Names, Classes, Schedules 2.1 PHARM

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

What is the generic name?

Shorter and simpler than the chemical name, but may still be difficult to pronounce

How are generic names written?

all lower case

Generic names provide a common

Global language for medication

Generics drugs are usually less

Expensive and contain the same active ingredient as their brand name version

What is a trade name?

Also known as the brand, proprietary, patent name

Who selects the trade name?

Company that manufactures the drug

What name is trade marked protected and capitalized?

Brand name

What happens once the patent and the FDA exclusivity period runs out?

There may be several brands for a single generic drug based on who manufactures it

What is the similarity between brand and generic?

They both contain the same active ingredient and the amount within each tablet

What is the difference between brand name and generic?

The other ingredients that make the tablet hold its shape that may affect how quickly it dissolves or gets absorbed, which affects a patient's response to it

What is common in hospitals?

Generic substitutions regardless of how the drug is ordered bc these substitutions are approved by the medical staff

What does phase 1 focus on?

Safety (route and dose)

How are drugs dispensed by a community pharmacy?

Directly to the consumer and states differ on how they substitute

What are the different states laws?

Some states require the prescription to be dispensed as written and other states have statues that permit generic substitution

How does SC handle dispensing brand versus generic prescription?

Prescriptions have two signature spaces at the bottom

In SC, if it's signed on the lower left what does that mean?

Dispensed as written

In SC if it's signed on the bottom right what does that mean?

Substitutions are permitted

What is the negative formulary list?

Some states maintain this which is a list of trade name drugs that cannot be automatically substituted with a generic

What is the negative formulary list based on?

Differences in bioavailability between generic and brand name drugs

What information is in the FDA orange book?

Bioequivelant data (what the generic drugs must prove that it is absorbed at the same rate and extent)

What group of drugs are compared in the FDA purple book?

For biologics there are biosimilar (interchangeable) drugs now published

What are some safety considerations?

LASA drugs, tall man letters and packaging

What are LASA drugs?

look alike, sound alike drugs

What can LASA drugs occur with?

Brand names, generic names, sometimes the packaging

What are tall man letters?

Capital letters in the middle of the name (if a drug has this be extra vigilant because that means it can be confused with something else)

How are brand names written out?

Capitalised

What is a packaging concern?

Same sizes, colors, thing Quaid twins and heparin

What is the black box warning?

A label that is required when a drug may lead to death or serious injury so beware

What is the joint commission do not use list?

List of certain standards and things to watch out for

What are some things to pay attention to on the do not use list?

Do not write U, write out unit instead

Don't write qd or qod, write out daily or every other day

Do not use a trailing zero 5.0 mg, write 5 mg

Use a leading zero 0.5 mg

Do not write MS, write morphine sulfate instead

Do not write MSO4 or MgSO4 write out magnesium sulfate

Instead of writing U

Write out unit

Instead of writing qd, q.d., qod, etc

Write out daily or every other day

Instead of writing 5.0 mg

Write 5 mg

Instead of writing .3 mg

Write 0.3 mg

Instead of writing MS

Write morphine sulfate

Instead of writing MSO4 and MgSO4

Write magnesium sulfate

When can there be trailing zeroes?

Lab results

No cc write out

mL

FDA orange book has the

Bioequivelant drugs

Why wouldn't everyone respond the same to generic and brand?

Because the inactive ingredients may change and affect absorption etc

Why should you know the action of a drug and why it is ordered for the patient?

So you know the expected outcome and if it doesn't make sense for the patient you might have caught a mistake

What shouldn't you assume about normal dose?

That everyone has the normal dose (be alert if asked to give 8 tablets that should maybe be a red flag)

What is a contraindication?

Reason to not give a drug (like a potassium supplement to someone who is hyperkalemic)

What are critical assessments?

What to check before you give the med

What are the nursing responsibilities?

Know the brown and generic name

Action of drug and why it is ordered for this patient

Normal dose

Contraindications

Critical assessments

Evaluation

What are the controlled drug schedules?

Drug schedules classify controlled substances based on their abuse and addiction potential as well as their clinical usefulness

What can/can't healthcare providers do in regard to schedule 1 drugs?

Can't prescribe but they can be used in research

What are schedule 1 drugs (c1)?

Highest potential for abuse and addiction so the DEA deems them to have risk that outweighs their benefits

High physical and psychological dependence

Limited or no therapeutic use

No prescriptions permitted

What are some examples of schedule 1 drugs?

LSD (was gonna be an interrogation drug), heroin, peyote, silicibin (mushrooms), qualudes were a C2 until they noticed lots of patterns of abuse, marijuana at the federal level

What are schedule 2 drugs?

High potential for abuse

High physical and psychological dependence

Written prescription, no refills

What is the process of getting a C2 prescription?

Client must see their provider, the order must be written, no telephone orders to pharmacy allowed and the prescriber must be registered with the DEA and provide the DEA number on the prescription

Are refills permitted with C2 drugs?

No

How are schedule 2 drugs kept in facilities?

Federal law mandates that they are under double lock and key meaning that they are stored in a locked drawer, cabinet or locked room at all times

What are examples of C2 drugs?

Opioids, analgesics, morphine, barbiturates, amphetamines, cocaine

What are schedule 3 drugs?

Moderate abuse potential and physical dependency

High psychological dependence

Phone orders permitted, limited refill permitted

What is the prescription guidelines for schedule 3 drugs?

Prescription can be refilled five times within 6 months but you have to see the provider again during the 6th month to get a new prescription

What are examples of schedule 3 drugs?

Tylenol with codeine, ketamine, anabolic steroids, testosterone

How are schedule 3 drugs kept?

Under double lock and key

Which controlled drugs are under double lock and key?

C2-C5 because pharmacies and hospitals don't stock C1, all controlled substances are under double lock and key

What are schedule 4 drugs?

Low potential for abuse and dependence

Less restrictive with phone orders and refills permitted

What are the prescription guidelines for C4 drugs?

Can be refilled 5 times within 6 months

What are examples of schedule 4 drugs?

Anti anxiety medications, benzos, tramitol

What are schedule 5 drugs?

Lowest abuse potential and dependence

Least restrictive with prescriber and determine access/refills

What are the prescription guidelines?

Prescriber is the one who determines the number of refills with the prescription

Are all addictive drugs controlled by the FDA?

No, caffeine, alcohol, cigarettes aren't

What does teratogenic mean?

Dangerous to developing babies

When are the most dangerous times in pregnancy?

First and last trimester

Why is the first trimester so dangerous?

This is when the baby is undergoing very rapid cell division

When is the last trimester so dangerous?

There is increased placental blood flow so the baby is exposed to more of what the mom takes

Why is accutane no longer manufactured in the U.S.?

Bc of the baby effects and risk

What happened with the European medication for morning sickness?

Babies were born without limbs

Rules for pregnancy are the same as

Breastfeeding

What are the medications that have known outcomes that are bad for pregnant women?

Category x medications

Lower case is the

Generic name

Upper case is the

Trade name

Which is NOT on the MAR?

Controlled substance schedule

Drug classification

Number of capsules to be given

What is on the MAR?

Route of administration

Allergies

Drug name, dose, route, frequency

What classification system is based on the mechanism of action of the drug?

Pharmalogical