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120 Cards in this Set

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Who controls Rx drug advertising?
The FDA
Who controls OTC advertising?
The Federal Trade Commission (FTC)
Who controls pharmacist advertising?
Pharmacy practice acts
What must be provided in advertising to Health Care Professionals by Manufacturers?
Name of the drug, active ingredients, and summary of information regarding side effects, contraindications, and clinical effectiveness
What types of advertising does not have to meet manufacturer requirements?
Reminder advertisements with no indications or dose recommendations

Ads for bulk sale of drugs

Ads by pharmacists regarding compounding
Where can advertising be found?
Journals and periodicals

Broadcast media

Telephone communications
What type of information can labeling be provided in?
Brochures, booklets, mailing pieces price lists, references provided by manufacturer for use by health care professionals

Information must include everything required for labeling
What are some educational programs supported by manufacturers?
Draft Policy Statement on Industry - supported Scientific and Educational Activities

OIG Compliance PRogram for Pharmaceutical Manufacturers

PhRMA Code on Interactions with Healthcare Professionals

Continuing Education Programs
What is Direct to Consumer Advertising?
Must contain a true statement, brief summary, and be fair and balanced

Must contain adequate provisions to provide consumers with information regarding medication, uses, and side effects

Same rules as advertising to health care professionals
What are FDA Adequate Provision Requirements for advertising?
Summary of risks in audio/ visual format as long as it provides adequate provision for obtaining complete prescribing information from a toll free number, website, print advertisement in a concurrently running publication, and referral to a health care provider - "Ask your doctor or pharmacist"
What must be provided for advertising to be called "product specific"?
Name of drug, ide effects

Adequate provisions to obtain further information
What isn't provided in advertising that allows an add to be "non-product specific"?
No product name

Directs consumers to health care professional - does not have to follow provisions
Who established guidelines for off-label drug use?
FDAMA - relaxed prohibitions and established guidelines allowing off-label information to:

Health care practitioners, BMs
Health insurance plans, group health plans, governmental agencies
What must be provided for a drug to be approved for an off-label use?
Peer-reviewed journal information

Sales force generally must refer to medical science staff to provide this type of information

FDA must approve the content
Why must an Rx drug be adminstered by a licensed practitioner, according to the FDA?
Because of toxicity or other harmful effect, or the method of use, or the collateral measures necessary for its use it is not safe except under the supervision of a practitioner licensed by law to administer it
How must an Rx drug be dispensed?
Via a written prescription, oral prescription promptly reduced to writing, or a refill authorized by the practitioner
What must be included on the prescription in order to prevent being called misbranded?
Rx only
What is the FDA definition of an over-the-counter drug?
Based on a panel review, must be safe and effective for use by consumers without a prescription

Manufacturers must submit an application or petition for review
What is a proprietary drug?
Drug that meets FDA requirements for OTC medications

Cannot be a controlled substance or require a label indicating that it might be habit-forming

Cannot be a product that must be administered by a licensed practitioner or dispensed by a pharmacy
What is Virginia's definition of dispensing?
Delivery of a drug to an ultimate user or researcher by the order of a practitioner

Includes prescribing and administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery

Does NOT include transportation of mixed, diluted, or reconstituted products for the purpose of administration by a practitioner in an ofice setting directly to patients
Generally, what does dispensing generally relate to?
Providing medications through a pharmacy for the person to take away for personal use
Drugs provided to residents of nursing homes and other long-term care facilities are considered what?
As dispensed to a patient
Physicians and other providers that inject or provide medications in their office are considered what?
NOT dispensing - it is administration
What requirements must prescription drugs adhere to extensively?
Label and labeling requirements

Rx products that do not conform to this requirement might be considered misbranded unless excempted because dispensed by a pharmacy
How can dispensing pharmacists and pharmacies become exempt from extensive labeline requirements?
The label must:

meet the requirements established by the state, not be false or misleading

Packaging and labeling must conform to official compendia standards an dbe packaged and labeled appropriately

Drugs must be packaged in conformance with the Poison Prevention Packaging Act when required
What must be included when dispensing a prescription drug?
Name and address of dispenser (pharmacy)

Serial number of Rx (pharmacy's assigned number)

Date of Rx or filling

Name of prescriber (not address)
Name of patient (not address(
Directions for use and cautionary statements if necessary
What are the Poison Prevention Packaging Act of 1970's requirements for dispensing prescriptions?
Must be designed to protect children from accidental poisonings with household substances, including prescription drugs
Who delegates authority over the Poison Prevention Packaging Act, PPPA?
Consumer Products Safety Commission

Regulates and ensures compliance with requirements
What are the PPPA requirements for pharmacies?
Child-resistant containers for most OTC drugs and for all Rx drugs dispensed directly to the consumer

Applies to all legend and controlled drugs (exceptions permitted)
How can long-term care faccilities and other institutional settings be exempt from PPPA requirements?
If the facility personnel will administer the medications to the patient
What makes a container child-resistant?
Proven by the manufacturer such that 80% of children less than 5 years old cannot open them but at least 90% of adults can open them
When can a pharmacy dispense a product in a non-safety cap vial?
When the patient or physician requests exemption

Request may be oral but should be documented

Pharmacy may post a sign near the pharmacy department outlining the policy
How long must a pharmacy maintain a release form for a non-safety cap vial?
2 years from the dispensing date
What OTC products may be dispensed in a non-safety cap package?
Products marketed specifically for elderly or disabled individuals with proper notation that the packaging is not child-resistant
501 (g) of FD&CA exempts pharmacists from manufacturing requirements if they do not engage in what kind of compounding activities?
Manufacturing, preparing, propagating, compounding, or processing drugs or devices for sale other than the regular course of their business of dispensing or selling drugs at retail
What entitiy governs pharmacist compounding?
State Board of Pharmacy

Pharmacies do not have to comply with GMPs and adulteration provisions

Pharmacies are also exempt from labeling (misbranding) provisions
What compounding actions require pharmacists to register as manufacturers?
Changing the container, wrapper, or labeling products

Drug repackagers must register with the FDA (this is not compounding)
How much may a pharmacy compound in anticipation of a prescription
Very "limited quantities"

FDAMA attempted to remove stringent provisions of guidance but later the Supreme Court ruled compounding provisions unconstitutional
What would require the FDA to become involved in compounding?
If a pharmacy was involved in "significant" violations
The FDA must be granted authority to inspect a pharmacy to determine what?
To determine wheter a pharmacy is "manufacturing" vs. compounding

2003 NJ case, not the US Supreme Court establishted that the FDA must be granted authority to inspect
What is not permitted in compounding practices?
Agents withdrawn/ removed from the market for saety reasons

Drug products that cannot be shown in writing to be produced in an FDA-approved facility

Commercial or manufacturing or testing equipment

Making products for resale to third parties, including other pharmacies

Copies of existing products

Operating outside the confines of state law
How must a compounded non-prescription product be labeled?
According to FDA provisions as any other OTC agent

Cannot be prepared with any prescription ingredients

FDA might intervene if significant health hazards occur and pharmacy compounds on a regular basis
What is the definition of reconstitution?
Mixing of drug products for use by a patient pursuant to manufacturer's instructions

Not considered compounding
What is the definition of compounding?
Combining 2 or more ingredients into a single preparation and includes mixing, assembling, packaging, or labeling of a drug or device by a pharmacist or within a permitted pharmacy

Pursuant to a valid prescription issued for medicinal or therapeutic purpose in the context of a valid practitioner-pharmacist-patient relationship

OR in expectation of receiving a valid Rx based on observed prescribing patterns

OR for purposes of or incident to research, teaching, or chemical analysis not used for dispensing
Are prescribers that mix, dilute, or reconstitute a manufacturer's product for the purpose of administration to a patient considered as compounding?
NO
What must be on the label of a compounded prescription?
Name and strength of medications or list of active ingredients and strenghts

Pharmacy must number the prescription consistent with the compounding record

Beyond use date determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding

Quantity

May not distribute compounded products to other persons or commercial entities including pharmacies
How may compounded products be shipped?
Via mail IF integrity remains in place
What must be on the label for a compounded product to be administered by a physician?
"For Administering in Prescriber Practice Location Only"
Who may be involved in compounding in a pharmacy?
Technicians may compound under supervision of a pharmacst

Interns, Pharmacists
All drug products and excipients must meet what standards?
FDA approved standards including standards for appropriate pharmacopoeia
How must information pertaining to compounding be recorded?
Mintained as part of the prescription, formula record, formula book, or other record log or record

May be maintained electronically or manually so long as th einformation is readily retrievable
What information must be maintained as part of compounding record keeping?
Date of compounding and dispensing
Prescription number
Total quantity
Signature or initials of pharmacist or technician performing the compounding
Signature or initials of pharmacist responsible for supervising the pharmacy technician
Complete information regarding formulas used, equipment, environmental considerations and other factors necessary to replicate prescription
Written quality assurance plan describing specific monitoring and evaluation of compounding activities in accordance with USP standards
- Must include training, competence assessment, monitoring, and equipment calibration and end-product testing
For compounding of products in advance of dispensing, what must included in the records?
Generic name and quantity
Name of the manufacturer
Manufacturer's lot number and expiration date for each component or if unknown, the source of acquisition of each component
Assigned lot number if subdivided
Unit or package size and number of units prepared
Beyond use date
What activites are prohibited for compounding?
Products removed or withdrawn by the FDA because of safety concerns

Compounding "inordinate" amounts of drug product essentially copies of commercial products except if prescriber changes the speficications for the product; manufacturer or supplier cannot provide the commercially available product; compounding two or more commercially available products into the same prescription
When would compounding copies of commercial products be allowed?
When the prescriber changes the speficications for the product

The manufacturer or supplier cannot provide the commercially available product

If compounding two or more commercially available products into the same prescription
Who are considered a drug repackager?
FDA registered facilities that must comply with GMPs, including all labeling requirements and product integrity requirements

Repackage drugs from manufacturers and place them into new package
- Often unit-of-use packaging or other more convenient type of packaging
What does repackaging do to the NDC code?
Changes it - results in a new national drug code
What is the National Drug Code (NDC)
3 segment unique code identifying drug product and packaging type

First 5 numbers - manufacturer or distributor

Second 4 numbers - drug

2 Final numbers - package type
How is repackaging different from prepackaging?
When a pharmacy packages drugs from manufacturer's container to a customized unit dose or other type of unique dispensing systems for direct patient use

For customer use - has the pt's name on it or is intended to go directly to the patient
How does Virginia define repackaging?
Placing any drug from a manufacturer's original container into different packaging

VA regulations DO distinguish between repackagers and prepackaging drugs

Repackagers have to be registered with the FDA and comply with manufacturing practices
How long must records be maintained for products that are repackaged?
1 year or until the expiration date of the product, whichever is GREATER
What is required in records for repackaging?
Drug name
Strengh
Date repackaged
Quantity prepared
Initials of the pharmacist verifying the process
Assigned lot or control number
Manufacturer or distributor's name and lot or control number
Expiration date
How is the expiration date for a repackaged product determined?
6 months or 1 year if packaged in containers "better than PVC"

Most packaging does not meet better than PVC

Must comply with current USP standards for expiration dating
How must records for drugs placed into automated counting devices or dispensers be kept?
Must maintain filing record either manually or in a computerized record that is "readily retrievable"
What must be kept in the records for drugs placed into automated counting devices or dispensers?
Drug name and strengh
Name of manufacturer or distributor
Manufacturer's control or lot nubmer for all lots palced into bin at time of filling
Expiration date according to USP guidelines for repackaging
- If more than 1 lot number in bin, then expiration date of the first lot to expire determines expiration date if shorter than those proscribed by USP guidelines
Pharmacists may not substitue a drug not considered a therapeutic equivalent unless they have what?
Physician authorization
When is generic substitution not permitted?
the Physician specifically requires drug dispensed as written

Pharmacist must ensure that the drug has the same bioequivalence as the prescribed drug

Narrow therapeutic index drugs may be substitued in some cases, but should be done cautiously
What does therapeutic substitution require?
Provider authorization
Does Virginia require pharmacies to dispense a therapeutically equivalent product written for a brand name pruduct?
NO - VA permits, not requires
When may a pharmacist NOT dispense a therapeutically equivalent product written for a brand name product?
The prescriber indicated "brand medically necessary"

OR

The patient insists on the brand name drug
How must a physician document a prescription to be dispense with the brand name product?
Handwrite or stamp "Brand Medically Necessary"
What must pharmacies inform the patient when dispensint a therapeutic equivalent drug?
The subsutution

Label must include the name of the drug and the phrase "Generic for...brand name"

Must include the name of the manufacturer or distributor

Substituted product must be a lower retail price than the drug product prescribed
- Price cannot exceed the pharmacy's usual and customary price for the drug
What does the Controlled Substances Act (21 USC..)regulate?
The manufacture, distribution, and dispensing of drugs identified as having a high potential for addiction and abuse

Reduces the potential for diversion

System for regulating controlled drugs known as the closed distribution system
Who may dispense, admnister, manufacture, purchase, sell, or otherwise acquire controlled substances?
Only entities and persons registered with the DEA
Who must register with the DEA?
Pharmacies, but not pharmacists
Prescribers
Manufacturers
Distributors/ wholesalers
Researchers
Hospitals but not long-term care facilities
Who has the authority to classify drugs into Schedules I-V?
The Attorney General of the United States under the CSA

Applicants must be provided with an opportunity for a hearing
Who must the Attorney General consult with for a clinical and medical evaluation of a controlled substance inorder to classify it as a scheduled drug?
The Department of Health and Human Services - for a clinical and medical evaluation of the drug - to classify it into a schedule

If the Dept of Health and Human Services finds that the drug should not be controlled, the Attorney General must comply unless there is a finding of imminent hazard to the public safety
How does the Controlled Substances Act (CSA) define a drug as necessary for control?
Narcotic - natural or synthetic opium or opiate derivative including poppy straw, coca leaves, cocaine

Non-narcotic - has high potential for abuse and addition based on studies and or chemical properties but does not contain a narcotic substance
CSA estabilshes five categories of controlled substances according to what?
The potential for abuse
What is a Schedule I drug?
High potential for abuse

No currently accepted medical use in US

Lack of accepted information on safety even under medical supervision

Some researches may legally conduct experiements with these drugs if properly registered with the DEA

Even if states pass laws/ referendums approving medical use of Schedule I drugs, until recognized by the DEA, cannot enforce
What is a Schedule II drug?
High potenital for abuse

Currently accepted medical treatment in the US or currently accepted medical use with severe restrictions

Abuse can lead to severe physical or psychological dependence

Ritalin, amphetamines, Percocet, Oxycodone, Dilaudid
What is a Schedule III drug?
High potential for abuse but less than drugs in CI and CII

Currently accepted medical use in US

Abuse may lead to moderate or low physical dependence or high psychological dependence

Barbiturates, APAP/ASA with codeine; weight loss agents with amphetamine, anabolic steroids, GHB, paregoric
What is a Schedule IV drug?
Low potential for abuse relative to drugs or other substances in CIII

Current accepted medical use in the US

Abuse may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in CIII
Drugs with NMT 1mg difenoxin and not less than 25mcg of atropine sulfate per dosage unit, benzodiazepines, barbital, chloral hydrate, certain stimulants - diethylpropion, phentermine
What is a Schedule V drug?
Low potential for abuse relative to drugs or other substances in CIV

Current accepted medical use in the US

Abuse may lead to limited phsycial dependence or psychological dependence relative to the drugs or other substances in CIV

Can by sold by a pharmacist without a prescription in Virginia

Common agents include Robitussin with codeine
How may a manufacturer or other entity be excluded from Federal Scheduling?
By petitioning the DEA for exclusion of a substance under any of the federal schedules

DEA accepts or denies the request, notifies applicant, and issues a public notice with details of the final order in the Federal Register open for public comment for at least 60 days
What is Virginia's definition of a controlled substance?
Drug, substance, orimmediate precursor to substances listed in CI-V by the CSA or by the state Board of Pharmacy

Excludes distilled spirits, wine, malt beverages, and tobacco
Who has the authority to add or deschedule controlled substances?
Virginia Board of Pharmacy

Has the authority to consider same factors as defined by the CSA to schedule or deschedule substances not already deemed controlled substances by the DEA

Board must issue a regulation for public comment

Not all precursors automatically considered controlled substances even if another precursor is listed

Any change in federal controlled substance scheduling provisions may be enacted by the state Board after 120 days of the final publication in the Federal Register without public notice

Board must exempt nonnarcotic substances deemed OTC by the FEA from its scheduling authority
How long after final publication in the Federal Register without public notice may a change in the federal controlled substance schedulling provisions be enacted by the state Board?
120 days

Open for public comment for at least 60 days
In Virginia, what is a Schedule VI drug?
Prescription drug not otherwise deemed controlled by the DEA
How must commercial containers of controlled substances be labeled?
Must be labeled with the designated schedule by placing the C-I, C-II, C-III, C-IV, C-V OR

Symbol may be a C with the schedule number inside of it
Who must be registered with the DEA?
Every entity involved in the manufacture, distribution, purchase, or dispensing of a controlled substance

Except ultimate consumer

Provides tight control and accountability

Not every INDIVIDUAL health care practitioner must be registered but employer or affiliated health care setting must be registered
What activities require registration with the DEA?
Manufacturing, dispensing, researching, narcotic treatment programs, chemical analysis, and import and export of controlled substances

Each entyty must provide separate registrations for each site where it conducts business

Practitioners and prescribers need ontly one DEA registration number
What must the DEA issue to a business before it can begin?
A Certificate of Registration
How often before expiration does the DEA offer renewal notices for registration?
60 days prior to expiration
When should a registrant who did not receive a renewal notice for registration notify the DEA?
Within 45 days of expiration
What is Virginia's definition of a controlled substance?
Drug, substance, orimmediate precursor to substances listed in CI-V by the CSA or by the state Board of Pharmacy

Excludes distilled spirits, wine, malt beverages, and tobacco
Who has the authority to add or deschedule controlled substances?
Virginia Board of Pharmacy

Has the authority to consider same factors as defined by the CSA to schedule or deschedule substances not already deemed controlled substances by the DEA

Board must issue a regulation for public comment

Not all precursors automatically considered controlled substances even if another precursor is listed

Any change in federal controlled substance scheduling provisions may be enacted by the state Board after 120 days of the final publication in the Federal Register without public notice

Board must exempt nonnarcotic substances deemed OTC by the FEA from its scheduling authority
How long after final publication in the Federal Register without public notice may a change in the federal controlled substance schedulling provisions be enacted by the state Board?
120 days

Open for public comment for at least 60 days
In Virginia, what is a Schedule VI drug?
Prescription drug not otherwise deemed controlled by the DEA
How must commercial containers of controlled substances be labeled?
Must be labeled with the designated schedule by placing the C-I, C-II, C-III, C-IV, C-V OR

Symbol may be a C with the schedule number inside of it
Who must be registered with the DEA?
Every entity involved in the manufacture, distribution, purchase, or dispensing of a controlled substance

Except ultimate consumer

Provides tight control and accountability

Not every INDIVIDUAL health care practitioner must be registered but employer or affiliated health care setting must be registered
What activities require registration with the DEA?
Manufacturing, dispensing, researching, narcotic treatment programs, chemical analysis, and import and export of controlled substances

Each entyty must provide separate registrations for each site where it conducts business

Practitioners and prescribers need ontly one DEA registration number
What must the DEA issue to a business before it can begin?
A Certificate of Registration
How often before expiration does the DEA offer renewal notices for registration?
60 days prior to expiration
When should a registrant who did not receive a renewal notice for registration notify the DEA?
Within 45 days of expiration

Registrants that do not renew in a timely manner face penalties and fines
What is the DEA registration form number for Dispensers?
Form 224

Available in hard copy or on-line
What is the DEA registration form number for manufacturers, distributors, and narcotic treatment programs?
Form 225

Available in hard copy or on-line
How must a registrant who changes name or address notify the DEA?
Must apply to the DEA in WRITING to request the change

DEA issues a new certificate of registration

New and old certificates must be maintained until expiration
How can a DEA retistration be terminated?
Death of a person, corporation, or discontinuance of business or professional practice - must notify the DEA to terminate registration

DEA must approve transfers or assignments per a written request
What forms should be returned with controlled substances upon discontinuance of a business?
Certificate of Registration

222 Forms

Return to DEA - Washington, DC office
How must controlled substances be disposed upon discontinuation of a business?
Must be on Form 222

Pharmacist must receive written permission from pharmacy owners

may be transferred to a manufacturer, wholesaler, or pharmacy holding DEA registration
When must the Board of Pharmacy be notified when a pharmacy closes, goes out of business, or changes ownership?
At least 14 days in advance of closure or change in ownership

Must provide the Board with information related to the disposition of all controlled substances in CII-VI

If drugs are to be transferred to a different licensee, must provide name and address to the Board of Pharmacy
How does the DEA require a controlled transfer proposal be sent when a pharmacy closes/ goes out of business/ changes ownership
Must be sent by registered or certified mail to the special agent in charge of the DEA region of the registrant

DEA also requires that information include the date on which controlled substance transfer will occur

Complete inventory must be taken upon date of transfer
When must manufacturers and distributors/ wholesalers register with the DEA?
Each year at the end of the month assigned by the DEA for the registration year
When must pharmacies, hospitals/ clinics, and teaching institutions register with the DEA?
Once every three years in the month assigned by the DEA
Most entities (except importers/ exporters) can reapply for DEA re-registration within what timeframe?
Within 60 days of expiration

Importers/ exporters have 120 days
Who is exempt from DEA registration?
Agents or employees of registered manufacturer, distributor, or dispenser of any controlled substance when acting in the usual course of business or employment

Common or contract carrier or wharehouseman or an employee thereof possessing the controlled substance in the normal course of business
- FedEX, UPS, USPS, etc need NOT be registered

(differs for entities registered with the DEA to destroy controlled substances already dispensed)
What are the DEA requirements for Practitioner Registration?
Physicians, dentists, veterinarians, or other state-authorized prescribers must register
In Virginia, who is authorized to prescribe for controlled substances?
MD
OD
Podiatrists
Dentists
Veterinarians
Licensed nurse practitioner - II-VI
Licensed physician assistant CIII-VI only
TPA-certified optometrist may only prescribe oral analgesics listed in CIII-CVI appropriate to relieve ocular pain
Who may prescribe under a hospital's DEA number?
Dispensing, administering, and prescribing by practitioners in a hospital setting registered with the DEA as long as:

Is in usual course of professional practice
Individual proactitioner authorized by jurisdiction in which he is practicing
Hospital or other institution where he is employed assures that the individual can dispense, administer, or prescribe drugs within the jurisdiction
Individual acting within the scope of employment of hospital or institution
Hospital or institution maintains a list of internal codes accessible to other DEA registrants and law enforcement personnel upon request