Pennsylvania MPJE Review (Cacciatore)

Food drug and cosmetic act of 1938

First legislation that required new drugs to be proven safe prior to marketing and established the FDA

Durham Humphrey amendment of 1951

established 2 classes of drugs OTC v RX and refills and verbal prescriptions

Kefauver Harris amendments

required new drugs to be proven safe and effective for their claimed use. Also increased safety requirements and established GMPs. Also gave FDA power over drug advertising

Prescription drug marketing act of 1987

bans RE-importation of prescription drugs and insulin products in the US and bans sale, trade or purchase of drug samples or device samples. cannot resell drugs purchased by hospitals

Requirements for drug samples

written request

requires signature

only provided to practitioner (or on their request to a facility)

cannot be shared with community pharmacies EVEN if operated by a facility

Drug quality and security act

Addressed large scale compounding and established track and trace system (drug compounding quality act and drug supply chain security)

drug compounding quality act

503b facilities are permittted to compound sterile products without patient specific labels but must follow GMP

Pennsylvania requires 503b facilities to do what?

register with the PA dept of health and receive a certificate of registration

outsourcing facilities that meet the drug compounding act requirements are exempt from what

premarket approval requirements, adequate directions for use, and drug track and trace provisions

which outsourcing facility s exempt from GMP?

503A (not 503B)

requirements of outsourcing pharmacies

licensed pharmacist with direct oversight

register as an outsourcing facility with the fda

report to the secretary of HHS at time of registration and every 6 months after

be inspected by the fda

report serious ADRs within 15 days

label products with a statement identifying them as compounded

outsourcing facilities may not compound a drug product that includes a bulk drug substance unless

it is on the 503b bulk list or is on the fda shortage list

bulk drug substances must be accompanied by

a valid certificate of analysis and comply with USP or national formulary monoraph

what is a 503A facility

compounding pharmacies that are not registered with FDA as an outsourcing facility- MAY ONLY compound for an individual prescription or medication order [limited anticipatory compounding allowed]

503a pharmacies are regulated by

797 and 795 standards

503a limits to interstate distribution

5% unless entered into a MOU with the FDA M

MOU with fda for 503a

a pharmacy is distributing an inordinate amount of compounds if the number of rx is >50% the sum of the rx orders OR rx picked up

Even with an MOU, compounding pharmacies must still

prepare compounds based on an individual patient

Drug supply chain security act (trace and trace) provides what

a uniform national framework for an electronic track and trace system for rx drugs as they move through supply chains

Drugs exempt from track and trace

blood products, radioactive drugs, imaging drugs, iv products for fluids, dialysis solutions, gases, compounded drugs and sterile water

Transaction data

manufacturers are required to provide for each product sold, wholesalers must then pass along to the buyer

transaction data includes

transaction information, history, and statement

transaction information

NDC, size, and qty + date, name and address of both seller and buyer!

transaction history

paper or electronic statement that includes prior transaction information t

transaction statement

paper or electronic statement by the seller that the seller is authorized, received from an authorized person and did not knowingly ship or suspect illegitimate product

how long must product tracing information be maintained ?

6 years by each partner

pharmacies may only receive drugs with

product identifiers

PRODUCT IDENTIFIER

SNI (standardized numerical identifier)- national drug code + serial number, lot number, and expiation date (must be readable by machine and a human)

suspect products

reason to believe are potentially counterfeit/stolen/ or adulterated

Illegitimate products

credible evidence shows that the products are counterfeit

pharmacies must investigate how much of the suspect or illegitimate product?

3 products or 10% (whichever is higher) OR if less than 3 all of it

FDA form 3911

notifies fda of suspect or illegit drugs

how long you have to notify trade partners of suspect or illegit drugs

24h

transactioon information and transaction statements must be exchaged in what manner

secure and electronic

if pharmacy is distributing (providing drug to anyone other than the pt) they must have

wholesale distribution license and must pass DSCSA transaction data (exceptions include - sharing between 2 entities that are under common ownership, providing a product to another dispenser on a patient specific basis, dispensing under emergency, or dispenser is distributing minimal qty to a licenses practitioner for office use.

adulteration

filthy putrid or decomposed

prepared or held under insanitary conditions

not made under GMP

manufactured in a place that denies inspection, delays or refuses

the container is composed of ant bad substance

unsafe color additive

strength or quality differs from standard (USP) or what it claims

mixed or packed with anythung that reduces its strength or quality

Misbranding

label is false or misleading

fails to contain:

name and address of manufacturer, packer or distributer

brand or generic name

net qty

weight of active ingredient
RX only

route of admin if not oral

special storage instructions if appropriate

manufacture control number (lot) number

expiration date

adequate information for use (PI, Medication guide or PPI if required)

If otc drug and fails to have the following it is misbranded

ident of the product in a principal display panel

name and address of manufacture

net qty

cautions and warnings

adequate directions for use

content and format of otc product labeling in drug facts (active ingredients, purpose and uses, warnings, directions, other information, inactive ingredients, questions)

misfilling an rx is always

misbranding

wrong strength of a drug in an rx is

adulterated and misbranded

Not meeting REMs requirements means the drug is

misbranded

expired drug would mean the rx is

adulterated and misbranded (if label has incorrect BUD)

counting medication on a dirty tray is

adulteration

incorrect temperature storage of a drug means

adulterated

failure to dispense with a child proof container when required is

misbranding

after animal studies the drug company files a

IND

after ind is approved you may begin

cinical trials if IND approves

conducted in healthy volunteers, primary concern is safety of drug

Phase 1 study

is the drug effective in those with the disease

Phase 2

large scale studies investigating safety and effectiveness

Phase 3

after completion of phase 3 trials you can submit

NDA

postmarketing studies

phase 4

special warning products in the FDCA

yellow 5

aspartame

sulfites

mineral oil

wintergreen oil

sodium phosphates

isopernerol inhalation

potassium salts for oral ingestions

ipecac syrup

Phenacetin

Salicylates

Minor sore throats

alchol warning

contraceptives and nonoxynol 9

acetaminophen warnings

liver toxicity

warfarin

NSAID warnings

stomach bleeding

Iron product warnings

accidental overdose

OTC Packaging requirements

tamper evident

tamper resistant exceptions

derm, toothpaste, lozenges, insulins

rules for repackaging otc

subject to gmp including labeling and tamper evident packaging

can an otc product be written for rx

yes, follows all rules of rx NOT otc

Recall with reasonable probability of adverse effect or death (worst)

Class 1

Recall that may cause temporary or reversible effects

Class 2

Recall not likely to cause adverse health effects

Class 3

otc drug advertising is regulated by

FTC

advertising og rx drug prices is considered what kind of ad?

reminder ad- cannot comment on safety efficacy or indication and must include all fees in the cost

PA forbids advertisement of

controlled substances

supplied by the manufacturer and written for a layperson

PPI

required to be given to [patient in the outpatient pharmacy setting

PPI

PPI is required for

Oral contraceptives

estrogen containing products

For hospitalized patients a PPI must be given

at first admin of the drug and every 30 days thereafter

failure to provide a PPI

misbranding

similar to PPI but different requirements for inpatients

MedGuides

Required to be given for all new and refill prescriptions dispensed in the outpatient setting when:

1. patient labeling could prevent adverse effects

2. serious risks

3. adherence is crucial

MedGuides

who approves medguides?

fda

all of these require what?

• accutane

• antidepressants for kids

• coumadin

• epogen

• forteo

• lindane

• tamoxifen

• nsaids

• opioids

• benzos

MedGuide

failure to provide a medguide would be

misbranding

This is NOT a replacement for medguide or ppi

consumer medication information (CMI)

Side effect statement is required when?

all new and refill prescriptions! aka call your dr for advice…. (can be found anywhere)

May include a medication guide, a PPI, a communication plan, elements to assure safe use, and an implementation system

REMS programs

may include the following:

• special training for providers

• special certifications for pharmacies

• dispensing only in certain settings

• safe use conditions (labs)

• monitoring of patients

• enrolling in a registry

Elements to assure safe use

who registers with IPLEDGE

prescribers, patients, pharmacies, wholesalers

NDC first 3-5 digits

labeler code

NDC second grouping of digits

specific drug, strength, and dosage form

ndc last digits

package size

if a supplement or device has an NDC what would that be

misbranded

orange book

approved drug products with therapeutic equivalence

Drug products in identical dosage forms and routes of admin → IDENTICAL

pharmaceutical equivalent

bio equivalent, same clinical effect and safety profile

Therapeutic equivalent

drug products that the fda considers to be pharmaceutically AND therapeutically equivalent

A

drug product the FDA considers NOT pharmaceutically AND therapeutically equivalent

B

products with actual or potential bioequivalence problems but for which scientific evidence has established bioequivalence

ABP

purple book

biologic product equivalence

highly similar to the reference product (may have minor differing inactive ingredients) no clinically meaningful difference in terms of safety purity and potency

biosimilar

shown to be biosimilar, expected to produce the same clinical result

interchangeable product

only biological products that have been designated “——————-” can be substituted for the original product by the pharmacist

interchangeable

in PA, pharmacists are able to substitute an A rated generic product and interchangable biologics without contacting the provider UNLESS

the drug has a narrow therapeutic index

interchangeable for lantus

semglee

deemed low risk medical devices, ex dental floss

Class 1

higher risk medical devices ex syringe

class 2

highest risk medical device ex heart valve

class 3