Law Midterm

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Choose each correct answer "Dispense" under the CSA includes which of the following:

A. Administering a controlled substance (e.g., an injection) B. Prescribing a controlled substance C. Dispensing from a community pharmacy

A physician who is out of town for 7 days would like to telephone a prescription to your pharmacy for oxycodone 15mg, 1 tab, po, q4h prn pain; nothing else works for this patient. Under federal law which of the following is/are true? (Choose each correct answer.)

A. An emergency phone order is permissible under these circumstances D. You are permitted to dispense a quantity sufficient to cover the emergency period (7 days)

"Prescription" under the CSA would include which of the following?

A. An order for a controlled drug dispensed to a patient at a community pharmacy.

Which of the following is/are "mid-level" practitioners Please choose each correct answer

A. Certified registered nurse anesthetists B. Physician assistant C. Optometrists D. Nurse midwives

Which of the following is a schedule II? Please select each correct answer.

A. Codeine 15mg B. Hydrocodone 5mg with acetaminophen 325mG D. Lisdexfetamine 10mg caps

(Choose each correct answer.) Administrative agencies such as the DEA:

A. Enforce the law. B. Promulgate (write) regulations. C. Are part of the executive branch.

Which of the following is/are C-V (select all correct answers)

A. Ezogabine B. Lacosamide D. Gabapentin E. Lyrica F. Lomotil G. Epidiolex

You have received a prescription for a controlled substance from Lucretia P. Driftwood, a (female) Nurse Practitioner. Her DEA number is MH7251376I. The DEA number is invalid because the check digit does not match the 7th digit II. The DEA number is invalid because the second letter does not match the first letter of her last name III. The DEA number is invalid because the first letter is incorrect.

A. I only

The "public interest" standard, as applied by the Department of Justice through the DEA (select each correct answer)

A. Is the lens used for reviewing applications for registration C. Would take into account the presence of a 'supporting' state license D. Would take into account the ability to participate in Medicaid and/or Medicare E. Would take into account any act that is inconsistent with the public interest

Which of the following is/are C-II (select all correct answers

A. Pentobarbital capsules D: Secobarital injection G: Amobarbital capsules

Which of the following is/are C-IV? (select all correct answers)

A. Phentermine B. Phenobarbital C. Meprobamate

Select each correct answer. You discover that the physical inventory for diazepam 5mg tablets is five short of what you should have after subtracting records of dispensing from records of receipt. What factors are relevant to determine whether this is "significant".

A. The volume of diazepam 5mg dispensed in your pharmacy B. Patterns associated with shortages of other controlled substances C. Strange behavior by co-workers

Which of the following must register with DEA as a ³distributer´"(Select all that apply

A. Wholesalers E: Pharmacies when they exceed 5% of total dosage units by "non-prescription" sales

A patient approaches you to transfer a prescription for tramadol from another community pharmacy in the 'chain' where you work. The chain has a centralized database of prescription drug information. Under federal law:

A. Yes you may do this without contacting the other site if the database will automatically record the transaction and the refill

You receive a prescription for 180 oxycodone 5mg with instructions to take "1 tablet every 4 hours as needed for pain". It is issued by an oncologist, you have no reason to suspect forgery and you know that the patient is suffering from severe pain associated with metastasis to the bone. The patient's medical record indicates that has been treated for opiate addiction recently having received several weeks of Suboxone (buprenorphine) therapy. Can you fill this oxycodone prescription?

A. Yes, there is a legitimate medical purpose

You receive a faxed order for a 30-day supply of Oxycontin 80mg "1 tablet 2x daily" for a patient at a long-term care facility

A. You may fill this prescription as is

Which of the following is a schedule II? Please select each correct answer.

A: Codeine 15mg tablet B: Clorpheniramine w/hydrocodone liquid (Tussionex) C: Cocaine ophthalmic drops F: Dexmethylphenidate 5mg

The "public interest" standard, as applied by the Department of Justice through the DEA (select each correct answer)

A: Is the lens used for reviewing applications for registration C: Would take into account the presence of a 'supporting' state license D: Would take into account the ability to participate in Medicaid and/or MedicarE E: Would take into account any act that is inconsistent with the public interest

Select each correct answer.) You discover that the physical inventory for diazepam 5mg tablets is five short of what you should have after subtracting records of dispensing from records of receipt. What factors are relevant to determine whether this is "significant

A: The volume of diazepam 5mg dispensed in your pharmacy B: Patterns associated with shortages of other controlled substances C: Strange behavior by co-workers

You receive a prescription at your community pharmacy for suboxone and the patient informs you that it is to prevent immediate withdrawal from addiction to heroin. There is no evidence of chronic pain, and the prescription is correct in all other ways. Can you legally fill this prescription?

A: Yes, suboxone is approved for this purpose

³Dispense´under the CSA includes which of the following: i. Administering a controlled substance (e.g., an injection) ii. Prescribing a controlled substance iii. Dispensing a controlled substance by a community pharmacy

A: i, ii, and iii

When completing an inventory of controlled substances:

An exact count of all CII medication is required

Which of the following is a schedule III? Please select each correct answer.

B. Codeine 15mg with acetaminophen 325mg tablets D. Dronabinol 2.5mg capsules G. Dianabol 10mg

Fillomena T. Firefly ("Fill"), a pharmacist, receives a prescription for oxycodone 15mg, 100 tabs, but only has 10 in stock. She calls her colleague, Haywood Jabuzzoff, in the pharmacy across the street and Haywood tells her he can spare a bottle of 100 tablets. Fill says she will take them. In order to legally obtain the oxycodone, Fill must

B. Execute a 222 Order Form by properly completing the form, keep copy 3 and send copies 1 and 2 to Haywood's pharmacy

A hospice patient presents a prescription for 60 morphine 60mg sustained-release, take 1 tab 2x daily. She requests a 14 days supply today to find out how well it works for her and asks if she could get 28 tabs today and the remainder in a week. You have 300 in stock. Can you grant this request?

B. Yes, she has up to 60 days to get the remainder

CV controlled substances: i. Are limited to 5 refills within 6 months ii. Must contain the following on the prescription label dispensed to the patient "Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it is intended" iii. Under federal law may be dispensed without a prescription if the statement "Rx-only" is not present (i.e., "non-legend" drug)

B. iii only

The "corresponding responsibility" rule: i. relates to the requirement that patients are equally responsible for success in medication therapy ii. relates to the rule that counseling may not be delegated iii. requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose

B. iii only

Which of the following is/are C-III (select all correct answers)

B: Anabolic steroids D: Acetaminophen 325mg with codeine 15mg E: Dronabinol capsules F: Butalbital with aspirin G: Paregoric (camphorated tincture of opium

Which of the following is/are C-V (select each correct answer)

B: Lacosamide (Vimpat) D: Promethazine with codeine (10mg/5ml) liquid F: Lomotil (diphenoxylate with atropine)

The ³corresponding responsibility´of pharmacists (Please select each correct answer

B: Permits only prescriptions that are issued in the usual course of professional practice C: Requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose

Which amendment to the Food, Drug, and Cosmetic Act required proof of bioequivalence compared to the "pioneer" or brand-name drug

B: Waxman Hatch (Drug Price Competition and Patent Term Restoration Act) 1984

You receive a telephone order for a 30-day supply of Oxycontin 80mg "1 tablet 2x daily" from the physician next door for a patient residing in a nursing home; a written prescription could be delivered by office staff, but it is not not convenient.

B: You may fill not fill this without a written prescription, this is not an emergency

Which of the following is/are C-IV (select all correct answers)

B: diazepam (Valium) C: Tramadol (Ultram) D: Carisoprodol (Soma)> E: Meprobamate (Miltown) G: Modafinil (Provigil)

Which of the following agencies regulate controlled substances? i. The federal agency is called the Federal Trade Commission ³FTC´ii. The Virginia state agency is called the Board of Pharmacy iii. The federal agency is called the Food and Drug Administration ³FDA´

B: ii only

According to federal law, CV controlled substances: i. Are limited to 5 refills within 6 months ii. Must contain the following on the prescription label dispensed to the patient "Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it is intended" iii. May be dispensed without a prescription if the statement "Rx-only" is not present in labeling (i.e., "non-legend" drug)

B: iii only

For the purposes of receiving telephone orders, an "emergency situation":

C. Requires that no alternative medication is available

The Orphan Drug Act:

C: Provided incentives for the manufacturer to develop products with limited market potentiaL

You receive a fax order for a 30-day supply of methylphenidate 10mg "1 tablet 2x daily" for a patient enrolled in the hospice program

C: You may fill this; no follow-up prescription is required

The landmark case US v. Sullivan (decided by the US Supreme Court) i. Established that Congress µinterstate commerce¶power extends to dispensing by a pharmacist even though it is completely 'intra-state' in nature ii. Determined that the FDA¶s paper new drug application policy ³Paper NDA´is inconsistent with the Drug Efficacy (Kefauver-Harris) amendments to the Food, Drug, and Cosmetic Act iii. Established that pharmacy practice could be regulated by federal law

C: i & iii

You receive an emergency telephoned prescription for hydrocone 5mg/acetaminophen 325mg. The pharmacist immediately reduces the order to writing and properly prepares and dispenses the prescription. i. Follow-up prescription (Authorization For Emergency Dispensing) within 7 days ii. Maximum 5-day supply iii. Sufficient supply to cover the emergency period

C: i and iii

The policy of the federal government with regard to medical cannabis

D: Has become more flexible in recent years with regard to state-regulated programs

The Secure and Responsible Disposal Act of 2010

D: Requires DEA to make regulations that will create a process for disposal of unused/unwanted controlled substances

Which of the following would be correct regarding records of receipt by a pharmacy for controlled substances i. Invoices are acceptable records for all schedules of drugs ii. DEA Form 222 or CSOS is required for Schedule II medication iii. An invoice is required for Schedules III-V

D: ii and i

Prescriptions may be filed as follows: I. Three separate files: CII's, CIII-V's, and non-controls II. Two separate files: CII's, and CIII-VI III. Two separate files: CII-V's and CVI's

E. I, II, &III

Which of the following conditions must be met for a controlled substance prescription to be issued? i. the prescriber must be an "individual practitioner" ii. the prescriber must be authorized by state law to prescribe controlled substances iii. the prescriber must be registered with DEA, or qualify under an exception

E: i, ii, & iii

According to federal law, prescriptions may be filed as follows: i. Three separate files: CII's, CIII-V's, and non-controls ii. Two separate files: CII's in one, and CIII-V's plus non-controls in another (as long as controls are readily retrievable) iii. Two separate files: one for controls and another for non-controls (i.e., Virginia C-VI)

E: i, ii, and iii

Which of the following is/are "mid-level" practitioners for DEA purposes (assuming the state allows them to prescribe). Please choose each correct answer

Nurse practitioners> B: Pharmacists C: Optometrists D: Physician assistants

The Secure and Responsible Disposal Act of 2010

Required DEA to make regulations that will create a process for disposal of unused/unwanted controlled substances

To prescribe controlled substances in Virginia, "individual practitioners" must be:i. Permitted by state law ii. Registered with the DEA iii. Registered with the Board of Pharmacy

i and ii

You are presented with a prescription for 60 methadone 5mg tablets for a patient with chronic pain; directions to take "1 tab, orally, twice daily" delivered to you at your community pharmacy. You have 100 tablets in stock. She says she wants try a 5-day supply (10 tablets) it to see if it works, and if it does work will pick up the remainder. Without adding facts, please select the single best answer.

✓E. You may dispense the 5-day supply, and supply the remainder within 30 days of writing


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