RXPREP Chapter 2: Pharmacy Laws & Regulations Flashcards
Which body reviews the drug data provided by the manufacturer to make sure that drugs marketed in the US are safe and effective?
Center for Drug Evaluation & Research (the largest of FDA’s 6 centers)
The drug approval process consists of how many phases?
four phases
Which phase of the drug approval process?
- on animals
- relative safety
- therapeutic potential
pre clinical testing
Between which phases is the IND present?
between pre-clinical and phase I
Which phase of the drug approval process?
- 20-100 healthy volunteers or people with the disease
- safety
- side effects
- PK and PD
phase I
Which phase of the drug approval process?
- 100-300 people with the disease
- efficacy and safety
- find optimum dose or dose range
phase II
Which phase of the drug approval process?
- 300-3000 people with the disease
- efficacy compared to placebo or standard-of-care
- AE
phase III
Which phase of the drug approval process?
- lon term efficacy and safety
- high risk patient monitoring
- other peopulations and new uses
phase IV
Between which clinical phases is the NDA present?
between phase III and IV
If animal research indicates a relatively safe drug with potential therapeutic use, the manufacterer will file an
Investigational new drug (IND)
files to the FDA
What phase of the drug approval process assesses the drug’s safety?
ALL phases
what does IND approval represent?
the FDA’s permission to begin phase I clinical studies in HUMAN subjects
In what phase would you apply for FDA approval if your drug is proving to be promising?
phase III (NDA)
the ________ is used for drugs, and a ___________ is used for biologics
(NDA)
NDA
biologics license application
in order to change a label, add a new indication, add a new dosage strength of a drug or change drug manufacturing processes, a company must submit a
supplemental new drug application (sNDA); or a supplemental biolgoics license application (sBLA)
*this is how off-label uses become official indications
Each OTC category has an OTC monograph that dictates the specific conditions (dosing, labeling, indications) for drugs to be:
“generally recognized as safe and effective”
Which act created an administrative order that allowed the FDA to more easily publish and update OTC monographs? (previously was a 3 phase process)
the CARES act
3/2020
Which adminstrative order process?
requester submits OMOR
FDA files OMOR
FDA issues proposed order
public comments on proposed oder
FDA issues final order
industry-initiated order
Which adminisrtative order process?
FDA issues proposed order
public comments on proposed order
FDA issues final order
FDA-initiated order
Generic drug companies can file one of two abbreviated applications for generic drug approval:
abbreviated new drug application (ANDA)
505 (b)(2) application
This generic drug approval process requires a review of the generic product’s chemistry, the manufacturing controls and the labeling
ANDA
Under an ANDA, a generic drug company must provide study data to establish that the generic drug has the same:
active ingredient
route of adminisrtation
dosage form
strength
as te branded drug!
What is it called when drugs have the same rate and extent of availability at the site of action in the body to the brand drug?
bioequivalent
What can be different between generic and brand?
inactive ingredients (coloring, excipients, binders)
this generic drug approval process allows the manufacturer to submit previously published reports of safety and effectiveness
505b2
*unlike a generic approved by the ANDA, the drug can be marketed in a different strength or formulation than the previously approved product
un approved drug will have an NDC number but will not be lsited in the FDA’s approved drug products with therapeutic equivalence evaluations, commonly known as the
orange book
All drugs can cause some adverse events, which should be reported to the
FDA’s medwatch program
Medwatch interacts with FDA’s…
FDA’s adverse event reporting system (FAERS)
___________ is designed to identify AE NOT found in clinical trials
medwatch
Who can submit reports to medwatch?
healthcareprofessionals, includin rph; patients, and consumers
What is the post marketing surveillance component of phase IV?
the manufacturer sends collected reports to the FDA quarterly in the first 3 years, then every year
A drug recall is carried out by the drug company and can be intiated by
the manufacterer or the fda
manufacterers should notify the FDA ___ days prior the withdrawin an approved drug from sale
180 days
prescription drug advertising is regulated by the:
OTC drug advertising is overseen by
FDA
federal trade comission (FTC)
the fda requires an advertisement to contain three items:
the name of the drug (Brand and generic)
at least one FDA approved use for the dru
the most significant risks of the drug
any false or misleadin statements in the advertisement could be considered: adulterated or misbrandin?
misbranding
this law required that the food or drug label could not be false or misleading
and required that no adulterated or misbranded drugs could be sent through interstate commerce
wiley act/pure food and drug act of 1906
this law led to requirements for drugs to demonstrate safety prior to release
food, drug, and cosmetic act (FDCA) in 1938
*birth of the FDA
this act required that the manufacterer prove the safety of a drug before it could be marketed. adequate directions for safe use and a list of all ingredients had to be included on the label and product claims had to be accurate
FDCA
filthy, putrid or decomposed
adulterated
lack of required information on the package
misbranded
false or misleading information
misbranded
prepared or stored in unsanitary conditions
adulterated
contaminated
adulterated
drug is recognized in official compendia but its strength is different from official standards, or the purity or quality is lower than the official standards
adulterated
drug is not recognized in the official compendia but its strength is different from that listed on the label
adulterated
example: a vaccine which must be stored in the freezer has been stored in the fridge for the past week; vials of injectable pain mediction are found to contain glass shards; a manufacterer does not perform adequate sterility tests before distributing an IV drug
adulterated
examples: an herbal product claims that it cures cancer; a product’s labeling does not include information about risk in pregnancy; an OC product is dispensed without the required patient package insert
misbranded
example: a bottle of thyroid tablets are labeled as containing 60m but actually contain 30mg as determined by USP testing standards – adulterated or misbranded?
both!
the strength is lower than the standard (adulterated) and the product is falsely labeled (misbranded)
this was the first time that a clear distinction was made between OTC and rx drugs and the labeling requirements for each were differentiated
durham-humprey amendment of 1951
this amendment named three conditions that would make a drug available only by rx:
- drugs that are habit formin
- drugs considered unsafe for use except under supervision due to toxicity concerns
- drugs limited to rx use only under a manufacterer’s new durg application
durham-humphrey amendment
this amendment dealt with thalidomide
kefavuer-harris ammendment of 1962
“the first safe sleeping pill” used in pregnancy
// aka drug efficacy amendment
this amendment implemented:
- manufacterers must prove that a drug is both SAFE and EFFECTIVE before it can be fda approved
- after the drug is on market, manufacterer’s must continue to report serious SE to the FDA
- individuals must give their informed consent when they are study subjects of a clinical trial
kefauer-harris amendment of 1962
what did the fda conduct in order to determine the effectiveness of drugs approved between 38 and 62?
retrorespective evaluation
“DESI program”
the FDA was allowed to establish _____ for drug manufacturing and to perform inspections
current good manufacturing practice (CGMPs)
assured the identity, strength, quality, purity, prevention of errors
this act established regulations surroundin controlled substances that all manufacterers, importers, exporters, distributors, researchers, hospitals, pharmacies, prescribers, and pharmacists must follow
controlled substance act of 1970
- this act established a closed system for manufacturing, distributing, and dispensing drugs to reduce drug diversion
Who enforces the CSA?
DEA
this act requires a numer of household subtances and drugs to be packaged in children-resistant packaging
poison prevention packaging act of 1970
difficult for ages <5
this act amended the FDCA to require drug establishments that are engaged in manufacturing, preparation, propagation, compounding or processing of a drug to register all of their drugs with the FDA. (NDC)
drug listing act of 1972
the NDC number (10-11 digit code) has three segments:
labeler code (manufacterer, repackaer, or distributor)
product code (identifies the strength, dosage, and formulation)
package code (package size and type)
this act made it a federal crime to tamper with OTC products, and required tamper-resistant features on OTC meds
federal anti-tampering act of 1982
which products are exempt from using tamper resistant features in the packaging?
skin products
insulin
lozenges
toothpaste (dentifrice)
an ___ drug treats a disease that affects less tan 200k people in the US or offers no reasonable expectation that the sales revenue will recover the cost of research and development
orphan
- this act offers incentives to manufacturers of orphan drugs, including a tax credit (50% of the clinical testing costs) and a SEVEN years of market exclusivity
this act streamlined generic drug approvals and to grant patent protection to drug innovators
hatch-waxman act (drug price competition and patent term restoration act) of 1984
- the purpose of the legislation was to increase the availability of generics and cut costs for the patient and the healthcare system
Which legislation made it possible for generic drug companies to file one of two abbreviated applications for generic drug approval (ANDA) and the 505b2 application?
hatch-waxman act
the hatch-waxman act grants up to how many years of market exlucisvity to the company that created the brand name drug to make up for the effort the company spent conducting clinical trials to establish safety and efficacy
hatch-waxman act, 5 years
this act was enacted to reduce public health risks from adulterated, misbranded, counterfeit or expired drugs
prescirption drug marketing act of 1987
- the law prohibits reimportation; prescription drug products manufactured in the US and subsequently exported to a forein country cannot be reimported back into the US
the sale of drug samples and coupons was prohibited
patients cannot buy drugs in other countries and bring them into the us except under what conditions?
quantity is <90 day supply and is for the patient (cannot be resold)
an effective treatment is not available in the US and the condition is serious, and the drug being imported has no unreasonable risk
conerns about improper medication use and inefficient use of federal dollars spent on healthcare led to
the omnibus budget reconciliation act
OBRA requires pharmacists to perform prospective drug utilization review (DUR) and counseling for all medicaid beneficiaries before dispensing the prescription to the patient
omnibus budget reconciliation act of 1990
this act established regulations for dietary supplements that were different from those for drugs or conventional foods
DSHEA
dietary supplement health and education act of 1994
dietary supplements may only claim to address
a nutrient deficiency, support health or be linked to body functions
must include a disclaimer
this act required the establisment of registry for clinical trials, enabled the manufactuter to discuss off-label drug use when requested, and extended an amendement previoulsy passed (prescription drug user fee act) that PERMITS the fda to charge a manufacturer fees to expedite the drug review process
fda modernization act of 1997
under the FDAMA, wording was simplified to
rx only
what are the four programs to help speed development and review of new drugs
fast track designation: drugs to treat serious conditions and fill unmet needs
breakthrough therapy designation: drugs showin substantial improvement over current therapy
accelerated approval: approval can be based on a surrogate endpoint to meet and urgent need
priority review designation: fda will review within six months
DATA 2000 permitted _________ to prescribe through and dispense controlled substances in an office based setting
physicians
in 2016, the comprehensive addiction recovery act allowed __________ and _____________ to treat patients for opioid dependence as well
NPs and PAs
the risk evaluation and mitigation strategy (REMS) program was part of what legislation?
the FDA amendments act
biologic interchange information can be found in what book
the purple book – called the lists of licensed biological rpducts with reference product exlusivity and biosimilarity or interchangability evaluations
this act followed an outbreak of fugal meninigitis due to improper practices at the new england compounding center
drug quality and security act of 2013
this act gave the FDA increase autority to regulate compounding
compounding quality act
503b= outsourcing facilities
to prevent counterfeit drugs from entering the market, the drug supply chain security act established …. requirements to document trasactions of rx products through the supply distribution chain
track and trace
records must be kept for 6 years
the pregnancy and lactation labeling final rule 2014 places information into three categories:
pregnancy:
lactation:
females and males of reproductive potential:
True or false
CARA permits pharmacists to partially fill schedule II drugs at the request of the patient or prescriber
true
*in iowa, patient can request
any remaining opioids must be filled within ___ days from the date the prescription was issued/written
30
partial fill are permitted for schedules III-V for up to six months from the issue date
