Pharmacy Practice Flashcards

1
Q

The advertised price of a prescription drug shall be in effect for:

A

The period of time stated in the advertisement

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2
Q

A pharmacist can make changes on a prescription to the (select all):

A

Drug strength, directions

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3
Q

Pharmacy students may only be granted intern permits after completing how many years of professional study?

A

One year

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4
Q

Who is permitted to counsel patients:

A

Pharmacists, pharmacy intern (not technicians)

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5
Q

Orders for PRN controlled substances in an institutional setting are not valid beyond:

A

72 hours

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6
Q

Orders for PRN controlled substances in an institutional setting are valid for how many administrations?

A

Only one administration (can be given anytime within the 72 hours)

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7
Q

An institutional dispenser may dispense how much of controlled substance to a medical attendant accompanying a patient in a transfer if it is expected to exceed 3 hours?

A

A single dose of a controlled substance

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8
Q

By which method(s) can unwanted controlled substances be disposed? Select all that apply

A

Surrender to the NY Department of Health, Return to the supplier

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9
Q

If the Department does not grant approval for the person to destroy controlled substances, the person shall surrender the controlled substances to the New York State Department of Health, Bureau of Narcotic Enforcement in the following manner:

A

(i). the person shall request a surrender date from the bureau on which to surrender the controlled substances to the bureau.

Such a request shall be made on forms provided by the bureau and must include the following information:

(a) . an inventory of all controlled substances to be surrendered;
(b) . the identity of at least two persons who conducted the inventory of the controlled substances to be surrendered. Such persons shall be New York State licensed practitioners, pharmacists or nurses;
(c) . the reason for the surrender of each controlled substance; and
(d) . the proposed date of surrender and an alternative date.
(ii) . a person may surrender controlled substances only after receiving a surrender date in writing from the bureau. The controlled substances must be shipped to the bureau no later than 5 days from the date the bureau has set as the surrender date.

Note: The bureau may set a date different than the date requested by the applicant.

Any record required to be kept under this section shall be kept for a period of 5 years.

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10
Q

The NY State Board of Pharmacy must be notified when the % of stockholders at a pharmacy corporation changes by:

A

10%

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11
Q

The Board of Pharmacy must be notified within how many days of a change in the supervisor of a registered pharmacy establishment?

A

within 7 days

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12
Q

Which of the following is not required to be electronically prescribed in the state of New York?

A

Behind-the-counter medications

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13
Q

Prescriptions may be written using the following (select all that apply):

A

Typewriter, computer, ink, non-erasable ballpoint pen, indelible pencil (not erasable)

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14
Q

Institutional dispensers with limited licenses (3a) must keep a record of controlled substance administration that includes all of the following EXCEPT:

A

Patient room number

(must include patient name, prescriber name, date and hour of administration, drug name, quantity of drug administered, balance on hand after administration, signature of the person administering the substance)

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15
Q

Which of the following is not a Schedule A poison?

A

Aconite

Poisons: poisonous vegetable alkaloids, arsenic, atropine, potassium cyanide, strychnine, corrosive sublimate, chloral hydrate

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16
Q

Which of the following is true regarding the prescribing of a controlled substance?

A

An authorized practitioner may issue a prescription in the absence of an initial prescriber if medical records indicate continual prescribing and they have direct consultation with the original prescriber assuring need.

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17
Q

Written prescriptions can be signed using a:

A

Handwritten signature (cannot be stamped or electronic)

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18
Q

What is the minimum amount of continuing education hours required for pharmacists for each 3-year registration period?

A

45 hours

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19
Q

You must register with the State Education Department every 3 years to practice your profession or use your professional title in New York State. Once you are licensed, about 4 months before your initial 3-year registration expires, you will be sent a registration renewal application assigning you to a 1-time transitional registration period. This period will…

A

end with the month prior to your date of birth between 2 and 3 years from the date of your first registration. This allows the adjustment of your triennial registration cycle to coincide with the month of your date of birth and helps to ensure a speedy renewal of your registration. The registration fee for this transitional period will be prorated so that you pay only for the number of months included in the period. Thereafter, you will be registered for a 3-year period beginning on the first day of your month of birth.

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20
Q

Prescription counseling must be performed when:

A
  • there is a new Rx for a new patient
  • there is a new medication for an existing patient
  • when there is a change in dose, strength, route, or directions for an existing Rx
  • must at least offer to counsel every time Rx is refilled
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21
Q

Methadone short term detoxification treatment may not exceed a period of:

A

30 days

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22
Q

Which of the following is true regarding pharmacy interns in the state of NY? Select all that apply.

A
  • May administer influenza vaccinations to persons 18 and older
  • intern applicants who are enrolled in pharmacy education programs must have completed their first year of professional study in order to be eligible, PharmD program graduates in NY do not need intern hours outside of the program.

• Interns can perform all the same tasks as pharmacists except interns cannot sell self-defense sprays, sign the Official New York State Rx Form or initial or sign a prescription without a pharmacist doing the same.

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23
Q

Pharmacists must keep records of all controlled substance transactions for a period of at least:

A

5 years from the date of the transaction

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24
Q

Who may review and electronically sign a prescription prior to transmission from a doctor’s office? Select all that apply

A

Only prescribers. Once signed, an agent or employee of the practitioner may transmit the Rx on behalf of the practitioner. The act of transmission must be independent of the review and signature process

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25
Q

A pharmacy must contain the following utensils: (select all that apply)
See blue book pg. 27

A

Mortar and pestle, balance device sensitive to 6 mg, graduate devices to measure from 0.1-500 mL. If needed, a pharmacy should also contain metric (apothecary) weights.

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26
Q

In addition, the pharmacy which dispenses radioactive drugs shall be equipped with at least the following:

A

a) laminar flow hood
b) dose calibrator
c) exhaust hood and filter system
d) chromatography apparatus
e) apparatus or materials for the determination of pH
f) single-channel and/or multichannel scintillation detection system
g) microscope

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27
Q

A pharmacy must keep which references?

A

• Copies of laws, rules, and regulations governing the practice of pharmacy in New York, and other reference resources as necessary

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28
Q

All electronic prescriptions must have a(n):

A

III. NPI number. All electronic prescriptions must have the same required information as written prescriptions, but must also have an NPI number.

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29
Q

Cabinets or safes to store Schedule II controlled substances must be bolted or cemented to the floor or wall if it weighs less than:

A

750 pounds

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30
Q

Who will be held responsible for misconduct in a pharmacy?

A

The supervising pharmacist and the owner

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31
Q

Exact copies of advertisements must be kept by the licensee releasing such advertisements for at least how long after their last appearance?

A

1 year (should be kept in the appropriate medium in which they were released)

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32
Q

For how long after the most recent entry must patient medication profiles be kept in a retrievable form at a pharmacy?

A

5 years after the most recent entry

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33
Q

Which poison schedule includes “…any drug, chemical or preparation which is liable to be destructive to adult human life in quantities of 60 grains or less.”? Blue book (pg. 3)

A

Schedule B poisons

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34
Q

Chains that have more than how many pharmacy locations must provide written prescription related-information in foreign languages for non-English speaking patients? See blue book pg. 24

A

8 locations

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35
Q

Pharmacies must keep controlled substance inventory records for at a period of at least:

A

5 years (in NY), 2 years (federal law)

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36
Q

Which of the following can be sold at auction granted there is/are proper registration/certificates? (can only sell to registered pharmacies)

A

I, II, and III: Non-controlled substances, controlled substances, drug in bulk can all be sold as long as there is proper registration and certificates. The place of auctioning must be registered by the Board of Pharmacy and be supervised by a licensed pharmacist. There must also be certificate issued by the Board of Pharmacy showing drugs in open containers have been inspected and deemed appropriate for auction.

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37
Q

What is the allowed ratio of full-time pharmacy interns to preceptors? See blue book pg. 25

A

1:1 (2:1 if part-time)

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38
Q

A sign and/or notice of the Drug Retail Price List for the top 150 most frequently prescribed medications should be:

A

posted in each pharmacy

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39
Q

A hospital physician may supervise up to how many physician assistants?

A

6

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40
Q

Standing orders or specific controlled substances orders, for individual patients, to be given at specified times while in an institution, are valid for:

A

7 days

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41
Q

Standing orders or specific controlled substances orders, for stabilized patients with convulsive disorders or chronic spasticity or minimal brain dysfunction, to be administered at specified times while in an institution, are valid for:

A

30 days. Law also applies to patients in residential health care facilities, or in prisons, which possess class III controlled substances licenses.

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42
Q

Methadone long-term detoxification may not exceed a period of:

A

180 days. Anywhere between 30-180 days.

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43
Q

Patient information required to be on a prescription issued on an official New York State prescription form includes all of the following EXCEPT:

A

Patient telephone number.

Required info includes patient name, patient gender, patient age or DOB, and patient address, city, and zip code.

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44
Q

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

A

5 years

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45
Q

All of the following are able to prescribe therapeutic drugs in New York within their scope of practice EXCEPT:

A

Doctor of Chiropractic

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46
Q

Drugs may not be sold at auction if they are expired or within how long before the expiration date?

A

30 days

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47
Q

Patients have the following options for sharing their prescriptions through shared databases among pharmacies:

A

I, II, and III:

I) The patient can select which pharmacies can share information to have prescriptions dispensed. II) The patient can allow prescription information to be shared through a database to be dispensed at any pharmacy. III) The patient can request prescriptions not be shared in a database and a firewall will need to be placed to protect the information.

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48
Q

A person must be how many years of age to be eligible for licensure as a pharmacist?

A

21 years and older

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49
Q

When mail-order pharmacies send a prescription where an alternative drug was dispensed after consultation with the prescriber, the pharmacy must: See green book pg. 77

A

Make two documented call attempts to the patient within 48 hours of mailing/delivery

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50
Q

Prescriber information required to be on a prescription issued on an official NY state prescription form includes all the following EXCEPT:

A

Office hours.

Must include: prescriber name, prescriber profession, office address and zip code, office telephone number, and NY license number. The DEA number is also required for controlled substance prescriptions.

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51
Q

What type of pharmacy may accept returns of medications for redispensing? See blue book pg. 40

A

Health care facility pharmacy (if they meet certain requirements- see pg. 40)

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52
Q

Medication carts, with the proper safeguards, may be used to stock (Select all that apply):

A

Schedule III controlled substances, Schedule IV controlled substance, Schedule V controlled substances, non-controlled substances

**Schedule II controlled substances may not be stored in medication carts.

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53
Q

All of the following are needed for a medication cart to be used to stock controlled substances EXCEPT:

A

Fingerprint ID.

Locked drawer, independent locking device, double-keyed locks, and having the medication cart stored in a secure location must be present in order to store schedule III-V medications. Access to the carts should be limited to specific authorized persons.

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54
Q

A pharmacist may have personal supervision of how many pharmacies at the same time?

A

One

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55
Q

Which of the following requirements applies to pharmacist name badges? Select all that apply.

A

Must be legible, must be worn while working

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56
Q

Drugs may be returned from a nursing home and repackaged into blister packs for redispensing as long as (select ALL that apply): See blue book pg. 40

A
  • It has not been more than 90 days since the repackaging
  • the expiration and repackaging dates are clearly marked on the package
  • the lot number is marked on the package
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57
Q

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?

A

2 weeks.

Note: the controlled substances must be destroyed in the presence of a witness who shall be a NY State licensed practitioner, pharmacist or nurse.
Such requests must be in writing and include the:
• inventory of controlled substances to be destroyed
• the specific method of destruction to be employed
• the date, time, and location of intended destruction.
• the identities of at least 2 persons to conduct and witness the destruction
• the reason for destruction
Keep the record for at least 5 years.

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58
Q

Which of the following must be electronically prescribed in the state of NY?

A

Prescription medical devices, controlled substances, non-controlled substances, hypodermic needles and syringes

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59
Q

Copies of a controlled substance prescription can be given to:

A

Only the prescriber

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60
Q

The sale of drugs at an auction must be filled with the Board of Pharmacy at least 7 days before the date of auction.

A

The date, and time, and location of auction must be included in the filing with the Board.

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61
Q

How many sets of forms are included in a DEA Official Order Forms book?

A

7 sets of forms

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62
Q

Patient profiles at the pharmacy must contain all of the following, similar to OBRA’ 90 requirements EXCEPT:

A

Preferred drug brands

Must include: 
•	Patient name, address, phone number
•	DOB or age
•	Gender
•	Chronic diseases
•	Comprehensive list of medications and relevant devices
•	Known allergies and drug interactions
•	Any other relevant information for counseling
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63
Q

Patient records must be kept: in a retrievable form for:

A

for 5 years following the date of the most recent entry.

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64
Q

What does EPIC stand for in the state of New York?

A

Elderly Pharmaceutical Insurance Coverage. The program assists those 65 years and older with supplementing drug costs from out-of-pocket Medicare Part D.

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65
Q

Each pharmacy can only be provided a maximum of how many DEA Official Order Forms books at one time?

A

6 books

66
Q

Those engaged in instructional activities that require Scheduled II-IV controlled substances must first obtain a:

A

Class 5 license

67
Q

All of the following are true regarding the transfer of drugs between pharmacies EXCEPT:

A

The transferring pharmacy must be part of the same company.

Non-controlled substances, needles, and syringes may be transferred form one pharmacy to another in the appropriate quantity to cover the amount needed for a prescription. The prescription must be waiting to be filled in order for items to be transferred.

68
Q

Pharmacists may provide immunizations to patients that are:

A

18 years and older (2 years and older for influenza)

69
Q

Which type of formulary requires that substitution of a medication be allowed for all medications except those specifically prohibited?

A

Negative formulary

70
Q

What person(s) are able to conduct and witness the destruction of controlled substances? Select all that apply

A

Practitioners, Pharmacists, Nurses

71
Q

How many continuing education hours must be from live courses during each 3-year registration period

A

23 hours

72
Q

The active ingredient in self-defense sprays must be:

A

Oleoresin of Capsicum

73
Q

The New York State Board of Pharmacy must be notified within how many days of change in 10% or more of stockholders of a pharmacy corporation? See blue book pg. 25

A

30 days

74
Q

Which of the following references is/are required to be possessed by a pharmacy in order to operate? Select all that apply:

A

Pharmacy Guide to Practice (Pharmacy Handbook), controlled substances statue (Article 33 of Public Health Law), and Rules and Regulations on Controlled Substances (Chapter II, Subchapter K, Part 80)

75
Q

All of the following drug products must have a patient package insert (PPI) provided upon each dispensing EXCEPT: See blue book pg. 52

A
  • Testosterone drug products
  • A PPI must be provided upon dispensing of these products: oral contraceptives, estrogenic drug products, progestational drug products

Note: Patient package inserts for estrogens dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first estrogen and every 30 days thereafter, as long as the therapy continues.

76
Q

Which drug characteristics authorize the FDA to require a medication guide?

A
  • the drug is one for which patient labeling could help prevent serious adverse effects.
  • the drug has serious risks relative to benefits that patients should be made aware of because it could affect their decision to use or continue to use the product.
  • the drug is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.
77
Q

Pharmacists may provide influenza immunizations to patients that are:

A

2 years and older

78
Q

Drug product information required to be on a prescription issued on an official NY state prescription form includes all of the following EXCEPT: days supply

A

Required information includes:

Drug name, drug strength, dosage form, quantity, and directions for use. The max daily dose is also required on the prescription for controlled substances.

79
Q

Which agency or agencies enforce standards of professional conduct of the pharmacy profession? Select all that apply.

A

Office of the Professional Discipline, State Education Department

The exception to this is medicine and physician’s assistants, in which standards of professional conduct are enforced by the Office of Professional Medical Conduct and the NY State Department of Health.

80
Q

The New York Board of Pharmacy consists of how many pharmacists?

A

9 (these pharmacists must be licensed for at least 5 years)

81
Q

The Board of Pharmacy must be notified within how many days of a change of location and mailing address? See blue book pg. 25

A

30 days

82
Q

Which of the following situations is an exception to required electronic prescribing? Select all that apply:

A

Exceptions include: the prescriber having a waiver of electronic prescribing from the proper authority; sending a prescription to another state; electronic or technical difficulties/failure that impair the ability to send prescriptions; and when the prescriber feels it would not be practical for the patient to receive a prescribed product in a timely manner.

83
Q

A private practice physician may employ or supervise up to how many physician assistants?

A

No more than 4 PAs and 2 registered specialist assistants

84
Q

The NY Board of Pharmacy shall have at least how many public representatives serving on the Board?

A

2

85
Q

Medications dispensed by a practitioner should have the following included on the container label (select all that apply):

A
  • name and address of the dispenser
  • the name and address of the patient
  • delivery date
  • drug name
  • drug strength
  • directions for use
86
Q

Pharmacies used for training pharmacy interns may have one intern per how many prescriptions or drug orders dispensed annually?

A

5000

87
Q

Specialist’s assistants may be registered in all of the following categories EXCEPT:
Gynecology

A

May be registered in radiology, urology, orthopedics, or acupuncture

88
Q

A waiver of electronic prescribing can be granted for up to:

A

1 year

89
Q

Who has the responsibility to inform the patient or patient’s caregiver whether the brand name or generic of a medication is prescribed?

A

The prescriber

90
Q

Pharmacies should compile a drug retail price list and update it at least once every:

A

1 week

91
Q

The public representatives serving on the NY Board of Pharmacy are appointed by:

A

Board of regents (the professional pharmacy association in NY may nominate candidates for consideration)

92
Q

Which of the following is true regarding prescriptions and foreign countries? Select all that apply:

A
  • Written prescriptions issued in a foreign country for non-controlled medications and hypodermic needles may be filled. A physician and patient relationship must exist for a prescription from a foreign country to be valid. However, for prescriptions to be valid, the prescribed product must be FDA-approved for sale in the U.S., and the prescription may not be shipped to a foreign country. The U.S. Territories of Puerto Rico, Guam, and American Samoa are not considered foreign countries.
  • Controlled substance prescriptions issued in a foreign country cannot be filled because the Official NY State Prescription is required, and it is very unlikely foreign countries would have the prescriptions and DEA registration to do so.
93
Q

How long are the appointed terms for members of the NY Board of Pharmacy?

A

5 years

94
Q

Mr. Bates is a patient that comes in for a prescription written for a generic medication. The pharmacy does not have the generic medication in stock, but Mr. Bates is in severe pain. Which of the following responses is appropriate? See blue book pg. 18

A
  • Dispense the brand name of the medication to the patient since the patient requires alleviation of severe pain.
  • In medical emergencies, prescriptions for generic medications may be substituted for a brand-name product with the generic is out of stock. A medical emergency constitutes situations where the patient is in severe pain that needs to be alleviated, situations where disability may be caused by not receiving the medication, or where a patient may take their life if not promptly treated.
95
Q

Which information that is not required on written prescriptions must be included on an oral prescription?

A

Date received, time received, signature or initials of receiver

96
Q

Schedule A poisons sold at retail must have all of the following information recorded in a book at sale EXCEPT: Age of the purchaser

A

Must include: name and address of the purchaser, the sale date, name and quantity of the poison, name of the dispenser, and the reason for the purchase

97
Q

What is the allowed ratio of registered pharmacy technicians to pharmacists?

A

2: 1 (this does not include other staff members that are helping with other non-prescription filling duties).
* May have up to four unlicensed persons in the performance of the activities that do not require licensure. The total number of individuals assisting a pharmacist cannot exceed four individuals at one time.

98
Q

A returned medication accepted by a health care facility pharmacy can be redispersed if (select all that apply):

A

It is a unit dose medication, the medication is properly sealed, the medication is properly labeled.

99
Q

If a person must surrender controlled substances to the Department of Health, they must do so within how many days of the designated surrender date?

A

5 days

100
Q

Who can grant a waiver of electronic prescribing to a practitioner?

A

The New York State Health Department

101
Q

A medical facility has an approved waiver from electronic prescribing and has sent a prescription by fax. Which of the following are requirements for a fax prescription?

A
  • Must be manually signed
  • Must be on an official NY State prescription form if issued in NY
  • Must be an original hard copy prescription
102
Q

Prescribers must register with the NY State Department of Health Bureau of Narcotic Enforcement to prescribe controlled substances, and this registration must be renewed every:

A

2 years

103
Q

Repacking of a medication shall include records of all of the following information EXCEPT: expiration date of medication repacked

A
  • Must include: drug name, drug strength, drug quantity
  • Lot #
  • Date of repacking
  • # of packages prepared
  • # of dosage units in each package
  • name of manufacturer, and/or distributor
  • the signatures of the person repacking
  • the supervising pharmacist
104
Q

A pharmacist dispensed a 30-day supply of Lyrica for a patient. How many days before the end of the supply can the pharmacist dispense a refill of Lyrica, assuming there are refills?

A
105
Q

A pharmacist dispensed a 30-day supply of Lyrica for a patient. How many days before the end of the supply can the pharmacist dispense a refill of Lyrica, assuming there are refills?

A

7 days (for all schedule III-V controlled substances)

106
Q

Hospitals must report medication errors that result in (select all that apply):

A

Permanent harm, near death of a patient, death of a patient

107
Q

Under what program are hypodermic needles and syringes allowed to be sold without a prescription?

A

Expanded Syringe Access Demonstration Program (ESAP)

108
Q

Mr. Douglas comes into the pharmacy wanting to purchase hypodermic needles and syringes without a prescription. In order for him to be able to do this, all of the following must apply (select all that apply):

A
  • the pharmacy must have a special permit to sell them without a prescription
  • the patient only purchases 10 or fewer hypodermic needles/syringes
  • the patient must be at least 18 years of age or older.
109
Q

Narcotic addiction treatment programs must file a report summary of controlled substance activity in the preceding month to the Department by the:

A
110
Q

Unless there is an exception, which of the following is/are required to send prescriptions electronically?

A

All practitioners EXCEPT veterinarians must send prescriptions electronically.

111
Q

Within how many business days must a pharmacist communicate with a prescriber that a medication has been substituted when an FDA-listed interchangeable product (biologic) when DAW is not on the prescription?

A

5 business days

112
Q

Without a practitioner’s authorization, a pharmacist can add the following to a controlled substance prescription (select ALL that apply):

A

Patient address, patient age, patient sex

113
Q

Graduate of nonregistered and nonaccredited pharmacy programs working full-time for at least 12 months means there must be how many total hours completed working as a pharmacy intern?

A

2080

114
Q

When a brand name medication is dispensed in place of a generic product in cases of an emergency situation, what must be recorded on the back of the prescription? Select all that apply.

A

The date, hour, and nature of the emergency situation must be recorded on the back

115
Q

Pharmacy chains with how many stores in the U.S. must participate as a take-back site as part of the Drug-Take-Back Act?

A

10 or more stores

116
Q

Who is allowed to request non-child-resistant drug containers?

A
  • Patient, Prescriber (there should be some form of written record of such requests).
  • A patient may change their mind at any time.
  • However, the prescriber cannot issue a blanket waiver for all prescriptions (only the patient)
117
Q

Who enforces the Poison Prevention Packaging Act (PPPA)?

A

U.S. Consumer Product Safety Commission (CPSC)

118
Q

What constitutes a test failure for unit dose packaging?

A

When any child opens or gains access to the number of individual units that may produce serious personal injury or serious illness, or, when a child opens or gains access to more than 8 individual units (whichever # is lower)

119
Q

The PPPA authorizes manufacturers and packers to package such substances in non-complying packaging of a single size provided that:

A

complying packaging is also supplied and the non-complying packages are conspicuously labeled to indicate that they should not be used in households where young children are present.

The label “This package for households without young children” must appear conspicuously on the package. If the area of the principal display panel is too small to accommodate the statement required, the substitute statement, “Package not child-resistant” may be used.

120
Q

Upon the closing of a pharmacy, records from the sale of self-defense sprays must be forwarded to whom?

A

The State Police Records Unit

121
Q

Pharmacist misconduct can include:

A

Dispensing the wrong drug, incorrect drug strength, dosage form, and/or wrong directions

122
Q

Controlled substances 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 locked storage unit as long as it does not exceed a:

A

72-hour supply

123
Q

In order to obtain a license as nuclear pharmacist, a pharmacist must complete:

A

at least 200 hours of didactic instruction and supervised practical experience in nuclear pharmacy.

124
Q

Official NY State prescription forms may be canceled by the commissioner by notifying the prescriber how long before such cancellation date?

A

6 months

125
Q

A pharmacist must complete at least:

A

500 hours of supervised practical experience in nuclear pharmacy, along with 200 hours of didactic training requirements, to become a certified nuclear pharmacist.

126
Q

What information is required to be on a pharmacist’s ID badge?

A

Name, title

127
Q

What is an outsourcing facility?

A

A facility that is engaged in the compounding of sterile drugs, is registered as an outsourcing facility with the Secretary of Health and Human Services, and complies with the applicable requirements of federal and state laws, including section 503B of the Federal Food, Drug, and Cosmetic Act.

128
Q

In New York, what entity regulates the health professions?

A

The State Education Department, under the direction of the NY State Board of Regents, administers professional regulation through the Office of the Professions.

129
Q

What is the composition of the NY State Board of Regents?

A

It includes 17 members elected by the NY State legislature to serve 5-year terms.

130
Q

What is the main function of the NY State Board of Regents?

A

To supervise educational activities within the state.

131
Q

Who is responsible for appointment the members of the Board of Pharmacy?

A

The Regents appoint members on the recommendation of the Commissioner of Health.

132
Q

What purpose does the Board of Pharmacy serve?

A

The Board of Pharmacy assists the Regents and the department on matters of professional licensing and professional conduct.

133
Q

The Board of Pharmacy is compromised of how many members? (as of April 25, 2021)

A

13 total. Includes 9 licensed pharmacists (licensed for at least 5 years), 2 registered pharmacy techs, and 2 public (non-pharmacist) members

134
Q

A Executive Secretary is also appointed to the Board of Pharmacy by…

A

the Regents on the recommendation of the Commissioner of Health. The person filling this position must also be a pharmacist licensed in NY for a minimum of 5 years.

135
Q

How do you register a pharmacy?

A

Ensure that the pharmacy contains the necessary equipment, utensils, and stocks of drugs sufficient to allow the prompt and efficient compounding and dispensing of prescriptions, pay the $345 fee.

136
Q

Renewal of pharmacy registration is required:

A

Triennially (once every 3 years) Must be conspicuously displayed in the pharmacy at all times.

Note: at the time of renewal, the owner of each pharmacy shall report under oath to the department any facts required by the Board

137
Q

What is the pharmacy registration renewal fee?

A

$260 or a pro-rated portion thereof as determined by the department

138
Q

Whose name must be included on the pharmacy registration in cases where the owner is not a licensed pharmacist?

A

The name of the supervising pharmacist

139
Q

What must be done when the pharmacist that personally supervises the pharmacy is replaced with another SP?

A

The owner must notify the Board of the change within 7 days and apply for an amended registration.

140
Q

What state government entity issues licenses for controlled substance privileges?

A

The NY State Department of Health (NYDOH)

141
Q

Registered community pharmacies without an automated dispensing system do not have to…

A

obtain a controlled substance license, but they are required to maintain federal DEA registration.

142
Q

What facilities may qualify for a class 3 license (institutional dispenser)?

A

Hospitals, veterinary clinics, mental hospitals, and similar facilities. Nursing homes may also qualify.

143
Q

For what purposes can controlled substances be used under a class 3 license?

A

Only for treating inpatients and/or outpatients seen in the facility.

144
Q

Before handling a controlled substance, an institutional dispenser must obtain a:

A

a Certificate of Approval from the Commissioner of Health

145
Q

Institutions obtaining official New York State prescriptions shall establish a system of control and security, which will include the following:

A
  • a record of all such prescriptions received
  • a record of all such prescriptions assigned to staff practitioners
  • a system requiring that such prescriptions be kept under lock and key when not in use
  • a system whereby official prescriptions are surrendered to the institution if the practitioner to whom they were assigned terminates his affiliation with the institution
  • a system whereby the Bureau of Narcotic Enforcement, New York State Department of Health, is notified immediately of the loss, destruction or theft of any such official prescriptions assigned to the institution
  • a system whereby the institution has a sufficient number of official prescriptions in reserve for use by the institution
146
Q

A supervising pharmacist (i.e. pharmacist manager or pharmacist-in-charge) may be a part-time employee.

A

False, must be a full-time employee. 30 hours or more/week is considered full-time.

147
Q

What is the pharmacy is open less than 30 hours per week?

A

In these cases, the SP must be employed for a majority of the time the pharmacy is open.

148
Q

Every pharmacy shall be under the immediate supervision and management of a…

A

licensed pharmacist (not necessarily the SP) at all hours when open.

149
Q

How many pharmacies can a pharmacist supervise at one time?

A

One

150
Q

If a pharmacy get a new SP, in what time frame must the Board of Pharmacy be notified?

A

Within 7 days

151
Q

Who is responsible for notifying the Board of Pharmacy when there is a change in the identity of the SP?

A

The pharmacy owner

152
Q

What information must be included on a Rx for a non-controlled substance medication?

A

• Prescriber’s name, address, phone #, profession, registration #, and
signature (electronic signature for e-Rx)
• Date written
• Patient’s name, address, and age
• Name, strength, and quantity of the prescribed drug or device
• Directions for use

153
Q

If missing or unclear, what info. can the pharmacist add to the face of the Rx with permission of the prescriber? *does not need to be recorded on Rx if info is readily retrievable from the computer

A
  • Patient’s address and/or age*
  • Strength and/or quantity of the drug
  • Directions for use
  • Prescriber’s address, phone #, and/or profession*
154
Q

When a pharmacist reduces an oral Rx to writing, he/she must…

A

sign or initial the Rx. (can be done electronically). For refills, also include date, time, and name of prescriber on the back.

155
Q

What does it mean when a prescriber indicates “PRN refills” on a non-controlled substance Rx?

A

Limited to one refill

156
Q

The date on the label of a refilled Rx bottle must be the…

A

date of the refill.

157
Q

Pharmacies must maintain a readily retrievable daily record of all prescriptions…

A

filled and refilled

158
Q

What information must be recorded in the daily record?

A

The prescriber, the patient, the signature or initials of the dispensing pharmacist, and the Rx #

159
Q

The daily record may be maintained by…

A

a manual system or by an electronic data processing system (computer).

160
Q

When refiling a Rx, what information must be documented on the Rx?

A
  • Amount dispensed
  • Date dispensed
  • Signature of dispensing pharmacist
161
Q

If the prescriber fails to furnish the original official NY Rx within 72 hours, the pharmacist must notify…

A

the NYDOH in writing within 7 days from the date of dispensing.