Week 2: Mid Level Practioner & Basic laws

Mid Level Practitioners List

* Nurse Practitioner (NP)
* Midwives (CNM)
* Optometrists (OD)
* Physician Assistants (PA)

How can you identify a Mid Level Practitioner via DEA Number

it starts with an M

More info about NPs Nurse Practitioner and their Mid Level Practitioner Status

No direct supervision required for perscribing

have a collaborative practice with an MD or even a health system

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have their own notepad

More info about CNMs (midwives) and their Mid Level Practitioner Status

Only can rx to women

unless partners therapy/communicable diseases therapy

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have their own notepad

More info about OD (Optometrists) and their Mid Level Practitioner Status

Can do topical products in office w/ separate training:

* Phase 1: Antibiotics/Antimicrobials, Decongestants/anti-allergenics, NSAIDs
* Phase 2: Beta Blockers, alpha agonists

also can do oral meds

More info about PA (Physicians Assistants) and their Mid Level Practitioner Status

PA need MD name on the Rx

NOT autonomous

Supervision of the MD to Rx specific things (ex you do all my BP for me)

Who can ask for a drug recall

FDA

Who actually physically recalls the drugs based off the FDA’s specificaiton

NOT FDA

Manufacturer and even the board of pharmacy if its bad enough

Class 1 Drug Recall

Drug that could cause really serious harm or kill someone

Specific law with NYS about Class 1 Drug recall

pharmacies must notify all pts that have been perscribed and who are currently taking such recalled drug WITHIN 3 DAYS of the pharmacy being notified

Class 2 Drug Recall

might cause temp health problem

Class 3 Drug Recall

Unlikely to cause an Adverse health rxn but violates FDA labeling or manufacturing

In Class Q: In the US who sets the standards for compounding, biologics, pharmaceutical manufacturing and other fields

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FDA

USP

DEA

CDC

USP

In Class Q: In 1901, children who recieved antitoxin for diptheria tx died of tetanus bc the horse serum that had been used to preparre the antitoxin was contaminated w/ tetanus, which act was the response to this?

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Pure FOod and drug act of 1906

Drug importation act of 1884

Biologics control act of 1902

Food Drug and Cosmetics Act of 1938

Biologics Control Act of 1902

In Class Q: The pure food and drug act of 1906 was propelled through the legislative process bc of which two people or tragic events? (2)

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Dr harvey washington wiley and the poison squad

francis kelsey phd and the thalidomide tragedy

upton sinclair and his book the jungle

exir of sulfanilamide made by se massengill co and the deaths that resulted from it

Pure food and drug act of 1902 was for:

* Dr harvey washington wiley and the posion squad
* Upton sinclair and his book the jungle

In Class Q: The Harrison narcotics tax act of 1914 gave a doctor the right to rx opiates to an addict t or f (to help control the addiction)

False

addiction was not considered a disease

In Class Q: What was part of the Kefauver-Harris ammendment of 1962

requires drug manufacturers to show the effectiveness of prroducts

report ae to fda

informed consent was required from participants in clinical studies

all the above

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need to edit this one!

requires drug manufacturers to show the effectiveness of their products

In Class Q: After the food, drug and cosmetic act of 1938 (FDCA) was passed drugs needed to be PURE and SAFE? True or False

True, no effectiveness yet

In Class Q: What was the first act or law requiring drugs to be proven SAFE before being marketed?

Pure food and drug act of 1906

food, drug and cosmetics act of 1938

prescription drug marketing act of 1987

durham-humphrrey amendment of 1951

Food, drug and cosmetics act of 1938

In Class Q: The Durham Humphrey ammendment of 1951 did what:

Established Purity and Safety

Established two classes of drugs: Rx legend (Rx) and OTC (over the counter)

Provided the modern scenario for approving new drugs

required testing and approval of “medical devices

Established two classes of drugs: rx and otc

In class question: The Food, drug and cosmetic act of 1938 did all the following (select all that apply)

Extended control to cosmetics and theraputic devices

standards of identity quality and fill of container for foods

providing the safe tolerences be set for poisonous substances

all the above

In Class Q: Which Act/law required imported drugs to meet the standards for strength and purity established in the USP

Purer food and drug act of 1906

biologics control act of 1902

Harrison narcotics tax act of 1914

Drug importation act of 1884

Drug importation act of 1884

is the USP funded by the government

nope its independent and non profit

How does USP collect their data for manufacturing?

Crowd sourcing to create basically open source product (safety data) for public use

What organization sets the standards for pharmaceutical manufacturing, compounding and biologics?

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Hint 797, 800

USP

Does the USP have enforcing authority?

nope

True or False: FDA will look to the USP for what standards to make into law

True!

(so the FDA still has enforcement power but the USP dictates what the rules are basically bc the FDA trusts this independent org)

when was USP founded

1820

Which act was the first to reference USP for standards of strength and purity (aka good enough for america standard)

Drug importation act of 1884

Which act was a response to diptheria antitoxin derived from horses being infected with tetanus?

Biologics control act of 1902

What 2 things did the biologics control act of 1902 state?

established safety and purity of serum, vaccines and other biologic products

Also

mandated anual licensing of establisments that manufactured or sold serums, vaccines anti toxins and similar products

Which standard came first for oral drugs: purity safety or efficacy and with what act?

purity

Pure food and drug act of 1906

Which standard came second for oral drugs: purity safety or efficacy and with what act?

safety

Food Drug and Cosmetic Act of 1938

Which standard came third for oral drugs: purity safety or efficacy and what amendment?

efficacy

Kefauver-Harris Amendment of 1962

Which act involved Dr. Harvey Washington Wiley (testing borax levels in pts) and Upton sinclair (w/ the jungle)

The pure food and drug act of 1906

What act prohibited interstate commerce in misbranded and adultered foods, drinks and drugs only?

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Hint BELOW:

purity only

Pure food and drug act of 1906

What main things did the Harrison Narcotics Tax act of 1914 do (2 things, one thought process so 3 total)

Regulated and taxed the production, importation, distribution and use of opiates

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intended to curve the growing number of opium addictions

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Clause was added that said you could not prescribe opiates to an addict (since addiction was not considered a disease yet)

Which act was a “replacement” for the Pure Food and Drug Act of 1906?

Food, Drug and Cosmetic Act of 1938

Which act established purity and safety for Drugs?

Food Drug and cosmetic act of 1938

Which act was a response to the sulfonamide disaster in 1937? (sulfonamide elixer that had antifreeze in it to make sweet for kids, 107 people died)

Food, Drug and Cosmetic Act of 1938

What act extended FDA’s Coverage to also cover Cosmetics and therapeutic Devices?

Food, Drug and Cosmetic Act of 1938

Which act required new drugs to be shown specifcally Safe?

Food Drug and Cosmetic act of 1938

Which act required manufacturers to provide safe tolerences to be set for poisonous substances and standards for identity, quality and fill of container for foods?

Food drug and cosmetic act of 1938

Full list of food, drug and cosmetic act of 1938 things that were covered

* extended control to cosmetics and theraputic devices
* required that new drugs were shown to be safe
* need a safe tolerence to be set for poisonous substances and to set standards of identity, quality and fill of container for foods
* authorized factory inspections

What amendment is known also as the prescription drug amendment?

Durham Humphrey Amendment of 1951

What are three amendments to the Food, Drug and Cosmetics act of 1938?

* Medial Device amendments of 1976
* Kefauver Harris Amendment of 1962
* Durham Humphrey Amendment of 1951

which amendment established the two main classes of drugs: rx legend and otc?

Durham Humphrey Amendment of 1951 aka the prescription drug amendment

Which amendment required either a written rx from a physician or an oral rx to be immediately reduced to writing to be valid rxs?

durham humphrey amendment of 1951 or the prescription drug amendment

Which amendment authorized refills on rxs and added a path for manufacturers to switch their products to OTC from RX?

durham humphrey amendment of 1951

what amendment established the first guidance on the minimum that is required on a rx?

durham humphrrey amendment of 1951 aka rx drug amendment

The full list of things the Durham Humphrey Amendment of 1951 aka Rx drug amendment added (5)

* 2 classes of drugs: rx and otc
* reqirement for either a written rx from an md or an oral rx from an md thats immediately put into writing
* so cant just type up an oral into the computer, have to write it down first
* refills on rxs
* path for manufacturers to switch their products to OTC from Rx
* Guidance on minimal information on a drug label
* before doc didnt want pt to knwo what drug they are taking (sometimes would put the NDC on there) and if the pt asked what it was to the pharmacist they owuld have to tell them to ask the MD
* Name/address of pahrmacy, serial number of rx, date of filling, name of md, name of pt, directions for use, any applicable warning labels

Which amendment established standards on Efficacy (so now have all 3: purity, safety and efficacy)

Kefauver Harris amendment of 1962

which amendment was a response to thalidomide trying to gain approval in the US for pregnancy N/V but could have birth defects

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HINT below:

Kelsey PhD wanted more data on this drug

Kefauver Harris Amendment of 1962

Full list of Kefauver Harris Amendment of 1962 clauses (WAY too much will have to condense)

EFFICACY time!

* its bc Kelsey wanted more info on the efficacy vs safety of Thalidomide
* Drug manufacturers show effectiveness of their products
* report AE to FDA
* Advertisements to prescribers disclose the risks and benefits/FDA juristiction on rx advertisements
* Manufacturing
* inspection of drug manufacturers every 2 years mandate
* FDA issues the GMP (Good Manufacturing practice) cGMP (current GMP) which states how drugs should be manufactured or repackaged
* This does NOT include the 795, 797, or 800. both are from the USP’s data but one is just USP and the other is FDA law for big manufacturing
* manufacturers to include full info on AEs and CIs (start of the package insert)
* Modern Drug approval process points:
* FDA needs to approve NDA (New drug application)
* FDA needs to approve IND (investigational new drug application)
* Informed consent for participating in clinical trials
* make a flashcard
* These steps:
* Initial drug discovery, Preclinical/animal testing (now have alt path of no animal testing route)
* IND application (to allow human testing trials)
* Phase 1, Phase 2, and phase 3 trials
* NDA application to put onto market
* Phase 4/post marketing studies
* Then FDA has to look over safety vs efficacy and research methods for NDA (6 months to 1-2 years)

Which amendment stated that benefits and risks of the drug must be put into all drug advertisements?

Kefauver Harris Amendment of 1962

Do compounding pharmacists follow GMP or cGMP and if not which do they follow and what do they do?

No

they follow 795 (non sterile) 797 (sterile) 800 (hazard). both GMP and those above are getting info from usp though

Which Amendment set the framework for modern drug approval process?

Kefauver Harris Amendment of 1962

Pre clinical trials info and what amendment put it into place

Kefauver Harris Amendment of 1962

* initial drug discovery w/ animal testing (but do have alt no animal harm route)
* then file IND (investigational new drug) application to get approval to do human testing

Phase 1 trials info and what amendment put it into place

Kefauver harris Amendment of 1962

* 20-100 healthy males w/o disease to establish minimum on safety and dosing basically

Phase 2 trial and what amendment put it into place

Kefauver Harris Amendment of 1962

100 to 500 people w/ the disease in question

* initial safety data and dosing data
* see if any initial efficacy

Phase 3 clinical trial info and what amendment put it into place

Kefauver Harris Amendment of 1962

* 1000 to 5000 people w/ disease
* ALSO submit the pre NDA at the start here

NDA info and what amendment established it

Kefauver Harris amendment of 1962

* formal approval to put drug on market
* 60 days to even say theyll look at app
* review safety vs efficacy, package insert, manufacturing facilities, study methods for 6 months to 2 years
* also gives advice on how to make application approvable

What Act established the Materials safety data sheets (MSDS) which is for compounding

Occupational Safety and Health Act of 1970 (OSHA) and Niosh

What Act established specific requirements for child resistant tops and other packaging laws

Poison Prevention Packing Act of 1970 (PPA)

Who enforces the Poison Prevention Packaging Act of 1970

Consumer Product Safety Commission (CPSC)

Is the Consumer Product Safety Commision (CPSC) apart of the US gov?

Nope, its independent of the gov but has enforcing power on household products to protect kids

Specific Requirements listed under the Poison Prevention Packaging Act of 1970

* Most Household items and drugs have to be in child protective bottles/caps to protect frrom serious injurry or illness
* Pharmacist is responsible for ensuring drugs are in child proof containerrs
* Rx drugs from the manufacturer must be in child resistant containers may be directly dispensed to pts in that container
* Plastic vials that have previously been dispensed to the pt cannot be reused for refills
* glass vials are an exception (bc glass doesnt break down readily like palstic does)
* Institutionalized pts not required to get child resistant containers unless they are being discharged with those meds
* Recommends pharmacists get written authorization from pts for conventional packaging (not child resistant)
* Products that are exceptions to the rule
* SL nitroglycerin and others (for like emergency use)
* Manufacturers can choose one of their stock bottles to be not child proof from PPPA’s size options

what part of the US gov is CDER a subsection of? (Center for Drug Eval and Research) and what do they do

part of FDA

regulates OTC, rx, biological theraputics and generic drugs aka i think does drug approval process

What is an abreviated drug application and what is it for?

Generic Drugs

brand already has all the efficacy and safety data so generics just prove they are the brand

4 subtypes of Faster drug approval processes (aka accelerated approval) (according to FDA website)

* Accelerated approval
* Fast Track
* Breakthrough therapy
* (priority review which he doesn’t talk about)

Accelerated aproval subtype definition

Drugs for serious conditions that fill an unmet medical need are approved faster. their data is based on a __surrogate endpoint.__ (whcih may or may not predict disease progression)

they can apply for it after phase 2 ends

still need phase 4 data but allow pts to try it

Fast track approval subtype definition

facilitate the development, and expedite the review of drugs to __treat serious conditions__ and __fill an unmet medical need__ (inc qol, dec death etc)

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they are the favorite kid: FDA wants this drug to be approved so will help them out at every step, has rolling review from fda (they approve each section at a time)

Breakthrough Therapy approval subtype definition

\n \n Expedite the development and review of drugs which may demonstrate __substantial improvement over available therapy__.

same thing as fast track but with improvement on current therapy

Expanded Access/Compassionate Use approval

to allow patients who have exhausted all other options for treatment with a life threatening illness to use this new experimental treatment

its at phase 1

are told all the risks and possible benefits

drug isnt fda approved yet

What is DESI (Drug Efficacy Study Implementation) ex drugs for ref

FDA went back and checked drugs that it approved from 1938 to 1962 again for efficacy (or even sometimes redid trials). drugs approved before 1938 are exempt (digoxin)

in response to the Kefauver harris amendment of 1962

ex drugs:

* hydrocortisone pramoxine hcl
* nitroglycerin
* phenobarbital belladonna
* librax

Which amendment required testing and approval of medical devices like IUDs and divided medical devices into 3 classes

medical device Amendments of 1976

3 classes:

Clsas 1: tounge depressors

Class 2: wheelchairs

Class 3: artificial hearts

In Class q: The Food, Drug and Cosmetics Act of 1938 (FDCA) was influenced and eventually passed into law because of a tragedy involving which drug?

Thalidomide

Sulfonamide Elixer

Diptheria Toxoid

Chicken in a bottle

Sulfonamide Elixer: bunch of kids got sick bc they had antifrereze in them. so Safety ammendment passed.

In Class q: the Kefauver Harris Amendment of 1962 dictated that:

Informed consent was required from participants in clinical studies

authorization of refills on rx is legal

FDA has control over cosmetics and theraputic devices

FDA could do factory inspections

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DOUBLE CHEKC WITH OTHER IN CLASS QUESTION BC I GOT THIS WRONG BC OF THAT ONE

Informed consent was required from participatnts in clinical trials

B: was Durham Humphrey Amendment of 1951

C was the food drug and cosmetic act of 1938

D: initial factory inspection one was food, drug and cosmetics act of 1938

In class q: what amendment to the FDCA (food drug and cosmetics act of 1938) provided the modern scenario for approving new drugs?

Drug efficacy study implementation

Durham humphrey amendment of 1951

Kefauver harris amendment of 1962

Kefauverr harris amendment of 1962

In class q: An IND (investigational new drug) application has 3 phases. after which phase may a manufacturer submit to the FDA to market the drug?

Phase 1

Phase 2

Phase 3

Phase 3 (i think he means when do you submit the NDA)

In class q: the center for drug evaluation and research (CDER) is part of which gov agency?

DEA

FDA

EPA

CDC

FDA (FDA approves drugs, CDER approves drugs)

in class q: the FDA has several drug approval processes, which is based off a surrogate endpoint (and you ask for after phase 2)

Breakthrough therapy designation

Fast track

abbreviated drug application

Accelerated approval

Accelerated approval = surrogate endpoint

which drug approval process is for generics to get approved

Abbreviated drug application

which drug approval process is for an “unmet medical need” so gets guided through the process (no current tx)

fast track

which drug approval process is for a drug that **has improved clinical outcomes** (NOT SURROGATE) not achieved by any current available drugs

breakthrough therapy designation

which drug approval process is for pts with no other tx options to try this not fda approved drug thats currently at phase 1 outside of the clinical trial

Expanded access/compassionate use