Law Practice Quiz Review
What is the maximum amount of ethylmorphine a finished drug product can contain to be classified as schedule V? a. 100 mg b. 10 mg c. 120 mg d. 2.5 mg
a. 100 mg not more than 100 mg of ethylmorphine per 100 mL or per 100 g
Under HIPAA which of the following documents must be provided to a patient no later than the first date of delivery of health care services? a. Notice of Privacy Practices b. Protected Health Information Form c. Patient Authorization Form d. Copy of the pharmacy's Standard Policies and Procedures
a. Notice of Privacy Practices
Peyote has high potential for abuse and no medical use in the US under the CSA, it should be classified as a(n): a. Schedule I drug b. Schedule II drug c. Schedule III drug d. Unscheduled drug
a. Schedule I drug
Vitality Products makes "All-Natural Magnesium Citrate Powder" and advertises that: "Magnesium Citrate helps prevent heart attacks, lowers high blood pressure..." In light of the manufacturer's marketing, this product is most likely considered a: a. drug b. food c. dietary supplement d. cosmetic
a. drug The term "drug" means- (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B) or (C).
Under federal law, how often must a pharmacy submit self-certification of employee training on sales of listed chemical precursors (SLCP)? a. every year b. every 2 years c. every 3 years d. on January 1 of every year
a. every year
All of the following are examples of drugs that presently require a REMS EXCEPT: a. levothyroxine sodium tablets b. oxycodone c. isotretinoin d. thalidomide
a. levothyroxine sodium tablets List of drugs with REMS: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
Which of the following requires child resistant packaging: (1) Aspirin tablets- more than 25 tablets per container; (2) A unit dose pack of acetaminophen containing 4 tablets, 500 mg each; (3) A single unit dose tablet of ibuprofen weighing 600 mg a. 1 onlyterm-34 b. 1 and 2 c. 2 and 3 d. 1, 2, and 3
b. 1 and 2 because 3 is a single unit dose package, it is accepted Exempted products: - OTC drugs- one size of an OTC product designed for seniors/elders or handicapped may be in non-compliant packaging BUT- this packaging must include this statement: "This package for households without young children" OR if label is too small, it may contain "Package not child-resistant" - Drugs dispensed to institutionalized patients- Hospitals, LTC, nursing homes, rehab facilities - Examples of specific prescription drugs and controlled substances: a. Sublingual Nitroglycerine tablets b. Oral contraceptives- in memory and dispenser packages c. Preparations in aerosol containers intended for inhalation d. Methylprednisolone tablets containing not more than 84 mg per package (Medrol dosepaks)
Permission to use child resistant packaging on ALL prescriptions may be given by the: (1) Pharmacist; (2) Prescriber; (3) Patient a. 1, 2, and 3 b. 3 only c. 1 or 2 d. 2 or 3
b. 3 only Individual patients may make a BLANKET request that all of their prescriptions be filled in non-child resistant packaging Prescribers may request that A SINGLE prescription (or prescriptions they are prescribing for) be dispensed in a non-child resistant package, but they CANNOT make a BLANKET request
A pharmacy compounded the following prescription: 8g of codeine phosphate with a non-narcotic cough suppressant mixed with 500cc simple syrup. in which schedule would this be placed? a. II b. III c. IV d. V
b. III Not more than 1.8 grams of codeine per 100 mL or not more than 90 mg per dosage unit, with one or more active, non-narcotic ingredients in recognizes therapeutic amounts - if greater than this, goes into CII (1.8 x 5 = 9 g per 500cc- max for CIII)
Janet McMillian is a nurse practitioner, which of the following is an authentic DEA registration number for her? a. AM1643267 b. MM1643267 c. BM1643261 d. AJ1643261
b. MM1643267 Registrant type (first letter of DEA Number): - A/B/F/G: Pharmacy / Hospital/Clinic / Practitioner / Teaching Institution - M: Mid-Level Practitioner (homeopaths, naturopath; optometrists, PA, Pharmacist- if granted independent prescribing authority in their state, NPs) - P/R: Manufacturer / Distributor / Researcher / Analytical Lab / Importer / Exporter / Reverse Distributor / Narcotic Treatment Program - Last name- first letter of last name or company name. Practitioner's aren't required to get a new number if they change their last name - Unique identifier is randomly generated - The last digit is the validity check - TO CHECK IF A NUMBER IS VALID: - Add the first, third and fifth digits: 1+3+5= 9 - Add the second, fourth, and sixth digits and multiply by 2: (2+4+6)x2= 24 0 Add the two sums together= 9+24=33 - The last digit of the summed total should match the last digit of the DEA#
Which of the following programs is designed to provide health care for the indigent? a. Medicare b. Medicaid c. Medicare Part A d. Medicare Part D
b. Medicaid
Prescription for compounding orders 6.5 g acetaminophen with 1.4 g codeine. The resulting mixture should be filled in 20 capsules of equal weight. This compounded product should be classified as: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V
b. Schedule III each capsule will contain 70 mg of codeine, this is less than 90 mg per dose and the codeine is mixed with a non-scheduled substance 1400 mg codine/20 capsules = 70 mg
Under the FDCA, a drug: a. must be labeled, "Caution Federal law prohibits dispensing without a prescription" or "RX Only" b. is a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals c. is a product intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body d. is a product where the container or labeling bears the trade name of the drug product
b. is a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals a. is incorrect because OTC drugs do not need this c. is the definition of a cosmetic d. generic drugs will not have the trade name
Patient presents for a refill, but has no refills authorized. The pharmacist prepares the refill, applies the label, and sets it aside on the shelf for patient pickup before calling the doctor for authorization. This is: a. adulteration b. misbranding c. both d. neither
b. misbranding
On a busy morning, a patient presents a prescription for 250 mg Augmentin tablets. The pharmacy tech fills the prescription and prints the label. While verifying, the pharmacist doesn't notice that the medication in the bottle is 500 mg Augmentin. This is: a. adulteration b. misbranding c. adulteration and misbranding d. neither adulteration or misbranding
b. misbranding What is misbranded (THINK LABEL) - False or misleading labeling - Labels lacking: NAME and PLACE of business of the manufacturer, packer or distributor, and ACCURATE statement of the QUANTITY of the contents in terms of weight, measure, or numerical count. - Labels of drug lacking: name of drug, the name and quantity (or if determined appropriate, the proportion of each active ingredient, and the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package for OTC - Lacking: adequate directions for use - Habit forming drug warning- up to manufacturer's discretion for labeling, but required to describe the habit forming characteristics on the drug in the Drug Abuse and Dependence section of package insert - Established name of drugs- law requires listing of any active ingredients for both prescription and nonprescription drugs and the quantity of each active ingredient. Usually need to include a list of the established name of each inactive ingredient in alphabetical order (unless nonprescription drug is also a cosmetic or not for human use). - Adequate directions for use- labeling must include adequate directions for use and adequate warnings against use by children and others for whom it may be dangerous. - Adequate labeling must include: a. Quantity or dosage for each intended use and for persons of different ages and physical conditions b. Frequency of administration/application c. Duration of administration/application d. Time of administration/application (in relation to meals, onset of symptoms, or other factors) e. Route or method of administration or application f. The preparation necessary for use (shaking, dilution, etc.) g. Adequate information for use- some drugs can't be labeled adequately to protect the consumer (prescription drugs) which makes them exempt. Label must include: h. Drug's indications i. Side effects j. Dosages k. Routes, methods, frequency, and duration of administration l. Contraindications m. Other warnings and precautions that enable a practitioner to administer, prescribe or dispense the drug safely n. Imitation drugs are considered misbranded
Pharmacy must register as a distributor if it distributes: a. more than 2% of its controlled substances inventory to another registrant in one year b. more than 5% of its controlled substances inventory to another registrant in one year c. more than 3% of its controlled substances inventory to another registrant in 3 years d. more than 2% of its controlled substances inventory to another registrant in 6 months
b. more than 5% of its controlled substances inventory to another registrant in one year
Which DEA form is used to report theft or loss of controlled substances? a. Form 222 b. Form 41 c. Form 106 d. Form 224
c. Form 106
Which DEA form is used t report spillage/damage? a. Form 106 b. Form 222 c. Form 41 d. Form 46
c. Form 41
Which of the following can be ordered using DEA Form 222? I. Pentobarbital capsule; II. Pentobarbital suppository; III Phenobarbital tablet; IV. Marijuana to be used for medical purposes a. I only b. I and II c. I and IV d. I and III
c. I and IV DEA Form 222 required for CI and CII Pentobarbital capsule - CII Pentobarbital suppository - CIII Phenobarbital tablet - CIV Marijuana - CI
The provisions of OBRA-90 a. require than an offer to counsel must be face to face with patient b. require than an offer to counsel must be made only by the pharmacist c. apply only to patients covered by Medicaid d. allow an offer to counsel be made by posting a sign in or near the pharmacy
c. apply only to patients covered by Medicaid - offer doesn't have to happen face to face, can happen over the phone - any pharmacy personnel can offer a counsel - cannot post a sign as offer to counsel
Which of the following statements is true under the FDCA? a. compounding a prescription product that is commercially available is never permitted b. if a compounded product contains no prescription drug ingredients, the pharmacy is permitted to compound and sell the product "over the counter" without receiving a prescription drug order c. compounding for a doctor to administer the drug in her office is permitted even if the pharmacist doesn't know the specific identity of the patient d. a pharmacy is always required to have a patient specific prescription in hand before compounding
c. compounding for a doctor to administer the drug in her office is permitted even if the pharmacist doesn't know the specific identity of the patient - would not be able to compound products for doctors to SELL in their office - compounding commercially available products is permitted if there is a shortage of that drug - compounding and selling over the counter is considered manufacturer - a pharmacy can compound a prescriptions based on historical fills
Which of the following statements is accurate regarding the labeling requirements for OTC which are transferred from a larger container provided by the manufacturer to a smaller container for the sale to public? a. this practice is unsafe, and prohibited by federal law b. this practice is permitted, provided that the name and quantity of the unsafe drug is placed on the label c. the activity is regulated by the FDA as drug manufacturing d. the FDA takes no position in this issue
c. the activity is regulated by the FDA as drug manufacturing
A drug product consisting of tablets may be declared adulterated for all of the following reasons EXCEPT: a. the active ingredient has undergone partial decomposition b. the tablets contain an unapproved color additive c. the strength on the label does not match the strength of the drug in the container d. the manufacturing plant failed to meet cGMP
c. the strength on the label does not match the strength of the drug in the container **this is MISBRANDING Drug is deemed adulterated if it is: - Prepared packed or held in conditions where it may have been contaminated - Exposed to a container that may have contaminated it - Manufactured under conditions that do not conform to current good manufacturing practices (GMP) - Drug is adulterated if its strength, quality, or purity differs from those on the label or from compendia standards if it's subject to compendia.
On March 15, 2018 a patient's father presents a prescription for 30 Adderall 5mg dated January 20, 2018. Under federal law, should the pharmacist: a. not fill the prescription since more than 30 days have passed since the prescription was written b. fill the prescription as written c. verify with the patient's provider whether there is still a legitimate medical purpose for the prescription d. not fill the prescription because it raises red flags regarding drug diversion: a person is presenting a prescription in someone else's name and the prescription was written more than 60 days ago
c. verify with the patient's provider whether there is still a legitimate medical purpose for the prescription *might want to ask for an updated prescription from the provider just to have an updated written date, but don't need to Under federal law, CIIs do not expire not uncommon for a patient's parent to have prescription filled
What is the maximum quantity of opium a compound can have to be classified as a Schedule V? a. 4 mg/mL b. 2 mg/mL c. 1.5 mg/mL d. 1 mg/mL
d. 1 mg/mL
Which of the following are Schedule IV drugs: 1. Xanax; 2. Barbital; 3. Torbutrol a. 1 only b. 1 and 2 c. 1 and 3 d. 1, 2, and 3
d. 1, 2, and 3
Which of the following can be transferred from one pharmacy to another for refill fill purposes? I. Lorazepam II. Augmentin III. Dilaudid IV. Levothroid a. II and IV b. I, II, IV c. IV d. I, II, and IV
d. I, II, and IV (I think b was a typo)
A new cough syrup contains 15 mg of codeine phosphate and 100 mg of guaifenesin in each 10 mL dose. A fluid ounce container of this produce would likely be classified as: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V
d. Schedule V Not more than 200 mg of codeine per 100 mL or per 100 g
The organization responsible for overseeing the selection of a non-proprietary name for a new drug is: a. FDA b. FTC c. USP/NF d. USAN
d. USAN United States Adopted Names USP/NF - have more to do with strength and purity FTC - regulates OTC advertisement to consumers FDA - does not give name even though it is reviewing the product
Under the Dietary Supplement Health and Education Act, a dietary supplement may contain any of the following? a. an approved drug product b. a conventional food c. a natural product d. a vitamin
d. a vitamin 1. the term "dietary supplement" - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E)
The corresponding responsibility doctrine requires that the prescriber: a. ensures that there is a legitimate medical purpose for all of a patient's controlled substance prescriptions b. and the pharmacist keep corresponding documentation regarding a patient's controlled substance prescriptions c. correspond with other practitioners the patient sees before prescribing any controlled substances for the patient d. and the pharmacist both must ensure the proper prescribing and dispensing of controlled substances
d. and the pharmacist both must ensure the proper prescribing and dispensing of controlled substances *Therefore, pharmacists must be particularly alert that the controlled substance prescriptions they receive and dispense are for a legitimate medical purpose and are issued by a lawful practitioner in the usual course of professional practice
A patient presents a prescription for 60 Vicodin to the pharmacy and tells the pharmacist he would like to get 30 tablets now and he'll return for the other 30 in aa week if the medication doesn't upset his stomach. The pharmacist is permitted to: a. dispense 30 only after calling the prescriber for permission b. dispense 30 tablets as requested by the patient c. advise the patient that the entire fill of 60 tablets must be supplied as written d. dispense the 30 tablets as requested, but advise the patient the balance must be filled within 30 days
d. dispense the 30 tablets as requested, but advise the patient the balance must be filled within 30 days b. technically correct, but d. is better - if requested by patient, a prescription may be partially filled. any remaining portion CANNOT be filled more than 30 days after the date of issue - if pharmacy can't supply the full quantity - remainder must be filled within 72 hours - terminally ill patient - partially filled within 60 days of date issued. No portion may be filled after 60 days. - LTCF patients - partially filled any number of times within 60 days, no portion may be filled after 60 days.
A hospital may use tax free alcohol for all of the following purposes EXCEPT: a. for clinical outpatient prescriptions when no charge is made to the patient b. for prescription use in inpatients c. for laboratory tests performed for hospital inpatients d. for laboratory tests performed for a private physician's office
d. for laboratory tests performed for a private physician's office for a., thing that makes it allowed is "when no charge is made to the patient"
The daytime pharmacist at Be Well Pharmacy arrives to open the pharmacy and discovers that the night shift pharmacist needed a container of 200 Dilaudid 2 mg tablets and obtained it from the Neighborhood Pharmacy down the street. Later that morning, the Be Well Pharmacy's order arrives from the wholesaler, and included three containers of 200 Diluadid 2 mg tablets. The daytime pharmacist wants to replace the borrowed container. What should she do? a. she cannot return the Dillaudid, because it's illegal to borrow opioids from another pharmacy. b. she can return the Dilaudid, and must complete a DEA Form 222, send the form to the Neighborhood Pharmacy, Neighborhood Pharmacy must retain a copy of the form, send a copy back to Be Well, and send the original to the DEA. c. she can return thee Dilaudid, complete DEA Form 222, and retain copy 3 at the pharmacy, and send copy 2 and 3 to Neighborhood Pharmacy d. she should have Neighborhood Pharmacy prepare DEA Form 222, send copy 1 and 2 to Be Well Pharmacy, Be Well Pharmacy should then send the Dilaudid container to Neighborhood Pharmacy, and retain copy 1 of the DEA Form 222, and send copy 2 to the DEA.
d. she should have Neighborhood Pharmacy prepare DEA Form 222, Neighborhood Pharmacy will retain copy 3 (BLUE) and send copy 1 and 2 (BROWN AND GREEN) to Be Well Pharmacy, Be Well Pharmacy should then send the Dilaudid container to Neighborhood Pharmacy, and retain copy 1 of the DEA Form 222, and send copy 2 to the DEA. **typo in question option but this was the answer Process: 1. Copy 1/top/brown sheet- SENT TO SUPPLIER (they fill out the NDC, packages shipped and date shipped 2. Copy 2/middle/green sheet- SENT TO DEA (VIA THE SUPPLIER- purchaser sends along with copy 1 and supplier sends to DEA when fulfilling the order with their included information) 3. Copy 3/bottom/blue sheet- STAYS WITH PURCHASER (the recipient of the order)- PURCHASER WILL ENTER NUMBER OF CONTAINERS RECEIVED AND DATE RECEIVED WHEN ORDER ARRIVES
During Phase I of an Investigational New Drug Application: a. the drug is tested on a large number of animals to determine efficacy b. the drug is tested on a large number of animals to determine safety c. the drug is tested on a limited number of healthy patients to determine efficacy d. the drug is tested on a limited number of healthy patients to determine safety
d. the drug is tested on a limited number of healthy patients to determine safety Phase 1- SAFETY (20-80 healthy volunteers) - detect adverse effects (toxicity, metabolism, bioavailability, elimination, pharmacological actions), not test efficacy Phase 2- EFFICACY (100's of patients) - determine efficacy of the drug and the dosages at which efficacy occurs Phase 3 (1,000's of patients) -tested for safety and efficacy in hundreds or thousands of patients- THINK DOUBLE BLIND PLACEBO CONTROL Animal testing happens prior to IND application