved Testing Phases (double blind, placebo controlled)
Phase I-lab animals, safety, 6 yr/5000 cmpds Phase II-hlthy,(50-100), dose, safe, PK, 2 yr/5cmpd Phase III-treat ill(100-500),SE, PD, dose curve, 2yr Phase IV-treat ill(1000-5000), LT use, special grps
FDA Phase IV
File NDA at FDA Review process &
approval (or not)
Year 1 or more
Post Marketing Surveillance
Additional testing as required by the FDA
Continuous monitoring of drug in public use
Generic Medications
Patent for 17 years on parent compound
Expires! Law suits? Open season for
manufacturers to capture the generic market on that particular drug
FDA Pregnancy Safety Categories
Category A adequate studies indicate no risk to the fetus in the 1st trimester & no evidence of risk in later trimesters.
Category B animal reproduction studies have not demonstrated a risk to fetus, but no well controlled human studies.
Category C animal studies report adverse effect on fetus, no human studies, benefit/risk.
FDA Pregnancy Safety cont.
Category D there is evidence of human fetal risk, but the potential benefits from the use of the drug may be acceptable if safer drugs are not available or ineffective.
Category X studies in animal or humans demonstrate fetal abnormalities or adverse reaction reports indicating fetal risk. Risk outweighs any benefit. These drugs should not be used in pregnant women.
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