Ch. 4: Texas Pharmacy Act (TPA) Flashcards

1
Q

Texas Pharmacy Act

A
  • Primary law governing pharmacy practice in Texas
  • Establishes TSBP and provides the board with certain authorities/responsibilities in regulating the practice of pharmacy
  • Purpose: promote, preserve, and protect the public health, safety, and welfare of Texans
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Class A Pharmacy License

A
  • Community Pharmacy

- Must register with a Class A-S license if compounding sterile products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Class B Pharmacy License

A

Nuclear Pharmacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Class C Pharmacy License

A
  • Institutional Pharmacy (hospital)
  • Must register with a Class C-S license if compounding sterile products
  • TSBP prohibited by law to adopt rules regarding tech:pharmacist ratios in Class C pharmacies
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Class D Pharmacy License

A

Clinic Pharmacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Class E Pharmacy License

A
  • Nonresident Pharmacy

- Must register with a Class E-S license if compounding sterile products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Medication vs Prescription Order

A
  • Med Order: order from practitioner/designated agent for administration of a drug or device
  • Prescription Order: order from practitioner/designated agent TO A PHARMACIST for a drug dispense OR an order from APRN/PA
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

TSBP Composed of…

A
  • 7 pharmacists
  • 1 pharmacy tech
  • 3 public members
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

TSBP Qualifications

A
  • Must include representation for pharmacists employed by Class A and Class C pharmacies
  • Pharmacists MUST be a resident of Texas, licenses for 5 years preceding appointment, in good TSBP standing, and actively participating in pharmacy
  • Pharmacists CANNOT be lobbyists for a profession regulated by TSBP or an officer/employee/paid consultant to Texas trade association in healthcare
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

TSBP Public Members CANNOT be….

A
  • Registered/certified/licensed by occupational regulatory agency (nurse, physician, etc.)
  • Employed/participate in management of business or entity regulation by the Board or receiving fund from the Board
  • Owner/person who controls >10% interest in business/entity regulated by or receiving funds from the Board
  • Officer/employee/paid consultant to Texas trade association in healthcare
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Appointment/Terms of Office for TSBP

A
  • Appointed by governor with advice/consent of Senate
  • Appointed for 6 year term
  • May not serve >2 consecutive, full terms
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Board Powers/Duties

A

-Administering and enforcing the TPA and rules/other laws related to the practice of pharmacy
Regulate practice by:
-Issuing/renewing licenses
-Determining/issuing standards for recognizing/approving degree requirements of CoP
-Specifying/enforcing requirements for practical training including internships
-Regulation training/qualifications/employment of pharmacist interns/techs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Pharmacist Licensing in Texas

A
  • Unlawful to practice in Texas without a license or fraudulently to obtain a license
  • May not use “Registered Pharmacist”, “R.Ph.,” etc. unless person is licensed to practice pharmacy in Texas
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Pharmacist Licensure Qualifications

A
  • Min. 18 yo
  • Completed internship
  • Graduated/received professional practice degree
  • Pass NAPLEX/MPJE
  • Hasn’t had pharmacy license restricted/suspended/revoked/surrendered in another state
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Examination Retake

A
  • May retake NAPLEX/MPJE 4 additional times each

- If failed 5 times, must meet additional requirements to be allowed to take exams again (includes paperwork)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Licensure by Reciprocity

A
  • Must provide proof of initial licensure by examination and that current license/other licenses hasn’t been suspended/revoked/etc.
  • Must pass Texas MPJE (score of 75+)
  • Texas allows a pharmacist to reciprocate his/her license from a state where a pharmacist obtained a license by examination or reciprocity
  • *Special rules apply for licensed military members/vets/spouses**
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Internship

A
  • Pharmacist intern: student intern/resident intern/extended intern who is participating in Board approved internship program
  • Differences of interns on other flashcards
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Student Intern

A
  • Individual registered with board, enrolled in professional sequence at CoP, and is participating in Board-approved internship
  • Status expires if ceases enrollment at CoP, fails NAPLEX and/or MPJE, or fails to take NAPLEX/MPJE within 6 months of graduation
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Resident Intern

A

Individual who is registered with the board who has graduated CoP and is completing an accredited residency program

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Extended Intern

A

An individual registered with Board who is no longer a student intern and other individuals in specific circumstances (foreign graduates or those seeking reissuance of pharmacist licensure)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Goal of Internship

A

Pharmacist intern to attain knowledge, skills, and abilities to safely, efficiently, and effectively provide pharmacist-delivered patient care to a diverse patient population and practice pharmacy under the law/regulations of Texas.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Objectives of Internships (11)

A
  • Provide drug products
  • Communicate with patients about prescriptions, non-Rx meds, devices, diet supplements, CAM, diagnostic aids, etc.
  • Communicate with HC professionals
  • Practice as part of patient’s interdisciplinary HC team
  • Maintain professional, ethical standards
  • Compound
  • Retrieve/evaluate drug information
  • Manage general pharmacy operations
  • Participate in public health, community service, and professional activities
  • Demonstrate scientific inquiry
23
Q

Intern Duties

A
  1. May perform any duties of a pharmacist while working under a pharmacist registered as a preceptor or HC professional preceptor
  2. Interns may not present themselves as a pharmacist, sign documents that require pharmacist signature, or supervise techs
  3. When not being supervised by preceptor, mainly functions as a pharmacy tech w/o counting towards pharmacists:tech ratio
24
Q

Hour Requirements for Interns

A
  • 300 hours IPPE
  • 1440 hours of APPE
  • Max of 50 hours/week
25
Q

Preceptor Requirements

A
  • Current, active pharmacist license
  • 1+ year of experience or 6 months of resident training
  • Completed 3 hours preceptor training through ACPE course
  • 3 hours of preceptor training Q2years
  • License that hasn’t been disciplined
  • Can be pharmacists or other HC professionals
  • 1:1 preceptor:intern unless part of CoP, then direct supervision for dispensing and general supervision otherwise
26
Q

License Renewal

A
  • Renewed annually or biennially (TSBP now biennially)
  • Licenses expire on last day of assigned month
  • “Timely receipt” of renewal application/fee means received in Board’s office on last day of expiration month, no grace period, mostly online now
  • If license expired <90 days, may renew by paying renewal fee (1.5x amount of renewal few) and report required CE
  • License expired > 90 days but less than 1 year pay 2x renewal fee and report CE
  • After one year, license cannot be renewed… see TSBP for alternatives to reexamination
27
Q

Inactive Status

A

If not actively practicing pharmacy, pharmacists can place their license in “inactive status”

28
Q

CE Requirements

A

Must complete at least 30 CE hours during preceding licensing period (2 years) including:

  • At least 1 year related to Texas law/rules
  • Between September 2021-September 1, 2023: 1 hour annually (2 total hours) of best practices, alternative tx options, and multi-modal approaches to pain management
  • At least 2 contact hours related to prescribing/monitoring CS (completed by Sep. 1 2021 and reported on next license renewal after Sep. 1, 2021)
  • Between Sept. 2020 - Sept 1, 2022: pharmacist must complete a human trafficking prevention course approved by Texas Health and Human Services Commission (only counts towards 30 CE if ACPE approved too)
  • Between Sep 2021 - Sep, 1 2023): 1 contact hour for mental health awareness
29
Q

Methods of Obtaining CE

A
  • Any ACPE course
  • Completing a one credit hour course for each year of their licensing program which is part of an ACPE-accredited CoP
  • Taking/passing NAPLEX as a pharmacist during preceding licensing period
  • Some additional methods listed on another flashcard
  • *Keep CE records for 3 years**
30
Q

Additional Methods to Obtain CE per TSBP (10)

A
  1. Completing courses that are part of CoP program
  2. Complete CPR course (1 hour)
  3. Completing ACLS courses for initial certification (12 hours)
  4. Completing ACLS courses for recertification (4 hours)
  5. Attending TSBP meeting (3 hours)
  6. Participating in TSBP Task Force (3 hours)
  7. Attending programs presented by TSBP
  8. Completing Institute for safe Medication Practices Medication Safety Self-Assessment (3 hours)
  9. Passing Board of Pharmaceutical Specialties certification exam (3 hours)
  10. Completing programs accredited by Accreditation Counsel for CME as Category 1 CME
31
Q

CPE Monitoring Services

A
  • CPE Monitoring Service is joint effort between ACPE and NABP to allow pharmacists to electronically track CE from ACPE accredited providers
  • Set up NABP e-profile at CPE Monitor website and provide that CPE Monitor ID when taking CE from ACPE accredited providers
32
Q

Licensing Pharmacies

A
  • Cannot use the term Pharmacy or Apothecary in business title without being licensed as a pharmacy
  • Separate license needed for each location
  • Only one license for each location (can operate Class A pharmacy under Class C license, but subject to those regulations)
  • Qualifications/requirements on another flashcard and online, need inspection by TSBP before issuing license
  • Inspection can be waived if other pharmacy licenses held UNLESS compounding sterile products (MUST have inspection then)
  • Failure to engage in business as described in application for license within 6 months of date of issuance can be penalized
  • Any changes to location/name require a new license, moving requires at least 30 days of notice to TSBP
33
Q

Requirements on Pharmacy License Application

A
  • Signature of PIC
  • Notarized signature of owner
  • Approved credit application from primary wholesaler
  • Sworn disclosure statement
  • Business Formation documents
  • *Can be waived for certain pharmacy classes and business types**
34
Q

Generically Equivalent

A

Drug that is pharmaceutically and therapeutically equivalent

35
Q

Pharmaceutically Equivalent

A

Drug products have identical amounts of the same active chemical ingredient in the same dosage form

36
Q

Therapeutically Equivalent

A

Pharmaceutically equivalent drugs that when administered in the same amounts provide the same therapeutic effect, identical in duration/intensity

37
Q

Interchangeable

A

Biologic product designed as biosimilar and therapeutically equivalent to another product approved by FDA

38
Q

Permissive Substitution

A

Pharmacist may dispense generically equivalent product or interchangeable biological product IF:

  1. Product costs less than brand name prescribed
  2. Patient doesn’t refuse sub
  3. Prescribed has not prohibited substitution by dispensing directive
39
Q

Dispensing Directive

A
  • Practitioner may prohibit generically equivalent or interchangeable biologic product by writing across Rx in their own handwriting “Brand (Medically) Necessary”
  • Two line prescription forms, check boxes, or other notations on drug order indicating “substitution instructions” aren’t valid to prohibit substitution
  • Dispensing directive may not be preprinted, rubber stamped, or otherwise reproduced on script
40
Q

Verbal Rx Dispensing Directive

A
  • Practitioner may prohibit sub. by specifying “Brand (medically) necessary”
  • For Medicaid patient, prescriber may also mail/fax written script with written dispensing directive to patient within 30 days
41
Q

Electronic Rx Dispensing Directive

A
  • Practitioner may prohibit sub. by specifying “Brand (medically) necessary” on eRx
  • For Medicaid patient, prescriber may also mail/fax written script with written dispensing directive to patient within 30 days
  • Out-of-State/Country: prescriptions must authorize substitution rather than prohibit it
42
Q

Pharmacist Responsibility for Sub

A
  • Patient notification: inform patient that less expensive generic has been dispensed and ask patient to choose between that prescribed and dispensed
  • Within 3 days of dispensing biologic equivalent, communicate to prescribing practitioner the specific product provided to patient including name/manufacturer/NDC (includes medical record system/script claims system accessible to provider)
  • Determine drug/product dispensed (must be level A in Orange Book and interchangeable in Purple… otherwise professional judgement)
  • Labeling must include “Substituted for brand prescribed (or ‘Brand name’)” <= brand name is what was actually prescribed
43
Q

Subbing Dosage Form

A
  • May dispense with pt consent and notification to prescriber a dosage form different from that prescribed IF:
    1. Contains identical amount of active ingredient as that prescribed
    2. Isn’t EC or time-released
    3. Doesn’t alter clinical outcomes
44
Q

Display of Pharmacy Licenses

A
  • Shall display licenses to public view
  • Class A and C must display “pharmacy” or similar word/symbol in front of pharmacy if they serve general public
  • Proof of each pharmacist/intern/tech/trainee license upon request
45
Q

Emergency Refills

A

Pharmacist can exercise professional judgement in refilling script w/o authorization of prescriber (NOT CII) IF:

  1. Failure to refill script may result in patient suffering
  2. Natural/manmade disaster prohibits pharmacist from contacting provider or not contact can be made after reasonable effort
  3. Quantity of drug dispense limited to 3-DS
  4. Governor declares disaster and if notified by TSBP, can dispense 30-DS
  5. Permits dispensing enter unit-of-use products like contraceptive, inhalers, ophthalmic solutions
  6. Pharmacist informs pt at time of refill is being given without prescriber authorization and it will be required for future refills
46
Q

Additional Emergency Refill Requirements

A
  • Pharmacist informs provider of emergency refill at earliest reasonable time
  • Pharmacist maintains record of emergency refill containing the information required to be maintains on Rx
  • Pharmacist labels the refill as a prescription
47
Q

Auto-Refill Programs

A
  1. Pharmacies may use programs that automatically refill scripts that have existing refills to improve patient compliance/adherence
  2. Patients must affirm that they wish to enroll in these programs (documented by pharmacy!)
  3. Patients have option to withdraw at any time
  4. Auto-refill programs are acceptable for CIV, CV, and dangerous meds (NOT acceptable for CII and CIII)
48
Q

Accelerated Refills/90-DS

A

Pharmacist may dispense 90-DS of dangerous drug (NOT CS) from prescription that specifies smaller amount IF:

  1. Total quantity dispensed doesn’t exceed total prescribed (including refills)
  2. Patient consents to dispensing
  3. Physician has been notified electronically/on phone
  4. Drug isn’t psychotropic
  5. Patient is at least 18 yo
49
Q

Bioterrorism/Epidemic/Pandemic Disease Reporting

A
  • Pharmacist shall report to TX Dept of State Health Services any unusual/increased prescription rates/trends that may be caused by bioterrorism, epidemics, or pandemics
  • Includes an increased number of prescriptions to treat resp/GI complaints and sales of OTC products to test resp/GI/fever
50
Q

Administration of Epi

A
  • Pharmacist may administer epi through auto-injector in an emergency
  • Law provides liability protection for pharmacist who in good faith administered epi
  • Immediately after administering epi, pharmacist ensures that 911 is called and patient is evaluated by medical personnel
  • Pharmacist must report such administration to patient’s primary care provider within 72 hours of administration
51
Q

Rx for Epipens

A
  • Pharmacies are allowed to dispense epi auto-injectors to various entities based on prescriptions without needing patient’s name
  • Provider or delegated prescriptive authority may issue an order for epi-auto injector to be stored at specific types of entities (requirements on another flashcard)
52
Q

Requirements to Prescribe Epi Auto-Inj

A
  • Name/signature of prescribing physician/other person
  • Name of entity to which the order is issued
  • Quantity of epi auto-inj to be obtained/maintained under the order
  • Date order was issues
53
Q

Epi Auto-inj can be dispensed to ____ (10) without patient-specific information…

A
  • Law enforcement agencies
  • Day care centers
  • Child care facilities
  • Day camp/youth camps
  • Private/independent institutions of high learning
  • Amusement parks
  • Restaurants
  • Sport Venues
  • Youth centers
  • Other entities designated by rule of Texas Health/Human Services Commission
54
Q

Asthma Meds/Epi Auto-inj can be dispensed to ____ (3) without patient-specific information…

A
  • School district
  • Open-enrollment charter school
  • Private school