drugs, history, FDA, & society

pharmacology

the basic and clinical applied science that deals with the fate and actions of drugs in the body

drugs

any substance used in the diagnosis, prevention, or treatment of disease

pharmacology is a combo of the greek words

pharmakon (poison)

logos (study of)

humans have sought ______ to combat sickness and death since the earliest of times

plant and animal products

doctrine of signatures

people thought that God had made herbs for the use of men and given them particular Signatures that could be read to cure disease

example of doctrine of signatures

walnuts were a cure to ailments of the head because they look like a head

oldest prescriptions were found on

clay tablets written by sumerian physicians around 3000 BC

hippocrates promoted the idea that

disease results from natural causes rather than evil spirits

in the early years, medicines were developed by

isolation and use of nature substances from botanical, mineral, and animals sources

quinine

a drug used today to treat malaria

the first specific drug used to treat an infectious disease

found in the bark of some trees

synthesis of aresenicals

attaching arsenic atom to a carbon atom

led to the use of arsphenamine to treat syphilis

digitalis

purple flower used to make tea to treat congestive heart failure

became digoxin which is still the drug of choice for congestive heart failure and atrial fibrillation

a german chemist isolated the alkaloid morphine from

opium

the source of opium is the

poppy plant

the isolation of morphine lead the way to techniques for the isolation of

caffeine, atropine, strychnine

caffeine works by stimulating the

CNS, heart, and muscles to relieve mental and physical fatigue and increases mental alertness

atropa belladonna (devil's cherries)

entire plant is extremely poisonous

2 alkaloid substance isolated from this plant: atropine and scopolamine

atropine

dilates the pupils

ingestion in excess amounts is a poison

scopolamine

used for motion sickness, sedative, truth serum, and mydriasis (excessive/prolonged pupil dilation)

salicylic acid

sourced from willow bark

chemical precursor to aspirin

acetylsalicylic acid

aspirin

acetyl derivative of salicylic acid

epinephrine/adrenaline

hormone and neurotransmitter

first hormone isolated

produced in some neurons of the CNS and the adrenal medulla from amino acids phenylalanine and tyrosine

acetylcholine

in the ANS

acts on peripheral and central nervous system

only neurotransmitter used in the motor division of the somatic nervous system

in cardiac tissue acetylcholine neurotransmitter has an

inhibitory effect, which lowers heart rate

acetylcholine behaves as an excitatory neurotransmitter at

neuromuscular junctions in skeletal muscle

Sulfanilamide

antibacterial portion of the dye prontosil used as the first effective antibiotic treatment for pneumonia, meningitis, and other bacterial diseases

sulfa drugs pre-dates the clinical use of

penicillin

sulfa powder and sulfa tablets greatly reduced mortality during

WWII

sulfas are used today to treat

infections of the urinary tract

penecillin was discovered because it was discovered that

a mold known as penicillium notatum inhibited growth of staphylococcus aureus

the FDA is the

regulatory agency that is involved in regulation of drug development

prior to and at the start of the 20th century _______ of food and drugs was common

tampering and mislabeling

the pure food and drug act 1906 was prompted by

unsanitary and unsafe conditions in the meat packing industry

the pure food and drug act 1906 required that

drugs meet standards of strength and purity

the burden of proof was on the FDA to show that the drug was false/fraudulent before it could be taken off the market

in 1933 it was well known that

the 1906 drug law was obsolete but a bill to revise the law stalled in Congress

in 1937 107 people died from poisoning by untested

Sulphonamide which was mixed with diethylene glycol (similar to antifreeze) which is toxic to the liver to dissolve the sulphonamide

in 1938, congress passed the

food and drug cosmetic act in response to the strep-elixir incident

the food, drug and cosmetic act of 1938 required

proof of a drug's safety and purity

mandated that manufacturers obtain pre-market approval from the FDA

regulated labeling and packaging of drug products

durham-humphrey act of 1952

granted the FDA authority to determine which drugs may be sold without a prescription

OTC drugs are sold with

lower dosage than their prescription counterparts and used primarily to treat symptoms, not cure diseases

Kefauver-Harris Amendments to the food, drug and cosmetic act

required proof of efficacy as well as safety for new drugs and drugs approved since 1938

established guidelines for adverse event reporting, clinical testing, and advertising

orphan drug amendments of 1983

provides manufacturers incentives, such as tax deductions for their clinical trials, to manufacture drugs that treat rare diseases

FDA expanded access program, 1987, streamlined in 2017-18

more commonly known as early access programs or compassionate use exemptions

began during the AIDS crisis

allow the FDA to permit pharmaceutical companies to broaden access to investigational products while they are still undergoing clinical trials

rare disease

<200,000 people

expedited drug approval act of 1992

allowed accelerated FDA approval for drugs of significant medical need

required detailed post-marketing surveillance

FDA modernization act of 1997

allowed drug manufacturers to discuss unapproved or off label indications for drug products with practitioners

for accelerated drug approvals for life-threatening medical disorders

made provisions for pediatric drug research

revised communications between FDA and researchers conducing clinical trials

dietary supplement health and education act of 1994

dietary supplements defined as vitamins, minerals, herbs, botanicals, other plant-derived substances, amino acids, concentrates, metabolites, and constituents and extracts of these substances

FDA oversees the safety, manufacturing, and health claims made by dietary supplements

FDA does NOT evaluate

efficacy of supplements

FDA must demonstrate that a supplement is unsafe before

taking action against it

federal food, drug, and cosmetic act of 2006

required the dietary supplement industry to report all serious dietary supplement-related adverse drug events to the FDA

FDA amendments ACT (FDAA-2007)

in response to the safety issues of COX-2 inhibitors that led to cardiac issues and strokes

gave enhanced authority to FDA to manage safety of approved drugs

focused on risk evaluation and mitigation strategies for new and already approved drugs

objective of the FDA amendments ACT (FDAA 2007)

to ensure that benefits of a drug outweigh risks

FDA reviews OTC drugs for

misbranding and adulteration

FDA sets guidelines to which OTS drugs are

safe and effective

FDA has authority to prevent sales and to

withdraw OTC drugs from the market

FDA regulates the supplemental product manufacturers to asses for

purity

contaminants

contents within the package match the label

controlled substances are

drugs that have some potential for abuse or dependence

does the FDA regulate controlled substances

yes

controlled substances act 1970

the DEA administers and regulates manufacturing and distribution of substances with potential for abuse including

opioids, stimulants, and sedatives

before the controlled substances act OTC medications contained

opium and cocaine

on March 22, 2016 the FDA required a

boxed or black box warning, which is the strongest warning, about the serious risks of misuse, abuse, addiction, overdose, and death for all short-acting opioid pain medications

opioids include

morphine

hydrocodone

codeine

a boxed warning was issues in 2013 for long acting opioid pain meds like

oxycontin

opioids _____ meant for long term use

aren't

FDA is responsible for protecting the public health by

Assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation

FDA is responsible for advancing public health by

Helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health

FDA has the responsibility for regulating the

Manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors

FDA plays a significant role in the nation's counterterrorism capability by

ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats

long term use of opioids can cause

hearing loss