Intro to Pharm and Drug Approval Process 1.1

What is pharmacology?

The study of medicine and how drugs treat disease and also examines how drugs are administered and how they travel through the body and the responses they produce

What can tell you a lot about a patient?

List of meds

All ACE inhibitors end in

-pril

What medications do you get put on first?

The older ones before the latest and greatest

What are therapeutic agents classified as?

Medicines, biologics or complimentary therapies

The terms "drug" is simply a

Chemical that produces a response

A medicine is

When a drug is administered for a specific condition

Some of the first drugs came from

Plant sources

What are the drugs that come from plant sources?

Alkaloids (end in -ine like morphine and nicotine)

Glycosides (digoxin)

Resins (absorb water)

Oils (castor oil, eucalyptus)

What is castor oil?

Really old laxative

Volatile oils have

A smell

Drugs can also be extracted from

Body fluids or glands of animals

What are the drugs that come from animals?

Enzymes (pepsin, pancreatin)

Hormones (estrogen, insulin, primarily is an estrogen product that they extract from the urine of a pregnant mare)

Vaccines (made from egg proteins)

Animal oils

What do animal products include?

Biologics

What are vaccines considered?

Biologics

What are biologics?

Specific agents produced in living tissues or microorganisms such as vaccines, hormones or enzymes; they also include natural blood products such as coagulation factors and albumin

What are manufactured compounds?

Drugs synthesised in a lab (most drugs nowadays) which includes inorganic substances and salt as well as complex organic substances

What are some manufactured compounds?

Metals (iron, aluminium, iodine)

Inorganic salts (NaCl, lithium)

Organic (steroids, neurotransmitters)

What are complementary and alternative medicines (CAMs)?

Include vitamins, minerals, plant extracts and dietary supplements, these products meet certain standards but they don't undergo the testing and scrutiny required for drugs and are overseen by another federal agency (NOT THE FDA)

When did modern pharmacology start?

In the 1800s when chemists began to isolate active ingredients used in drugs

Prior to the 19th century, what were the standards and guidelines?

There weren't many to protect the public, which is why so many drugs contained high levels of dangerous or addictive substances therefore overtime it became evident that drug standardisation was needed (not just for prescribing drugs but also for protecting the public as well)

What are some examples of drug availability before laws and standardisation?

Bayer's manufactered Bayer's heroin as a nonaddictive substance that was a substitute for morphine

Cocaine was used topically for toothaches for children

Paregoric was used for diarreah (5 drops for a 5 day old newborn)

What does USP-NF stand for?

US Pharmacopoeia—National Formulary.

What do the initials USP on a drug label mean?

Verifies the purity and exact strength of a drug

What was the NF originally?

This was used by pharmacist and physicians because it provided the chemical formulas and prescribing information of each drug (came after the USP)

What does the USP-NF still do?

Publishes specific dad about drugs reffered to as the official monograph

What does the USP designation mean?

Verifies the exact amount on the label and that it is pure, and that in the particular tablet there is exactly what they say and it contains however many mg of the active ingredient

What is the drug monograph?

The leaflet that comes inside the prescription

What does the drug monograph tell you?

Everything you need to know about preparing the medication (used as a liability so the manufacturer can say they gave you all the information)

What lead to the FDCA?

The U.S. began adopting stricter drug laws to protect the public and they passed laws to prevent any manufacturers from making false therapeutic claims, which lead to the Food Drug and Cosmetics Act

How did the FDA come about?

The FDCA was instituted but tragedies were still occurring from people taking untested drugs so they added amendments that required manufacturers to provide documented evidence of efficacy and safety of all new drug products and thus marked the start of the FDA drug approval process that we know today

What is the role of the FDA?

To protect the public and it does so by overseeing food manufacturing and the development of new drugs, it exerts strong control over the development, approval and marketing of all new deugs

What can the FDA do the drug availability?

It can halt it at any given time during the process

The FDA was originally

The FDCA, plus a bunch of ammendments

What does the FDA prevent?

Sale of drugs that have not been tested

What are the stages of the FDA approval process?

Stage 1: Preclinical investigation (before people)

Stage 2: Clinical Investigation

Stage 3: new Drug Application (NDA) review (thorough review of data and getting ready for marketing)

Stage 4: Post-marketing surveillance (the forever stage, med watch)

Which stage involves animal testing?

Stage 1

Approximately how long is stage 1?

Takes anywhere from 1 to 3 years to complete

What does the preclinical investigation (stage 1) aim to do?

It involves lab research on cells and animals, it wants to answer if the drug is potentially hazardous to humans

What does animal testing not tell us?

It doesn't tell us how humans will respond but it does provide useful safety and efficacy data prior to human testing

When will we use primates?

If there is animal toxicity concerns but there is value or promise, since they are more similar to humans (but they are expensive)

What does stage 1 determine?

-Therapeutic use and what disorders it may treat

-probable harm (provides info abt potential harm to humans but also how a drug will affect a developing fetus because testing on human fetuses is not allowed)

Why are the results of animal testing always considered inconclusive?

Because human reactions to a drug can be very different than that of test animals, and animal data's only provides an estimate on the potential drug doses range

When does the testing move to stage 2?

If the data are favourable the drug manufacturer applies for an investigational new drug (IND) and if it gets approved by the FDA then they can begin to test on human subjects

Which is the longest stage of the drug approval process?

Stage 2

How long can stage 2 be?

Anywhere from 2 to 10 years

How many phases are in stage 2?

3 phases aka clinical trials

What is the goal of phase 1?

Determine the safe dose range, its upper and lower limits and the best route of administration

What is the sample size in phase 1?

Less than 100 healthy volunteers with or without a disease depending on the drug

What does healthy mean with the sample size?

The subjects have few to no comorbidities

What is the goal of phase 2?

Therapeutic range, Determine what dose is most effective, if efficacy is demonstrated the study moves to the next phase

What is the sample size of phase 2?

100 to 300 patients with a specific condition who are given various therapeutic doses with the range determined in phase 1

What is the goal of phase 3?

To determine if the new drug is better than what already exists (than the existing treatment)

What is the sample size of phase 3?

Largest sample size, anywhere from 1000 to 3000 participants, patients are treated with the therapeutic dose determine in phase 2 which is then compared to existing treatment options

What are the different type of testing found in stage 2?

Single and double blind studies

What are important features of clinical trials?

They are randomised and patients must be informed that they many not receive the new drug

What is a single blind study?

The patient doesn't know whether they are in the treatment or the control group, but the physician/researcher dows

What is the gold standard in clinical research?

The randomised double blind study where half get the new drug and half get an existing treatment or placebo, but neither the patient nor the administering physician/researcher knows who is in what group

What is stage 3?

The new drug application (nda) review

What happens in stage 3?

The FDA reviews the new drug application filed by the manufacturer and they scrutinise the animal and human data and the research design, the FDA inspects the facility where the drug will be manufactured and the manufacturer finalises the brand name and labeling of the drug to be marketed. If everything is deemed favourable the new drug application is approved and now the drug becomes available to the population at large and samples are provided to physicians by pharmaceutical reps

In what stage does the brand name get finalized?

Stage 3

What are the patent rights and exclusivity?

The manufacturer has patent rights and exclusive rights granted by the FDA which may run concurrently and FDA exclusivity varies by drug type. Generic equivalence can on,y be manufactured after patents and exclusivity have expired and once this happens the profit margins for the original drug developer drop

What is the purpose of patent rights?

To incentivise manufacturers to develop new drugs

Why does the FDA hold a tremendous amount of power over the pharmaceutical industry?

It can halt testing at any time and it can extend exclusivity as well

What is stage 4?

Post-marketing surveillance (this is the forever stage because it involves people and there is a voluntary system called med watch where physicians and the FDA can continue to monitor the drug and the ongoing data)

Stage 4 is also called

Phase 4

What happens in stage 4?

The FDA continues to collect data on side effects for every drug and increase as it makes it way to larger and more diverse populations

What authority does the FDA have?

They can remove drug availability at any time

When can some removed drugs be used?

On seriously ill patients if the benefits outweigh the risks

What can the FDA do for promising drugs?

Expedite the entire process (what happen with the COVID vaccine but it lost people's trust in the system)

What does the FDA hold annual public meetings for?

To discuss the process and publishes new drug availability and drug recalls

What is the conflict of interest with the FDA?

The pharmaceutical companies finance the FDA, but the U.S. also produces more drugs than anywhere else

The FDA maintains a

Continuous surveillance for harmful effects

What is medical marijuana not legalized?

It's not produced by big pharma to they lobby against it even though there are medical uses

What is off the label use?

When side effects for one drug are used to treat something else (illegal for reps to advertise this but they still do), like the motion sickness patches are used for old people that can't contain their oral secretions (the death rattle)

Why can someone have a unique reaction?

Based on age, gender, comorbidities, so the drug is tested for the general population, but it is possible for someone to be the outlier and have an effect

How should the nurse respond to a client who asks about the safety of herbal products she is considering taking?

Herbal products meet certain guidelines, but less research has been done on them regarding safety and efficacy (guidelines are not as strict and are regulated by another company that is not the FDA)

A physician writes an order for Mr. jones. Macrobid PO TID with meals starting today at dinner. Which element is missing from the order to ensure safe administration?

The dose of the medication (times of administration are not assigned on the medication administration sheet, doctors only provide frequency; patient allergies are not on the order but they are on the MAR, the oatient's response to medication is what you document after you give it)

What medications are derived from an animal source?

Cod liver oil, flu vaccine (biologic from animal protein), estrogen cream or patch

What is ramipril?

Ace inhibitor

Treats high blood pressure

Assess blood pressure before because if it is already low that would be a contraindication

Ace cough is a side effect (non hacking persistent cough)

What is glipizide?

Antidiabetic, more specifically sulfonyleureas (oral glycemic agent)

Given for hyperglycemia so check their blood sugar

Make sure they eat something after taking it

XL extended release can't crush or chew

What is levothyroxine?

treats hypothyroidism

Have on an empty stomach for absorption

Take apical pulse for one minute before giving it

What is Chlorothiazide?

Diuretic, specifically thyozide diuretic

Makes you void more, so increased urine output

Decreases blood pressure, so have to assess blood pressure before and monitor urine output

What is warfarin?

Given at hour of sleep or bedtime

Anticoagulant which means it prevents blood clots and does so by preventing clotting factors

PTINRN is monitored to know whether the warfarin dose is therapeutic (too little, subtherapeutic is just as dangerous as toxic)

What does phase 1 focus on?

Safety (route and dose)

What does phase 2 focus on?

Efficacy

What does phase 3 look for?

Always looking for safety but comparing efficacy of new treatment to existing treatments

What is stage 4 sometimes called?

Phase 4 the forever ohase

What can drugs be classified as?

Prescription or over the counter

Do both prescription and ivermectin the counter go through the same approval process?

Yes

If the response is desirable it is called

Therapeutic response

If the response is undesirable it is called an

Adverse effect

Since the goal of any drug is to be therapeutic,

Drugs are classified as such

What is a drug

An agent that is capable of producing a biological response in the body

What is the therapeutic class?

Based on how a drug is used clinically

What are examples of therapeutic class?

The big umbrella, analgesics reduce pain, antihypertensives lower blood pressure, antiemetic relieved nausea and vomiting

What are the pharmalogic class

More specific than therapeutic classification, under the big umbrella, beta blockers

What is a prototype drug?

Usually the first in a class and often get replaced by better drugs developed within that class later on; most classifications contain a prototype and by knowing the prototype you can extrapolate your understanding of the class

What must you know about a medication and a patient as a nurse?

Who, what, when, how and why a patient is getting a medication

What is the chemical name?

It describes the drug's molecular structure, these are often very difficult to pronounce and rememeber