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62 Cards in this Set

  • Front
  • Back

Pure Food & Drug Act of 1906

Prohibited drugs passing through interstate commerce to be adulterated or misbranded

Food, Drug, & Cosmetic Act of 1938 (FDCA)

New drugs must be safe when used as directed on the labelLabels had to have adequate directions & warnings if habit-forming

Durham-Humphrey Amendment of 1951

Created 2 classes of drugs: OTC & prescriptionCreated the required “legend”; “Caution Federal law prohibits without a prescription” (now “Rx Only”)

Kefauver-Harris Amendment of 1962

All new drugs had to prove efficacy as well as safety;Gave FDA control over Rx drug advertisingRequired consent of drug test volunteersRequired reporting of adverse drug reactionsCreated Good Manufacturing Practices (GMP)

Poison Prevention Packaging act of 1970

protect children under 5 years of age from accidental poisoning The U.S. Consumer Product Safety Commission (CPSC) has had the responsibility for overseeing the enforcement of this law since 1973 Do not confuse the PPPA with the Anti-Tampering Act, which is designed to protect all consumers by requiring tamper evident packaging.

Federal Anti-Tampering Act of 1982

Select OTC & cosmetic items should have a tamper resistant seal which readily shows evidence of tampering

Waxman-Hatch Amendment of 1984

Streamlined the process for new generic drugsGives manufacturers incentives to make new drugs

Prescription Drug Marketing Act of 1987

Placed stringent controls on drug samplesDrug wholesales must be licensed by statesBanned re-importation of drugs into US

Dietary Supplement Health Education Act 1994

Exempts vitamins, minerals, amino acids & herbal products from FDA controls requiring proven efficacy before marketing

FDA Modernization Act of 1997

Fast-track process for NDA submissionsClarified condition for compoundingThe Rx “legend” was replaced with “Rx Only”Encouraged manufactures to give pediatric dosing & new uses for existing drugs

Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

This law established two parallel, mandatory reporting systems for serious adverse events, one for OTC drugs and the other for dietary supplements.

4 parts of definition of "drug"

Part A - Article recognized in the official US Pharmacopoeia/National Formulary (USP/NF) or the official Homeopathic Pharmacopoeia of the United States, or any supplements of these references.Part B - Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.Part C - Article (other than food) intended to affect the structure or any function of the body of humans or other animals.Part D - Article intended for use as a component of any articles specified in the above but not including devices or their components, parts, or accessories.

dietary supplement

a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the above.

meant to "supplement" the diet

A prescription must be for a _____ _______ ______

legitimate medical purpose

Tamper-Resistant Prescription Law [Section 7002(b) of the U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007] says what?

medicaid rx's have to be on tamper resistant. can fill emergency if get a real rx in 72 hours.

Electronic prescriptions were authorized under what?

the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (known as Medicare Part D)

GENERIC name for a new drug is held by

the United States Adopted Names Council (USANC).

An NDC # denotes approval by the FDA




T or F?

FALSE

closed system means what?

only those persons or entities registered with the DEA may legally engage in manufacturing, distributing, prescribing, and dispensing of controlled substances. The Attorney General of the United States has the authority to add or remove a drug from one federal schedule to another.Individual states identify who does this in state law (eg: TN Code 39:17, 403 - the Commissioner of Health and Commissioner of Mental Health jointly have this responsibility in Tennessee)

DEA registration is done with who and must be done for what intended purposes? How often?


If for dispensing how often must one register?

Every person who manufactures or distributes any controlled substance, or who proposes to engage in the manufacture or distribution of any controlled substance, must register annually with the Attorney General.


Every 3 years

legitimate DEA number?

XX123456Z




(1+3+5)+ 2(2+4+6)= YZ use Z

Schedule 1

Has NO currently accepted medical use in treatment in the United States. a lack of accepted safety for use under medical supervision.

Schedule 2

abuse may lead to severe psychological or physical dependence.

Schedule 3

abuse may lead to moderate or low physical dependence or high psychological dependence.

Schedule 4

abuse may lead to limited physical dependence or psychological dependence relative to the drugs or other sub- stances in schedule III.

OTC schedule V must include

Must keep a log book with the following:1. date of sale2. name & address of purchaser3. name & quantity of CS sold4. name/initials of pharmacist

No more than 240 cc of CS containing opium, no more than 120 cc of any other CS, no more than 48 dosage units of opium containing product, or 24 dosage units of other CS containing product in a 48-hour period

Who can dispense a non-rx Controlled substance?

IT HAS TO BE AN RPH

What schedules require the “Federal prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” on it?

2, 3, and 4

Who can transfer controlled substances?

The transfer may take place only by direct communication between two licensed pharmacists.

what information is required when transferring a controlled substance?

name, address, and DEA of receiving pharmacy
name of pharmacist


name of pharmacist giving the transfer
date

on the transfer'ed rx what info must be on there?

Date of issuance of original prescription• Original number of refills authorized on original prescription• Date of original dispensing• Number of valid refills remaining and date(s) and locations of previous refill(s)• Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription information was transferred• Name of pharmacist who transferred the prescription

How long do you keep an rx?

2 years from the date last dispensed

What does a CS Prescription Document require as far as information?

normal label things plus initials of dispenser

conditions for emergency oral C2's

The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period.The prescription must be immediately reduced to writing by the pharmacist and must contain all required information, except for the signature of the prescribing individual practitioner.If the prescribing individual practitioner is not known to the pharmacist, he or she must make a reasonable effort to determine that the oral authorization came from a valid registered individual practitioner.

What are the conditions of the hardcopy when it is received for an emergency C2?

received within 7 days, normal stuff + AUTHORIZATION FOR EMERGENCY DISPENSING w/ date of the oral order. must contact DEA if prescriber does not issue a hard copy.

multiple months of C2's is fine if what conditions are met?

The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.The issuance of multiple prescriptions is permissible under applicable state laws.The individual practitioner complies fully with all other laws and requirements.

if you partial a c2 and cannot fill the rest, what has to happen?

If the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist must notify the prescriber. No further quantity may be supplied beyond the 72 hours without a new prescription.

You can partial C2's for terminally ill or LTCF patients: T OR F?

TRUE

How long is a C2 good for that is written for a LTCF patient?

60 days

labeling requirements do not apply to institutionalized patients for C3-5 substances under what conditions?

not in the hands of final user prior to administration, and it is limited to 34 days supply or 100 units whichever is less.

record keeping policy for Controlled substances

Controlled substance records must be kept for at least 2 years at the place of registration. Records that must be kept at the registered location include prescription records, inventories, and executed order forms. (DEA Form 222 or electronic orders). Financial and shipping records (such as invoices and packing slips) may be kept at a central location rather than the registered location if the registrant has notified the DEA of his or her intention to keep central records.

how often must a controlled substance inventory be taken?

q 2 years (6 month lee-way)

What are the DEA forms and what do they do?

DEA form 222 – ordering schedule 2 controlled substancesDEA from 224 – application for DEA certificate of registrationDEA form 106 – reporting theft or lossDEA form 41 – Disposal of out-of-date controlled substances (Reverse distributors)

how long must you keep a 222 form?

2 years

How many patients can a prescriber dispense to?

30 the first year, 100 the second year provided an active DEA registration for that purpose is on file.

narcotic treatment FDA approved drugs? (2)


Can a pharmacist dispense with an order?

LAAM
Methadone

HELL NO!!!!

A vs B vs AB rated ?

A= equivalent


B= not equivalent


AB= had a problem, fine now

Who writes a PPI?


What happens when you fail to give a PPI?


How often is it dispensed to an inpatient?

MFR


Misbranding


initial plus every 30 days for length of therapy

classes of medical devices?

Class I medical devices pose the least potential harm to users. Examples include needles, scissors, and latex gloves.Class II medical devices require more regulation than Class I devices to ensure safety and effectiveness. Examples include insulin syringes, infusion pumps, thermometers, and electric heating pads.Class III medical devices are often life-sustaining devices, pose a potential or unreasonable risk of injury or illness, or do both. Class III devices require premarket approval. Examples include pacemakers, soft contact lenses, and replacement heart valves.

OTC label requirements?

1. Identity2. Adequte directions for use3. Ingredients (including inert or inactive ones)4. Net quantity of contents5. Expiration date of the product6. Lot number of the product7.Name & place of business of the manufacturer, packer or distributor8. Disclosure of certain contents & declaration of certainly warnings, including habit-forming ingredients & warnings, pregnancy/nursing warnings, & aspirin warnings

Who provides Med Guides and who dispenses them?

MFR and Outpatient pharmacies

Sudafed laws

3.6, 5.7, 28.8

formerly
3.6, 9

requirements to be child resistant

To pass the child-resistant test, 80% of children under 5 years of age in a test panel should not be able to open the package within 10 minutes.To make sure the packaging can be opened by older adults, 90% of adults between 50 and 70 years of age in a test panel should be able to open the package within 5 minutes, and then do so a second time within 1 minute.

exceptions to child proofing?

prescriber, patient, in-patient

When must a pharmacy register as a mfr?

A pharmacy that repackages OTC products or in any way changes the container, wrapper, or labeling of these products for resale must register as a manufacturerA pharmacy that is in the business of repackaging prescription drug products for sale to other health care providers must register as a manufacturer

What is GMP?

GMP is a set of regulations that specify the minimum standards required to manufacture pharmaceutical products in the United States.A manufacturer must be registered with the FDA and must describe its manufacturing and production processes as part of the NDA process.

Canada Policy?

no more than 90 days
carried on the person
FDA approved
Not a controlled substance or biological product

are drug samples legal for outpatient pharmacies?

it is illegal for out-patient pharmacies to obtain, posses or distribute samples

Types of Drug recalls?

Manufacturers are encouraged, not forced to issue recallsClass I recall drug may cause serious injury or death; recall extends to stocks in pharmacies & patient possessionClass II recall drug may cause temporary or reversible effects, remote probability of serious adverse effects; recall is just stocks in pharmaciesClass III recall unlikely to cause any adverse health consequences

OBRA '90

Although the applicable provisions of OBRA ’90 specifically applied only to Medicaid patients, most states passed regulations that applied to all patients.The primary purpose of the pharmacy provisions of OBRA ’90 was to save the federal government money on the theory that improving the quality of drug therapy would reduce the costs of health care. One of the primary mechanisms for accomplishing this goal is drug use review (DUR), which consists of retrospective review, educational programs , and prospective review.

involves screening, counseling, and maintain a pt profile

Adulteration

Adulteration refers to the composition of a product. Note in the definition that a drug may be adulterated even if it is proven to be “pure.” A product is adulterated if it Contains, in whole or part, any filthy, putrid, or decomposed substance Has been prepared, packaged, or held under unsanitary conditions where it may have been contaminated Has been manufactured under conditions that do not meet the GMP standards Contains an unapproved color additive Contains a drug recognized in official compendia, but its strength, purity, or quality is lower than the official standards, unless plainly stated on its labelHas a container composed of a poisonous or deleterious substance that may leach into the product contentsContains a drug not recognized in official compendia, but its strength, quality, or purity is lower than that listed on the labelContains any ingredient as a substitute for the active drug

Misbranding

doesn't meet PPPA of '70, no prescription for the drug, anything is actually mislabled, not tamper resistant with the '82 thing.