Review of Everything Flashcards
1
Q
Which duties may be performed by a pharmacy technician in a Class A pharmacy?
A
a. Initiating and receiving refill authorization requests.
b. Initiating electronic transfer requests between pharmacies sharing a common database.
c. Entering prescription data into a computer system.
d. Taking a stock bottle from the shelf for a prescription.
e. Preparing and packaging prescription drug orders.
f. Affixing prescription labels and auxiliary labels to a prescription.
g. Reconstituting medications.
h. Loading bulk drugs into an automated counting or dispensing device provided a pharmacist verifies that the device is properly loaded prior to use.
i. Loading prepackaged containers previously verified by a pharmacist or manufacturer’s unit-of-use packages into an automated dispensing machine.
j. Bulk compounding.
k. Compounding nonsterile prescription drug orders after appropriate training.
I. In a Class A-S pharmacy, compounding sterile preparations after appropriate training.
m. Receiving oral prescription drug orders for dangerous drugs and reducing these orders to writing either manually or electronically. (Pharmacy technicians only)
n. Transferring or receiving a transfer of original prescription information for a dangerous drug on behalf of a patient. (Pharmacy technicians only)
o. Contacting a prescriber for information regarding an existing prescription. (Pharmacy technicians only)
Note that pharmacy technicians can receive verbal prescriptions, transfer prescriptions, and receive transfer of prescriptions for dangerous drugs but not for controlled substances.
2
Q
Which individual is responsible for ensuring all inventories of controlled substances are taken?
A
Pharmacist-in-charge
3
Q
Pharmacist Bill orders and receives a bottle of generic glipizide from his supplier. Bill notices the label of the bottle is crooked and some of the lettering on the label appears to have different fonts in the same word. Bill calls the supplier to verify the transaction data and learns that the lot number on the bottle is not a valid NDC number for that brand of glipizide. What is Bill required to do?
a. Order a Class I recall of the drug.
b. Notify FDA and all trading partners of this illegitimate product.
C. Take steps to work with the manufacturer to prevent the illegitimate product from reaching patients.
d. Notify the DEA
A
B. and C.
This product is illegitimate under the Drug Supply Chain Security Act (DSCSA). After identifying a product is illegitimate, a pharma- cist must notify FDA using Form 3911 within 24 hours and take steps to work with the manufacturer to prevent the product from reaching patients. While a recall may be initiated, that is not an obligation of the pharmacy. The DSCSA is enforced by the FDA, not the DEA, so there is no requirement to notify DEA.
4
Q
What is required on the label of an OTC product?
A
a. A principal display panel, including a statement of identity of the product.
b. The name and address of the manufacturer, packer, or distributor.
c. Net quantity of contents.
d. Cautions and warnings needed to protect user.
e. Adequate directions for safe and effective use (for layperson).
f. Content and format of OTC product labeling in “Drug Facts” panel format including:
* (1) Active Ingredients.
* (2) Purpose.
* (3) Use(s) indications.
* (4) Warnings.
* (5) Directions.
* (6) Other Information.
* (7) Inactive Ingredients (in alphabetical order).
* (8) Questions? (optional) followed by telephone number.
Note: OTC products must have adequate directions for safe and effective use while prescription products must have adequate information for use (i.e., the package insert).
5
Q
A pharmacy in Texas must comply with a request from a patient for a copy of his or her prescription records within
A
15 days
In TX, 30 days federal
6
Q
Pharmacist Sally received a Preliminary Notice Letter from the Texas State Board of Pharmacy indicating that the Board intended to initiate disciplinary action against her license for allegedly making several dispensing errors. She was given an opportunity to attend an informal conference with a Board panel at which the Board offered to settle the case with a reprimand of her license and payment of an administrative penalty of $1500.
A
If Sally agrees to this settlement, she will sign an Agreed Board Order.
If Sally and the Board agree to this settlement, Sally cannot appeal the decision.
A settlement offered by the Board of Pharmacy through an informal conference is called an Agreed Board Order. If this order is accepted and agreed to by the licensee and the Board, the order cannot be appealed. A reprimand is considered disciplinary action, and the Board does have the authority to discipline a pharmacist’s license for making dispensing errors.
7
Q
What prescriptions for dangerous drugs can NOT be filled by a Class A pharmacy in Texas?
A
Prescriptions from:
DTM via verbal
Canadian/Mexican Practioners via electronic, fax, or verbal
DTM - Physician Delegated TX Pharmacist Performing Drug Therapy Management
8
Q
What prescriptions for controls schedules III-V can NOT be filled by a Class A pharmacy in Texas?
A
Prescriptions from:
DTM
Canadian/Mexican Practitoners,
Out-of-state Dependent Practitioners
9
Q
What prescriptions for controls schedules II can be filled by a Class A pharmacy in Texas?
A
Prescriptions from:
TX Practitioners Except for Optometrist
10
Q
Who is responsible for making a copy of DEA Form 222 when ordering Schedule II controlled substances?
A
The purchaser
11
Q
Which types of prescriptions are limited to a 10-day supply?
A
Prescriptions for opioids for acute pain
12
Q
Unless an exemption applies, pharmacists must check the Prescription Monitoring Program (PMP) before dispensing which medications?
A
Opioids
Benzodiazepines
Barbiturates
Carisoprodol
13
Q
Dextromethorphan
A
- Texas Health and Safety Code Chapter 488 prohibits over-the-counter sales of products containing dextromethorphan to customers under 18 years of age.
- Business establishments (including pharmacies) must require identification that indicates a customer is 18 years of age or older before providing a product containing dextromethorphan.
- These provisions of the law do not apply to products dispensed pursuant to a valid prescription.
14
Q
A pharmacy may dispense epinephrine auto-injectors pursuant to a valid prescription that does not have a patient name to which entities?
A
a. Law enforcement agencies;
b. Day care centers;
c. Child care facilities;
d. Day camps or youth camps;
e. Private or independent institutions of higher education;
f. Amusement parks;
g. Restaurants;
h. Sports venues;
i. Youth centers; and
j. Any other entity designated by rule of the Texas Health and Human Services Commission.
15
Q
Pharmacist Harry works at Community Health Services Clinic and has entered into a Drug Therapy Management Protocol with Dr. Patel that allows Harry to sign prescription drug orders for Dr. Patel’s patients. Which statements regarding this arrange- ment are true?
a. The prescriptions signed by Pharmacist Harry must be filled at the Community Health Services Clinic pharmacy.
b. Community Health Services Clinic must be a federally qualified health center, hospital-based clinic, or academic healthcare insti- tution for the prescriptions to be valid.
c. The prescriptions may not be called into a pharmacy to be dispensed.
d. The prescriptions may only be for dangerous drugs.
A
B, C, D
Signing a prescription drug order for a dangerous drug (no controlled substances) if:
(1) The delegation follows a diagnosis, initial patient assessment, and drug therapy order by the physician;
(2) The pharmacist practices in a federally qualified health center (FQHC), hospital, hospital-based clinic, or an academic healthcare institution; and
(3) The federally qualified health center, hospi- tal, hospital-based clinic, or academic healthcare institution in which the pharmacist practices has bylaws and a medical staff policy that permits a physician to delegate to a pharmacist the management of a patient’s drug therapy.
A prescription drug order “signed” by a pharmacist may be faxed to a pharmacy but may not be issued verbally.
16
Q
Regarding prescriptions that were filled but never picked up from a pharmacy.
A
- Prescriptions that have not been picked up or delivered may be returned to the pharmacy’s stock for dispensing.
- Pharmacist must evaluate quality and safety of the returned prescriptions.
- Returned prescriptions cannot be mixed in with manufacturer’s containers and must be placed in a new container when dispensed unless the prescription is in the manufacturer’s original container and the label from the undelivered prescription information is removed to prevent disclosure of patient information.
17
Q
Which individuals may administer an influenza vaccine under Texas law?
A
Pharmacist & Pharmacist Intern
18
Q
Your pharmacy has been asked to provide an Emergency Medication Kit for a nursing home. What is true?
a. A pharmacy may provide an Emergency Medication Kit to a nurs-ing home, but the kit may not contain any controlled substances.
b. A pharmacy may only provide an Emergency Medication Kit to a nursing home if the drugs are stored in an automated dispensing machine.
c. Only Class C pharmacies may provide an Emergency Medication Kit to a nursing home.
d. A pharmacy that provides an Emergency Medication Kit to a nursing home must maintain a perpetual inventory of any controlled substances in the emergency kit.
A
D
a. This rule allows a Class A or C pharmacy or a Class E pharmacy located within 20 miles of a facility to provide pharmacy services to facilities licensed under Health and Safety Code Chapter 242 (Convalescent Homes, Nursing Homes, and Related Institutions) or Chapter 252 (Inter- mediate Care Facilities for Individuals with an Intellec- tual Disability) using an Emergency Medication Kit as outlined in Section 562.108 of the Texas Pharmacy Act. It also allows a U.S. Department of Veterans Affairs phar- macy or other federally operated pharmacy to provide pharmacy services using an Emergency Medical Kit at an institution licensed under Chapter 242 that is a Texas State Veterans Home.
b. An application to TSBP is required before providing these services.
c. DEA Rule 1301.27(b) requires automated dispensing sys- tems in long-term care facilities to be registered with DEA. However, if the automated system is being used solely as an emergency kit and not for routine dispens- ing of controlled substances, a DEA registration is not required.
d. Access to the Emergency Medication Kit is limited to pharmacists and healthcare personnel employed by the facility.
e. Contents of the Emergency Medication Kit shall be deter- mined by the consultant pharmacist, pharmacist-in- charge of the provider pharmacy, medical director, and director of nursing and shall be limited to those drugs necessary to meet the resident’s emergency medication needs. This refers to a situation in which a drug cannot be supplied by a pharmacy within a reasonable time.
f. Stocking of drugs in an automated pharmacy system must be done by a pharmacist, pharmacy technician, or pharmacy technician trainee unless the system uses bar- coding, microchip, or other technologies to ensure that the containers or unit-dose drugs are accurately loaded and other specific requirements are met.
g. A record must be maintained of all drugs sent to and returned from the remote location and should be kept separate from the records of the provider pharmacy and from other remote site records.
h. A perpetual inventory of all controlled substances must be maintained for each remote location, and each remote location’s controlled substances must be inventoried on the same day as the provider pharmacy’s inventory.
Texas laws and rules do not have specific quantity limits or a list of specific drugs that can be stored in an Emergency Medication Kit.
19
Q
In a rural hospital, a pharmacy technician may perform what duties without direct supervision of a pharmacist?
A
a. Entering medication orders and drug distribution infor- mation into a computer system.
b. Preparing, packaging, or labeling prescription drugs pursuant to medication orders if a licensed nurse practi- tioner or pharmacist verifies the accuracy by electronic supervision before administration to the patient.
c. Filling medication carts used in the rural hospital.
d. Distributing routine orders for stock supplies to patient care areas.
e. Accessing and restocking automated medication supply cabinets.
Note: A nurse or practitioner at the hospital or a pharmacist through electronic supervision must verify the accuracy of the pharmacy technician performing these duties.
20
Q
Outsourcing prescription drug dispensing to another pharmacy is legally known as
A
Centralized prescription dispensing
21
Q
At which class of pharmacy are drugs not stored or dispensed?
A
Class G
process prescription drug orders or medications orders for other pharmacies, but do not possess or dispense drugs
22
Q
A zero report must be sent to the Prescription Drug Monitoring Program if a pharmacy does not dispense any controlled substance pre- scriptions for how many consecutive days?
A
7 days
23
Q
The daily sales purchase limit for pseudoephedrine products is
A
3.6 g
24
Q
The monthly sales purchase limit for pseudoephedrine products is
A
9 g
25
CMS requires that consultant pharmacists perform a medication regimen review for long-term care patients ___
every 30 days
26
To qualify as an Authorized Nuclear Pharmacist, a pharmacist who does not hold a Board of Pharmaceutical Specialties certification as a Certified Nuclear Pharmacist must complete a structured educational program of how of how many hours?
700 hrs
| 200 hrs didactic training & 500 hrs supervised experience
27
The purpose of a peer review committee in a pharmacy is to ___
Evaluate the quality of care in a pharmacy by reviewing errors or other quality issues
28
Drugs R Us Pharmacy is located on the ground floor of a high-rise office building and offers **delivery of prescriptions to the workers of the various companies** in the building. Several of the companies have established a procedure to have the prescription delivered to the front desk of their offices, and employees are notified by the front desk clerk that their prescriptions are ready for pickup at the front desk. Which statements regarding this arrangement are true?
a. This arrangement likely violates HIPAA privacy requirements.
b. This arrangement is an added convenience for patients and acceptable and legal.
c. This arrangement violates the prescription pickup rule because prescriptions delivered to a patient's place of employment are allowed only if the patient is present to accept delivery.
d. This arrangement is valid for dangerous drugs but not for con- trolled substances.
Answer A, C
a. No person, firm, or business establishment may participate in an arrangement whereby prescriptions are solicited, collected, picked up, or advertised to be picked up from any location other than a pharmacy licensed by the Board.
b. A pharmacy may, at the request of a patient, pick up pre- scription orders at the office or home of the prescriber, the residence or place of employment of the patient, or a hospital or medical care facility where the patient is receiving treatment.
c. A pharmacy may deliver prescription drugs (labeled for a specific patient) to the:
* (1) Office of the prescriber if the prescription is for a dangerous drug or for a single dose of a controlled substance that is for administration to the patient in the prescriber's office;
* (2) Residence of the patient;
* (3) Place of employment of the patient if the person is present to accept delivery; or
* (4) Hospital or medical care facility where the patient is receiving treatment.
## Footnote
STUDY TIP: An exception to this rule "a" is use of an automated dispensing and delivery system as provided in the remote pharmacy rules above.
Note: Federal law is more restrictive and only allows a pharmacy to deliver a controlled substance prescrip- tion for a specific patient to a prescriber's office if it is to be administered by injection or implant for mainte- nance or detoxification treatment. TSBP may need to modify this rule to match the federal law.
29
Dr. Trang calls your pharmacy in Houston, Texas, and asks if she can call in a prescription for Vicodin for Mr. Garcia, a cancer patient who is well known to you. Dr. Trang explains that her e-prescribing system is not working, that Mr. Garcia cannot get relief from any other pain medication, and that Mr. Garcia is unable to get to her office to pick up a written prescription. She asks if you can fill the prescription and deliver it to Mr. Garcia's house. Which is true?
1. In an emergency situation, a practitioner may provide a ver- bal prescription for a Schedule II controlled substance to a pharmacy.
STUDY TIP: Communication must be from the prescriber and not a desig- nated agent.
2. "Emergency" means that the immediate administration of the drug is necessary for the proper treatment of the ultimate user, no alternative treatment is available, and it is not possible for the prescribing practitioner to provide a written prescription.
3. The quantity prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period.
4. The prescription order must be immediately reduced to writ- ing by the pharmacist and contain all information except the practitioner's signature.
5. If the prescriber is not known to the pharmacist, the phar- macist must make a reasonable effort to determine that the phone authorization came from a valid practitioner.
6. Within 7 days after authorizing an emergency telephone pre- scription, the prescribing practitioner must furnish the phar- macist a valid electronic prescription for the controlled sub- stance prescribed.
STUDY TIP: DEA permits the practitioner to provide either a written or electronic prescription within 7 days after authorizing an emergency verbal prescription for a Schedule Il drug. Texas law specifies an electronic prescription must be provided, but if the practitioner has a waiver, it makes sense that they would need to send a written prescription.
7. If the prescriber fails to deliver an electronic (or written) pre- scription, the pharmacist must notify the nearest DEA office.
## Footnote
STUDY TIP: Remember the quantity that may be prescribed verbally in an emergency is not limited to a specific day's supply (e.g., 48 hours, 72 hours, 7 days). It is the amount needed to treat the patient during the emergency period. The only time limit is the 7 days required when the prescriber must send an electronic prescription to the pharmacy.
30
What must be included as part of a prospective drug regimen review?
(1) Known allergies.
(2) Rational therapy-contraindications.
(3) Reasonable dose and route of administration.
(4) Reasonable directions for use.
(5) Duplication of therapy.
(6) Drug-drug interactions.
(7) Drug-food interactions.
(8) Drug-disease interactions.
(9) Adverse drug reactions.
(10) Proper utilization including overutilization and underutilization.
31
Pharmacist Ann is the owner and pharmacist-in-charge at City Drug, a busy community pharmacy in Waco, Texas. In a routine audit, Ann discovers a shortage of 500 dosage units of phentermine. Ann questions her pharmacy technician, who admits to stealing the drugs.
Because this is theft it must be reported to both DEA and TSBP. Whether it is "significant" does not apply since it is a theft rather than a loss. Phentermine is a controlled substance under both fed- eral and Texas law so it must be reported to both DEA and TSBP, and DEA requires the initial report to be sent within 1 business day.
32
A busy mother comes to your pharmacy to pick up a prescription for clobetasol **cream** 0.1% for her 12-year-old son. The prescription was electronically transmitted from Dr. Turner's office to your pharmacy earlier that day, was filled by another pharmacist, and is now ready for pickup. When the mother arrives, she informs you that the pre- scription was supposed to be for clobetasol **lotion** 0.1%, even though the prescription was written by Dr. Turner for clobetasol cream 0.1%. What is true?
a. Because the prescription is for a child, you must call Dr. Turner to have the prescription changed from a cream to a lotion.
b. Because the prescription was filled by another pharmacist, you must call Dr. Turner to have the prescription changed from a cream to a lotion.
c. You can substitute the lotion for the cream and then send notification of the change to Dr. Turner.
d. You must send the mother back to Dr. Turner to get a new writ- ten prescription for the lotion.
C
Texas rules permit a pharmacist to substitute a different dosage form on a prescription and notify the prescriber later as long as the product contains the identical amount of the active ingredient, it is not an enteric-coated or time-released product, and it does not alter clinical outcomes. There are no restrictions related to age that would impact this.
33
Who is authorized to witness the destruction of dispensed dangerous drugs by a consultant pharmacist at a nursing home?
Destruction is witnessed by a
* peace officer or agent of the Board,
* Texas Department of Health and Human Services, or
* Texas Department of State Health Services, or
* 2 of the following persons from the facility:
* - the facility administrator,
* - the director of nursing, or
* - a licensed nurse.
34
Which drugs may be dispensed by a Class A pharmacy if prescribed for treatment of narcotic addiction?
Buprenorphine
Buprenorphine/Naloxone combination
35
When a pharmacy requests a transfer of a prescription from another pharmacy, the pharmacy where the prescription is held must com-plete the transfer
Within 4 business hours
36
Transfers
1. Transfers may be communicated verbally or via fax. Note: Pharmacy technicians cannot perform transfers of con- trolled substance prescriptions.
2. Transfers may also be conducted electronically as long as specific requirements are met.
3. Transfers of controlled substance prescriptions are allowed only one time unless the pharmacies share an electronic, real-time database.
4. DEA and TSBP rules do not generally permit a pharmacy to transfer a controlled substance prescription that has been received at a pharmacy but not yet filled at another pharmacy. Note: By policy, DEA and TSBP allow a controlled substance prescription to be transferred or forwarded to another phar- macy if the original prescription was transmitted electroni- cally and it can be forwarded electronically.
5. The prescription that is transferred must be voided in the computer system (or by writing "void" across the prescrip- tion if using a manual recordkeeping system).
6. An individual may not refuse to transfer a prescription, and transfers must be completed within 4 business hours of a request.
7. The electronic transfer of multiple or bulk prescription transfers is permitted.
37
Which of the following are true regarding balances in pharmacies?
a. A Class A prescription balance or analytical balance with weights is required if a pharmacy engages in com- pounding nonsterile preparations that require weigh- ing a component of the preparation. See Nonsterile Com- pounding Rule 291.131.
b. All balances must be registered with TSBP and shall be inspected for accuracy by the Board.
## Footnote
Note: The nonsterile compounding rule also requires the balance to be calibrated, that the accuracy of the balance be verified by the pharmacy at least every 12 months,
38
All partial dispensings of Schedule II controlled substances for a nursing home patient must be completed within
60 days
## Footnote
There are 3 different rules related partial dispensing of Schedule II controlled substance prescriptions.
If the pharmacy is unable to dispense the full quantity, the remaining balance must be dispensed within 72 hours.
If the patient or prescriber requests a partial quantity, the remaining quantity must be dispensed within 30 days.
If the patient is terminally ill or in hospice and this is indicated on the prescription, partial dispensings must be completed within 60 days.
39
Pharmacist Fred believes that customers would like to buy small quantities of nonprescription drugs and decides to repackage bot- tles of 100 ibuprofen 200 mg tablets into amber prescription vials of 10 tablets and then sells them to the public. The vials are labeled with the name of the drug, the manufacturer, the lot number, and the expiration date from the original bottles.
Repackaging of drugs is considered manufacturing and pharmacies generally cannot repackage drugs since they are not registered with FDA as a manufacturer. An exception to this is that a pharmacy can repackage or prepackage drugs for their own use, such as a hospital pharmacy that prepackages into unit-dose quantities or using blister packages for nursing home patients. However, because Fred is resell- ing these products to the public, this is not permitted.
40
On November 30, 2024, Dr. Williams asks you to prepare a custom- ized medication package (Med Pak) for a patient to assist with the patient's compliance. The patient takes the following 3 drugs every morning: Losartan 25 mg, Synthroid 0.125 mcg, and Hydrochloro- thiazide 25 mg. The stock bottles of the drugs to be used in the Med Pak have the following expiration dates: Losartan-December 2026; Synthroid-November 2025; Hydrochlorothiazide-June 2025. What should be listed as the beyond-use date for the Med Pak?
June 30, 2025
41
A pharmacist receives prescriptions for 12 different patients from the same physician over a 3-hour period. All of the prescriptions are written for patients from out of state and for the same combina- tion of Vicodin, Xanax, and Soma. Which of the following are true? Select all that apply.
a. If the pharmacist confirms that the physician has a valid license and DEA number, the prescriptions are likely valid and can be filled.
b. If the pharmacist calls the physician and the physician confirms that he or she wrote the prescriptions and saw the patients, the prescriptions are likely valid and can be filled.
c. The prescriptions are not likely to be valid because they appear to have not been issued for a legitimate medical purpose.
d. If the pharmacist fills the prescriptions, he or she could be sub- ject to disciplinary action by TSBP.
The prescriptions are not likely to be valid because they appear to have not been issued for a legitimate medical purpose.
If the pharmacist fills the prescriptions, he or she could be sub- ject to disciplinary action by TSBP.
## Footnote
This question illustrates the application of the pharmacists' corre- sponding responsibility rule. Pharmacists must identify "red flags" that indicate that a prescription may not have been issued for a legit- imate medical purpose and, if those "red flags" cannot be resolved, the prescription cannot be filled. Simply checking that the prescriber is licensed and calling the prescriber may not be sufficient to resolve the "red flags." These are not valid prescriptions, and filling these prescriptions could subject a pharmacist to disciplinary action.
42
Which of the following is likely to be outside the scope of practice for a dentist to prescribe?
a. Alprazolam
b. Amoxicillin
c. Oral contraceptives
d. Lidocaine gel
Oral contraceptives
43
Dr. Smith sets up a new private practice near your pharmacy. Soon after, you begin to receive several prescriptions for methadone writ- ten by Dr. Smith. You call Dr. Smith and she explains to you that she is treating patients for opioid addiction. You should
Explain to Dr. Smith that she cannot prescribe methadone to treat opioid addiction, and that you must refuse to fill any fur- ther prescriptions for methadone from Dr. Smith.
## Footnote
A prescription for methadone can only be legally prescribed and dis- pensed to treat pain. While it can be used to treat opioid addiction, this can only be done in a DEA-registered narcotic treatment facility.
44
Dr. Garcia is exempt from the mandatory electronic prescription requirements for controlled substances. On September 3, 2024, Dr. Garcia issues 3 prescriptions to Sally for Adderall. Each pre- scription is for a 30-day supply. The prescriptions are each written on separate Texas Official Prescription Forms, and all are dated September 3, 2024. Prescription #1 contains no additional instructions. On Prescription #2, Dr. Garcia writes "Do not fill before October 1, 2024." On prescription #3, Dr. Garcia writes "Do not fill before November 1, 2024."
Prescription #1 is valid and must be dispensed by October 4, 2024. Prescription #2 is valid and must be dispensed by November 2, 2024. Prescription #3 is valid and must be dispensed by December 2, 2024.
## Footnote
DEA permits practitioners to prescribe multiple prescriptions for a Schedule II controlled substance on the same day with instructions for one or more of the prescriptions to be filled at a later date. When this is done, the total quantity of the Schedule II controlled substance prescribed may not exceed a 90-day supply. Because Texas requires Schedule II prescriptions to be filled within 30 days of the date of issue or the first date authorized to be filled, each prescription in this case must meet that requirement.
45
Which of the following products is required to be dispensed with the warning "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"?
a. Buprenorphine
b. Naloxone
c. Robitussin A-C
d. Lipitor
e. All of the above
Buprenorphine
## Footnote
Although most pharmacies place the "transfer" warning on all pre- scription labels, it is only required on Schedule II-IV controlled sub- stances. It is not required on Schedule V products such as Robitus- sin A-C because in many states (but not Texas), Schedule V products can be purchased without a prescription. The other products are not controlled substances.
46
How many public members are appointed to the Texas State Board of Pharmacy?
3
## Footnote
TSBP is composed of 11 members:
7 pharmacists
1 pharmacy technician
3 public members
47
A pharmacist received a bottle of generic tetracycline capsules from a wholesaler. The label stated that each capsule contained 500 mg of the drug when it only contained 250 mg of the drug. There was noth- ing about the drug that would indicate to the pharmacist that this problem existed. The pharmacist dispensed several prescriptions before the problem was detected. Which of the following statements is true regarding the tetracycline?
a. It is adulterated only.
b. It is misbranded only.
c. It is both adulterated and misbranded.
d. It is neither adulterated nor misbranded but is instead a minor technical violation of the potency requirements. It is in violation of the Poison Prevention Packaging Act.
It is both adulterated and misbranded.
## Footnote
Because the tetracycline was dispensed with a label that indicated an incorrect strength compared to the drug that was actually in the bottle, the product is misbranded. However, because the product's strength differs from that which it represents (i.e., what it says on the label), it is also adulterated.
48
Pharmacist Jessica works as the only pharmacist during the over- night shift at a hospital pharmacy in Beaumont, Texas. How many pharmacy technicians may Jessica supervise during her shift?
a. Not more than 3
b. Not more than 6 as long as there are no more than 3 pharmacy technician trainees
c. Not more than 6 as long as only 3 technicians are involved in sterile compounding
d. As many as required, as there is no limit
As many as required, as there is no limit
## Footnote
There is no pharmacy technician ratio in hospital (Class C) pharmacies.
49
Pharmacist Vincent has some expired morphine tablets he would like to send to a reverse distributor for destruction. What documen- tation is required to accomplish this?
a. DEA Form 41
b. DEA Form 106
c. DEA Form 222
d. An invoice
DEA Form 222
## Footnote
This is a transfer of a Schedule II controlled substance from one DEA registrant to another and is accomplished with a DEA Form 222. DEA Form 41 is used to destroy controlled substances when they are destroyed by the registrant on the premises.
50
A nonprescription bottle of 14 grain aspirin tablets cannot contain more than ___
36 tablets
## Footnote
Salicylates (21 CFR 201.314)-Aspirin and other salicylate drugs must have special warnings for use in children includ- ing warning regarding Reye's syndrome. Retail containers of 1% grain (pediatric) aspirin cannot be sold in containers holding more than 36 tablets.
51
Physician Assistant Nancy from Dallas, Texas, calls in a prescription for Billy, the 6-year-old son of Mrs. Davidson, to Pharmacist Adam. The prescription is for a 30-day supply of phenobarbital with 2 refills. Pharmacist Adam fills the prescription, and Mrs. Davidson picks it later that day.
a. Pharmacist Adam filled an invalid prescription because a pre- scription for phenobarbital from a physician assistant is not legal.
b. Pharmacist Adam filled an invalid prescription because a pre- scription from a physician assistant for a 6-year-old child is not legal.
c. Pharmacist Adam filled an invalid prescription because the pre- scription was not issued electronically, and Pharmacist Adam failed to confirm that an exception to the electronic prescribing requirement was met and that an emergency existed.
d. Pharmacist Adam is not required to confirm that an exception to the electronic prescribing requirement applied or that an emer- gency existed.
Pharmacist Adam is not required to confirm that an exception to the electronic prescribing requirement applied or that an emergency existed.
## Footnote
There are many exceptions to the mandatory electronic prescription requirement for controlled substances, but the law and TSBP do not require pharmacists to confirm that one of the exceptions apply or that it is an emergency for a verbal prescription. Physician assistants in Texas may prescribe Schedule III-V controlled substances.
52
Which of the following is not part of the transaction data required to be maintained by a pharmacy when it purchases most prescription drugs from a wholesaler or manufacturer?
a. Transaction Information
b. Transaction History
c. Transaction Statement
d. Transaction Certification
Transaction Certification
## Footnote
The Drug Supply Chain Security Act (DSCSA) requires that all sales of prescription drugs (with some exceptions) be accompanied by "Transaction Data" which include Transaction Information, Trans- action History, and a Transaction Statement.
53
Under the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, the maximum quantity that can be dispensed is a
a. 7-day supply
b. 14-day supply
c. 30-day supply
d. 60-day supply
30-day supply
## Footnote
Under the iPLEDGE REMS for isotretinoin, prescriptions are lim- ited to a 30-day supply. Readers should be familiar with which drugs and drug categories require REMS and elements of some of the most common REMS.
54
The Texas State Board of Pharmacy is composed of
11 members consisting of 7 pharmacists, 1 pharmacy technician, and 3 public members
55
Before requesting reinstatement of a license that was revoked or lift- ing of a restriction on a license, a pharmacist must wait
At least 12 months
## Footnote
Licenses that have been restricted or even revoked may be reinstated, but the minimum amount of time before a reinstatement can be requested is 12 months.
56
Which of the following products requires a prescription to be dispensed?
a. Humalog R
b. Humulin N°
c. Lantus
d. Both a and c
Humalog R & Lantus
## Footnote
While most insulin products require a prescription, some older forms of insulin, including Humulin N, are available without a prescription. When some drugs in the same drug class are classified as OTC and oth- ers are prescription only, you should be familiar with those differences.
57
Manuel is preparing a total parenteral nutrition (TPN) sterile prep- aration for a single patient consisting of dextrose, amino acids, and various vitamins. The TPN is prepared in a USP 797-compliant area of the pharmacy department. Manuel does not have stability infor- mation for the formulation. What is the maximum beyond-use date (BUD) that can be assigned to the preparation if it is to be stored under refrigerated conditions?
a. 30 hours
b. 3 days
c. 9 days
d. 14 days
9 days
58
# Sterile Compounding (USP 797)
What is considered low risk?
Compounded with aseptic manipulations entirely within ISO Class 5 or better conditions.
59
# Sterile Compounding (USP 797)
What is considered medium risk?
Multiple individual or small doses of sterile products are used to prepare a product administered to multiple patients or one patient on multiple occasions; or
Involves complex aseptic manipulations other than single volume transfer; or
Requires an unusually long compounding process.
60
# Sterile Compounding (USP 797)
What is considered high risk?
Nonsterile ingredients are used to prepare a sterile product; or
Sterile ingredients or devices or components are exposed to air quality inferior to ISO Class 5 for more than 1 hour; or
Nonsterile water-containing preparations are exposed more than 6 hours before being sterilized.
61
# Sterile Compounding (USP 797)
What are examples of low risk?
Single transfers of sterile dosage forms from ampules, bottles, and vials using sterile syringes and needles, other administration devices, and other sterile containers; and
Manually measuring no more than 3 manufactured products to compound drug admixtures and nutritional solutions.
62
# Sterile Compounding (USP 797)
What are examples of medium risk?
TPN fluids with multiple injections, detachments, and attachments of products to deliver to a final sterile container;
Filling reservoirs and infusion devices with multiple sterile products;
Batch compounding from all sterile components; and
Transfers of volumes from multiple ampules or vials into a single final sterile product.
63
# Sterile Compounding (USP 797)
What are examples of high risk?
Dissolving nonsterile bulk drug powders to make solutions which will be terminally sterilized.
64
# Sterile Compounding (USP 797)
How is low risk compounds stored?
May be stored 48 hours at room temperature, 14 days if cold (refrigerated), or 45 days if frozen.
65
# Sterile Compounding (USP 797)
How is medium risk compounds stored?
May be stored 30 hours at room temperature, 9 days if cold (refrigerated), or 45 days if frozen.
66
# Sterile Compounding (USP 797)
How is high risk compounds stored?
May be stored 24 hours at room temperature, 3 days if cold (refrigerated), or 45 days if frozen.
67
Which type of pharmacy may be in possession of prescription drug samples?
A Class D pharmacy owned by a charitable organization that is part of a healthcare entity providing care to indigent or low- income patients at no or reduced cost
## Footnote
STUDY TIP: TSBP rules on samples are consistent with federal law and prohibit most pharmacies from selling, purchasing, trading, or possessing prescrip- tion drug samples. The only exception is for pharmacies that are owned by a charitable organization or by a city, state, or county government and that are part of a healthcare entity providing care to indigent or low-income patients at no or reduced cost. Such samples may only be provided at no charge to patients.
68
What is a Class A pharmacy?
Community
## Footnote
* Mailservice Pharmacy
* Telepharmacy → remote dispensing site or remote healthcare site
69
What is a Class B pharmacy?
Nuclear
## Footnote
Requires 700 hrs: 500 supervised experience, 200 hrs didactic training
70
What is a Class C pharmacy?
Institutional
## Footnote
Telepharmacy → remote healthcare site only
71
What is a Class D pharmacy?
Clinic
## Footnote
* Limited formulary
* May not possess nalbuphine (Nubain), ED drugs, & Controlled substances
72
What is a Class E pharmacy?
Nonresident
## Footnote
Out of state but dispensing in TX
73
What is a Class F pharmacy?
Freestanding Emergency Medical Care Facility
## Footnote
Limit to 72 hr supplies
74
What is a Class G pharmacy?
Central Prescription Drug Order or Medication Order Processing
## Footnote
* Do not possess or dispense drugs
* Process RX orders or Med orders only
75
How often must a Class A pharmacy conduct an inventory of controlled substances?
Annually
76
During each 2-year license renewal cycle to maintain certification to administer vaccinations and immunizations, a pharmacist must obtain how many hours of continuing education relating to disease states, drugs, and administration of immunizations or vaccines?
3 hrs
## Footnote
In order to maintain immunization certification, a pharmacist must obtain 3 hours of continuing education related to disease states, drugs, and administration of immunizations or vaccines. These 3 hours may be part of the required 30 hours.
77
To renew a pharmacist license, a pharmacist who engages in com- pounding sterile preparations shall complete
4 hours of continuing education related to sterile compounding If compounding high-risk products
2 hours of continuing education related to sterile compounding if compounding low- or medium-risk products
## Footnote
The number of continuing education hours related to sterile com- pounding required to renew a pharmacist's license depends upon whether the pharmacist is engaged in compounding high-risk prep- arations or not. If the pharmacist is engaged in high-risk compound- ing, 4 hours of continuing education are required. If the pharmacist is only engaged in low-risk and medium-risk compounding, 2 hours of continuing education are required.
78
How can a prescriber prohibit generic substitution on a written prescription?
By writing the words "medically necessary" or "brand medically necessary"
## Footnote
On a written prescription, the dispensing directive to prohibit generic substitution must be the words "medically necessary" or "brand medically necessary" and must be written in the prescriber's own handwriting on the prescription.
79
Records of withdrawal of drugs when the pharmacy department is closed in a Class C pharmacy that employs a full-time pharmacist-in- charge must be verified by a pharmacist
Within 72 hrs
## Footnote
Drugs may be removed from a Class C pharmacy when the phar- macy department is closed, but a record of those withdrawals must be made. If the Class C pharmacy employs a full-time pharmacist- in-charge, those withdrawal records must be verified by a pharma- cist within 72 hours. If the Class C pharmacy only has a part-time or consultant pharmacist, withdrawal records must be verified within 7 days.
80
How many continuing education units (CEUs) are required to renew a pharmacist license?
3.0 CEUs
## Footnote
This is a good example of making sure you read the question care- fully. The question is asking about continuing education units, not continuing education hours. As pointed out in a study tip in the book, 1 continuing education hour equals 0.1 continuing education units (CEUs). A pharmacist in Texas must obtain 30 continuing edu- cation hours or 3.0 CEUs to renew their license.
81
Which of the following is not considered disciplinary action on a pharmacist's license?
a. A reprimand
b. A suspension
c. A remedial plan
d. A revocation
A remedial plan
## Footnote
Reprimands, suspensions, and revocations are all examples of dis- ciplinary action that can be taken against a pharmacist's license. A remedial plan provides an option to settle a case without the action being considered disciplinary action, but it is only available as an option for certain types of violations.
82
If a supplier cannot provide the entire quantity of a Schedule II controlled substance ordered on a DEA Form 222, the remaining quantity must be sent
Within 60 days
## Footnote
The supplier of a Schedule II controlled substance may send a partial quantity of the amount ordered on a DEA Form 222, but the remain- ing quantity must be sent within 60 days. After 60 days a new DEA Form 222 would need to be sent in order to obtain the remaining quantity.
83
The Texas State Board of Pharmacy's policy regarding the filling or refilling of a dangerous drug prescription issued by a practitioner who subsequently dies is that a pharmacist
May provide up to a 30-day supply and inform the patient to find a new practitioner
## Footnote
Both the Texas Board of Medicine and Texas Board of Pharmacy have agreed by policy that, for a dangerous drug prescription that has refills, if the prescriber has retired or died a pharmacy may provide up to a 30-day supply to the patient and should inform the patient they should obtain a new practitioner to obtain further medication.
84
Which of the following is NOT a permissible use or disclosure of protected health information under HIPAA?
a. Providing a list of all prescription medications to a patient's primary care physician
b. Sending prescription information to a third-party insurance company for payment purposes
c. Sending coupons for diapers to all pharmacy patients taking pre- natal vitamins
d. Providing a face-to-face recommendation of an OTC product to a patient based on the patient's symptoms and drug allergy profile
Sending coupons for diapers to all pharmacy patients taking pre- natal vitamins
## Footnote
Sending coupons to all pharmacy patients who are taking prenatal vitamins would be a violation of HIPAA because the pharmacy is using protected health information (PHI) to identify patients in order to market products to those patients. Providing a list of all prescription medications to a patient's primary care physician falls under the treatment exception to the use of PHI. Sending prescrip- tion information to a third-party insurance company for payment purposes falls under the payment exception. Providing a face-to-face recommendation of a product is specifically identified as treatment and is not considered marketing under HIPAA.
85
Which type of pharmacy may provide remote pharmacy services at a remote dispensing site through use of a telepharmacy system?
Class A pharmacy
## Footnote
Under the telepharmacy rules there are slightly different require- ments and restrictions depending on if the telepharmacy is located at a remote healthcare site or a remote dispensing site. At a remote dis- pensing site, telepharmacy services can only be provided by a Class A pharmacy. At a remote healthcare site, telepharmacy services may be provided by a Class A or Class C pharmacy.
86
For which of the following prescriptions may a pharmacist accelerate or advance refills?
a. A prescription for a quantity of 30 Lipitor with 2 refills
b. A prescription for a quantity of 30 Valium with 3 refills
c. A prescription for a quantity of 30 tetracycline with 2 refills for a 16-year-old patient
d. A prescription for a quantity of 30 tablets of Effexor for a 30-year-old patient
A prescription for a quantity of 30 Lipitor with 2 refills
## Footnote
Pharmacists may accelerate refills on prescriptions but cannot do so for controlled substances, for psychotropic drugs, or for patients under 18 years of age.
87
Which of the following products or prescriptions is exempt from the Poison Prevention Packaging Act's requirement for child-resistant containers?
a. A prescription for 50 Nitro-Bid 6.5 mg capsules
b. A prescription for 100 Isosorbide 10 mg sublingual tablets
c. A prescription for 20 Erythromycin stearate 500 mg tablets
d. Ibuprofen 200 mg tablets in a 30-count bottle
A prescription for 100 Isosorbide 10 mg sublingual tablets
## Footnote
The Poison Prevention Packaging Act has very specific exemptions for certain prescription drugs, including for sublingual nitroglycerin and sublingual and chewable isosorbide dinitrate of 10 mg or less.
88
A mail-service pharmacy located in El Paso, Texas, would obtain which type of pharmacy license?
Class A
## Footnote
Since this pharmacy is located in Texas and fills prescription drug orders, this pharmacy would obtain a Class A (community phar- macy) license. The fact that they deliver prescriptions by mail would not change the type of license they obtain. A Class E license is only available for pharmacies located outside of Texas.
89
The pharmacist-in-charge of a pharmacy must have a policy and pro- cedure to ensure that recalled drugs are removed from a pharmacy's inventory
Within 24 hours
## Footnote
Pharmacies in Texas must have a policy and procedure to ensure that recalled drugs are removed from a pharmacy's inventory within 24 hours of notification of a recall.
90
Dr. Galloway issues a prescription for Percocet on July 7, 2024. What is the last day the prescription can be dispensed?
August 6, 2024
## Footnote
A Schedule II prescription in Texas must be dispensed within 30 days of the date issued or the first date indicated it can be filled.
91
For which class of recall is there a reasonable probability that the product could cause serious adverse effects or death?
Class I recall
## Footnote
The most serious drug recalls, those in which there is a reasonable probability that the product could cause serious adverse effects or death, are Class I recalls.
92
Class I Recall
Product may case serious adverse health issues or death
93
Class II Recall
Product may cause temporary or medically reversible adverse effects but the probablity of serious adverse effects is remote
94
Class III Recall
Product is not likely to cause adverse health consequences
95
Which of the following are grounds for discipline of a pharmacist's license? Select all that apply.
a. Refusing an inspection
b. Failure to wear a lab coat while working
c. Physically abusing a Board employee
d. Failure to maintain required records
Refusing an inspection
Physically abusing a Board employee
Failure to maintain required records
## Footnote
TSBP rules provide a comprehensive list of grounds for discipline of a pharmacist's license. Included on that list are refusing an inspec- tion, physically abusing a Board employee, and failure to maintain required records.
96
A nursing home patient who is prescribed estrogen must receive a copy of the patient package insert
a. After 1 week of therapy
b. Prior to the administration of the first dose and then every 30 days
c. Annually
d. If the doctor specifically requests it be given
Prior to the administration of the first dose and then every 30 days
## Footnote
The patient package insert rules have specific requirements for insti- tutional patients that state that the patient should receive a patient package insert prior to administration of the first dose and every 30 days thereafter. This is the type of legal requirement that may not be done in practice but could be asked on the MPJE.
97
When must a pharmacy electronically transmit the dispensing of a controlled substance prescription to the Texas Prescription Monitoring Program (PMP)?
a. Immediately after the prescription was completely filled
b. No later than the next business day after the date the prescription was completely filled
c. No later than 7 days after the date the prescription was com- pletely filled
d. No later than 21 days after the date the prescription was com- pletely filled
No later than the next business day after the date the prescription was completely filled
## Footnote
The Texas Prescription Monitoring Program requires pharmacies to electronically transmit the dispensing of a controlled substance pre- scription no later than the next business day after the date the pre- scription was completely filled. This is likely done automatically by the pharmacy's computer system, but you are expected to know this type of legal requirement.
98
What is the maximum ratio of pharmacists to pharmacy technicians and pharmacy technician trainees in a Class A pharmacy?
a. 1:6 as long as the maximum number of pharmacy technician trainees is 2
b. 1:6 as long as the maximum number of pharmacy technician trainees is 3
c. 1:4 as long as 1 of the technicians is registered (only 3 can be trainees)
d. 1:4 as long as 2 of the technicians are registered (only 2 can be trainees)
e. None of the above
1:6 as long as the maximum number of pharmacy technician trainees is 3
## Footnote
A Class A pharmacy may have a maximum of 6 pharmacy techni- cians for each pharmacist that is working as long as not more than 3 of the pharmacy technicians are pharmacy technician trainees.
99
A pharmacist receives a written prescription for fentanyl from a practitioner who is exempt from the mandatory electronic prescription requirements. The pharmacist consults with the prescriber of the medication. After such consultation, which of the following pieces of information may not be changed on the prescription even if the prescriber authorizes the change?
a. Patient's address
b. Patient's name
c. Drug strength
d. Drug quantity
e. Directions for use
Patient's name
## Footnote
There has been some uncertainty as to what information a pharmacist may change on a written Schedule II prescription after consulting with the prescriber, since DEA removed their previous guidance on this issue and indicated they will address this issue by rule. By policy, TSBP has indicated that items such as drug strength, quantity, and directions for use may be added or changed after consulting with the prescriber, and a pharmacist may add missing items such as the patient's address. The name of the patient is an element that cannot be changed and would require a new prescription.
100
Which of the following are required elements of a pharmacy library in a Class A pharmacy? Select all that apply.
a. Texas pharmacy laws and rules
b. General drug information reference
c. Pharmacotherapy: A Pathophysiologic Approach
d. Basic antidote information and phone number of the nearest regional poison control center
Texas pharmacy laws and rules
General drug information reference
Basic antidote information and phone number of the nearest regional poison control center
## Footnote
It is recommended that you memorize the library requirements for each class of pharmacy. All classes of pharmacies must have Texas pharmacy laws and rules, general drug information reference, and basic antidote information and phone number of the nearest regional poison control center.
101
A DEA Form 41 is used to document
a. Transfer of controlled substances to another registrant
b. Transfer of controlled substances to a reverse distributor
c. Significant loss or theft of controlled substances
d. Destruction of controlled substances
e. None of the above
Destruction of controlled substances
## Footnote
A DEA Form 41 is used to document destruction of controlled sub- stances. Transfers of controlled substances to another registrant, including a reverse distributor, are documented using a DEA Form 222 for Schedule II controlled substances and an invoice for Schedule III-V controlled substances. A significant theft or loss of controlled substances is documented using a DEA Form 106.
102
DEA Form 222
Transfer of a schedule II controlled substance from one DEA registrent to another or ordering substances
Transfer of a controlled substance to a reverse distributor
103
DEA Form 224
For dispensers including retail phar- macies, hospitals/clinics, practitioners, mid-level prac- titioners, and teaching institutions. The renewal form is DEA Form 224a.
104
DEA Form 225
For manufacturers, distributors, researchers, analytical laboratories, importers, and exporters. The renewal form is DEA Form 225a.
105
DEA Form 363
For narcotic treatment facilities. The renewal form is DEA Form 363a
106
DEA Form 41
Used to destroy controlled substances when they are destroyeed by the registrant of the premises
107
DEA Form 106
A significant theft or loss of controlled substance
Within 45 days, initiating within 1 day of discovering
DEA, TSBP, local police
108
DEA Form 107
A significant lost or disappearance of listed chemicals
Within 15 days
109
Drugs dispensed for outpatient use in a Class F pharmacy may not exceed a
a. 24-hour supply
b. 48-hour supply
c. 72-hour supply
d. 7-day supply
72-hour supply
## Footnote
A Class F pharmacy is issued to freestanding emergency medical care facility. Class F pharmacies may maintain and use drugs to treat patients of the facility, but must limit drugs for outpatient use to a 72-hour supply.
110
In which location must a perpetual inventory be kept of all controlled substances?
a. A Class A pharmacy
b. A Class C pharmacy
c. Any remote pharmacy location
d. All of the above
Any remote pharmacy location
## Footnote
While many pharmacies maintain a perpetual inventory of all controlled substances, it is only required to do so at remote pharmacy locations where controlled substances are stored. Class C pharmacies must maintain a perpetual inventory of Schedule II controlled substances, but not all controlled substances.
111
The Texas Prescription Monitoring Program (PMP) is administered by
a. The Drug Enforcement Administration
b. The Texas Department of Public Safety
c. The Texas Department of State Health Services
d. The Texas State Board of Pharmacy
The Texas State Board of Pharmacy
## Footnote
The Texas Prescription Drug Monitoring Program is administered by the Texas State Board of Pharmacy. It was previously administered by the Texas Department of Public Safety.
112
Which of the following controlled substances must not be ordered on DEA Form 222 with additional controlled substances? Select all that apply.
a. Fentanyl
b. Cocaine
c. Etorphine hydrochloride
d. Carfentanil
Etorphine hydrochloride
Carfentanil
## Footnote
Orders for carfentanil, etorphine hydrochloride, and diprenorphine must only contain orders for those substances. These are superpotent narcotics primarily used as animal tranquilizers.
113
If a pharmacist performs the final check after an automated pharmacy dispensing system has completed the prescription and prior to delivery to a patient, an automated pharmacy dispensing system in a Class A pharmacy must be tested for accuracy at least
a. Monthly
b. Quarterly
c. Every 6 months
d. Every 12 months
Every 12 months
## Footnote
The Class A pharmacy rules provide that when the final check of an automated pharmacy dispensing system is made by a pharmacist after the system has filled the prescription, the automated system must be tested for accuracy every 12 months. If the final check is conducted by having the pharmacist verify the loading of bulk drugs and all order entries into the system, the automated system must be checked for accuracy monthly.
114
Anabolic steroids are classified under which schedule?
a. Schedule II
b. Schedule III
c. Schedule IV
d. Schedule V
e. None of the above
Schedule III
## Footnote
Anabolic steroids are classified as Schedule III controlled substances under both federal and Texas law.
115
Sterile preparations must be compounded in a primary engineering control device which is capable of maintaining at least
a. ISO Class 3 conditions
b. ISO Class 5 conditions
c. ISO Class 7 conditions
d. ISO Class 8 conditions
ISO Class 5 conditions
## Footnote
Primary engineering control devices, including laminar air flow hoods and biological safety cabinets, must be maintained under ISO Class 5 conditions.
116
What must be provided prior to the first dose and every 30 days thereafter to a patient in an institutional setting who is taking an estrogen prescription?
a. A safety data sheet
b. A package insert
c. A patient package insert
d. A Medication Guide
A patient package insert
## Footnote
A patient package insert must be provided prior to the first dose and every 30 days thereafter to a patient in an institutional setting who is taking an estrogen prescription. Patient package inserts are different than medication guides and should not be confused with package inserts which are not intended for patients.
117
Which inventory does not require the signature of the PIC to be notarized within 3 working days? Select all that apply.
a. Change of ownership inventory
b. Change of PIC inventory
c. Initial inventory
d. Annual inventory
Change of PIC inventory
Initial inventory
## Footnote
All controlled substance inventories must contain the signature of the pharmacist-in-charge (PIC) and must be notarized within 3 working days, except for initial inventories and change of PIC inventories.
118
Which of the following may not be on a Class D pharmacy's formulary even if it has been granted permission to have an expanded formulary?
a. Amoxicillin
b. Birth control pills
c. Flexeril
d. Cialis
e. Both c and d
Cialis
## Footnote
A Class D (Clinic) pharmacy may only have a limited formulary of drugs but can request an expanded formulary if they are serving 80% indigent patients. However, even with an expanded formulary. a Class D pharmacy may not possess controlled substances, nalbuphine, and drugs to treat erectile dysfunction such as Cialis.
119
What is the maximum number of physicians a pharmacist may enter into a protocol to provide drug therapy management services?
a. No more than 3 physicians
b. No more than 5 physicians
c. No more than 7 physicians
d. There is no maximum number
There is no maximum number
## Footnote
The Drug Therapy Management Under Protocol rules do not specify a maximum number of physicians that a pharmacist may enter into a protocol with.
120
A physician issues a prescription for lidocaine in order to obtain a supply for the use in his or her office. What notation must the prescriber place on this prescription to make it a legitimate prescription that a pharmacist can fill?
a. "Not for resale"
b. "Own Use"
C. "General Office Use Only"
d. "Office Use"
e. None of the above
None of the above
## Footnote
Prescriptions for "office use" are not valid as prescriptions because prescriptions generally have to be issued for a specific patient. There are a few exceptions to this, such as epinephrine auto-injectors, but the proper way for a practitioner to obtain drugs for office use is to order them from a drug wholesaler or pharmacy with proper docu- mentation, not by writing a prescription.
121
A fire broke out in the front part of Debra's pharmacy, but the flames did not reach the prescription department. Can the drugs still be dispensed?
a. Yes, as long as the containers are all closed
b. Yes, unless the drugs are heat sensitive
c. Yes, but only after notifying patients that their prescription may have been exposed to smoke
d. No, the smoke from the fire may have adulterated the drugs
No, the smoke from the fire may have adulterated the drugs
## Footnote
These drugs would be adulterated and could not be dispensed to patients. Even when a drug is held under conditions where it may have been contaminated it is considered adulterated.
122
Pharmacist Kurt reconstitutes a pharmacy bulk package of vancomy- cin to make a batch of 10 IV bags for dispensing today. What is the risk level of the batch of preparations he is compounding?
a. Immediate use
b. Low risk
c. Medium risk
d. High risk
Medium risk
## Footnote
Preparing several sterile products to be administered to multiple patients is considered medium-risk sterile compounding.
123
Which of the following disciplinary actions taken against a phar- macist's license means that a license is not in effect for a specified amount of time?
a. Revocation
b. Suspension
c. Restriction
d. Reprimand
Suspension
## Footnote
A suspension of a pharmacist's license means that the license is not in effect for a specified amount of time, such as for 1 month, 6 months, or 1 year.
124
What is the youngest age patient whom a pharmacist may provide a flu vaccine without a referral from a physician?
a. Greater than age 7
b. Greater than age 10
c. Greater than age 14
d. None of the above
Greater than age 7
## Footnote
Pharmacists are permitted to administer most vaccinations to patients 14 years of age or older. In order to encourage more children to get flu vaccines, however, pharmacists may administer flu vaccines to patients 7 years of age or older.
125
Evaluation of pharmacists compounding high-risk sterile products must be conducted at least
a. Every month
b. Every quarter
c. Every 6 months
d. Annually
Every 6 months
## Footnote
Evaluation and testing of sterile technique is required to be con- ducted at least annually if compounding low- and medium-risk products and at least every 6 months for high-risk products.
126
Ms. Nguyen comes into the pharmacy to pick up while Pharmacist Marie is on a lunch break at Joe's Discount Pharmacy, but the prescription department is still open. The prescription was called in earlier in the day, and the prescription has already been filled and checked by Pharmacist Marie. The prescription is for methotrexate, and this is a drug that Ms. Nguyen has never taken before. Which of the following are true? Select all that apply.
a. Pharmacist Marie must return from her lunch break to counsel Ms. Nguyen.
b. The prescription can be given to Ms. Nguyen by the pharmacy technician as long as written information regarding the drug is provided along with a notice that a pharmacist is available during normal business hours to answer any questions she may have.
c. Pharmacist Marie cannot leave the facility for her lunch break.
d. The prescription department cannot remain open while Pharmacist Marie is on a lunch break.
The prescription can be given to Ms. Nguyen by the pharmacy technician as long as written information regarding the drug is provided along with a notice that a pharmacist is available during normal business hours to answer any questions she may have.
Pharmacist Marie cannot leave the facility for her lunch break.
## Footnote
Pharmacists are permitted to take a 30-minute break and leave the pharmacy. During this absence of the pharmacist, prescrip- tions that have been filled and checked by the pharmacist may be given to the patient. Because this is a new prescription, counseling is required, but since the pharmacist is not in the pharmacy, coun- seling is provided utilizing the same rules that apply when prescrip- tions are delivered to a patient at their home. This is done by pro- viding written information regarding the drug, along with a notice that a pharmacist is available during normal business hours to answer any questions.
127
A pharmacist's continuing education records must be maintained
a. For 1 year
b. For 2 years
c. For 3 years
d. Until the next renewal cycle
For 3 years
## Footnote
Most records must be kept for 2 years, but continuing education records must be maintained for 3 years. This rule was more impor- tant when pharmacists kept manual records of continuing educa- tion, but all ACPE-accredited continuing education are now tracked online through NABP's CPE Monitor.
128
Which of the following may a pharmacy technician NOT perform?
a. Prescription data entry
b. Taking a new prescription for lefunamide over the phone
c. Overriding a drug interaction alert
d. Bulk compounding
Overriding a drug interaction alert
## Footnote
A pharmacy technician can perform all of these duties except over- riding a drug interaction alert, as that is a function that requires the professional judgment of a pharmacist.
129
A pharmacy that plans to change location must notify TSBP at least how many days before the planned move?
a. 10 days
b. 14 days
c. 30 days
d. 60 days
30 days
## Footnote
Most notifications to the Board of Pharmacy must be made within 10 days. One of the exceptions to this is a notification of change of location of a pharmacy, which must be made 30 days prior to the planned move.
130
A student intern designation expires if a student fails to take the NAPLEX/MPJE
a. Within 3 months after graduation
b. Within 6 months after graduation
C. Within 1 year of graduation
d. Within 18 months of graduation
Within 6 months after graduation
## Footnote
A student intern designation expires if a student fails to take the NAPLEX/MPJE within 6 months of graduation
131
Orange book
Approved Drug Products w/ Therapeutic Equivalence Evaluations
Primary source for determining the therapeutic equivalency of drugs
Texas statute uses this one
132
Purple book
Lists biological products that are considered biosimilars provides interchangeable evaluations of products
FDA uses this one
133
Red book
contains drug pricing info
134
Pink book
Immunizations & vaccine presentable dx
Info on vaccine safety
135
Green Book
FDA approved animal drugs
136
Yellow Book
Info & recommendation on international travel (vaccine & info on health risk)
137
Verifying a DEA Registration (Number)
1. Step 1-Add 1st, 3rd, and 5th digits.
2. Step 2-Add 2nd, 4th, and 6th digits and multiply sum by 2.
3. Step 3-Add the sum of steps 1 and 2, and the last digit of the sum should correspond to the last digit of the DEA number.
4. Example: DEA #AB1234563.
* a. 1+3+5 = 9.
* b. (2+4+6) × 2 = 24.
* c. Total = 33.
138
Phase I Trial
small groups of healthy participants w/out disease
20-80 ppl
goal: study the properties of the drug & determine safety
139
Phase II Trial
larger size groups w/ disease of 100 or more
goal: Study the effectiveness of the drug
140
Phase III Trial
larger group 1000+ w/ disease
goal: drug safety, efficacy, & closing further study can go to FDA for approval
141
Phase IV Trial
post marketing surveillance.
conducted after drug is approved & looks at safety, efficacy, & drug longterm
142
Federal Food, Drug, & Cosmetic Act 1938
Established the FDA
1st Legislation that required new drug to be proven safe prior to marketing
143
Durham-Humphry Amendments of 1951
2 classes of drugs: prescription & OTC
authorized verbal prescriptions & prescription refills
144
Kefauver-Hamis Amendments 1962
* required new drugs to be proven safe and effective for claimed use
* ↑ safety requirements for drugs and established Good Manufacturing Practices (GMPs) for manufacturing drugs
* gave FDA jurisdiction over prescription drug advertising
145
Prescription Drug marketing Act of 1987 (PDMA)
Bans reimportation of prescription drugs and insulin products except by the mfc.
Bans the sale, trade, or purchase of prescription drug samples.
* Except: pharmacies owned by charitable organization or by a city... providing care to indigent or low-income patients at no or reduced cost. Samples may only be provided at NO COST
Mandates the storage, handling, and record keeping requirements. for prescription drug samples.
Prohibits, with exceptions, the resale of prescription drugs purchased by hospitals or healthcare facilities
146
Drug Quality & Security Act (DQSA) 2013
- large scale compounding facilities.
- establishment of a uniform track and trace system
147
Drug Compoundinging Quality Act (DCQA)
503A - Compound products pursuant to an individual prescription or med order
* interstate distribution: limit to 5% based on pt specific Rx’s
503B "outsourcing facility". Sterile products not based on patient specific Rx’s
* Regulated by FDA
148
Drug Supply Chain Security Act (DSCSA)
* Track & Trace
* Uniform framework for electronic track and trace as they move through supply chain & sets national standards for states to license drug wholesale distributor
* “Transaction Data": Transaction Information, Transaction History, Transaction Statement
* Transactional Data is kept for 6 yrs
149
Schedule I (C-I) Drugs
* High potential for abuse and severe potential for dependence (addiction).
* No currently accepted medical use in treatment in the U.S.
* Lack of accepted information on the safety of their use under medical supervision.
150
Schedule I (C-I) Drugs Examples
Opiates and derivatives such as:
* heroin
* dihydromorphine;
Hallucinogens such as:
* marijuana,
* lysergic acid diethylamide (LSD),
* peyote,
* mescaline;
Depressants such as methaqualone.
151
Schedule II (C-II) Drugs
* High potential for abuse.
* Have currently accepted medical use in treatment in the U.S. or currently accepted medical use with severe restrictions.
* Abuse of the drug or other substances may lead to severe physical or psychological dependence (addiction).
152
Schedule II (C-II) Drugs Examples
Opium and other narcotics such as:
* morphine,
* codeine,
* dihydrocodeine,
* oxycodone,
* acetaminophen with hydrocodone (Vicodin"),
* methadone,
* meperidine,
* hydromorphone,
* fentanyl, and
* cocaine
Stimulants such as:
* amphetamine,
* methamphetamine,
* phenmetrazine,
* methylphenidate
Depressants such as
* pentobarbital (Nembutal Sodium),
* secobarbital (Seconal),
* amobarbital (Amytal Sodium, Tuinal),
* glutethimide (Doriden),
* phencyclidine.
153
Schedule III (C-III) Drugs
* Potential for abuse less than Schedules I and II.
* Have currently accepted medical use in treatment in the U.S.
* Abuse of the drug or other substance may lead to moderate or low physical dependence (addiction) or high psychological dependence (addiction).
154
Schedule III (C-III) Drugs Examples
Narcotic Schedule II drugs, but in combination with another ingredient such as
* aspirin with codeine
* acetaminophen with codeine (e.g., Tylenol #3).
Nonnarcotic drugs including suppository forms of:
* amobarbital,
* secobarbital,
* pentobarbital
Stimulants such as:
* chlorphentermine,
* phendimetrazine,
* benzphetamine
Anabolic steroids including testosterone
Ketamine and paregoric
Fiorinal, a combination of butalbital, aspirin, and caffeine.
155
Schedule IV (C-IV) Drugs
* Low potential for abuse relative to Schedule III drugs.
* Have currently accepted medical use in treatment in the U.S.
* Abuse may lead to limited physical or psychological dependence (addiction) relative to Schedule III drugs.
156
Schedule IV (C-IV) Drugs Examples
Products with:
* No more than 1 mg of difenoxin
* No less than 25 micrograms of atropine sulfate per dosage unit
Depressants such as:
* alprazolam,
* chloral hydrate (Noctec),
* diazepam,
* lorazepam,
* phenobarbital (Luminal)
Stimulants such as:
* diethylpropion (Tenuate)
* phentermine
Other drugs such as:
* carisoprodol,
* tramadol,
* pentazocine,
* butorphanol.
157
Schedule V (C-V) Drugs
* Low potential for abuse relative to Schedule IV drugs.
* Have currently accepted medical use in treatment in the U.S.
* Abuse of the drug or other substance may lead to limited physical or psychological dependence (addiction) relative to Schedule IV drugs.
158
Schedule V (C-V) Drugs Examples
Pregabalin (Lyrica)
Antitussive products containing codeine
Antidiarrheal products containing opium
Certain antiseizure drugs such as:
* brivaracetam (Brivact)
* lacosamide (Vimpat®).
159
Concentration Limits Codeine
Schedule V limit = 200 mg/100 ml.
Schedule III limit = 1.8 g/100 ml and 90 mg/dosage unit.
160
Concentration Limits Dihydrocodeine
Schedule V limit = 100mg / 100 ml.
Schedule III limit = 1.8g / 100 ml and 90 mg/dosage unit.
Note: Anything above limit would be Schedule II.
161
Concentration Limits Opium
Federal Schedule V limit = 100mg / 100 mL .
Texas Schedule V limit = 50mg / 100 mL.
Schedule III limit = 500mg / 100 ml and 25 mg/dosage unit.
## Footnote
STUDY TIP: The Schedule V opium limit under Texas law is 50 mg/100 ml or half the concentration under federal law. This stricter requirement means that most of the commercially available Schedule V products containing opium can- not be purchased without a prescription in Texas. These products are Schedule III controlled substances under Texas law and require a prescription.
162
Concentration Limits Morphine
Schedule V limit = None (no morphine products are Schedule V; they are either Schedule II or Schedule III).
Schedule III limit = 50mg / 100 ml.
163
Reprimand
Public and formal censure of license.
164
Restriction
Limit, confine, or restrain a license with certain terms or conditions.
165
Suspension
License not in effect for a specified amount of time.
166
Probation
Placing a license under a period of supervision by the Board for a term and under conditions as determined by the Board, including a probation fee.
167
Revocation
License is void and no longer in effect.
168
Retire
License is withdrawn and no longer in effect.
169
Administrative Penalty
A fine; may be included with other sanctions above
## Footnote
Cannot exceed $5,000 per violation, but every day a vio- lation occurs is a separate violation.
Civil penalties for license violations and unlawful prac- tice can be as much as $1,000 per day
170
Schedle III-V Invoice must contain:
1. Name of controlled substance
2. Dosage form and strength
3. Number of units per container (e.g., 100-tablet bottle)
4. Quantiy received (containers)
5. Date of receipt
6. Name, address, and DEA number of registrant from where controlled substance was received
171
Official Preescription Forms are issued to prescribers by TSBP and contain security features including:
1. A unique control number
2. A pantograph that reveals the word "VOID" when the form is copied
3. Thermochromic ink on the front w/ the symbol "Rx" that disappears briefly when rubbed
4. A watermark of the Seal of Texas that is visible from either side in regular light
