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Texas MPJE
When used PRN, psychotropic drugs for CMS long-term care patients must be limited to - ✔ ✔ 14 days, unless Practioners documents rationale for longer duration
All controlled substance inventories must contain signature of PIC and must be notarized within 3 working days except what inventory? - ✔ ✔ initial inventory
change of PIC inventory
A pharmacy must report to the Texas State Board of Pharmacy within___ days after the permanent closing of a pharmacy. - ✔ ✔ 10 Days after closing
Sales of pseudoephedrine-containing products to an individual in Texas are limited to ____ grams per day and____ grams per 30 days. - ✔ ✔ 3.6 grams per day and 9 grams per 30 days
FDA Orange Book uses two letter code system: - ✔ ✔ First letter is key,
A= drug products that FDA considers pharmaceutically and therapeutically equivalent
B= drug products that FDA considers NOT pharmaceutically and therapeutically equivalent
AB= products with actual or potential bioequivalence problems, but for which adequate scientific data has established bioequivalence
FDA Orange Book: When there are multiple pharmaceutically equivalent reference drugs that have not been determined to be bioequivalent the FDA implemented: - ✔ ✔ a three character code (AB1, AB2, AB3 etc)
If a generic drug establishes bioequivalence with one of the reference drugs it will receive the same three letter code
FDA Orange Book: Products with no known or suspected bioequivalence issues...(AA, AN, AO, AP, AT) - ✔ ✔ AA= conventional dosage forms
AN= solutions/powders for aerosolization
AO= injectable oil solutions
AP= injectable aqueous solutions
AT= topical products
Scheduling authority for controlled substances (federal versus texas state) - ✔ ✔ Federal= US Attorney General
Texas= The Commissioner of Texas Department of State Health Services
A pharmacy may compound narcotics pursuant to a prescription; however, DEA limits the compounding of aqueous or oleaginous
Practitioner DEA registration begins with.... - ✔ ✔ "A", "B", "F" or "G" (Department of Defense Contractors aka military)
Mid-level (ambulance, animal shelters, vet techs) or Advanced Practice Practioners (PA/NPs) with authorization to dispense controlled substances DEA registration begins with.... - ✔ ✔ "M"
How do you verify a DEA number? (Ex. DEA #AB1234563) - ✔ ✔ Step 1: Add the 1st, 3rd, and 5th #
Step 2: Add the 2nd, 4th and 6th # and multiply sum by 2 Step 3: Add the sum of step 1 and step 2, the last digit of the total should correspond with the last digit of DEA #
Step 1= 9
Step 2= 24
Step 3= 33
What DEA form is used to apply for DEA Registration? - ✔ ✔ DEA Form 224 for dispensers
Who does not have to register with the DEA? - ✔ ✔ An agent of employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment
A common or contract carrier or warehouseman or an employee thereof whose possession is in the usual course of business or
employment (a nurse in hospital or pharmacist in pharmacy for example)
An ultimate user (patient) who possesses such substance for a lawful purpose
Officials of the US. Armed Services, Public Health Service, or Bureau of Prisons acting in the course of their official duties.
Do interns, residents, staff physicians, and mid-level practitioners who are agents or employees of a hospital need their own DEA # to administer, prescribe, or dispense controlled substances while doing their jobs? - ✔ ✔ No, they can use the hospital/institutions DEA #
The hospital must assign a specific internal code for each authorized user of hospital's DEA#
The hospital must assign a specific internal code for each authorized user of hospital's DEA#, how is the internal code written? - ✔ ✔ As a suffix of the hospitals DEA#
example: AP1234563-
Is the Temporary Use of DEA Registration Upon Sale of Pharmacy permitted? - ✔ ✔ Yes, if the new owner has not yet obtained a DEA
Discuss the administration and provision of dangerous drugs by practitioners: - ✔ ✔ Texas generally does not permit practitioner dispensing unless except in the case of:
Physician may provide 72 hr supply in office to meet patients immediate need (no controlled substances)
Physicians in certain rural areas where there is no pharmacy may dispense dangerous drugs to patients and be reimbursed for the cost
Veterinarians are allowed to dispense to their own patients without being licensed as a pharmacy+
A confidential record is privileged and a pharmacist may release a confidential record only to: - ✔ ✔ (1) the patient or the patient's agent
(2) a practitioner or another pharmacist if the release is necessary to protect the patient's health and well-being
(3) the board or to a person or another state or federal agency authorized by law to receive the confidential record
(4) a law enforcement agency engaged in investigation of a suspected violation
(5) a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties
(6) an insurance carrier or other third party payor authorized by the patient to receive the information.
Discuss what constitutes as "unprofessional conduct" - ✔ ✔ "unprofessional conduct" is defined as engaging in behavior or committing an act that fails to conform with the standards of the pharmacy profession, including, but not limited to criminal activity or activity involving moral turpitude, dishonesty, or corruption.
-dispensing fraudulent prescription
-delivering prescriptions
-sharing compensation w/ practitioner that was received from an individual who received pharmacy services
-refusing inspection
-Subverting or attempting to subvert NAPLEX/MPJE
-failing to practice pharmacy in an acceptable manner
-Obstructing a board member from performing their duties
(3) "Misrepresentation" means a manifestation by words or other conduct which is a false representation of a matter of fact.
What are the grounds for disciplining a pharmacy's license? - ✔ ✔ (1) the pharmacy employs or allows such an individual with revoked/suspended/surrendered license access to prescription drugs;
(2) the pharmacy possesses or engages in the sale, purchase, or trade or the offer to sell, purchase, or trade prescription drug samples
(3) the pharmacy engages in the sale, purchase, or trade or the offer to sell, purchase, or trade of: (A) misbranded prescription drugs; or (B) prescription drugs beyond the manufacturer's expiration date.
(5) the owner or managing officer has previously been disciplined by the board
(6) a non-resident pharmacy fails to reimburse the board or its designee for all expenses, including travel, incurred by the board in inspecting the non-resident pharmacy as specified in
(7) the owner, managing officer(s), or other pharmacy employee(s) displays abusive, intimidating, or threatening behavior toward a board member or employee during the performance of such member's or employee's lawful duties; or
(8) the pharmacy waived, discounted, or reduced, or offered to waive, discount, or reduce, a patient copayment or deductible for a compounded drug in the absence of: (A) a legitimate, documented financial hardship of the patient; or (B) evidence of a good faith effort to collect the copayment or deductible from the patient.
A pharmacy fails to establish and maintain effective controls against diversion of prescription drugs when: - ✔ ✔ (1) there is inadequate security or procedures to prevent unauthorized access to prescription drugs;
OR
(2) there is inadequate security or procedures to prevent the diversion of prescription drugs.
Describe the boards disciplinary procedures against a license - ✔ ✔ (1) "Probation" means a period of supervision by the board imposed against a license or registration for a term and under conditions as determined by the board, including a probation fee.
(2) "Reprimand" means a public and formal censure against a license or registration.
(1) The application shall be given under oath and on the form prescribed by the board.
(2) A person applying for reinstatement or removal of restrictions may be required to meet all requirements necessary in order for the board to access the criminal history record information, including submitting fingerprint information and being responsible for all associated costs.
(3) A person applying for reinstatement or removal of restrictions has the burden of proof.
(4) On investigation and hearing, the board may in its discretion grant or deny the application or it may modify its original finding to reflect any circumstances that have changed sufficiently to warrant the modification.
(5) If such application is denied by the board, a subsequent application may not be considered by the board until 12 months from the date of denial of the previous application.
(6) The board in its discretion may require a person to pass an examination or examinations to reenter the practice of pharmacy.
(7) The fee for reinstatement of a license or registration shall be $ which is to be paid to the Texas State Board of Pharmacy and includes the processing of the reinstatement application.
What are the goals of pharmacy internship? - ✔ ✔ The goal of internship is for the pharmacist-intern to attain the knowledge, skills, and abilities to safely, efficiently, and effectively provide pharmacist- delivered patient care to a diverse patient population and practice pharmacy under the laws and regulations of the State of Texas
What are the competency objectives of internship - ✔ ✔ A) Provides drug products.
(B) Communicates with patients and patients' agents about prescription drugs
.
(C) Communicates with patients and patients' agents about nonprescription products, devices, dietary supplements, diet, nutrition, traditional nondrug therapies, complementary and alternative therapies, and diagnostic aids.
D) Communicates with healthcare professionals, patients and patients' agents.
(C) applied to the board to take the NAPLEX and Texas MPJE within six calendar months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission;
(D) Applied to the board for re-issuance of a pharmacist license which has expired for more than two years but less than ten years and has successfully passed the Texas MPJE, but lacks the required number of hours of internship or continuing education required for licensure;
(E) is a resident in a residency program in the state of Texas and has not previously failed more than once either the NAPLEX or Texas Pharmacy Jurisprudence Examination; or
(F) been ordered by the Board to complete an internship.
Minimum intern hours for pharmacist licensure? - ✔ ✔ 1740
A pharmacist-intern participating in a board-approved internship program may perform any duty of a pharmacist provided the duties are delegated by and under the supervision of: - ✔ ✔ (1) a pharmacist licensed by the board and approved as a preceptor by the board; or
(2) a healthcare professional preceptor
When not under the supervision of a pharmacist preceptor, a pharmacist-intern may function as a pharmacy technician and perform all of the duties of a pharmacy technician without registering as a pharmacy technician provided the pharmacist-intern: - ✔ ✔ (1) is registered with the board as a pharmacist-intern;
(2) is under the direct supervision of a pharmacist;
(3) has completed the pharmacy's on-site technician training program;
(4) has completed the training required for pharmacists in (relating to Pharmacies Compounding Sterile Preparations) if the pharmacist-intern is involved in compounding sterile preparations; and
(5) is not counted as a pharmacy technician in the ratio of pharmacists to pharmacy technicians.
A pharmacist-intern may not: - ✔ ✔ (1) present or identify himself/herself as a pharmacist;
(2) sign or initial any document which is required to be signed or initialed by a pharmacist unless a preceptor cosigns the document; or
A person whose pharmacy license, license to practice pharmacy, pharmacy technician registration, or pharmacy technician trainee registration in this state has been revoked or restricted whether voluntarily or by board action, may, after the first anniversary of the effective date of the revocation or restriction, petition the board for reinstatement or removal of the restriction of the license or registration.
(b) The petition must be in writing and in the form prescribed by the board.
(c) A person petitioning for reinstatement or removal of a restriction has the burden of proof.
Requirements for Application for a Pharmacist License Which Has Expired - ✔ ✔ <90 days, the person may renew the license by: (1) paying to the board a renewal fee that is equal to 1.5x the renewal fee for the license
90 days but >1 year, the person may renew the license by: (1) paying to the board a renewal fee that is equal 2x the renewal fee for the license
1 year or more. If a person's license to practice pharmacy in Texas has been expired for one year or more, the person may not renew the license and shall apply for a new license.
What is the minimum requirement for security of the pharmacy (i.e., alarms)? - ✔ ✔ At a minimum, the pharmacy must have a basic alarm system with off-site monitoring and perimeter and motion sensors
How shall prescription hard copies be separated/stored according to TSBP rules?
291.34 (a)(2)(3) - ✔ ✔ Three (3) separate files
*CII
*CIII, IV, and V
*Non-controlled substances
Must storage area be on site for hard copies of prescriptions?
291.34 (a)(1)(A)(B) - ✔ ✔ YES
*Shall be kept by the pharmacy at the pharmacy's licensed location and be available, for at least two years
If an inventory or other record is requested by an authorized agent of the Texas State Board of Pharmacy, how long does the pharmacy have to supply the records?
291.34 (a)(1)(B) - ✔ ✔ Supplied by the pharmacy within seventy- two (72) hours
