Law test 1
versed
"Midazolam" benzodiazapine for sx amnesiac, sedative, antianxiolytic Schedule IV
Risperdal
(Risperidone) antipsychotic used to treat schizophrenia; Serotonin/Dopamine antagonist Not a CS
Lyrica
(pregabalin) Diabetic neuropathic pain treatment Gamma Aminobutyric Acid; Schedule V
What actions are permissible in a hospital that has tax-free alcohol? (Ach3)
-available to hospitals for medicinal, mechanical and scientific purposes and in tx of pts. May be used only for inpatients. (-charity clinics may use for medicinal purposes for out-patients if they do not charge.)
Standards of practice, examples
-checking the work of technicians filling prescriptions. -generic drug substituted for the prescribed drug be therapeutically equivalent. - taking action when detecting a potentially serious drug interaction -checking prescriptions dispensed by automation -HIPPA
Reasons to Regulate the Pharmacy Profession through licensure (3)
1. To increase the quality of health care 2. To reduce the cost of health care 3. To inhibit the criminal abuse of drugs
Why is defining the "practice of pharmacy important"? (4) 1. establishes, 2-4. Distinguishes
1. establishes a professional identity to society and courts 2. distinguishes pharmacy from the practice of medicine 3. distinguishes pharmacist from ancillary personnel 4. Distinguishes pharmacists from unlicensed persons from performing pharmacy related roles.
Licensing of Pharmacists- specific requirements may vary from state to state but most states require that applicants meet 5 criteria:
1. graduation from a pharmacy school 2. completion of specified internship requirements 3. attainment of a specific age 4. a passing score on the NAPLEX 5. demonstration of good moral character
grounds for discipline (8)
1. providing of false/ fraudulent info when applying for a license. 2. violation of any statute pertaining to the practice of pharmacy 3. conviction of a felony 4. conviction of an act involving moral turpitude 5. unprofessional conduct 6. immoral conduct/ character gross immorality 7. Habitual intemperance 8. incompetence
4 types of market failures
1. public goods (orphan drugs, vaccines) 2. Externalities (antibiotic overuse) 3. Natural Monopolies (patent exclusivity) 4. Information asymmetry (drug use recommendations)
A narcotic C-III may not contain more than ___ of codeine per ___ or not more than ___ per dosage unit
1.8 grams, 100 ml, 90 mg
DD: To be admitted to a comprehensive maintenance program, narcotic-dependent individuals must have been physiologically dependent on narcotics for at least
12 months
BOP: qualifications for license
18yo, degree from CoP, 1500 hrs to sit on exam, passed exam, does not have an encumbered license or a pending disciplinary action,
CS: C-V: cannot contain more than ___ diphenoxylate and not less than ___ of atropine sulfate per dosage unit.
2.5mg diphenoxylate, 25 mcg
The Marketing Act of 1987 guarantees a company that discovers, patents, and develops a new drug exclusive marking rights for up to:
20 years
CS: The maximum amount of codeine that can be contained in a schedule V cough syrup is:
200mg per 100 ml
Marinol (dronabinol) is a C-__ drug
3
CS: Dispensers must register with the DEA every ___
3 years
CSA: Law limits sale of ephedrine, PSE, or PPA to no more than ___ to a single purchaser per day.
3.6 gm
ipecac: The maximum volume of Ipecac Syrup that may be sold without a prescription is:
30 mL
OTP: "qualifying" physicians may treat only ___ opioid dependent pts in the 1st year and can submit a notification of need & intent to treat up to ___ such pts in subsequent years.
30, 100
A pharmacy that compounds many prescriptions may be cited by the FDA of the volume of its prescriptions being sent out-of-state is in excess of ______%
5
BOP = ___ members
7, 5 of the members shall be graduates of a school or college of pharmacy and shall have been licensed as pharmacists and actively engaged in the practice of pharmacy for at least 5 years prior to their appointment and two shall be public members.
CSA: No consumer may purchase more than ___ of ephedrine, PSE, or PPA, within a 30 day period, or ____ within a 30 day period by mail order.
9 gm. 7.5 gm.
Grandfathered drugs are A) often not listed in the Orange Book B) found in the Orange Book as Code B only C) found in the Orange Book as Code AB only D) to be prescribed only by generic name E) found in the Orange Book as Code A only
A
HHS: Who is authorized to designate the "official" name of a new drug? A) Secretary of HHS B) Executive Director of APhA C) Director of HCFA D) Director FDA E) US congress
A
HIPPA: How often must a pharmacy have a patient sign a new notice that s/he has been informed of the pharmacy's privacy practices under HIPAA requirements? A) NO requirements are specified by HIPPA B) Every time a refill is dispensed C) Every 6 Months D) Every year E) every time a new prescription is filled
A
OTC: The requirement for over-the-counter drugs to have "adequate directions for use" A) Means that the directions will be clear to a layperson for safe use of the product B) Applies only to products intended for oral consumption C) applies only to products for pediatric use D) includes the listing of potential side effects and toxicity E) includes the presence of bilingual directions
A
Samples of prescription drugs received from the pharmaceutical companies may be A) given to patients by the prescriber B) dispensed from a hospital pharmacy for inpatients C) dispensed from a hospital to outpatients D) sold through community pharmacies E) traded to another pharmacy for other drugs
A
The federal act that specifically limits the reimportation of drug products that were previously exported by a pharmaceutical manufacturer is the: A) Prescription Drug Marketing Act of 1987 B) Durham-Humphrey Amendment 1951 C) FD & C Act of 1938 D) DSHEA E) Kefauver-Harris Amendment of 1962
A
The primary objective or charge for individual state boards of pharmacy is the A) protection of the general public B) protection of the profession C) protection of individual pharmacists D) enforcement of federal laws E) serving as an intermediary bw chain, independent & institutional pharmacies
A
label: The label of a parenteral product is not required to list the presence of a(an): A) inert gas B) buffer system C) antimicrobial preservative D) antioxidant E)) chelating agent
A
medicaid: What permanent identification must a pharmacy possess if it plans to electronically bill Medicare or Medicaid for prescriptions A) NPI B) NDC C) FDA registration number D) AWP E) DEA number
A
medicare: The term "donut hole" refers to a component of which one of the following? A) Medicare Part D B) National Drug Code C) Medicare Part B D) Poison Prevention Act E) Prescription Drug Marketing Act of 1987
A
refill: Federal guidelines indicate that the pharmacist should indicate the date on which a prescription refill is dispensed A) on the back of the prescription B) on the front of the prescription C) on the prescription label D) in a special refill log book E) on the counseling sheet given to the patient
A
Definition of Narcotic (per the CSA)
A narcotic controlled substance is a natural or synthetic opium or opiate AND any derivative, such as poppy straw, coca leaves, cocaine, and ecgonine.
ads: the advertising to the general public of OTC drugs is basically under the regulatory responsibilities of the: A) FTC only B) FDA and FTC C) FDA only D) DEA E) HCFA
A) FTC only OTC, Rx drugs - FDA
rems: isotretinoin
ACCUTANE, AMNESTEEM, CLARAVIS. Used for treatment of severe recalcitrant cystic acne only after other treatments have failed. Acts by inhibiting sebaceous gland activity and has anti-keratinizing and anti-inflammatory properties. BLACK BOX for suicidal thoughts/behaviors. STRINGENT guidelines for using and prescribing include iPLEDGE program. Causes severe birth defects.
CS: percodan
ASA/Oxycodone CII; Pain Relievers (Analgesics); Pain Relief Moderate to Severe; Treats Muscle Spasms, Pain and Rigidity
CS: 5 examples of C-III drugs
ASA/codeine, APAP/codeine, anabolic steroids, Marinol (dronabinol), Tussionex
CSA: AIW
Administrative Inspection Warrant: is similar to a search warrant (SW) in that NO CONSENT IS REQUIRED but differs in the "probable cause requirement" An AIW may only be served during regular business hours.
A pharmacy providing services under the Medicare Modernization Act of 2003, that uses the program's discount cards, may establish a formulary limiting the drugs to include at least 2 drugs in each class except for certain classes where substantially all drugs must be included: (6)
Antidepressants Antipsychotics Anticonvulsants Antiretrovirals Antineoplastics immunosuppressants (Ach6)
CS: diphenoxylate
Antidiarrheal, activates opiod receptors in the abdomen, Tx of noninfectious nonspecific diarrhea, ADRs mild cramping similar to Loperimide BUT HIGH DOSES CAUSE CNS EFFECT AND TOX Schedule??
4 examples of C-V drugs
Antitussives: Robitussin AC (guaifenesin/codeine) Anti-diarrhea: Lomotil (diphenoxylate/ atropine sulfate) Lyrica (pregabalin), Phenergan (promethazine/ codeine)
CS: can you mail CS's?
As of 1994 CS's may be mailed provided they meet the packaging standards established by the U.S. Postal Service.
CS: Dronabinol is a Schedule III controlled substance that is related most closely to A) cocaine B) marijuana C) LSD D) morphine E) methylphenidate
B
HIPAA: Which of the following is MOST important to consider in determining whether a community pharmacy is required to meet HIPAA regulations A) The prescription volume is greater than 20,000 per year B) Identifiable patient health information is transferred electronically C) The pharmacy accepts Medicaid prescriptions D) The store's annual income is greater than one million dollars E) The pharmacy has more than 10 employees
B
Which of the following laws first required the statement "caution: federal law prohibits dispensing without a prescription" on drug product packaging? A) FD & C Act of 1938 B) Durham-Humphrey Amendment of 1951 C) Kefauver-Harris Amendment D) Prescription Drug Marketing Act E) Pure Food and Drug Act of 1906
B
claim: A cosmetic company begins marketing an OTC topical cream that is claimed to reverse psoriatic lesions. This claim may be legally challenged by the: A) FDA only B) FDA and FTC C) FTC only D) DEA E) HCFA
B
label: Which of the following must be present on the labels of nonprescription drug products intended for oral use? A) Sodium content of active ingredients B) total sodium content of both active and inactive ingredients C) Sodium chloride content of active ingredients D) Total sodium chloride content of both active and inactive ingredients E) no requirements have been established
B
cs: Controlled substance inventories I. may be done at any time during the workday II must be taken at least once each year III must be made for each registered location
B) III only NOTE: But, if you also figure in the state requirements, the correct answer would be D) II & III only
222: The original portion (copy 1) of the Form 222 is eventually kept on file by the A) DEA B) Supplier C) FDA D) Purchaser E) Prescriber
B) Supplier, copy 1, tannish
label: the presence of which of the following adjuvants in a commercial drug product requires a special label warning? A) antioxidants B) tartrazine C) sodium benzoate D) surfactants E) artificial flavors
B) Tartrazine (yellow No. 5)
CS: examples of C-IV Drugs
BZD's (alprazolam, diazepam, etc); PB (phenobarbital), Soma (carisoprodol/ as of January 11th, 2012)
CS: A physician who is a resident in a hospital and does not have a DEA registration number A) may not prescribe controlled substance B) may only prescribe controlled substances C) may prescribe controlled substances using the hospital DEA number plus an assigned suffix D) May prescribe controlled substances only in schedule III-V E) May prescribe only for inpatients
C
If a specific lot of a pharmaceutical company's tablets fails to meet the expected expiration dating, the lot may be considered to be: A) adulterated B) unstable C) misbranded D) a class III recall E) a felony
C
Which organization is primarily responsible for evaluating the safety and effectiveness of drugs used in veterinary practices? A) SPCA B) FTC C)FDA D)humane society E) HCFA
C
preg: With respect to pregnancy warnings, category D indicates that the drug A) is safe for 98% of all females during pregnancy B) should not be used during the first trimester C) should be administered only if the potential benefits are acceptable despite the potential risks D) should not be used during pregnancy E) does not pose any danger to either the mother or fetus
C
What is the time interval during which newly eligible individuals may enroll in Medicare Plan D without a penalty? A) 3 months B) 6 months C) 7 months D) 9 months E) 1 year When is open enrollment?
C (enrollment period starts 3 months prior to 65th bday and ends 4 months after) open enrollment for 2013 was Oct 15- Dec 7th
CS: Under which of the following conditions may practitioners of "Traditional Chinese Medicine" sell ephedra-containing products? A)The level of ephedra is less than 1 mg/dose B) Only a 10 day supply of product is sold C) The label does not indicate that the product is a dietary supplement D) A prescription is issued for the product E) Sales are not legal
C)
HIPAA: A customer had a prescription originally filled on December 1, 2009 and at that time acknowledged receiving the pharmacy's notice of privacy rights under HIPAA. She also receives a refill dispensed January 2, 2009. What is the earliest date that the pharmacy may discard the patient's acknowledgement? A) 12/1/10 B) 1/2/10 C) 12/1/15 D) 1/2/14 E) never
C) 12/1/2015
CS: A 35- year old customer wishes to know how many 30 mg Sudafed tablets he can purchase at one time. Which of the following is the correct answer? A) 12 B) 60 C) 120 D) 240 E) 300
C) 120
label: Excipients included in pharmaceutical dosage forms are usually found on which of the following lists? A) DSHEA B) HPLC C) GRAS D) Top 200 E) USP
C) GRAS
adulterated: A drug product consisting of tablets may be declared adulterated for all of the following reasons EXCEPT: A) active drug has undergone partial decomposition B) contains an unapproved color additive C) does not indicate # of tablets present D) inactive ingredient has undergone partial decomposition E) manufactured in a plant that fails to meet GMP's
C) does not indicate # of tablets present
The CSA is enforced by the ___.
CSA: Controlled Substance Act (1970) is enforced by the DEA: Drug Enforcement Administration
CS: Peyote
Cactus plant that bears small button growths. these buttons contain mescaline, a hallucinogenic sometimes used in the religious rights of the Native American church Schedule I
CMS
Center for Medicare and Medicaid Services - administrative agency within the federal Department of Health and Human Services; responsible for the operation of Medicare and Medicaid
BOP oversee's which laws?
Chapter 461 HRS (Pharmacist and Pharmacy) - protect the general public from dishonest, fraudulent, unskilled or otherwise unqualified pharmacists (this law is read in conjunction w HRS chapter 436B, Professional and Vocational licensing Act) Ch 16-95, HAR
CQI
Continuous quality improvement
222: A DEA form 222a is used A) to order Schedule II controlled substances B) to order all controlled substances C) to return unused controlled substances D) as a requisition form for Form 222 E) to register a practitioner with DEA
D
OH: A hospital that has two 55-gallon drums of tax-free grain alcohol must: A) report the amount remaining to the ATF every six months B) inventory the stock every month C) inventory the stock every 6 months D) maintain a running inventory of the volume E) take a year-end inventory
D
USP: The USP/NF is best described as a publication that is published by: A) the HHS B) the FDA C) the Pharmaceutical Manufacturer's Association D) an independent organization E) a coalition of US pharmaceutical companies
D
label: Which one of the following is the correct format for the listing of ingredients on a product label? A) The additives and active ingredients intermixed but in alphabetical sequence B) Additives and active ingredients intermixed but ranked by decreasing concentrations C) Additives and active ingredients intermixed but ranked by increasing concentrations D) Additives listed separately from the active ingredients E) Additives listed separately by decreasing concentrations
D
misbranding: All of the following would be considered as incidences of misbranding EXCEPT A) one of the active drug in a product is not identified on the label B) the original bottle of 60 contains only 50 tablets C) the names of inactive ingredients are not on the label D) the level of alcohol in the product is 5% V/V but the label states 15% V/V E) the pharmacist dispenses a drug product without the required prescription authorization
D
safety: Which of the following was the first to require that pharmaceutical manufacturers prove the safety of prescription drugs before marketing? a) Durham-Humphrey Amendment of 1951 b) Prescription Drug Marketing Act of 1987 c) Kefauver-Harris Amendment of 1962 d) F D & C of 1938 e) Pure food and drug act of 1906
D
OH: Hospitals that plan on using large quantities of tax-free grain alcohol should obtain which of the following forms? A) ATF 11 B) ATF 222 C) DEA 222 D) ATF 1447 E) DEA 1447
D) ATF 1447
CS: The authority for determining the schedule for a potentially new controlled substance belongs to the: a) Director of the FDA b) President of the US c) Director of the DEA d) Attorney General of the United States e) Director of HHS
D) Attorney General of the US
CS: A "listed chemical" is defined by the controlled substances act as any chemical that is a) a controlled substance b) listed in the USP/NF c) listed in the USP DI d) used in manufacturing a controlled substance e) listed in the electronic orange book
D) used in manufacturing a controlled substance
OTP: ___ enacted in 2000 w intent of allowing addicts to be treated for addiction in office based settings (outside of OTPs).
DATA: Drug Addiction Treatment Act
HHS
Department of Health and Human Services. Establishes national standards, including HIPPA
An oral code is assigned by the _____, in the state of Hawai'i
Department of Public Safety, narcotics Enforcement Division
What is an example of a NTI drug?
Digoxin, Warfarin, Levothyroxine
DLA
Drug Listing Act, Assign of a unique and permanent drug code to each medication
CSA: drugs regulated in the Combat Methamphetamine Epidemic Act of 2005. (3) These drugs are called _____
Drugs regulated include ephedrine, pseudo ephedrine, and Phenyl propanolamine. These drugs are called "schedule listed chemical products."
CS: After dispensing prescriptions for several months for a schedule II analgesic, the pharmacist realizes that a patient with severe pain from bone cancer is addicted to the drug. Which one for the following actions is the most appropriate for the pharmacist? A) Report the situation to the state board of pharmacy B) Report the situation to the state medical board C) Report the situation to the DEA D) Refuse to fill an further prescriptions E) Continue to fill the prescriptions
E
PI: Hospital inpatients receiving oral estrogen therapy must receive pt package inserts a) every day b) only with the first dose c) only at the first dose and when being discharged d) at least every 7 days e) at least every 30 days
E
label: Which of the following is NOT required on the label of unit dose packages prepared in a hospital? A) name of the drug B) beyond-use expiration dating C) control number D) strength of drug E) manufacturer's expiration date
E
label: Which one of the following types of information is useful but not mandatory on the labels of OTC products? A) name of manufacturer B) address of manufacturer C) net contents D) adequate directions for use E) NDC number
E
legend: Which one of the following designations for drug products that require a prescription in the United States has replaced the designation "Caution: Federal law prohibits dispensing without a prescription"? A) Do not dispense without a prescription B) Do not transfer to a third party C) Federal law prohibits use by anyone other than the original patient D) Legend drug E) Rx only
E
According to the present DSHEA, an herbal product such as saw palmetto may be labeled to state: A) cures prostatitis B) help treat prostatitis C) will return the prostate to normal size D) helps in prevention of prostate cancer E) for the prostate
E (DSHEA: dietary supplement health and education act)
label: Which one of the following reference sources is the first choice when a manufacturer is determining the preferred name of an additive for a product label? A) CTFA Cosmetic Ingredient Dictionary B) Food Chemical Codex C) USAN D) USP Dictionary of Drug Names E) USP/NF
E) USP/ NF
OBRA: Who is responsible for the retrospective drug utilization reviews established by OBRA 90/ a) all dispensing pharmacists b) consultant pharmacists c) individual community pharmacies d) hospital pharmacies e) each state
E) each state
OBRA: The acronym, DUR, is most closely associated with which of the following A) Drug clinical trials B) Medicare reimbursement C) MedWatch D) Drug nomenclature E) Patient counseling
E) pt counseling
label: Which of the following information must be included in the bar code of drug products being sold to hospitals? I NDC numbers II Lot numbers III Expiration dates
I only
The term "grandfathered" refers to drugs that were marketed before
FD and C act of 1938
Who is responsible for determining if a food or drug is safe and effective enough to be sold to the public?
FDA
Med Watch
FDA utilizes a system to receive info about adverse events or product problems 1-800-332-1088
Ads: The main responsibility for oversight of prescription drug advertising rests w the A) FTC B) FDA C) HCFA D) DEA E) USP/NF
FDA- Rx, FTC - OTC (Ach2)
HCFA is under the jurisdiction of the A) Attorney General B) HHS C) JCAHO D) FDA E) Dept. of Justice
HHS
USP: What acronym is used by the USP to designate sterile products that are prepared in a home infusion pharmacy for delivery to a patient's home residence?
HSD
CS: Mescaline
Hallucinagenic substance found naturally in peyote cactuses ; Cause very severe side effects and binds to dopamine and serotonin receptors in the brain. Schedule I
HAR
Hawaii Administrative Rules
How may a physician obtain cocaine HCl powder for use as a local anesthetic in his office?
He may order it directly from a supplier using DEA Form 222
common examples of C-I Drugs (5)
Heroin, marijuana, herbal incense (synthetic cannabinoids), bath salts (synthetic cathinones), LSD
HSD
Home-use Sterile Drug Products
CS: A pharmacist may partially fill a Schedule II prescription I. and the remaining portion of the prescription may be filled within 72 hr of the partial fill II. if the pharmacist does not have enough medication in stock to completely fill the prescription III. If the patient only wants some of the medication prescribed.
I & II only
CS: A physician wishes to prescribe a schedule II controlled substance for a patient residing in a hospice. How may the prescription be conveyed to a pharmacy? I. As a written prescription II. By fax III. By email
I & II only
CS: Which of the following is/are true regarding the sale of codeine-containing schedule V cough medicine without a prescription I only a pharmacist may dispense the product to the consumer II a non-pharmacist may "ring up" the sale and collect payment for the product III Not more than 120mL or 24 dosage units of this product may be sold to the same purchaser in any 7 day period
I & II only
CSA: Which of the following are exempt from registration under the Controlled Substance Act? I. A US Army physician II. A US Public Health Service physician III. A foreign-trained physician
I & II only
Labels of OTC products that are for systemic use must include a warning specifically intended to protect: I pregnant women II nursing women III geriatric women
I & II only
OB: Which of the following reference sources contain significant information concerning the bioequivalence of drug products? I Electronic Orange book II USP/DI III USP/NF
I & II only
medicare: Which of the following statements concerning Medicare Plan D is/are correct? I The plan is voluntary for persons on Medicare II Insurance companies may limit prescription drug quantities to 30 day supplies for some drugs III Insurance companies may require participants to receive prescriptions from mail order pharmacies
I & II only
CS: which of the products listed below would be considered to be Schedule III controlled substance? I. A product that contains 90 mg of codeine per dose II. A product that contains 15 mg of hydrocodone per dose III. A product that contains 2.5 mg of diphenoxylate and 25 mcg of atropine sulfate per dose
I & II only III would be a CV
Which of the following drug products are controlled substances? I. Lyrica II. Versed III. Risperdal
I & II only Lyrica (Pregabalin) CV Versed (Midazolam) BZD CIV Risperdal (Risparidone) antipsychotic not a CS
222: Which of the following items must be ordered from a wholesaler on DEA order form 222? I Morphine HCL injection 10 mL vials (10mg/mL) II Meperidine HCL tablets 50 mg III diazepam tablets 10 mg
I and II only
CS: When a pharmacist conducts a controlled substance inventory, which of the following must be included I Drugs stored in a warehouse for the registrant at a different location II Drugs ordered by a customer but not yet paid for III All controlled substances dispensed over the past 30 days
I and II only
CS: Which of the following are NOT controlled substances? I Ergotamine tartrate II Papaverine III levorphanol
I and II only
Which of the following barbiturates are classified as Schedule II CS's? I amobarbital II pentobarbital III butabarbital
I and II only butabarbital =
When a schedule II prescription is partially filled for a LTCF patient I. the prescription is valid not more than 60 days from the issue date II. the pharmacist must write "LTCF patient" on the prescription III. the total quantity dispensed cannot exceed 100 dosage units
I and II only (long-term care facility)
CS: A pharmacist who fills an oral morphine sulfate prescription in an emergency does not receive a "cover" prescription from the prescriber. The pharmacist must I. notify the regional DEA office II. notify the state board of medicine III. call the patient and request that s/he obtain a written prescription to cover the oral order
I only
DSHEA: Which of the following statements on a cranberry extract label would be acceptable under DSHEA regulations I. To help maintain a healthy urinary tract in females II. To reduce the incidence and duration of UTIs III. TO reduce E coli counts during a UTI
I only
OB: Certain drug products are exempt from the requirement therapeutic equivalence because of: I. the grandfather clause II. their use in chemotherapy III. their high therapeutic index
I only
OH: Uses for tax-free alcohol purchased by a hospital may include: I. incorporation into formulas for inpatient orders II. incorporation into prescriptions for recently discharged patients III. selling of small amounts to independent pharmacies based upon their immediate prescription needs
I only
The classification of drugs into CS's by the federal government is based upon the drug's I. potential for abuse and dependence II. therapeutic index III. toxicity
I only
Under which of the following circumstances may Ipecac Syrup be sold w/o a prescription I. For future possible use during accidental poisoning II. Only if the household does not have small children III. For limited use in a weight-loss program
I only
Under which of the following situations would a drug product be considered misbranded? I. An original bottle labeled 50 tablets contains 60 tablets II. The concentration of tetracaine ointment 5% W/W is only 2% III. The manufacturer can not prove the sterility of a labeled "sterile Diphenhydramine Injection
I only
Which of the following forms are used to apply for a new DEA registration for a community pharmacy? I. Form 224 II. Form 222a III. Form 222
I only
inspection: Which of the following conditions must exist for the inspection of a pharmacy by an authorized inspector? I. inspection must be conducted during the regular business hours of the pharmacy II. The owner of the pharmacy or a designated supervising pharmacist must be present III. The inspector must have a search warrant
I only
ipecac: The label of a bottle of Ipecac Syrup sold OTC for accidental poisoning must: I. have its warnings printed in red ink II. contain the telephone number of the regional poison control center III. state that the appropriate dose is the entire bottle followed by a full glass of water
I only
CS: Which of the following are Schedule IV controlled substances? I. zolpidem II. buprenorphine III. methylphenidate
I only buprenorphine = C-III Methylphenidate (Concerta) = CII
CS: Which of the following barbiturates is classified in a controlled substance category IV? I. Phenobarbital II. Pentobarbital iII. Amobarbital
I only - these are all Barbiturates (sedatives) Phenobarbital (Luminal) long-acting C-IV Pentobarbital (Nembutal) short-acting C-II Amobarbital (Amytal) intermediate-acting C-II
CS: Which of the following are Schedule II controlled substances? A) morphine tablets B) fentanyl injection C)secobarbital capsules
I, II and III
222: Which of the following drug products must be ordered using DEA form 222? I. Methadone II. Sufentanil III. Percocet
I, II, & III
222: Which of the following is true of DEA Form 222? I May be used to transfer Schedule II drugs from one pharmacy to another II May be used to return Schedule II drugs to the supplier III It must contain the name and address of the supplier from whom schedule II controlled substances are being ordered
I, II, & III
CS: Controlled substance prescriptions I. may be written by typewriter (except for the prescriber's signature) II. Must have the name of the physician printed, stamped typed, or hand-printed on it. III. may be prepared by an agent of the prescriber for the prescriber's signature
I, II, & III
CS: When conducting controlled substance inventory, the registrant I. must make an exact count of open containers of schedule II substances II. may estimate the count of a schedule IV substance in an open container that originally held 500 tablets III. must make an exact count of all controlled substances in sealed, unopened containers
I, II, & III
CS: Which of the following are examples of Schedule I substances? I Lysergic acid diethylamide II Mescaline III Peyote
I, II, & III
CS: Which of the following controlled drugs may a pharmacist mail through the US postal service I. Schedule II's II. Schedule III's III. Schedule IV's
I, II, & III
HIPAA: A pharmacist telephones a patient's home concerning the availability of a prescription refill. With which of the following may the message be left? I patient's wife II patient's mother III patient's brother-in-law
I, II, & III
Mr. Hess has not picked up a prescription that was filled last week. Which of the following actions is (are) legal for the pharmacist to take? I. Call the pt at home and leave a message w/ his son II. call the pt and leave a message on his home answering machine III. Send an e-mail to the pt
I, II, & III
The statement, "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" is required on prescription containers for which of the following categories of drugs? I. Schedule II II. Schedule III III. Schedule IV (Ach5)
I, II, & III
Under which of the following situations would a drug product be considered adulterated? I. an herbal product that contains American ginseng rather than Chinese ginseng listed on the label II A product on the shelf for sale past its expire date III A sterile parenteral solution contains a few microorganisms
I, II, & III
Which of the following drug products must be purchased using a DEA Form 222? I. Methadone II. Methylphenidate III. Fentanyl
I, II, & III
label: The statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is not required for I. controlled substances dispensed for use in "blinded" clinical investigations II. dispensing Schedule V drugs III. dispensing controlled substances to be administered to a pt in an institution
I, II, & III
label: which of the following types of products in a hospital pharmacy must be barcoded? I prescription drugs II biological III nonprescription drugs
I, II, & III
mail: A pharmacist may fill prescriptions for and mail which of the following drugs through the US Postal Service? I Schedule II non-narcotics II Benzodiazepines III Schedule II narcotics
I, II, & III
rems: Which of the following entities must register in order to participate in the prescribing or dispensing of isotretinoin? I. Prescribers II. Pharmacies III. Drug wholesalers
I, II, & III
samples: Which of the following actions is (are) NOT allowed in a community pharmacy with respect to prescription drug samples? I. Storing II. Ordering based upon a specific prescriber's request III. dispensing upon receipt of a prescription
I, II, & III
label: According to federal law, a pharmacist must include which of the following on a prescription label? I Name of dispensing pharmacy II address of dispensing pharmacy III name of dispensing pharmacist IV A prescription serial number
I, II, & IV
medicare: When explaining the Medicare Plan D program to a married couple, the pharmacist should emphasize that which of the following applies to each individual? I. the original annual deductible II. the monthly premium III. the "donut hole"
I, II, and III
Partial filling (federal) of a schedule IV controlled substance prescription is permissible, provided that I. each partial filling is recorded II. the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed III. No dispensing after 6 mo from date of issuance. (HI 3 mo)(Ach5)
I, II,& III
222: Which of the following drug products must be purchased by pharmacies using DEA Form 222? I Strattera II MS Contin III Concerta
II & III
222: Which dosage forms of secobarbital must be ordered using a DEA form 222? I suppository II Injectable III Capsule
II & III only
A faxed Schedule II prescription from the prescriber to a pharmacy is permitted I. at any time as long as it is followed by a written "cover" prescription II. If a patient is a resident of a LTCF III. If the patient is a hospice patient
II & III only
CS: Schedule III, IV, or V controlled substances may be refilled I. not more than 6 times II. not more than for a 6 month period III. only if authorized by the prescriber
II & III only
Drug products with which of the following codes may be substituted for one another? I. B II. AB III. A
II & III only
PPPA: When refilling a prescription that requires a child-resistant container, the pharmacist must always replace which of the following I the glass container II the plastic container III The plastic closure
II & III only
USP: Which of the following reference book(s) are legal documents recognized by the federal government? I. Remington's Pharmaceutical Sciences II. Homeopathic Pharmacopeia of the US III. USP/NF
II & III only
Which of the following categories of drugs require the legend "Rx only" to be on the manufacturer's package I. Schedule V controlled drugs II. Schedule II controlled drugs III Schedule III and IV controlled drugs
II & III only
Which of the following statements concerning drug recalls is (are) accurate? I They occur only after fatalities have occurred II They may be ordered by the FDA III They may be voluntary actions by the pharmaceutical manufacturer
II & III only
label: the names of which of the following ingredients are required to be included on the labels of pharmaceutical products I. flavoring oils II coloring agents III antimicrobial preservatives
II & III only
sample: Which of the following protocols must a hospital pharmacy follow in order to possess pharmaceutical manufacturer's drug samples? I The hospital must be registered as a drug wholesaler II The hospital must store the samples separate from the regular stock III A licensed practitioner must have requested the samples from the company
II & III only
Schedule II prescriptions I. may only be refilled once II. may be partially filled under certain conditions III. written for a hospice pt may be faxed to a pharmacy
II & III only (Ach5), Hospice pts for narcotic C-II drugs. Faxed Rx can serve as the original.
222: Which of the following is true about DEA form 222? I If it contains incorrect information the supplier may correct it and initial the correction II If an order cannot be filled by a supplier the form must be returned to the purchaser III If any forms are lost, the loss must be reported to the DEA
II and III only
PPPA: Permission to not use a child resistant closure on a prescription may be granted by the I. Pharmacist II. Prescriber III. Patient
II and III only
label: The presence of which of the following drugs or adjuvants in a commercial drug product requires a special label warning? I. methylparaben II. sulfites III. aspartame
II and III only
CS: Which of the following products are Schedule III controlled substances? I. Percodan tablets II. Fiorinal Capsules III. Tylenol with Codeine #4
II and III only, percodan = CII
CS: A product that contains 60 mg of coedine and 325 mg of acetaminophen is most likely to be classified as Schedule:
III
CS: A pharmacist who does not receive a registration renewal form from DEA within 45 days before the expiration of his/her registration must notify I his/her state's board of pharmacy II the regional FDA III the DEA in writing and request renewal forms
III only
CS: Controlled substances prescriptions may be issued by prescribers I. to obtain controlled substances for dispensing in their office II. to prescribe drugs to be used by a patient for narcotic detoxification III. to prescribe controlled substance for a patient with chronic pain
III only
DD: A prescription for methadone is issued for the purpose of managing a patient's narcotic addition by a physician employed by a narcotic treatment facility. The prescription I. may be filled in most community pharmacies II. may be filled only in outpatient institutional pharmacies III. may not be filled
III only
DD: Patients treated in an ambulatory care comprehensive narcotic treatment program may receive methadone doses by which of the following routes? I IV II IM III oral
III only
Ephedra may no longer be present in which of the following products in a community pharmacy? I) nonprescription drug products II) Herbal teas III) Dietary supplements
III only
Oral orders for Schedule II drugs may be accepted and dispensed by a pharmacist I. if a patient is a regular customer of the pharmacy II. if the physician is more than 100 miles away from the pharmacy III. in an emergency situation
III only
PPPA: In which of the following situations are child-resistant closure NOT required? I) when a community pharmacist dispenses fewer than 10 tablets of a drug product II) when a hospital pharmacy is filling a Rx for an outpatient III) when a hospital pharmacy fills a prescription for an inpatient
III only
PPPA: Which of the following OTC products must be in a tamper resistant package? I topical lotion II hair shampoo III contact lens solution
III only
USP: Which of the following volumes of the USP DI contains significant information concerning the bioequivalence of drug products? I. Volume I II. Volume II III. Volume III
III only
Which of the following is true of Schedule V substances I. They all contain codeine II. When they are dispensed by the pharmacist, the federal transfer warning must be on the container labeling III. Some states may permit sale of these products without a prescription
III only
medicare: Which of the following actions by a company offering Medicare Plan D coverage is(are) NOT permitted? I charging a $250 deductible II eliminating an deductible charge to the patient III limiting the choice of pharmacies to only one community chain
III only
sample: Under which of the following conditions may a pharmaceutical sales representative distribute samples of a prescription drug product? I Upon written request from a community pharmacy II Upon written request from a hospital pharmacy III Upon written request from a physician
III only
CS: Eszopiclone is an example of a drug product in controlled substance schedule
IV
Phenobarbital (PB) is a drug that is classified as a Schedule ___ drug
IV
JCAHO
Joint Commission on Accreditation of Healthcare Organizations; the agency responsible for inspecting facilities in timed intervals in order for the facility to maintain "accreditation"
OTP: Only ___, ____, ____ and ____ are authorized drugs for treatment of opioid addiction.
LAAM (Levo-alpha-acetylmethadol), methadone, buprenorphine SL and buprenorphine-naloxone
3 main functions of BOP hawaii
Legislative - review statues, determine necessity to propose statutory amendments Adjudicatory - basically disciplinary actions - holding ch 91 HRS Executive - review each application for new licensees;
DSHEA statement --> allowed if sentence uses words like
Maintain or supports
new 2009 guideline made it easier for companies by not requiring __ approval for the off-label use and 60 day prior notification no longer required (Ach2)
NDA
what is the function of the NABP? (5) 1. oversees the administration of the ___ 2. serves as a forum for the development of ____ 3. develops model ____ & ___ for member boards 4. supervises ______ bw states 5. facilitates communication bw states in pharmacist _____
Naplex, professional policies and standards, legislation and regulation, licensure transfers, disciplinary actions.
Which law introduced DUR?
OBRA 90
OIG
Office of the Inspector General
OTPs
Opioid Treatment Programs
CS: 7 common examples of C-II Drugs
Opium, morphine, amphetamine, oxycodone, methadone, cocaine, fentanyl.
CS: Do pharmacists need to register with the DEA?
Pharmacists employed by a registered pharmacy or institution need NOT be individually registered.
trial: What number is given to the clinical trial phase that consist of post-marketing surveillance of a drug that was recently introduced to the market
Phase IV
The Consumer Product Safety Commission is responsible for which one of the following? (Ach3)
Poison Prevention Packaging Act (1970) establishes the standards for child resistant containers
CS: Lysergic acid diethyl amide
Powerful hallucinogen derived from ergot, a fungus found on rye and other grains. "acid" LSD. Schedule I
461-11 duties of registered pharmacist
RPh in charge of notify the board when you change jobs within 10 days.
BOP: RICO
Regulated Industries Office - reviews cases against pharmacists for possible disciplinary action
USAN
The United States Adopted Names Council (USAN) designates non proprietary (generic) names for drugs.
legend drug
Require a prescription by a licensed practitioner for dispensing; Drug label: "Caution: Federal law prohibits dispensing without a prescription", AKA prescription drugs
A new cough syrup contains 15 mg of codeine phosphate and 100 mg of guaifensesin in each 10 mL dose. A 4 fluid ounce container of this product would likely be classified as
Schedule V (CV cannot contain more than 200mg codeine per 100ml or 100g, this product would be 150mg/100ml, Ach5))
label: methylparaben
What ingredient in topical anesthetic is used as an antioxidant, bacteriostatic, and fungistatic with container that is repeatedly opened and closed. not used after 1984 because of reactions.
Proposed regulations from the FDA are first published in the: A) Federal Register B) Congressional Record C) New York Times and Wall Street Journal D) USP/NF E) Supplements of the USP/NF
a
orphan: A drug that is marketed for the treatment of a relatively rare disease is referred to as a(n): A) orphan drug B) me-too drug C) prodrug D) USAN drug E) first pass effect drug
a
CSA: A SW requires convincing a judge with evidence that ___ on the premises. An AIW under the CSA the probable cause requirement is defined as ___
a crime has been or will be committed, valid public interest
electronic prescription
a prescription or certificate of medical necessity, which is electronically transmitted or conveyed, including a fax.
misbranding: A pharmacist dispenses a refill for a prescription that originally was written for Adalat but labels the refill as Procardia. This action may be considered: a) misbranding b) adulteration c) misbranding since the generic name was not included d) proper since the correct drug was dispensed e) negligent only if the prescriber is not informed
a) misbranding
trial: Which of the following clinical trial stages is conducted exclusively in healthy humans? a) phase I b) phase II c) phase III d) phase IV e) phase I and II-
a) phase I make sure this is correct
Drug
articles recognized in the official USP, official homeopathic pharmacopoeia, or official National Formulary, or any supplement to any of them; (2) articles intended for use in the diagnosis, cure, mitigation, tx, or prevention of dis in humans or animals; (3) articles (other than food or clothing) intended to affect the structure or any function of the body of humans or animals;
BOP: powers and duties include
adopt, amend and repeal rules
NDA: The drug patent of an innovator company has expired. Which one of the following must a second drug company submit to place a generic form of the drug product onto the market? a) Investigational new drug application b) Abbreviated new drug application c)New drug application d)Generic drug application e) Supplemental new drug application-
b) abbreviated new drug application
label: When listing an ingredient on a product label, all of the following references may be used by manufacturers as primary sources for names EXCEPT: a) CRFA Cosmetic Ingredient Dictionary b) Facts and Comparisons c) Food Chemicals Codex d) USAN E) USP dictionary of Drug
b) facts & comparison's
samples: The selling of drug samples in pharmacies is prohibited by which one of the following Federal acts? a) DSHEA b) Prescription drug marketing act c) Durham Humphrey Amendment d) Sherman Act E) Drug price competition act-
b) prescription drug marketing act
OTP: the only drugs permitted (under DATA?) for the treatment of opioid dependent pts are
buprenorphine SL (Subutex) and buprenorphine-naloxone (Suboxone) tablets.
a civil law established by following earlier judicial dicisions
case law
list the Copy#, color, and who retains (for how long) DEA form 222
copy 1, tannish to supplier copy 2, green to DEA copy 3, blue retained by purchaser must be maintained separately from all other record and retained for 2 years. (Ach5)
Pharmacist in charge
during any absence of the pharmacist, rxs may not be filled, compounded, or received by telephone
grand: All of the following drugs fall into the category of "grandfathered drugs" EXCEPT a) thyroid b) ephedrine c) epinephrine d) phenobarbital e) ampicillin
e) ampicillin
The CSA created a closed system via registration and established _____
established national uniformity in the production, prescribing, and dispensing of (CS) controlled substances.
How would you define pharmacy practice? Now
far broader definitions reflecting the clinical roles the pharmacists perform such as DUR, providing clinical consultations to other health care professionals and pts, and administering immunizations
CS: DEA
federal agency responsible for enforcing laws and regulations governing narcotics and controlled substances
What is a food
food for human, dog, cat consumption, chewing gum --> Color additive not included --> food is not a drug
The purpose of the "board" is to protect the public ___, ___, and ____.
health, safety, and welfare
Misbranding
imitates another drug. ex; 1. label says Levoxyl 88 mcg but RPh put l-thyroxine 88 mcg in the bottle. 2. Dispensed Rx w refill but no refill authorized by dr.
is a fax an electronic Rx?
in Hawaii = yes
Color additive
is a dye, pigment, or other substance made by a process of synthesis or similar artifice. 2. when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through rxn w other substance) of imparting color thereto
misbranding
label is false or misleading, False or misleading labeling. Includes: Prescription container label, drug dispensed to a patient without "adequate directions for use", sold or refilled w/o a valid prescription, is dispensed without the required patient package insert (PPI) or Medication Guide, violation of child-resistant container law relating to Poison Prevention Packaging Act of 1970. KC pharmacist watered-down drugs = misbranding
BOP: Committees w/in the board
legislative, rules, scope
CS: anyone who ___, ___ or ___ controlled substance must register with DEA
manufactures, distributes or dispenses
Is amphetamine a narcotic?
no
CS: Are all C-II drugs narcotics?
no i.e. amphetamines
renewal of license, when and how many hours CE?
on or before Dec 31 q odd# year, 30 CE hours every 2 years
How frequently may a patient with a Medicare-endorsed discount change his/her provider?
once a year
Medicare: What are the 4 parts of Medicare?
part A: Hospital, inpatient part B: outpatient part C: Advantage part D: Rx
BOP: Exam, license
passing score = 75% for all exams if you fail, you can retake only the part you fail. can take 5 times? 90 days between. Law exam typically 30 days between.
trial: The first phase of a clinical trial, which evaluates the efficacy of the drug in treating a specific disease, is:
phase II
PPPA
poison prevention packaging act: mandates the use of safety caps. Not to be confused w "tamper resistant", the purpose of this act was to decrease the likelihood of childhood poisonings. Prohibits the reuse of plastic vials and requires child prevention packaging on all medications w a few exceptions.
Licensed physician vs practitioner
practitioner- dentist, vet, nurse
DSHEA statement --> not allowed if words like ____ are used
prevent
Civil action
private party sues for alleged injury --> monetary award
off-label prescribing and dispensing is legal under the FDCA. Off-label prescribing and dispensing requires ___ (Ach3)
professional evaluation of the risk vs benefit. (new 2009 guideline made it easier for companies by not requiring NDA approval for the off-label use and 60 day prior notification no longer required)
PHI
protected health information: info about a pts past, present, or future physical or mental health or payment for health care that can be used to id the person
in 1990 the OIG found that pharmacy boards focused too much on offenses such as alcohol and drug abuse and didn't focus enough on reviewing the _____ in their licensure actions. only in the past few years have state boards considered outcomes as being important.
quality of pharmaceutical care
Although the states are empowered to regulate the practice of the professions directly, the federal govt may indirectly regulate professional practice in 2 sig ways
regulating the drug product, may establish conditions for participating in programs that it funds
CSA: ___ and the ___ often work collaboratively when controlled substances are the subject of the investigation.
state boards, DEA
Adulteration
strength, quality, or purity differs from compendia standards unless plainly stated on the label
Packaging for a nonprescription products that is designed to prevent the addition of foreign material into the final product is best described as being:
tamper evident
HIPAA
the Health Insurance Portability and Accountability Act, a federal law protecting the privacy of pt-specific health care information and providing the pt w control over how this information is used and distributed.
perhaps the most important function of the state BOP is
the granting of licenses to pharmacists and to pharmacies. (ensures the competence of the individuals who practice pharmacy)
OB: the Electronic Orange Book uses the symbol "RLD," in a series of similar drug products to indicate:
the product used as reference standard
adulteration
the tampering or contamination of a product or substance, made less pure
CS: Manufacturers and distributors must register with the DEA every ___
year.
OTP: Can you dispense Suboxone at a retail pharmacy for maintenance of addiction?
yes
OTP: Can you dispense methadone at a retail pharmacy for pain?
yes, but if for anything other than pain then NO! Any licensed, registered pharmacy may dispense methadone, but only for its analgesic indication.
Is cocaine a narcotic?
yes, but it is a CII not a CI
