Law Exam 2
In which clinical trial phase is the manufacturer primarily studying the investigational drug in healthy volunteers for safety, toxicity, and PK purposes? A. Phase I B. Phase II C. Phase III D. Phase IV E. Pre-clinical trials
A
In an emergency situation you have how long to get the prescription in writing? A. 72 hours B. 7 business days C. 7 consecutive days D. 5 days
C
In the Orange book, A therapeutic equivalence rated _____ means products have an actual or potential equivalency problems. a. A b. B c. AB d. ANDA
C
Labels for OTC drugs include: a. Manufacturer's lot number b. intended route of administration, if not oral c. Active ingredients and quantity of certain other ingredients d. The Federal Legend
C
Medicare is a: a. State Program within a Federal Construct b. State funding with possible Federal Match c. Federal Programing & Federal Funding d. Federal Program within a State Construct
C
Pharmacies must limit interstate distribution of compounded products to less than ___ of their total prescriptions filled if they wish to be considered Compounding and not Manufacturing. a. 10% b. 15% c. 5% d. 25%
C
The Durham-Humphrey Amendment (Prescription Drug Act) determined a properly labeled prescription must include the patient's name, date filled, directions from prescriber, and all of the following except: a. Address and Name of the pharmacy b. Name and dosage of the drug c. Address of the patient d. Physician's name e. prescription number
C
The FDCA was not retroactive for drugs created before 1938. Which of the following is not among significant pre-1938 drugs? a. Thyroxine b. Digoxin c. Aspirin d. Nitroglycerin e. Phenobarbital
C
The NDA is submitted to the FDA: a. before Phase 1 trials b. after Phase 2 trials c. after Phase 3 trials d. after Phase 1 trials
C
The Nutrition and Labeling Education Act was influenced most by: a. Food Manufacturers/Producers b. Drug Wholesalers c. Fad diets of the 1980s d. Drug Manufacturers
C
The clinical trial phase including the largest, pre-market human testing phase and all emphasis on efficiency as a diverse population of subjects with the intended indication/disease state is: a. Phase I b. Phase II c. Phase III d. Phase IV e.Phase V
C
The first segment (five or six numbers) of the NDA identifies the: a) drug NDA file number b) drug product c) manufacturer d) FDA's prescription monograph code e) package size
C
Under the Kefvauer-Harris Amendment, drugs may only be marketed if: a. proven safe & effective for intended use. b. proven safe & effective with adequate labeling . c. proven safe & effective with adequate labeling and good manufacturing practices. d. prove safe & effective with adequate labeling and good manufacturing practices, and the manufacturer is registered.
D
Which form should be used to notify the DEA of a significant loss of controlled substances due to a burglary, a gap in inventory (meaning possible diversion or dispensing mistakes), or in-transit loss discovered after the pharmacist has signed for or taken custody of controlled substances shipped to the pharmacy. a. DEA Form 222 b. DEA Form 224a c. DEA Form 41 d. DEA Form 106
D
Which of the following DEA forms is required to destroy controlled substances? a) DEA 106 b) DEA 222 c) DEA 442 d) DEA 41 e) DEA 363
D
Which of the following persons does the controlled substances act empower to execute a form 222 on behalf of a retail pharmacy? A. Any licensed pharmacist employed by the pharmacy B. Any person who is authorized to sign the initial DEA registration or renewal application C. Any person granted power of attorney by the person who signed the most recent DEA registration or renewal application D. B and C E. All of the above
D
Which of the following requires all drug products to be proven both safe and effective before they could be marketed? A.The food drug and cosmetic act of 1938 B. The Durham-Humphrey amendment of 1951 C. The FDA modernization act of 1953 D. The Kefauver-Harris amendment of 1962 E. None of the above
D
OBRA 90 requires 3 duties be fulfilled. Which of the following is not one of those 3? a. Duty To Maintain Through Drug Inventories b. Duty To Maintain Patient Profiles c. Duty To Screen Therapy d. Duty To Counsel Patients About Their Drug Therapy (duty to warn)
A
Orphan drugs are: A. Intended for the treatment of rare diseases B. Chemically dissimilar to any other marketed drugs C. Intended for use in children under the age of 16 D. Intended for use in children under the age of 5 E. Permitted to be administered to children without permission of their parents
A
Products likely to cause injury or death would be recalled at level: a. Class I b. Class II c. Class III d. Market Withdrawal
A
The ANDA (Abreviated New Drug Application) applies to generic drugs, while the SNDA (Supplemental New Drug Application) is for: a. manufacturers interested in changing the process in their drug's synthesis, production procedure, packaging, labeling, etc. b. Drugs with major therapeutic gain (Type P for Priority), c. Drugs with similarities to drugs currently on the market (Type S for Similar) d. Orphan Drugs
A
The DEA registration number: a) Is a nine-character code consisting of two alphabetic letters followed by seven numeric digit b) Contains two letters, of which the second alphabetic letter represents the first letter of the registrant's first name c) Contains two letters, of which the first alphabetic letter represents the first letter of the registrant's last name d) All the above
A
The transferring of Controlled Substances in Schedule II requires: a. DEA Form 222 b. DEA Form 224 c. DEA Form 106 d .DEA Form 41
A
Total number of dosage units of controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy in ___
1 year
In the orange book, a generic drug with a brand name bioequivalent has which rating? A. AB B. BD C. QR D. ABS
A
Which of the following systems are permissible for filling prescriptions (assume all scripts are properly marked and/or readily retrievable in each filling system)? 1- One file: all prescriptions in a single file (with all controlled substances marked with a red "C" or easily retrievable) 2 - Two files: CII prescriptions in one file and all other prescriptions in a 2nd file (with all controlled substances marked "C" or easily retrievable) 3 - three files: CII in one file, CIII-V in a 2nd file, and non-controlled substance prescriptions in a 3rd file 1 only 3 only 1 and 2 only 2 and 3 only 1, 2, and 3
2 and 3 only
How long do you have to keep DEA222 forms until?
2 years/biennial
What schedule is Ritalin? What schedule is cocaine powder, USP? What schedule is anabolic steroids? What schedule is orazepam?
2, 2, 3, 4
How often do you renew your registration for dea number
3 years
Which DEA form do you need for destruction
41
A pharmacy can have less than ___ percent excess of total controlled substances without getting a distributor license
5
Drug recalls applying to products likely to cause life-threatening effects are classified as: a) Class I b) Class III c) Class 0 d) Class X
A
For drugs on the market between 1938 and 1962, the FDA provided the _____ which allowed manufacturers to show efficacy within a certain timeframe. a. DESI (Drug Efficacy Study Implementation) b. DEPR (Drug Efficacy Proof Report) c. DECR (Drug Efficacy Causes Reprot) d. DSSI (Drug Study Safety Implementation)
A
In order to introduce a generic version of a brand name drug into the market, the generic drug manufacturer must submit a(n) _______ to the FDA: a. ANDA b. SNDA c. NDA d. IND e.GINA
A
Under federal law, used CII order forms must be maintained for a period of at least: a) Two years b) Three years c) Five years d) Until the next controlled substance inventory e) For the business life of the pharmacy
A
Which federal amendment/act was enacted to streamline the generic drug approval process, while giving patient extensions to innovator (brand name) drugs? a. Waxman-Hatch amendment b. Kefauver-Harris amendment c. Durham-Humphrey amendment d. Prescription drug marketing act e.None of the above
A
Who can change the schedule of a drug? A. Us attorney general B. Us president C. Senator D. Anyone
A
Who must be registered with the DEA in order for a pharmacy to dispense controlled substances? 1-The pharmacy 2-The pharmacist in charge 3-Every pharmacist who dispenses controlled substances on a routine basis A. 1 only B. 2 only C. 3 only D. 1 and 3 E. 1, 2, and 3
A
You are due for your biennial (every 2 years) Controlled Substances Inventory. You have recorded the inventory date, time, drug names, strengths, and forms, and are ready to count. You are not allowed by the DEA to: a. Estimate the quantity of CII medications, provided there are fewer than 1000 units. b. Estimate the quantity of CIII-V medications, provided there are fewer than 1000 units. c. Consider unopened bottles to contain the exact count listed on the bottle, for all controls. d. Count out all CII's in opened containers.
A
How can you file you prescription records? A. C2s, c3-5s, and all the rest in separate folders B. C2's and C3-C5s together with the 3-5 indicated with a red C and the rest in a separate one C. Everything in the same one
A and B
What is an orphan drug?
A drug used to treat a disease that affects <200,000 people
What do you submit to file a generic drug?
ANDA (abbreviated new drug application)
Schedules of controlled substances are based on?
Abuse potential and dependence
Out of the drugs you inventoried, which ones do you have to keep exact count of assuming they are in 100 unit bottles?
Any C2
A complete controlled substances inventory is required how often under federal law: A. Annually B. Biennially C. Trienially D. Within 30 days of each DEA registration renewal date E. Only when the controlled substance inventory of DEA registration is transferred
B
A physician calls in a C-II script that meets the regulations for dispensing the C-II in an emergency situation, in what time frame must the physician provide the written version of the prescription to the dispensing pharmacy? a) 3 business days b) 7 calendar days c) 10 business days d) No written script is needed from the physician, as long as the pharmacist has transcribed all of the information into written format e) No written script is needed from the physician, as long as the pharmacist has transcribed all of the information into written format and the DEA has been informed in writing
B
Amphetamine (Adderall) falls into: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
B
Cocaine powder, USP is an example of a drug in which schedule of controlled substances? a) Schedule I b) Schedule II c) Schedule III d) Schedule IV e) Cocaine is illegal, thus not within any DEA schedule
B
Compounded aqueous solutions can be stored at a cold temperature for a. 7 days b. 14 days c. 30 days d. 365 days
B
Controlled substance act inventory requirements state that if a CIII, IV, and V drug product container contains in excess of ____________ tablets or capsules, then an exact count is required. a) 500 b) 1000 c) 2500 d) 5000 e) 10000
B
Controlled substance records must be retained by the registrant for how long? A. 1 year B. 2 years C. 5 years D. 10 years E. For the duration of the then current DEA registration period
B
Hydromorphone falls into: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
B
If a drug manufactured under conditions that do not meet the requirements of the GMP, the product is considered by the FDA to be: A. A generic substitute B. Adulterated C. Contaminated D. Misbranded E. Non-prescription
B
If a hypothetical dosage form contained 35mg Codeine per tablet, this would be: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
B
Medicare part D covers which of the following? 1- Outpatient hospital services 2- Outpatient physician services 3- Outpatient pharmacy services a. 1 only b. 3 only c. 1&3 only d. 2&3 only e.1, 2, & 3
B
Misbranding is a drug containing any of several potentially dangerous or addictive drugs, and a. its label indicates all addictive ingredients b. its label failed to indicate the accurate quantity or proportion of such drugs c. its label indicates all dangerous ingredients d. its label failed to indicate the consequences of all ingredients
B
Order forms are requested from the DEA using: a. DEA Form 224a b. DEA Form 222a c. DEA Form 106a d. DEA Form 41a
B
Pharmacies register every 3 years with the DEA to dispense controlled substances using: a. DEA Form 222 b. DEA Form 224 c. DEA Form 106 d .DEA Form 41
B
Prior to the first dose, and every 30 days, patients must receive patient package inserts for all of the following except: a. Accutane b. Warfarin c. Progesterone/Estrogen d. Statins
B
The DEA limits a pharmacy to this many Official DEA Order Forms (222), and requires them to be kept separately from all other pharmacy business materials: a. 49 (7 books of 7 forms) b. 42 (6 books of 7 forms) c. 36 (6 books of 6 forms) d. 42 (7 books of 6 forms)
B
The FDA Drug Approval Process was forever changed by: (choose the best answer) a. Durham-Humphrey Amendment b. Kefvauer-Harris Amendment c. Pure Food and Drug Act d. Orphan Drug Act
B
The _____________ Prohibits willfully soliciting, receiving, offering or paying any remuneration in exchange for referrals or the provision of Medicare/Medicaid paid goods/services. a. Anti Trust Laws b. Anti Fraud and Abuse Statutes c. Anti Solicitation Laws
B
The address printed on the DEA 222 order form for your pharmacy is incorrect, therefore you: a) Must rewrite the correct address before order schedule II drugs b) Must promptly return forms to the DEA to correct the error c) Must correct the address when the current supply of forms is exhausted d) Must notify your drug supplier of the correct address by affidavit with the order form e) None of the above
B
Which of the following could be a valid DEA registration number for John Nash, a physician assistant? A. AN7854222 B. MN8812960 C. JN46221151M D. PA5549615 E. A and D could both be correct
B
Which of the following restricts community/retail pharmacies from processing manufacturer prescription drug samples? a) The Durham-Humphrey Amendment b) The Prescription Drug Marketing Act c) The Waxman-health act d) The Robinson-Patman drug Distribution Act e) No restrictions exist for retail pharmacists
B
Which of the following statement(s) on a cranberry extract label would be acceptable under DSHEA regulations? 1 - use: to reduce E. Coli during a UTI; 2 - use: to reduce the incidence and duration of UTIs; 3 - use: to help maintain a healthy urinary tract a) 1 only b) 3 only c) 1 & 2 only d) 1 & 3 only e) 1, 2, & 3
B
You receive a recall notice from the FDA via your wholesaler that the product labeled as "warfarin 5 mg tabs USP" on your shelf mistakenly contains "warfarin USP and 0.1 mg of enoxaparin USP" in the tablets. Which of the following are true according to federal law? 1- The drug product is adulterated 2- The drug product is misbranded 3- This is a category IV recall situation A. 1 only B. 2 only C. 1 and 2 D. 2 and 3 E. 1, 2, and 3
B
For controls that are C3, when would you have to keep an exact inventory count?
Bottles larger than 1,000 count
A physician prescribes a drug for an off label use, he is: A. Working outside his scope of practice B. Breaking the law C. Within his rights of the federal law D. Violating claims
C
According to OBRA 90, a pharmacist is not required to offer to counsel a patient when the patient 1- appears to already understand the directions for use for the medication; 2 - is a health care professional; 3 - waives or refuses to accept the offer to counsel a) 1 only b) 2 only c) 3 only d) 1 & 2 only e) 2 & 3 only
C
According to the DSHEA, a product such as Saw Palmetto may be labeled to state that it: a) Cures prostatitis b) Helps treat prostatitis c) Supports a healthy prostate d) Prevents prostate cancer e) Will return the prostate to normal size and function
C
According to the IND process, the FDA has _______ to respond to a company with whether they think the drug is suitable for testing or not. a. 3 years b. 3 months c. 30 days d. 1 year
C
All other categories of compounded medication (other than aqueous, non-aqueous, and solids) must be scheduled to expire in: a. duration of therapy, but no more than 7 days b. duration of therapy, but no more than 14 days c. duration of therapy, but no more than 30 days d. duration of therapy, but no more than 365 days
C
Anabolic steroids are classified as: A. Schedule I B. Schedule II C. Schedule III D. Schedule IV E. Legend but not scheduled drugs
C
Anabolic steroids were put into this schedule to give the DEA better control over them: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
C
Cough preparations like Robitussin AC that have < ______mg of codeine per 100mL are Schedule 5. a. 100mg/100ml b. 150mg/100ml c. 200mg/100ml d. 300mg/100ml
C
Destruction of Controlled substances should include preparation of a written letter identifying 2 witnesses and be: a. Done annually using Form 222 b. Done every 3 months using Form 224 c. Done annually using Form 41 d. Done every 3 months using Form 41
C
Dr. Davis created his own IUD known as the ______________, which resulted in many cases of ______________ due largely to the ________ of the product. a. Dalkon Shield, PCOS, medication concentration b. Davis Shield, Pelvic Inflammatory Disease, medication concentration c. Dalkon Shield, Pelvic Inflammatory Disease, design d. Dalkon Shield, PCOS, research flaws
C
Enforcement of the poison prevention packaging act is largely under the jurisdiction of the: a) FDA b) Federal trade commission c) Consumer product safety commission d) Drug enforcement agency e) Office of drug control and security
C
If the manufacturer supplied bottle of ampicillin 500 mg capsules indicates an expiration date of "August 2017" the drug generally deemed to be good for dispensing until: a) August 1, 2016 b) July 31, 2017 c) August 30, 2017 d) September 30, 2017 e) August 1, 2018
C
The orange book is used to identify: a) Chemical generic names of all drugs b) Average wholesale pricing for the drug c) Therapeutically equivalent drug products d) Adverse effects of all FDA-approved drugs e) Drugs available in foreign countries
C
The primary basis for determining whether a marketed product will be considered a "drug" according to the FDCA is... a. It's chemical structure/nature b. It's safety and efficacy profile c. It's intended use d. It's DSM-IV classification e.It's ICD-10 classification
C
What does medicare part D cover? A. Inpatient hospital services B. Outpatient Physician services C. Outpatient Pharmacy services D. 1 and 2 E. All of them
C
Which of the following drug products must be purchased using a DEA form 222? 1 - Percodan (oxycodone/APAP); 2- Dilaudid (hydromorphone); 3 - Meridia (sibutramine) a) 1 only b) 3 only c) 1 & 2 only d) 1 & 3 only e) 1, 2, & 3
C
Which of the following has the authority to change the schedule of controlled drugs? a. Secretary of drug enforcement agency b. Office of inspector general c. Attorney general of U.S. d. Secretary of FDA e.President of U.S. via executive order
C
Who can request that a specific prescription be dispersed in non-child resistant packaging? 1 - patient; 2 - prescriber; 3 - pharmacist a) 1 only b) 3 only c) 1 and 2 only d) 1 and 3 only e) 1, 2, and 3
C
Who needs to register for a DEA? A. Pharmacist in charge B. All the pharmacists in the pharmacy C. The pharmacy
C
You have a drug called sawmellte. Per DSHEA which of the following words is appropriate: A. Cures BPH B. Treats BPH C. Promote prostate health D. Prevent development of BPH
C
You work in a methadone clinic. A glass bottle full of methadone has just fallen to the floor and shattered, spilling the contents everywhere. You should: a. Clean it up, carefully separate the methadone from glass, and send it to a "reverse distributor" using form 222. b. Clean it up, dispose of the medication, and record it as a loss on DEA Form 106. c. Clean it up, dispose of the medication, and record it as destroyed on DEA Form 41. d. Clean it up, dispose of the medication. No DEA Form is necessary.
C
where can the pharmacy store C2s? On the shelf dispersed In a safe locked up A and B
C
which of the following is a legitimate DEA number? a. AN1243579 b.BS7321878 c. MT6549325 d. BC8243956
C
Who authorizes PPPA? FDA or CPSC
CPSC
Which recall class would result in death?
Class 1
What should a pharmacy do if their address on their DEA form 222 is wrong
Contact the DEA
A Medicare Patient who has elected to pay for Part D coverage can expect all of the following except: a. Premiums of about 35$ per month b. 250$ deductible c. 25% copay up to 2250$ d. A donut hole between 2250$ up to 5100$. e. all of the above f. none of the above
D
A drug is adulterated if it: a. Fails to conform to compendial standards for purity, quality, or strength b. Has not been mfg'd within GMP standards c. Fails to be stored under USP standards d. all of the above e. none of the above
D
A drug is misbranded if it: a. has a false or misleading label b. has a label missing required information c. required information is not easily read d. all of the above e. none of the above
D
A physician has called in an emergency prescription for a fentanyl patch. You determine this is an emergency situation, and will dispense the fentanyl and require the physician to send you a written prescription within ______. You also see that you have 4 patches left in an open box. The prescription is for 8 patches. You know the shipment comes in tomorrow morning, and the patient agrees to come back. If the patient comes back within ______, you can fill the rest of the prescription, as long as it was documented on the script. If this were to occur in a LTCF, the prescription would be good for ______. a. 24 hours, 24 hours, 1 week. b. 48 hours, 72 hours, 6 months. c. 72 hours, 72 hours, 30 days. d. 7 days, 72 hours, 60 days.
D
A physician that prescribes a FDA approved prescription drug product for a non-labeled indication is... A. Negligent under a strict liability standard B. Setting up the pharmacy/pharmacist for a misbranding claim C. Practicing outside his/her scope of authority D. Within his/her rights under federal law E. Required to demonstrate the merits of the intended use if the FDA requests writing
D
A(n) _________________ must be substituted by manufacturers to the FDA in order to market a new drug. a) NDC b) FDA-C c) FDC d) NDA e) Form 222
D
According to federal law, schedule II drugs may be stocked/stored only in the following ways: 1) in locked vaults, safes, or cabinets; 2) in any areas if there are cameras or surveillance systems in place; 3) dispersed amongst the regular (non-controlled) inventory/stock a) 1 only b) 3 only c) 1 & 2 d) 1 & 3 e) 1, 2, & 3
D
According to federal law, zolpidem is an example of a drug product in which controlled substance schedule: a) I b) II c) III d) IV e) V
D
All of the following are true of CRC's except: a. At least 90% of adults, having been shown how, can open within 5 minutes b. Not more than 20% of children < 5, having been shown how, can open within 5 minutes c. Must meet USP standards for tightness, light resistance d. Are more properly termed "child-proof" e. May not be reused
D
Butorphanol and propoxyphene are narcotics belonging to: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
D
Compounded solid, non-aqueous products are good for 6 months or not more than ___ of the time remaining on the commercial product used to compound the medication, whichever is less. a. 10% b. 15% c. 5% d. 25%
D
Drug advertising is regulated through all of the following except: a. FDA via FDCA b. FTC via FTC Act c. Lanham Act (Trademark Act) d. Durham-Humphrey
D
How often must a DEA-registrant re-register with the DEA a) Annually- at the time the registrants state license is renewed b) Annually - on or before June 30 c) Every 2 years d) Every 3 years e) Only when the registrant moves the physical location or there is a change of ownership
D
Lorazepam is: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
D
OBRA 90 concerns Medicaid and requires states to participate in: a. Mandatory Rebates (Best price, average manufacturer's price) b. Demonstration Projects (CQI, determines benefit for patients) c. Drug Utilization Review (Retrospective, Educational, Prospective) d. All of the above e. None of the above
D
OBRA 90's "Prospective Drug Review" Includes all of the following except: a. Drug Interaction, Contraindication, Duplication, Allergy b. Correct dose, duration c. Clinical abuse/misuse d. Voluntary Patient Counseling
D
Pharmacies are allowed 3 ways to file prescription records. Which of the following is not one of those ways? a. 3 separate files; one for CII, one for CIII-V, and one for non-control prescriptions b. 2 separate files; one for CII, one for CIII-V along with non-control prescriptions but with a 1 inch red "C" marked on CIII-V's. c. 2 separate files; one for non-control prescriptions, one for CII-V with CIII-V marked with a 1 inch red "C". d. 2 separate files; one for non-control prescriptions, one for CII-V with CII's marked with a 1 inch red "C."
D
The DEA must investigate pharmaceutical thefts if: a. Replacement cost of controlled substances exceeds $500 b. Someone was killed or suffered significant bodily injury during the theft c. Those involved in planning or executing the theft crossed interstate or international lines. d. all of the above
D
The FDAMA established a new drug development process including: a. Pre-Clinical Testing (in-vivo & in-vitro animal testing) b. Filing an IND (Investigational New Drug) form with the FDA c. Clinical Trials (Phase I, II, III, IV) d. all of the above
D
The FDCA defines Drug as: a. articles used for food or drink for man or other animals b. Intended for cleansing, beautifying, promoting attractiveness, or altering appearance c. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for diagnosis, cure, mitigation, treatment, or prevention of disease or other medical conditions; AND Does not achieve its effect by chemical action or by being metabolized. d. Articles (other than Food) intended: For diagnosis, cure, mitigation, treatment, or prevention of disease, which affect the structure or function of body
D
The Food and Drug Administration Modernization Act (FDAMA) did all of the following except: a. permitted manufacturers to provide information about "off-label" use. b. enlisted States to enforce limits on compounding pharmacies in order to reduce bulk-compounding. c. Allow only "anticipatory compounding" in compounding pharmacies d. Developed a fast track approval system for drugs for rare diseases (found in populations < 200,000).
D
The Harrison Narcotics Act of 1914: a. taxed the production, sale, and use of opium b. required prescriptions for products exceeding the allowable limit of narcotics c. mandated increased record keeping for doctors and pharmacists dispensing narcotics d. all of the above e. none of the above
D
The Prescription Drug Marketing Act did all of the following except: a. Required state registration of all drug wholesalers, secondary distributers, repackagers, etc. b. Prohibited non-profits from re-selling drugs, with the exception of their own employees c. Strict record keeping of all "samples" of drugs d. Allows retail pharmacies to receive drug "samples" only upon written request
D
The Pure Food and Drug Act of 1906: a. was focused on accurate labeling of medications b. was able to be enforced upon the basis of adulteration c. was able to be enforced upon the basis of misbranding d. All of the above
D
The Waxman-Hatch Amendment (Drug Price and Patent Term Act) resulted in: a. Abbreviated New Drug Application for brand name drugs (show bio-equivalence) b. Patent Term Extensions to generic drugs (capped at 5 years) c. Applies to US drugs only d. Resulted in requirement of the FDA to publish the Orange Book, a book showing bio-equivalency of "brand" and "generics."
D
The term drug from Food Drug and Cosmetics act means: a) Articles recognized in the US Pharmacopeia or national formulary b) Articles (other than food) intended to affect the structure or any function of the body c) Articles intended to diagnose, treat, cure, mitigate, or prevent a disease d) All of the above e) None of the above
D
Who can sign a DEA222? A. Any licensed pharmacist B. The pharmacist that registered for the DEA C. POA D. Both 2 and 3 E. All
D
All of the following drugs do not require CRC's, except (note: there are multiple answers): a. Nitroglycerin SL b. Potassium Supplements < 50 Meq/dose c. OC's in memory aid containers d. Aspirin e. Acetaminophen f. Lidocaine
DEF
A drug product is adulterated within the meaning of the food drug and cosmetic act if: A. It consists in whole or in part of any filthy, putrid, or decomposed substance B. It has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health C. The methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices D. B and C are correct E. All of the above are correct
E
A pharmacy must register as a distributor, if it transfer to other DEA registrants, more than: a. 2 percent of all controlled substances in 1 year b. 5 percent of all controlled substances over the 3 year registration period c. 3 percent of all controlled substances in 2 years d. 4 percent of all controlled substances over the 3 year registration period e.5 percent of all controlled substances in 1 year
E
According to the federal controlled substance act, which of the following drugs is/are controlled substances? 1. Meperidine injectable solution; 2. Leaf/marijuana for medicinal use; 3. Fentanyl transdermal patch a) 1 only b) 3 only c) 1 & 2 only d) 1 &3 e) 1, 2, & 3
E
All of the following are correct descriptions of the Clinical Trials Phases except: a. Phase 1: small group of healthy individuals. Purpose: to evaluate toxicity, pharmacokinetics, and safety. b. Phase 2: 100 + patients who have the disease/symptoms. Purpose: to evaluate, preliminarily, the drug's effectiveness and dosage. c. Phase 3: 1,000's in RCT's to compare effectiveness of the new drug versus standard therapy. d. Phase 4: Post Marketing Studies e. Phase 5: Voluntary reporting of ADRs through FDA Medwatch program
E
Controlled substances are classified into schedules based upon: a) ARNQ chemical classification b) FDA indication for use c) DEA indication for use d) ARNQ narcotic classification e) DEA determined abuse and dependency potential
E
DEA forms 222a is used: a) To order schedule II controlled substances b) To order controlled substances in schedules III, IV, and V c) To register a practitioner with the DEA d) To return unused controlled substances e) To requisition a supply of DEA-222 forms
E
FDA-approved drug products that are considered therapeutically equivalent to a brand name drug under FDA regulations/guidance would be rated as a) TE b) BA c) RBQ d) EQ e) AB
E
FDCA defines drugs as: A. Articles listed in the USP and NF B. Articles (other than food) C. For diagnosis, cure, mitigation, treatment, and prevention D. Affect the structure and function of the body E. All of the above
E
Generally, drugs for antitussive, antidiarrheal and analgesic purposes are: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
E
If you have a significant loss theft you must? A. Contact the closest DEA office B. Call the police C. Fill out DEA106 D. 2 and 3 E. All of them
E
In dealing with the DEA, it is most important to: a. use the proper forms b. notify of address location changes/transfer of business/ending business, all in writing c. VOID all unused forms that will be returned (usually Form 222) d. Pay attention to dates and expirations e. all of the above
E
The FDCA defined Adulteration as: a. drugs not stored under USP standards. b. drugs which failed to conform to USP/NF standards for purity, quality, strength, and appropriate assays. c. A drug listed in the USP, but which did not meet USP specifications, unless variations from the USP were clearly labeled. d. A and B e. All of the Above
E
The FDCA defined Misbranding: a. in such a way as to regulate "incomplete labeling" b. as a drug containing any of several potentially dangerous or addictive drugs, and its label failed to indicate the accurate quantity or proportion of such drugs c. in such a way as to regulate "misleading labeling" d. A and C e. All of the above
E
The Food Drug and Cosmetic Act of 1938: a. was a direct result of "the sulfanilamide scare" in which 107 people died. b. gave the FDA broader power to regulate the safety of medications c. gave the FDA broader power to regulate medications prior to marketing d. A and B e. A, B, and C
E
The NDC code must a. be assigned by the FDA for every OTC and Prescription drug b. must be present on all drug packaging c. must be present on all dosage units d. is currently a 10 digit code, the first five digits identifying the manufacturer, the last five digits identifying the drug and package size. e. A and D f. All of the above
E
The Nutrition and Labeling Education Act a. Required supplements to limit claims at treating, preventing, or curing any disease b. Allowed well-being and structural/functional claims, but warned about "overstating" the benefits of supplements. c. Required supplements packages to read "Statement not Evaluated by the FDA" d. all of the above e. none of the above
E
The Office of The Inspector General enforces punishments for committing fraud against the federal government's Medicare and Medicaid programs, which can include all of the following except: a. $25,000 fine per violation b. 5 years in prison per violation c. restitution for improperly paid claims plus interest d. exclusion from Medicare/Medicaid e. All of the above
E
The Orphan Drug Act and the Waxman-Hatch Amendment were developed to a. speed up the process of FDA drug approval for non-generics b. speed up the process of manufacturing c. rectify the long drug approval process with tax benefits and patent period d. rewards for manufacturers who create drugs for rare diseases (<200,000 people with disease). e. C and D f. All of the above
E
Under federal law, which of the following is not required on the prescription label of a dispensed legend drug? A. Directions for use B. Name of patient C. A serial or unique identifying number D. Quantity dispensed E. All of the above are required
E
When pharmacies get together (illegally) to boycott a company, say Pfizer, this is known as: a. Price Fixing b. Monopolies c. Restraint of Trade d. Market Power e. Collusion
E
Whenever one DEA registrant distributes a schedule II drug to another DEA registrant: a) A DEA from 224a must be used b) A DEA form 42 must be used c) The drug must be sold "at cost" d) An invoice must be delivered along with the drug e) No invoice is needed, but a DEA form 222 is required
E
Which could be the correct DEA number for Dr. Robert Bridge, MD? a) MD3254769 b) AB1244696 c) AR1354783 d) RB2489436 e) BB7263546
E
Which of the following is/are true about theft of significant loss of controlled substances: 1- A report must be made on a DEA 106 form 2- The pharmacy most notify the nearest DEA office 3-The pharmacy should notify local police A. 1 only B. 3 only C. 1 and 2 D. 2 and 3 E. 1, 2, and 3
E
Which of the following, if done by a pharmacist, would likely violate the FDCA? a. Place a book describing scurvy and the role of vitamin C in the disease immediately next to the vitamin C on her shelf b. Recommend a book on the use of roots, leaves and extracts in Chinese medicine c. Place a book on the shelf next to the ginkgo biloba tablets that describes the virtues and uses for ginkgo biloba d. Recommend and sell a bottle of vitamin C for promoting a healthy immune system e.Recommend and sell a bottle of gingko biloba tablets for use in preventingAlzheimer's
E
What should be on a prescription? A. patient name B. date is filled C. drug D. sequential number or id E. all of the above
E. all of the above
A Therapeutic Substitution is when drugs have equal bio-equivalence, including the same peak, same AUC. An example would be: substituting acetaminophen for Tylenol. T/F
F
A sales rep is recommending the off label use of Warfarin for ear-aches. Presuming there is some scientific evidence, and you deem it reliable, this is kosher with the law. T/F
F
DTC (Direct to Consumer Advertising) is unlawful for manufacturers of drugs. T/F
F
Medicaid covers medically and financially indigent persons for: a. Hospital and physician services b. Diagnostics (lab, x-ray, etc) c. Skilled nursing and home health d. Dental and Optomatry e. Outpatient medications f. All of the above g. none of the above
F
Misbranding occurs when a drug is listed in the USP, but did not meet USP specifications (unless variations from the USP were clearly labeled) T/F
F
Mrs. Schmidt calls your pharmacy to find out the price of Cephalexin 500 mg capsules. A pharmacist tells her it's against federal law to disclose the price of prescription drugs to a patient prior to receiving an order for the drug. a) True b) False
F
Samuel Hopkins Adams wrote for Collier's Weekly about contaminated smallpox vaccines, which led to the Pure Food and Drug Act. T/F
F
Schedule II, III, IV, and V must be locked in a cabinet, per the CSA. T/F
F
T/F A patient calls the pharmacy and asked how much ceftriaxone costs. The pharmacy tells her he cannot answer that without a script. The pharmacist is breaking the law.
F
The CPSC (the Consumer Products Safety Commission) encourages the use of reversible caps by pharmacies for ease of use. T/F
F
The Dietary Supplement and Health Education Act (DSHEA) a. Created the current label format b. exempted restaurant prepared food c. standardized descriptors like "low calorie, sugar free, light, high fiber" d. regulated the nutrient/disease relationship claims (calcium for osteoporosis, etc) e. all of the above f. none of the above
F
The Durham-Humphrey Amendment (Prescription Drug Act) a. adds "efficacy" as a prerequisite for FDA new approval process b. adds pre-market approval by the FDA as opposed to pre-market notification c. established good manufacturing practices d. adds clinical study oversight safeguards and important patient protections e. all of the above f. none of the above
F
The FDA enforces the CSA (Controlled Substances Act) of 1970. T/F
F
The FDA takes a very limited interpretation of the idea of drug labeling. T/F
F
The Kefvauer-Harris Amendment (Drug Efficacy Act): a. created the ability for prescriptions to be taken down over the phone b. created the OTC class of drugs c. created refills d. required a cautionary statement on prescription medications requiring directions from the physician e. all of the above f. none of the above
F
The Kefvauer-Harris Amendment quickened the drug approval process. T/F
F
The Medical Device Amendment classifies artificial hearts, pacemakers, stents, and catheters as Class II. T/F
F
The Poison Prevention Packaging Act requires CRCs (Child-Resistant Containers) for all OTC's. T/F
F
The Pure Food and Drug Act adequately addressed regulation of drugs with emphasis on drug safety. T/F
F
The pharmacist notifies the DEA, using the proper form, when an in-transit loss of controlled substances has occurred and it was discovered before the pharmacist signed for or took possession of the controlled substances. T/F
F
True or false? A drugs manufacturer may not, under any circumstances, distribute scientific literature or medical journals regarding off label uses regarding one of its drug products True False
F
Under no circumstances can a pharmacy employ someone who has been convicted of a felony relating to controlled substances, or who has had an application for DEA registration denied, revoked, or surrendered for cause. T/F
F
The PDUFA was quickly updated by the _________, mainly in response to the ______ epidemic.
FDAMA, AIDS
Which act ensures safety and efficacy?
Kefauver Harris
What form is submitted after clinical trials are complete
New drug application
According to OBRA, it is mandatory to counsel unless:
Patient waives or refuses
Why did the Tamper Act of 1982 come out?
People were tampering with OTC medications
What phase of drug approval uses healthy people?
Phase 1
The orange book shows what?
Therapeutic equivalence
Contact the DEA if your pharmacy has not received their DEA Renwal Application form (DEA Form 224a) form within 30 days of current registrations' expiration. T/F
T
Drugs prior to 1938 remained immune to the Kefvauer-Harris Amendment (aka Kefvauer-Harris was retroactive to 1938) as well as the FDCA. T/F
T
Medicare Part D has a formulary, much like a regular drug plan from an insurance company. T/F
T
Pharmacists have a "Corresponding Responsibility" to decide that a prescription is valid. T/F
T
T/F A c3 can have 5 refills and must be filled within 6 months of the date.
T
The FDA has the power to recall drugs. T/F
T
The FDCA gave the FDA the powers (sanctions) of Criminal Prosecution, Seizure of Goods, and Injunction Relief, primarily based upon the areas of Misbranding and Adulteration. T/F
T
The PDUFA was intended to get the FDA an additional source of non-federal funding to reduce the 8 year NDA process to about 18 months. T/F
T
The Robinson-Patman Act was amended by the Nonprofit Institution Act so that nonprofits can be exempt from "price fixing." T/F
T
The Federal Anti-Tampering Act of 1982 was brought about because of tampering of _______ in Chicago and ________ in Washington, resulting in deaths.
Tylenol, Exedrin and Sudafed
Which act shortened the approval process of generic drugs
Waxman hatch
Can manufacturers make primary literature and journals for off label uses? Slide 98 of FDA?
Yes?
Know how calculate DEA numbers
do it
If a warfarin 5 is recalled because it turns out it has enoxaparin .1 mg is in the tablet as well this is A. Misbranding B. Adulteration C. Recall category 4 D. A and B E. All of them
good luck, not C or E
If you are transporting c2's what needs to be involved?
just a 222? maybe an invoice too? see other question in slide deck
The Kefvauer-Harris Amendment (Drug Efficacy Act) was passed into law mainly due to a severe adverse drug reaction (birth defect, 7,000 children in Europe) known as ____________, caused by the drug named ____________
phocomelia, thalidomide
Illinois has a ________ formulary, where there is a list of drugs which may be generically substituted for, and Missouri has a __________ formulary, where there is only a list of drugs which cannot be generically substituted for.
positive, negative
First 5 digits of NDC represent
the manufacturer
True or false? Federal law (controlled substances act) states that a schedule III controlled substances prescription shall not be refiled more than 5 times or more than six months after the date on which the prescription was written. True False
true