Juris exam 2

What agency is responsible for the federal Controlled Substance Act (CSA)?

Drug Enforcement Administration (DEA)

Which DEA form must be completed and submitted to the DEA upon discovering a **theft or significant loss** of controlled substances?

DEA Form 106

When a pharmacy submits a DEA Form 222 (single sheet) to purchase Schedule II controlled substances, who keeps the original copy of the DEA Form 222?

The supplier

What DEA form is necessary to **purchase or transfer** Schedule II controlled substances?

DEA Form 222

Which DEA registration form is used for pharmacies to register with the DEA **to possess and dispense** controlled substances?

DEA Form 224

Under Federal in which case(s) must an exact count be taken while performing a controlled substance inventory?

The bottle holds more than 1000 tablets or capsules

The scheduling of controlled substances at the federal level is performed by the

U.S Attorney General

Who is authorized to sign a DEA Form 222 at a community pharmacy?

The pharmacist who signed the most recent application for renewal of the pharmacy’s DEA registration or someone authorized under a power of attorney

Under Federal Law a pharmacy may keep what records at a central location other than the location registered with the DEA?

Controlled substance shipping and financial records

Drugs that have a high potential for abuse and severe potential for dependence with no currently accepted medical use in the U.s are classified as:

Schedule I

Which agency is responsible for the federal controlled substance act CSA?

Drug Enforcement Act

Under federal law, what is not a schedule III controlled substance?

Meperidine

Under federal law, which of the following is a Schedule II controlled drug?

Hydromorphone

Drugs that have high potential for abuse and severe potential for dependence with no currently accepted medical use in the U.S are classified as

Schedule I

T/F. Every business, including pharmacies that sell scheduled listed chemical products must be registered with the DEA number and renew their DEA license/registration every three years

False

The scheduling of controlled substances at the federal level is performed by the

U.S attorney general

T/F. Hospitals or other institutions may authorize the intern, resident, or foreign-trained physician to dispense or prescribe under the hospital DEA registration.

True

Under federal law how long must controlled substance records be maintained?

2 years

Under NYS Law how long must controlled substance records be maintained?

5 years

Under Federal Law Testosterone products are what class controlled substance?

CIII

Under NYS Law Testosterone products are what class controlled substance?

CII

Under Federal Law Benzodiazepines products are what class of controlled substance?

CIV

Under NYS Law Benzodiazepines products are what class controlled substance?

CIV

T/F. Under NYS and Federal Law CII controlled substances can be called in by agents of the prescriber

False

T/F. Under Federal Law Issuance of multiple prescriptions for schedule II controlled substances is allowed to achieve a 90 days supply.

True

T/F. Under NYS Law Issuance of multiple prescriptions for schedule II controlled substances is allowed to achieve a 90 days supply.

False

In Federal controlled substance law, if a pharmacist is unable to provide the complete quantity of a prescription for a schedule II controlled substance, the remaining quantity must be provided to the patient within a maximum of?

72 hours

Under federal law, within how many days after authorizing an emergency oral prescription of a CII controlled substance shall the prescribing individual provide a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist?

Seven days

The federal controlled substance act (CSA) does not defined what constitutes an emergency. Therefore, a practitioner may determine if an emergency exists and how many dosage units may be prescribed in an emergency.

True

Pursuant to federal law an agent of an authorized prescriber of controlled substances may delegate the transmission of an emergency oral order of a schedule 2 substance to a dispenser.

False

T/F. You receive a prescription for Adderall 20mg XR capsules, with the directions that read “Take 1 capsule by mouth everyday MDD= 1 capsule”. The prescriber has omitted their DEA number on the prescription. Without prescriber authorization you may add the prescriber DEA number to the prescription.

False

T/F. You receive a prescription for Adderall 20mg XR capsules, with the directions that read “Take 1 capsule by mouth everyday MDD= 1 capsule”. The prescriber has omitted the strength of the medication on the prescription. With prescriber authorization you may add the strength of the medication to the prescription.

True

T/F. You receive a prescription for codeine sulfate 30mg tablets with the directions that read “Take 1 tablet by mouth every six hours as needed MDD = 4 tablets”. The prescriber has omitted the patient age on the prescription. With prescriber authorization you may add the patient age to the prescription.

True

T/F. You receive a prescription for codeine sulfate 30mg tablets with the directions that read “Take 1 tablet by mouth every eight hours as needed MDD = 3 tablets”. The prescriber has omitted the quantity to be provided. With prescriber authorization you may add the quantity to be dispensed to the prescription.

False

Partial dispensing of CIII-V controlled substances is legal under federal law if no dispensing occurs beyond six months from the date on which the prescription was issued.

True

Pursuant to the New York State law known as I-STOP(aka PMP), which provision apply?

A practitioner must access the PMP within 24 hours prior to prescribing a controlled substance in schedule II-IV

Under federal law a CV controlled substance may be dispensed without a prescription to a purchaser at a retail location provided they are at least what age?

18

PMP is mandatory for whom?

Prescriber of controlled substances

T/F. The central fill pharmacy **receiving** the transmitted prescription must write the words “central fill” on the face of the original prescription.

False

Pharmacists may designate access for whom to the PMP registry?

Registered pharmacists

Registered pharmacy interns

Which changed may a pharmacists make on a prescription for a controlled substance transmitted to the pharmacy electronically?

Add a treatment code with practitioner authorization

A pharmacy must report to the I-Stop PMP regarding the filling of prescription for controlled substances in schedules II-IV within which time frame?

24 hours of the delivery of filled prescription

A prescriber receives a failed transmission message for an e-prescription. She reduces the prescription to writing on an official NYS prescription form. She indicates on the prescription that it was originally transmitted electronically to your pharmacy, and that the transmission failed. Before filling this prescription, the pharmacist must:

Check the pharmacy records to confirm if the original prescription was received and filled

Void the paper prescription if the original e-prescription successfully transmitted

What is the maximum allowable days’ supply on an appropriately coded anabolic steroid prescription?

6 months

Match the codes with the diagnosis codes

A: Panic disorder

B: ADHD

C. Movement disorder exhibiting seizure, convulsive, or spasm activity

D. Relief of pain in patients suffering from conditions known to be chronic or incurable

E. Narcolepsy

F. Hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroid or chorionic gonadotropin, metastatic breast cancer in women, anemia and angioedema

In New York State, pharmacists can provide a PMP report, upon request from the following law enforcement agent:

copies of a PMP report shall NOT be provided to Law Enforcement

In an emergency situation, a prescriber may orally prescribe a schedule IV controlled substance (except benzodiazepines) for not more than a

30 day supply

In hospitals, routine medication orders are renewed how often?

Not permissible

In a hospital, PRN orders for controlled substances are valid for what period of time?

72 hours

Controlled substances CIII through CV for a specific patient in an institution may be stored with the patient’s other medications in the care unit in a locked medicine cart or hocked storage unit as long as it does not exceed how many hour supply?

72 hour

Hypodermic needle and syringe prescriptions are valid for a of

2 years

When unwanted controlled substances are going to be destroyed, the person(s) wanting to destroy the substances must send a request for permission to the department at least how long in advance of the intended destruction date?

2 weeks

Medication carts, with the proper safeguards, may be used to stock

Schedule III, IV, V controlled substances

Within an emergency medication kit in a nursing home, how many of the allowable controlled substances may be in injectable form?

3

If an emergency kit is used at 8:30AM on March 30th, by when does the user need to notify the pharmacist?

8:30AM March 31st

Verbal orders for medications in emergency kits, located in a nursing home, after being reduced to writing, must be counter-signed by the prescriber within

48 hours

To qualify for a pharmacist’s license, an applicant shall be a minimum of what age?

21 years

State Board of Pharmacy (BOP) shall be notified within __ days of any change in the officers of the corporation or in stockholders holding ___ percent or more of the stock in the corporation

30 days and 10%

The BOP shall be notified within a period of ___ whenever any establishment registered by the board is damaged by fire, flood, or other disaster.

48 hours

You are the supervising RPh of your own pharmacy. You also own a generic wholesaler company with a partner. Your partner has fallen ill and will not the ability to be at the facility. You may legally take her place as the supervisor of the company.

False

In NYS Manufacturers, Outstanding Facilities (503b) and Wholesalers must maintain their records for how many years?

5 years

A pharmacy is required to have a weighing devise sensitive to what mg?

6 mg

What form does a pharmacy in NY use to order anabolic steroids?

No specific form is required

Which drugs are included in Schedule III?

Suboxone

Tylenol with 30 mg Codeine

The ownership of a registered pharmacy, upon resignation of a supervising pharmacist, must appoint another pharmacist as the supervisor

Immediately

The minimum period of time a pharmacist in NYS must be licensed and registered before being designated as the supervising pharmacist (pharmacist in change) is

There is no minimum time stated in the law

To be appointed as the supervising pharmacist in a community pharmacy that is open for 90 hours per week, the designated pharmacist must practice at that site for a minimum of how many hours per week?

30 hours per week

The minimum space designated as the compounding and dispensing area in a registered community pharmacy is

100 square feet

How many hours of formal continuing education on processes and strategies to reduce medication/prescription errors does a pharmacist in NYS need for maintenance of their registration?

3

How many hours of CE pertaining to pharmaceutical compounding does a pharmacist in NYS need for maintenance of their registration?

3 hours

Per registration period, how many hours of live continuing education does a pharmacist need for maintenance of their license registration?

23 hours

A New York State registered outsourcing facility reports to the executive secretary of the state board of pharmacy the identification of the drugs compounded. This report shall include NDC of the source drug on bulk, active ingredient, the strength of the active ingredient per unit, and other information. How often must report be provided to the secretary?

Every 6 months (twice a year)

You are a pharmacist working in a NYS Article 28 facility. You are supervising two registered pharmacy technicians, How many additional unlicensed persons can you supervise at the same time?

2

For a patient to receive expedited partner therapy, they must have parent consent if they are under 16 years of age.

False

Expedited partner therapy prescriptions can be written on an official NYS prescription form because they are part of the state wide blanket waiver.

True

Expedited partner therapy law overrides the requirement that prescriptions include a patient’s name, address, and age

True

A refill authorization or a new prescription for a drug a patient has recently been treated with is not considered a new prescription

True

You may dispense a prescription to a patient if the patient declines counseling or refuses to be counseled

True

Mail order and “internet” pharmacies must provide live counseling to a patient before the prescription can be mailed

False

Oral prescriptions (non-controls) may be called in from an agent (employee) of the prescriber

True

A prescriber’s written signature is qual to their E-signature and both are what validates a prescription

True

Every prescriber in NYS must use E-prescribing

False

A pharmacist or intern can only administer immunization and emergency treatment of anaphylaxis pursuant to non-patient specific order

False

Which immunizations may pharmacists and interns who are properly certified to administer to patients 18 years of age and older in NYS?

Pneumococcal

HPV

Hep A

Hep B

Diphtheria

Pertussis

Influenza

Zoster

Human papillomavirus

Measles

Rubella

Varicella

COVID-19

Meningococcal

Tetanus

Mumps

Which immunization may be administered by pharmacists in NYS to children as young as 2 years of age?

Influenza

Which of the following practitioners may a pharmacist enter into a collaborative practice agreement with in NYS?

Medical doctor

Pharmacists certified to engaged in collaborative drug therapy management can do what?

Change a prescription drug strength

Change the frequency of administration

Change the route of administration

Order laboratory tests to determine effectiveness

Who may write a non-specific order for a certified pharmacist to immunize for influenza?

NP

Nursing homes may accept returns of what?

Unopened blister packs

Verbal orders for medications in emergency kits, located in a nursing home, after being reduced to writing, must be counter-signed by the prescriber within

48 hours

Record of poison sales must be kept on file for inspection for at least how many years from the last entry?

5 years

Within how many business days following the dispensing of a substituted biological product, the dispensing pharmacist or the pharmacists’s designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer?

5 days

In this jurisdiction, when a prescriber indicates PRN refills on a non-controlled substance prescription what is the maximum number of times this prescription may be refilled?

1 time

A patient comes to your pharmacy to return a 80g tube of triamcinolone 0.1% cream they received yesterday. They realized they have 2 more tubes at home already. The box is still sealed by the manufacturer, therefore you may place the product back in stock for future use and give the patient a refund.

False

When repacking drugs in customized patient medication packages (patient med-pak or patient medication package, commingled) what is the longest expiration date that may be placed on the packaging?

60 days from the date of preparation or the shortest expiration date on the original containers

Which medication should not be included in customized patient packaging? aka pill-pack or commingled

Zolpidem

How many days prior to the state of drugs at auction must you file with the state board of pharmacy the date, time, and place of the auction?

7 days

An unlicensed person may measure, weigh, compound or mix ingredients, or engage in or assist in compounding

False

As a pharmacy owner you have the right to prevent or refuse to permit any board member or department representative to enter a pharmacy or any other establishment for the purpose of lawful inspection

False

In this jurisdiction, where there has been a Class I recall if a prescription drug, pharmacies shall make a reasonable attempt to notify all patients that have been prescribed and who are currently taking such recalled drug dispensed from such pharmacy by phone or by mail within how many days of the pharmacy being notified of such recall?

3 days