Review of Everything Flashcards
Which duties may be performed by a pharmacy technician in a Class A pharmacy?
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.
Which individual is responsible for ensuring all inventories of controlled substances are taken?
Pharmacist-in-charge
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
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.
What is required on the label of an OTC product?
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).
A pharmacy in Texas must comply with a request from a patient for a copy of his or her prescription records within
15 days
In TX, 30 days federal
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.
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.
What prescriptions for dangerous drugs can NOT be filled by a Class A pharmacy in Texas?
Prescriptions from:
DTM via verbal
Canadian/Mexican Practioners via electronic, fax, or verbal
DTM - Physician Delegated TX Pharmacist Performing Drug Therapy Management
What prescriptions for controls schedules III-V can NOT be filled by a Class A pharmacy in Texas?
Prescriptions from:
DTM
Canadian/Mexican Practitoners,
Out-of-state Dependent Practitioners
What prescriptions for controls schedules II can be filled by a Class A pharmacy in Texas?
Prescriptions from:
TX Practitioners Except for Optometrist
Who is responsible for making a copy of DEA Form 222 when ordering Schedule II controlled substances?
The purchaser
Which types of prescriptions are limited to a 10-day supply?
Prescriptions for opioids for acute pain
Unless an exemption applies, pharmacists must check the Prescription Monitoring Program (PMP) before dispensing which medications?
Opioids
Benzodiazepines
Barbiturates
Carisoprodol
Dextromethorphan
- 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.
A pharmacy may dispense epinephrine auto-injectors pursuant to a valid prescription that does not have a patient name to which entities?
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.
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.
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.
Regarding prescriptions that were filled but never picked up from a pharmacy.
- 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.
Which individuals may administer an influenza vaccine under Texas law?
Pharmacist & Pharmacist Intern
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.
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.
In a rural hospital, a pharmacy technician may perform what duties without direct supervision of a pharmacist?
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.
Outsourcing prescription drug dispensing to another pharmacy is legally known as
Centralized prescription dispensing
At which class of pharmacy are drugs not stored or dispensed?
Class G
process prescription drug orders or medications orders for other pharmacies, but do not possess or dispense drugs
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?
7 days
The daily sales purchase limit for pseudoephedrine products is
3.6 g
The monthly sales purchase limit for pseudoephedrine products is
9 g
CMS requires that consultant pharmacists perform a medication regimen review for long-term care patients ___
every 30 days
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
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
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.
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.
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?
- 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.
- “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.
- The quantity prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period.
- The prescription order must be immediately reduced to writ- ing by the pharmacist and contain all information except the practitioner’s signature.
- 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.
- 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.
- If the prescriber fails to deliver an electronic (or written) pre- scription, the pharmacist must notify the nearest DEA office.
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.
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.
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.
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.
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.
Which drugs may be dispensed by a Class A pharmacy if prescribed for treatment of narcotic addiction?
Buprenorphine
Buprenorphine/Naloxone combination
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
Transfers
- Transfers may be communicated verbally or via fax. Note: Pharmacy technicians cannot perform transfers of con- trolled substance prescriptions.
- Transfers may also be conducted electronically as long as specific requirements are met.
- Transfers of controlled substance prescriptions are allowed only one time unless the pharmacies share an electronic, real-time database.
- 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.
- 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).
- An individual may not refuse to transfer a prescription, and transfers must be completed within 4 business hours of a request.
- The electronic transfer of multiple or bulk prescription transfers is permitted.
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.
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,
All partial dispensings of Schedule II controlled substances for a nursing home patient must be completed within
60 days
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.
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.
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
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.
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.
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
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.
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.
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.
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.
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
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.
How many public members are appointed to the Texas State Board of Pharmacy?
3
TSBP is composed of 11 members:
7 pharmacists
1 pharmacy technician
3 public members
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.
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.
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
There is no pharmacy technician ratio in hospital (Class C) pharmacies.
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
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.
A nonprescription bottle of 14 grain aspirin tablets cannot contain more than ___
36 tablets
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.
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.
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.
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
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.
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
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.
The Texas State Board of Pharmacy is composed of
11 members consisting of 7 pharmacists, 1 pharmacy technician, and 3 public members
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
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.
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
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.
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
Sterile Compounding (USP 797)
What is considered low risk?
Compounded with aseptic manipulations entirely within ISO Class 5 or better conditions.
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.
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.
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.
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.
Sterile Compounding (USP 797)
What are examples of high risk?
Dissolving nonsterile bulk drug powders to make solutions which will be terminally sterilized.
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.
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.
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.
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
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.
What is a Class A pharmacy?
Community
- Mailservice Pharmacy
- Telepharmacy → remote dispensing site or remote healthcare site
