Federal Law

T/F: Federal law requires name of drug, and expiration date on the label.

False: Federal law DOESN'T require, but MI law does require it.

T/F: Product X is an OTC available in multiple sizes. All sizes are subject to PPPA and require child-resistant caps.

False: If an OTC product is marketed in several sizes, one package size is NOT required to have a safety closure. Such packages must include on their label the statement, "This package for households without young children".

T/F: All drugs on the market have a NDA.

False: Not all drugs on the market have a NDA, some drugs have been "grandfathered" and did not require NDA or found in orange book.

T/F: Off-labeled drugs should not be filled by pharmacists.

False: Off-labeled drugs may be filled by pharmacists using the discretion

T/F: Patient Package Inserts must only be provided in pharmacies.

False: PPI must be provided for anywhere the drug is provided, i.e. hospital, prescriber's office or pharmacy. For example if a patient received premarin in hospital or intrauterine device in office, must provide PPI to the patient. Supply on the first dose and then every 30 days thereafter

T/F: Soap is considered a cosmetic.

False: Soap is NOT considered a cosmetic

T/F: Pure Food and Drug Act of 1906 required manufacturers to list ingredients or directions on the product.

False: did not regulate cosmetic or medical devices, or require ingredients

T/F: On a prescription label, numbers should be spelled out and presented like "two".

False: number need to be in # form, i.e. "2"

T/F: Products that are "A" and "B" rating may be substituted for one another.

False: products that are "A" rated may be substituted for one another, while products that are "B" rating may NOT be.

T/F: Compounded radiopharmaceuticals and PET drugs must follow the compounding standards.

False: they are exempt

T/F: Compounded prescriptions may be sold to other pharmacies or third parties such as physicians.

False; Compounded prescriptions may NOT be sold to other pharmacies or PHYSICIANS

T/F: A husband and wife may share a Medicare Part D plan.

False; a husband and wife must have their OWN medicare part D plans

T/F: A pharmacy can actively solicit business for compounded drug products by advertising or promoting.

False; a pharmacy can NOT solicit business, but the pharmacy may advertise to both the public and health professionals that specializes in prescription compounding

Under the Kefaver-Harris Act of 1962, informed consent must be received in studies, which include phase ______ trials.

I-III

"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." This transfer warning is required on CS _____

II-IV (NOT V but standard of practice usually includes V as well)

Under OBRA90, who is eligible to offer counseling to the patient?

INTERN or Pharmacist

Which is preferred on a prescription label: specific hour designations (twice daily, 8 PM, every 12 hours) or in the morning, after breakfast?

In the morning and after breakfast type terms are preferred. Avoid specific hour designations if possible.

Under Medicare Part D, what are rules on the formulary?

Insurers do NOT have to include ALL drugs within each category 6 drug classes that require MOST drug products to be included: *anticonvulsants *antidepressants *antineoplastics *antipsychotics *antiretrovirals *immunosuppressants

This act focused on SAMPLES. It required drug wholesalers to be licensed by states, banned reimportation of rx produced in the US and banes the sale, trade, or purchase of prescription drug samples.

Prescription Drug Marketing Act 0f 1987

What is the rule on substitution of amino acids for TPN's?

Pharmacist is permitted to substitute amino acids relatively freely.

Whose responsibility is it to be aware of all recalls either received by mail or read in the pharmaceutical literature?

Pharmacists

PBM

Pharmacy Benefits Management

In this phase, a small group of HEALTHY individuals is given a drug. Testing is for toxicology, PK and pharmacological effect, as well as safety.

Phase 1

In this phase, a larger group (100 patients) are given the drug and have the disease state for which the drug is indicated. Testing is for EFFICACY of the agent, as well as ADR.

Phase 2

In this phase, a large group (>1,000) are given the drug and have the disease state. This is completed over many geographical regions. Individuals are given the testing drug or placebo to test the effect (i.e. double-blind trials).

Phase 3

After 6 months and the FDA reviewed/approved the NDA, the drug may be placed on the market. The company must complete phase ____ trials, which determine SE, ADR, and other information. All data must be submitted ANNUALLY to the FDA.

Phase 4, post-survelliance studies

This is the highest level of control for REMS program, requiring a registry and only allowing the medication to be given if you meet certain criteria

Restricted access implementation system

Salicylates, including ASA, must contain a warning regarding _____ _______.

Reye's Syndrome

Adulterated or Misbranded: A product's container is composed of a deleterious substance that may enter (leach) into the product contents

adulterated

Adulterated or Misbranded: It contains any ingredient as a substitute for the active drug

adulterated

Low risk or high risk compounding: preparing an infusion intended for multi-day use in a portable pump or reservoir system

high risk category I

Low risk or high risk compounding: Using "open systems" such as the compounding of morphine solutions for injection or infusion using morphine powder

high risk category II (greatest risk)

Low risk or high risk compounding: Using a non-sterile drug substances in preparing a product

high risk category II (greatest risk)

Low risk or high risk compounding: compounding sterile nutritional solutions using non-sterile ingredients during which the initial mixing is performed in an unsealed or non sterile reservior

high risk category II (greatest risk)

A facility that provides palliative and supportive care for the terminally ill

hospice

Under this REMS program: -a prescriber must be enrolled, drug wholesaler who ship the drug must be enrolled, pharmacies that dispense the drug and patients must be enrolled (M and F) -the patient is given a unique identifier code, which the pharmacy must check in the database to ensure the patient is enrolled and following program -A female patient must have the RX filled within 7 days of a negative pregnancy test -Pharmacist must educate patient on birth defect risks

iPLEDGE (isotretinoin-acutane REMS)

The barcode on the hospital container is considered part of the ______. Thus it is subject to GMP.

label (if barcode missing=misbranded)

This refers to written, printed or graphic material appearing on the immediate container of the drug product, as well as all labels on the immediate product, container, its wrapping or accompanying the product (i.e. prescription drug package insert)

labeling

The imprint code on RX and OTC drugs must identify the ______ and ______.

manufacturer and specific drug product

OBRA90 specifically provides patient counseling for ______ patients.

mediCAID patients

This requires a warning that specifies that it should be only used at bedtime and that it should not be used IN INFANTS except if advised by a physician. It should be discouraged to be used in pregnancy

mineral oil

Adulterated or Misbranded: A label is false or misleading

misbranded

Adulterated or Misbranded: A label is missing the name or location of the MANUFACTURER, packer or distributer

misbranded

Adulterated or Misbranded: A pharmacy dispenses a RX only drug without a legal prescription or an authorized refill

misbranded

Adulterated or Misbranded: A pharmacy dispenses a RX only drug without an authorized refill

misbranded

Adulterated or Misbranded: The bottle is missing the quality of container contents

misbranded

Adulterated or Misbranded: The label has inappropriate direction for use of non-prescription drugs or doesn't include warnings requires to product those using the medication

misbranded

Adulterated or Misbranded: The product doesn't contain a word, statement or other information required by law to be displayed in a prominent readable manner

misbranded

Adulterated or Misbranded: The product doesn't include the established name of the active drug

misbranded

Adulterated or Misbranded: The product doesn't state "RX only" if the drug is available by prescription only

misbranded

Adulterated or Misbranded: The product offers the sale of the drug under the name of another drug

misbranded

If a unit-dose product does NOT have an expiration date, this would be considered _______.

misbranded

A manufacturers label is missing the expiration date, this would be considered ______ (adulteration/misbranding)

misbranding

This refers to something on the label, which includes the prescription drug product insert

misbranding

ANDA

Abbreviated New Drug Application

The prime purpose of phase I trials is to evaluate _____.

safety (healthy volunteers)

This rating is considered to be bioequivalent to the innovator's drug product and are "therapeutically equivalent.

"A" rating

This rating is considered when the drug products meets "NECESSARY bioequivalence requirements"

"AB" designation (AB1, AB2)

This rating is considered when the products are found NOT to be bioequivalent

"B" rating

What are the labeling requirements on a manufacturers container?

-Name and address of manufacturer -Established name of drug -Net quantity in the package -Weight of each active ingredient contained in each dosage unit (i.e 10 mg or 2 mg/ml) -Caution or RX only -If dosage units not taken PO, the specified routes must be states -Special storage directions -Manufacturers control/lot number -expiration date established by manufacturer

Almost all anabolic steroids end in "-____"

-"androlone"

For individual packaged (unit dose) medications, what requirements must be on the label?

-Generic name/trade name -Qty of active drug present - Name of manufacturer -Repacker's LOT number - Expiration date*

What should also be located on the label, but in a less prominent position (i.e. bottom of the label, not to supersede critical patient information)?

-Prescription number -Expiration date -Quantity -Physical description -Pharmacy name, address and phone #

The top of the prescription label should specify: (5 things)

-patient name -prescription number -drug name (full generic and brand) -drug strength -clear directions for use provided in simple language

Ipecac syrup must be sold in ______ oz or ____ ml containers

1 oz=30 mL

Under the REMS program, if a drug program requires the use of a MedGuide, the patient must be provided with the MedGuide under the following circumstances.... (name 6 examples)

1) patient or caregiver requests 2) drug dispensed in outpt and produce will be used by pt without direct supervision of HC provider 3) first time a drug is dispensed to HC professional for administration to pt on output setting 4) first time drug is dispensed in outpatient setting of any kind 5) After Medguide is changed (i.e. new indication) 6) When drug is subject to REMS and requires Medguide

When a new or refilled prescriptions must be dispensed in a child-resistant closure must be used, unless... (name 3 exceptions)

1) patient requests it (no documentation required, but recommended) 2) prescriber requests it (must request on EACH INDIVIDUAL prescription) 3) the container is being used in the hospital or similar institution in which drugs are maintained or administered by health professionals.

The readability of the label should use familiar fonts such as ___ point TNR or ____ point Arial

12 point TNR or 11 point Arial

For AQUEOUS solutions made from solids obtained from commercially manufactured drug products, the beyond use date is ______ days when stored at COLD temp.

14 days

The first 5 digits of a NDC code represent the ________. The second 4 digits identify the ___________. The last 2 digits identifyEach the _____________.

1st 5 digits=manufacturer 2nd 4 digits=specific drug last 2 digits=package size

If no stability information available, non-aqueous liquids and solids made using commercially manufactured products should be not more than ____% of the time remaining on the commercial product or a maximum of ___ months, whatever is less.

25% or 6 months (compared to 25% or 1 year for unit dose)

Medicare enrollment may occur when a person becomes eligible the month of their birthday, either ____ months prior or _____ months after the birthday month.

3 months prior or 4 months after

For all other compounded medications with no stability information, no more than _____ days for beyond use date

30 days

Short term detoxification refers to treatment is for period not to exceed ____ days.

30 days (Short-term)

If a drug is discontinued, the NDC number may be reassigned if the FDA waits at least _____ years to reassign the number.

5 years

A pharmacy limits its interstate distribution of compounded products to not more than ___% of the total prescriptions filled by that pharmacy.

5%

If a formulary change occurs, CMS, plans and insurers must be given a ______ day notice.

60 day notice

Med Pak should have an expiration date not to exceed _____ days from the date the Med Pak was prepared

60 days

This limits the amount of sodium phosphate oral solution (oral laxative) to not more than _____ mL per OTC container

90 mL per OTC container

Long-term detoxification refers to treatment greater than ___ days but not to exceed ___ days

>30 but <180 days (long-term)

Adulterated or Misbranded: The product is NOT is accordance with USP/NF specifications

?

Form FDA 3500 ____ (A/B) is a mandatory reporting form for IND reporters, manufacturers, distributors, importers and user friendly personnel.

A (mandatory)

Pregnancy category ______: Adequate and well-controlled studies in pregnant women showing no risk to fetus

A (studies in pregnant women)

What is the rule for drug samples in a retail pharmacy?

A retail pharmacy may NOT possess ANY prescription drug samples obtained from ANY source EVER. If samples were found, it would be considered drug DIVERSION.

Which of the following populations are covered under MMA? (select all that apply) A) Medicare beneficiares B) Medicaid beneficiares C) nongovernmental employees

A) Medicare beneficiaries are covered under MMA

A published wholesale price for a drug product that may be used as the BASIS for pricing prescription drugs.

AWP (average wholesaler price)

The Controlled Substances Act is often abbreviated as _____.

ACT

The FDA requires Medguides for product when: 1) Patient labeling could prevent serious ADVERSE EVENT 2) Product has serious RISKS>benefits 3) patient ______ to directions is crucial.

ADHERENCE

If Drug does not conform to compendial standards and is labeled "USP, it is considered _______ (misbranded or adulterated).

ADULTERATED

A product when first approved NDA, it is considered a single source product. This allows a patient for a certain number of years. After the patent expires, any drug company may start to make the generic by submitting a ________

ANDA

The manufacturer-reported AWP will be phased out in favor of _______, which represents the value between the actual acquisition price (AAP) paid and the present AWP.

ASP (average sale price)

Which of the following acronyms will eventually replace the AWP when calculating the drug prices under the MMA?

ASP (average sale price)

Under this application, once a brand patent has expired, another company may produce a generic with a less rigorous testing process. The generic has to prove PK, bioavailability and pharmacological effect are similar to the brand.

Abbreviated New Drug Application

AAC

Actual Acquisition Cost

This represents a discounted price from the AWP, as it is the actual price the pharmacist paid when purchasing units of drug products.

Actual Acquisition Cost (AAC)

Adulterated or Misbranded: A product contains a drug NOT recognized in the official compendia, but its strength, quality or purity is LOWER than that LISTED ON THE LABEL

Adulterated (+Misbranded)

Explain any willing provider cause under Medicare

All RX benefit plans must accept participation from any pharmacy that agrees to the terms and condition of their drug plan.

What are the labeling requirements for additives?

All additives need to be listed alphabetically, but separate from the active ingredients. Flavors and perfumes may be simplified "cherry flavoring".

After the sponsor completes phase I-III, what is the next step?

Apply to the FDA with a New Drug Application (NDA), which takes about 6 months for review.

An individual is eligible for Medicare Part D at what dates, if her birthday in which she becomes eligible is July 1st?

April 1st-October 31st (3 months prior and 4 months after)

Who has the power to determine the schedule classification for new CS drugs?

Attorney General

AMP

Average Manufacturer Price

This is the average price paid by wholesalers to manufactures for drugs that are to be sold at retail

Average Manufacturer Price (AMP)

Pregnancy category _____: Adequate studies in pregnant women have NOT been conducted, but animal studies failed to show risk.

B

Form FDA 3500 ____(A/B) is a consumer friendly version of MedWatch form.

B (consumer friendly)

A bottle of tetracycline 500 mg actually contains tetracycline 250 mg tablets. Is this considered misbranded or adulterated?

BOTH, because mislabeled and contained different strength than indicated on the bottle.

Pregnancy category _____: Safety of drug during human pregnancy not determined, but animal studies showed positive for fetal harm or not conducted. Avoid unless benefit>risk.

C

At what intervals may a patient with Medicare PDP change his provider? A) every month B) every 6 months C) once a year D) whenever he desires E) never

C) once a year

This is a compilation of final regulations and notices by the federal government published annually.

CFR (code of federal regulations)

The PPPA was originally designed to protect ______ from accidental poisoning.

CHILDREN (<5 yrs)

What are the minimum interventions that must occur with MTM for Medicare Part D?

CMR and Targeted Medication Review

This class of drug recall means the drug product may cause serious, adverse health consequences including death. Recall should include stock in pharmacies and notifying the PATIENTS to whom the drug was dispensed.

Class I (contact patient)

This class of drug recall means the drug product may cause temporary or reversible side effects, but probability of severe adverse effects is low. The recall will usually include pharmacy stock.

Class II (pharmacy stock)

This calls of drug recall means the drug product is UNLIKELY to cause any adverse health consequence.

Class III (notification-no removal)

The _____ ____ _____ requires manufacturers to imprint solid oral dosage forms, whether RX or OTC.

Code of Federal Regulations (CFR)

This is a review of medications, offering interactive consolation and providing consultation summaries face-to-face or by the telephone

Comprehensive Medication Review (CMR)

Who is responsible for overseeing the Poison Prevention Packaging Act (PPPA)?

Consumer Product Safety Commission (CPSC)

An article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness or altering appearance.

Cosmetic

Pregnancy category _____: Evidence in humans has shown risk of harm to fetus based upon AR data. Drug should only be administered if benefit>risk

D

A pharmacy providing services under MMS may establish a formulary listing limiting the drugs to which of the following? A) top 200 frequently dispensed drugs B) only drugs available generically C) only brand-name drugs D) 100 brand name drugs plus their equivalent generic products E) at least 1 drug from each of the 8 therapeutic categories

E) at least 1 drug from each of the 8 therapeutic categories

This is a review of prescription drug use, prescribing patterns or drug utilization by patients. Its purpose is to determine if appropriate drugs are being prescribed and if those drugs are being used appropriately.

DUR (Drug utilization review)

This administration is responsible for federal controlled substances act. It is part of the US Department of Justice

Department of Enforcement Administration (DEA)

The DEA is part of the ____________

Department of Justice

This may be a vitamin, mineral, AA, botanical or another dietary supplement that supplements the diet.

Dietary ingredient

Drugs on the market prior to 1938 were grandfathered and not required to be proven SAFE by Food, Drug and Cosmetic Act of 1938. Name some of the grandfathered drugs.

Digoxin, Levothyroxine, Nitro and Phenobarbital

The administration of CS includes ________.

Drug Enforcement Administration

Who initiates drug recalls: FDA or drug manufacturer?

Drug manufacturer initiates drug recalls (voluntary or requested by the FDA). Technically, the FDA doesn't have the power to REQUIRE a drug recall.

What classes of drugs are usually NOT covered under Medicare Part D?

Drugs that are usually not covered include: *Barbiturates *Benzodiazepines *Weight loss drugs *Hair growth drugs *Drugs that increase fertility *Prescription vitamins (except prenatal and fluoride) *Outpatient drugs for which monitoring is required

This amendment created two classes of medications: OTC with adequate directions for use and federal legend drugs. Federal legend drugs were required to contain the legend "Caution: Federal Law prohibits dispensing of a prescription without a prescription". This amendment allowed for ORAL PRESCRIPTIONS and PRESCRIPTION REFILLS.

Durham-Humphrey Amendment of 1952

T/F: A patient and physician may request non-child resistant caps on all prescriptions, with a blanket request.

F: A patient may request a blanket non-child resistant cap request on ALL rx's, but a physician must request on EACH individual rx (doesn't require to be in handwriting, but preferred)

T/F: Drug starter packs are considered drug samples and are NOT allowed to be found in the retail pharmacy.

F: Although drug samples are NOT allowed, drug starter packs are not considered drug samples. Drug starter packs are ALLOWED. They contain a small qty of drug product which are distributed free of charge to the pharmacies.

T/F: Drug samples are not allowed in health care facility pharmacies.

F: Drug samples ARE allowed in healthcare facility pharmacies if requested by a licensed prescriber and if precise records are maintained. Must be stored separately than from normal drug stock.

T/F: A person who becomes habituated while using a prescribed narcotic is generally considered an addict.

F: Generally NOT considered an addict.

T/F: A hospital could buy a discounted price of keflex and resell the medication to a retail pharmacy.

F: Resale of medications from medical institutions received at a discounted price to retail is PROHIBITED

T/F: The prescription label doesn't need to include the prescribers name.

F: the label MUST include the prescribers NAME

This additive requires the presence of this additive must be disclosed and the "precautions" part of the labeling must specify that this agent may cause ALLERGIC reactions in some susceptible people

FD&C yellow #5 (tartrazine)

This act allowed for the fast-track review of new drug application for drugs intended to treat serious or life-threatening conditions. Replaced "Caution: Federal Law Prohibits dispensing without a prescription" to "RX only". Encouraged pediatric research.

FDA Modernization Act of 1997

Prescription advertising is regulated by FDA, while OTC advertising is regulated by ____

FTC (federal trade commission)

Responsible for investigating unfair business practices, including misleading OTC advertising.

Fair Trade Commission (FTC)

T/F: Product AB rating may be substituted with one another, regardless of the product number

Fale: Product AB ratings may only be substituted for another if AB1 and AB1. AB1 and AB2 may NOT be substituted for each other.

T/F: Prescribers who dispense prescriptions from their office such as intrauterine devices are exempt from the requirement of providing PPI.

False! Prescribers are still required. This also applies to LTC facilities such as nursing homes

T/F: Abbreviations for drug names may be used on the label, i.e. APAP for acetaminophen.

False: Abbreviations should NOT be used on the label

T/F: Products with "B" codes may be substituted for each other.

False: B codes may NOT be substituted for each other

This act required a new drug could not be marketed unless it was first proven to be SAFE. Also required LABELS with adequate directions for use and warnings about habit forming drugs. It applied to cosmetic and medical devices as well.

Food, Drug and Cosmetic Act of 1938

The FDA MedWatch voluntary reporting form is called ______

Form FDA 3500

GMP

General Manufacturing Practice

GRAS

Generally Recognized as Safe

This allowed for manufacturers of GENERIC products to submit an ABBREVIATED NEW DRUG APPLICATION that doesn't require costly clinical testing for approval. It also gave brand name drugs incentive to develop new drugs with an additional 5 year patent.

Hatch-Waxman Amendment (Drug Price Competition and Patient Term Restoration Act)

HIPPA

Health Insurance Portability and Accountability Act

Which of the following is (are) NOT permissible under the MMA? (select all that apply) I) Requiring a beneficiary to use mail order pharmacy) II) Requiring a beneficiary to use mail order pharmacy for 90-day supplies of maintenance drugs III. Changing the price of a drug product one month after establishing a certain price

I and II are NOT permissible (not required to use mail order. May obtain 90 day supply from participating pharmacies) III is permissible and may change the price of a drug product at anytime

Prior to testing of a new drug on humans, a sponsor (drug company, researcher, act) must submit an ______ to the FDA. The FDA has ______ days to decide whether the new drug is suitable for human testing.

Investigational New Drug (IND) FDA has 30 days to decide

The labeling for this product must contain a boxed statement in RED that states "For emergency use to cause vomiting in poising. Before using, call the physician, PPC or hospital ER immediately for advice". Plus a warning statement that says" Warning: Keep Out of Reach of Children. Do not use in unconscious persons or for poising of corrosives, cleaning fluid, gasoline or for strychnine".

Ipecac syrup

This requires a label warning that indicates user should NOT exceed prescribed dose and physician should be contacted if breathing difficulty persists.

Isoproterenol inhalation products

Name some drugs that are pregnancy category X.

Isotretinoin, cytotec, thalomid, and most statin drugs

If drug y has an expiration date of July 2015, when would the drug be removed from the pharmacy?

July 31 2015

This amendment resulted from public concern about thalidomide. It required all new drugs to be safe and EFFECTIVE for all drugs on the market after 1938.

KEfauver-Harris Amendment of 1962 (think kEf=effective)

Under this REMS program (a medication for IBS): -Medication guide with each RX -Prescriber must be certified in the prescribing program and submit a prescriber enrollment form. -Patient must sign acknowledgement form -Pharmacist may only fill rx if PPL sticker on them

LOTRONEX

This refers to written, printed or graphic material appearing on the immediate container of the drug product. If there is an outside container, it must also contain all the information from the immediate container.

Label

Does a prescription have to have adequate directions for use if dispensed by a pharmacist?

No a RX is not required to have adequate directions for use if it is dispensed by a pharmacist and contains RX only on the label.

Low Risk or High Risk Compounding: Transfer of a solution from a commercial vial or ampule with a needle or syringe.

Low risk

Low risk or high risk compounding: Compounding TPN solutions using commercially available sterile solutions

Low risk

Low risk or high risk compounding: Transfer of sterile solutions into ELASTOMETRIC devices

Low risk

How do FDA classify a unit-dose product with NO expiration date?

MISBRANDED

Failure to comply with the PPPA is considered _______ (misbranding or adulteration)

MISBRANDING

Part D spins must automatically enroll qualified beneficiaries into _____ unless they opt-out.

MTM (medication therapy management)

How are MedWatch forms submitted?

Mail, phone, fax or internet

Whose responsibility is it to send written recall notices to all wholesalers and pharmacies for recall in class I and II?

Manufacturers

The highest price allowed under a specific plan for a specific drug. If a person wants a more expensive vision, they must pay the difference

Maximum allowable cost (MAC)

What information is required to be located on the MedPak?

Med Pak requires all information for unit dose packaged, plus serial number for the patient MedPak and prescription serial number for each drug product.

This reporting system was developed by USP to allow hospitals to anonymously report, track and benchmark medication data. It was developed to reduce medication error locally and nationally.

MedMARx

This is a customized patient medication package containing several solid oral dosage forms with directions that specifically indicate the day and time the contents of each patient are to be taken.

MedPak's

Amendment to the FDCA for better classification of MEDICAL devices

Medical Device Amendment of 1976

What part of Medicare covers vaccines?

Medicare Part D now covers vaccines (prior to 2008 covered by Medicare Part B)

This act is sometimes referred to as the MMA, which is supervised by CMA. It is composed of 4 parts (A-D).

Medicare Prescription Drug Improvement and Modernization Act of 2003

This is a policy of health insurance sold by private insurance companies to fill the "gaps" in the original Medicare Plan Coverage.

Medigap policy (medicare supplemental insurance)

In MI, what is required to be placed on the label? Most recent date filled or original date?

Most recent date filled

The main objective of the orange book is to compare drug products that are _____.

Multi-source

This is a national drug code that helps to identify a drug and is used by 3rd parties for reimbursement.

NDC

A classification system for identifying a specific drug product; used nationally for reimbursement and identification of drug products.

NDC (national drug code)

OBRA90 was originally started to apply to MediCARE patients. However, in MI it is expanded to require counseling for all _____ prescriptions.

NEW

NPI

National Provider Identifier

Is there a MI authorized formulary?

No MI has no authorized state formulary, while some states have a positive or negative formulary.

Medications supplied to hospitals must contain a barcode, which indicates the NDC. Are hospitals required to utilize the barcode?

No although it required to be supplied with a barcode, hospitals are NOT required to use the barcode.

Drug X is no longer on the market because it was not effective. Can you compound drug X?

No if a drug is taken off the market, you can't compound it.

Each drug is required to have a NDC number by the FDA. Is the NDC number required to appear on the label or pre-packaged drug?

No the NDC is NOT required to be on the drug label or pre-packaged drug.

When preparing refills for a patient, can you reuse the plastic body and closure?

No you can NOT reuse the plastic body or closure. However, you may reuse the glass container, but the closure may lose the safety.

Is MI an orange book state?

No, MI is NOT an orange book state.

Are biosimilar drugs interchangeable like generic drugs?

No, one may never interchange biosimilar drugs

How should numbers be presented on the label, i.e. numbers or alphabetic characters?

Number "2" are required on the label, not "two.

This type of formulary is where the formulary permits some unlisted drug products to be dispensed.

OPEN formulary

This means use for indication has not been approved by the FDA

Off-label use

When can beneficiaries change medicare part D plans?

Once a year (nov 15-dec 31) , unless moves into different area, into nursing home or plan stops offering services in the area

This act provided various tax, licensing and faster NDA approval incentives to manufactures to make development of drugs for RARE DISEASE states more appealing.

Orphan Drug Act of 1983

The original drug and substituted drug must be _____ equivalent.

PHARMACEUTICALLY EQUIVALENT

Consumer Product Safety Commission (CPSC) is in charge of regulating the ________.

PPPA

Consumer Product Safety Commission (CPSC) is used to enforce the ______.

PPPA

PI

Package Insert

PPI

Patient Package Insert

This is a document is written in lay language and potential dangers inherent in the use of the product. It is given with potentially dangerous drugs. They must be provided to patients receiving products such as Accutane, statin drugs, or estrogen or progesterone products

Patient Package Inserts (PPI's)

What are the 5 levels of REMS?

Professional labeling and package insert, REMS-Medication guide, REMS-Communication plan, Elements to assure safe use-restrict access of drug, and implementation system (open, managed, controlled or restricted access distributions)

This act prohibited food and drugs that were distributed through interstate commerce to be ADULTERATED or MISBRANDED

Pure Food and Drug Act of 1906

This is a strategy to manage a known or potentially serious side effect

REMS (risk evaluation and mitigation strategies)

This is referred to the innovator's product that represent the standard used by new applicants to apply for an ANDA (in the orange book).

Reference Listed Drug (RLD)

REMS

Risk Evaluation and Mitigation Strategy (FDA Requirement for drug manufactures to develop strategies to assure safe use of a specific drug)

Under this REMS program: -prescriber must be certified by company-GlaxoSmithKline for outpatient or LTC -patient must be enrolled in the program -must be dispensed by specially certified pharmacies

Rosiglitazone REMS Program

Who is responsible for enforcing labeling on prescription labels: federal or state?

STATE (as with compounding)

The United Stated Adopted Name Council (USANC) is responsible for determining the generic name of a drug. However, the ________ is responsible for the final approval of the name.

Secretary of Health and Human Services (HHS)

Mrs. H currently has Medicare Part D, she will be traveling out of network to visit her daughter in Florida for a month. What steps does she need to take to obtain her prescriptions?

She will be "out-of-network". Visit a pharmacy and pay the usually price there. She is responsible for the difference between her usually cost and the new cost

Prescription vial labeling enforcement is left in the hands of ________ (federal or state).

State is responsible for enforcement

A company already produced drug X, but after on the market, they want to add a dosage strength, change the labeling or add a therapeutic indication. What application must be submitted?

Supplemental New Drug Application

SNDA

Supplemental New Drug Application

Under this registry (REMS) program, which was formerly known as STEPS -prescriber must enroll in registry -must verify negative pregnancy test -must fill out patient-physician form and send in -prescriber must obtain an authorization number from company and write on EVERY RX -RX must be filled at a speciality pharmacy for no more than a 28 day supply -Dispense the medication guide with EVERY rx

THALOMID REMS (thalidomide)

As part of the FDA Ammendments of 2007, the pharmacies are required to provide a statement and _______ on the labeling of all prescription and non-prescription drugs.

TOLL-FREE NUMBER (medication guide may count as this)

T/F: Procainamide is a narrow therapeutic index drug.

TRUE

This uses the larger letters in the drug name to make the drug name more easily distinguishable from drugs with similar spellings.

Tall-Man Lettering

Adulterated or Misbranded: A product has been manufactured under conditions that do NOT meed the standards of GMP

adulterated

Who requires REMS for a specific drug?

The FDA will require REMS to ensure benefits of drug outweigh risks

Who selects the unique brand/trade name?

The drug company

What is the expiration date of the MedPak?

The expiration date of the Med Pak is based on the beyond-use-date, but should NOT EXCEED 60 days from the date the Med Pak was prepared.

If you are repackaging from bulk to unit dose, what is the new expiration date?

The expiration date shall not exceed 25% time between the original expiration date from repackaging date or no more than 12 months from the date repackaged, whatever is less.

This type of substitution occurs when the pharmacy has the right to substitute a different drug for the one designated on the prescription or medical order, without contacting the prescriber (i.e. one cephlosporin for another). This occurs usually only to institution that utilize a formulary.

Therapeutic substitution

Name the tiers of medicare part D drugs

Tier 1-preferred generic Tier 2-preferred brand name Tier 3-non-preferred brand name Tier 4- rare, high cost drugs

Under this, administration of investigational new drugs to patients with life-threatening illnesses may occur without the patients being enrolled in the study.

Treatment IND's

T/F: Compounded products should be ones not already available from commercials sources, i.e. they can't be compounded versions of FDA-approved drug products

True

T/F: Implicit directions such as "Take 2 tablets twice daily" should be avoided. Instead explicit direction such as "take 2 tablets in the morning and take 2 tablets in the evening" are recommended.

True

T/F: The ingredients included in a compounded dosage form meet official standards (USP/NF). If an ingredient doesn't have an official monograph, it MAY be used in a compounded prescription if it is a component of or an approved drug product, or it is on a list of approved substances.

True

T/F: The pharmacy name, address, phone number should NOT supersede the above critical information and should be placed AWAY from the dosing instructions.

True

T/F: The prescription drug package insert is part of the labeling of a drug.

True

T/F: There are REMS programs available for Bosentan (Tracleer), Clozapine (Clozaril), Dofetilide (Tikosyn) and Alendronate (Fosamax).

True

T/F: Under Medicare, larger quantities (including 90-day supplies) may be obtained at participating LOCAL pharmacies.

True

T/F: Under Medicare, the sponsors cannot require beneficiaries to obtain their prescriptions through mail order pharmacy.

True

T/F: Mouthwash containing >3 g of ethanol is subject to PPPA and must have tamper-resistant packaging.

True (but contact solution AS WELL requires tamper-resistant packaging)

T/F: Unless the patient prefers it not to appear, the prescription label should include the purpose for use if it is included on the prescription, i.e. "for high blood pressure" not "HTN"

True! A patient can request the indication not to be on the label.

T/F: A brand name drug X is still patented. Another company can begin studies while the drug is still patented to produce a generic once the patient is up.

True! Can do studies while drug is still patented

T/F: Health care facilities are permitted to receive RX drug samples ONLY if a licensed prescriber has requested it and precise records are maintained. If samples are stored in the pharmacy, they must be SEPARATED from normal stock.

True! Must be requested by prescriber and stored separate from normal stock in the pharmacy

T/F: Vouchers or coupons are allowed and may be used to fill retail pharmacy stock at the manufacturers expense or a lower cost to the patient.

True! Vouchers and drug starter packs are allowed.

T/F: A patient with limited English proficiency, the pharmacist may put the directions and drug name in the preferred language.

True, but the drug name STILL has to be in English to aid emergency personnel

T/F: The manufacturer is required to provide a package insert in prescription drug packages

True: Information must be approved by the FDA, it is for informational use only NOT for promotional use

T/F: The quantity prepared for compounding must be reasonable for filling either an EXISTING prescription or those ANTICIPATED based on prescribing habits of local prescribers.

True: Must be based on existing prescription or anticipated prescribing habits

T/F: Retail pharmacies are banned from receiving any prescription drug sample under the prescription drug marketing act of 1987. Obtaining a sample would be considered drug diversion.

True: No drug samples in retain pharmacies

T/F: Practitioners licensed to prescribe are ALLOWED to receive drug samples as long as written request is made with their name, address, medial speciality, signature, name of drug, quantity, manufacturer and date of request.

True; must be kept by drug manufacturer for 3 years

The updated package insert requires, highlights (boxed warning, indications/usage and dosage/administration), table of contents, inclusion of the date the initial product was approved, patient counseling information and a ________ ________ ______.

Ttoll-free number for reporting SE

Chemical classification include type 1-6. Type ____ is the best type because it represents a new, unique drug is being placed on the market.

Type 1

Which USP edition contains information concerning the bioequivalence of drug products?

USP DI Volume III

This contains monographs of recognized drugs. Each monograph contains the drug's chemical characteristic and standards of quality. Not published by the US government.

United States Pharmacopeia/National Formulary (USP/NF)

Vaccine adverse events should be reported to ______

VAERS

This is a federally funded program that provides 16 vaccines to children at no cost, those who would otherwise be unable to pay for them.

Vaccines for Children Program (VCP

This is part of the ACA of 2012 that includes serves for women's visits, gestation diabetes screening, STD/HIV counseling and screening and contraceptives.

Women's Preventative Health Care Amendment

Pregnancy category _____: Studies in animals or reports in pregnant women indicate the risk of damage caused by the drug outweighs the harm

X

If the patient is enrolled in Medicare Part D, is the patient eligible for MTM?

Yes, patient is eligible for MTM through the pharmacy

Adulterated or Misbranded: A product has been prepared, packaged or held under unsanitary conditions where it may have been contaminated

adulterated

Refers to any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety and welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.

addict

Under the FDCA of 1938, there are specific labeling requirements for certain _____.

additives

A pharmaceutical manufacturer includes a color additive, that is not FDA approved, in a topical cream formulation. The product could be removed from the market as being ________

adulterated

Adulterated or Misbranded: A product contains a drug recognized in official compendia, but its STRENGTH, PURITY or QUALITY is LOWER than the official standards

adulterated

Adulterated or Misbranded: A product contains an unapproved color additive

adulterated

Adulterated or Misbranded: A product contains in whole or in part any filthy, putrid or decomposed substance

adulterated

This refers to the composition of the product

adulteration

This refers to any drug or hormonal substance related to testosterone that promotes muscle growth or any salt, ester or isomer of the drugs that promote muscle growth.

anabolic steroids (schedule III drugs)

This additive requires product precautions to specify the following type of warning: phenylketonurics: contains phenylalanine ___ mg per ___ unit

aspartame

This date is used to describe the dating drug products that are dispensed by pharmacists

beyond use date

This means the drugs have been clinically evaluated and have been shown to have similar PK properties (i.e ADME, time to peak, peak concentrations and area under the curve)

bioequivalent

This type of formulary is where only the drug products listed may be used in the institution.

closed formulary

Any person engaging in the maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of narcotic drug listed CII-V for use in maintenance detoxification treatment by another narcotic treatment program

compounder

An instrument/machine or related article that is recognized in USP/NF that is intended for the use in the diagnose, cure, mitigation, treatment or prevention of disease in man or animals

device

An OTC product that contains one or more dietary ingredients that is taken to improve upon a health condition or simply enhance health

dietary supplement

This refers to a dollar range in which a beneficiary must pay for ALL prescription drugs

donut hole

An article recognized in the official USP/NF or HPUS that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animal.

drug

Medication guides, also known as Mediguides, are provided to patients with comprehensive information for the patient. Medication guides are provided from the ____ ______.

drug manufacturers

This is equipment that meets 3 standards: 1) it can stand repeated use 2) primarily for medical purpose 3) appropriate for use in the home (i.e. wheelchair, oxygen tank or walker)

durable medical equipment (DME)

Low risk or high risk compounding: pooling sterile drug products for subsequent transfers

high risk category I

One of the purposes of the FDA's section known as the Office of Prescription Drug Promotion (OPDP) is....

educate health care providers about BAD ADVERTISING

This date is originated with the dating required on the manufacturers container, _________ date.

expiration date

This is taking out or removal of drugs listed in the CSA from the jurisdiction of the US

export

Therapeutic substitution is permitted only if the institution is using a _____ _______

formulary system

In MI, do NOT use the term generic substitution. Instead ______ ______ is preferred.

generic selection

In order for drug to be approved, company must register with the FDA, which will inspect the company at least every 2 years to ensure compliance with ______.

good manufacturing practices (GMP=minimum standards for manufacturers to produce products)

Low risk or high risk compounding: complex compounding involving numerous aseptic processes

high risk category I

These type of drugs have _______ _______ _______: carbamazepine, cyclosporine, digoxin, ethosuximide, levothyroxine, lithium, phenytoin, procainamide, tacrolimus, theophylline and warfarin.

narrow therapeutic indexes (NTI's)

For MTM, sponsors cannot require more than ____ chronic disease states and must include at least ____ out of 7 core chronic disease states (HTN, HF, DM, DL, COPD, bone disease, mental health). The patient must be taking many part D medication (2-8 minimum) and are predicted to incur a predetermined annual cost from medicare part D medications.

no more than 3 minimum disease states 4/7 core chronic disease states

Most drugs approved by the FDA are allowed variability of 90-110% of label claim; however, NTI drugs are only allowed _______% of label claim.

normal=90-110% NTI drugs=95-105%

This medicare part provides HOSPITAL insurance

part A

This medicare part provides medical insurance for PHYSICIAN services

part B

This part is medicare managed care, which provides everything the original medicare covers but may offer lower costs and extra services

part C

This medicare part provides prescription drug coverage

part D

This refers to drugs products that contain the same therapeutic moiety but may consist of different salts, strengths, dosage forms or esters.

pharmaceutical alternatives (usually NOT allowed)

Therapeutic equivalent drugs is used to denote drugs that are _______ _______ and bioequivalent (which means SIMILAR ADME pathway)

pharmaceutical equivalent

Once a prescription has been filled and dispensed, the prescription is legally owned by the _______.

pharmacy (can't be removed from files except under court order)

The following information must be found on a _____ ____ _____: description of drug, clinical pharmacology, indications/use, CI, warnings/precautions, ADR, potential for abuse, symptoms or treatment of overdose, dosage and administration, available dosage forms of the product, date of most recent revision of labeling and recommended or usual dose

prescription package insert (located with every prescription)

This prescription drug continuing sulfites or wines must contain an allergy warning on the labeling

sulfites

Certain drug products are exempt from the requirements of demonstrating therapeutic equivalence because of:

the grandfather clause

During the drug approval process, the FDA approves drugs based on their therapeutic and chemical classifications. Therapeutic classifications include type ______ and ______.

type P (priority-faster approval process of NDA) type S (standard/similar-slower approval process)