Texas MPJE: Dr. C's Review Chapter 4

Texas Pharmacy Act (TPA)

- primary law governing the practice of pharmacy in TX

- establishes TSBP and provides the Board with certain authorities/responsibilities in regulating pharmacy practice

- purpose of the Act and TBSP is to promote, preserve, and protect the public health, safety, and welfare of Texans

Class A Pharmacy License

Community Pharmacy

*Class A-S license for compounding sterile products

Class B Pharmacy License

Nuclear Pharmacy

Class C Pharmacy License

Institutional (hospital) Pharmacy

*Class C-S license for compounding sterile products

Class D Pharmacy License

Clinic Pharmacy

Class E Pharmacy License

Nonresident Pharmacy

*Class E-S license for compounding sterile products

Class ___, ___, and ___ pharmacies must be licensed with "-S" to allow the Board to know which pharmacies are compounding sterile products.

Class A, C, and E pharmacies (community, institutional, and nonresident)

Medication Order definition

an order from a practitioner or their DA for administration of a drug or device (inpatient setting)

Pharmacy definition

a facility at which a prescription drug or medication order is received, processed, or dispensed

Prescription Drug Order definition

an order from a practitioner or their DA to a pharmacist for a drug to be dispensed or an order from a PA or APRN (outpatient setting, nursing homes)

True or False: orders in a nursing home are considered prescription drug orders, but TSBP allows for alternative labeling for prescriptions in nursing homes that are similar to medication orders.

True, since they are administered

TSBP is composed of how many members?

11 members: 7 pharmacists, 1 pharmacy technician, 3 public members

TSBP must include representation for pharmacists employed in both Class ___ and ___ pharmacies.

Class A and C (community and institutional)

What are the requirements for a pharmacist member of TSBP?

1. A resident of Texas

2. Licensed for 5 years preceding appointment

3. In good standing with TSBP

4. Actively practicing pharmacy

Pharmacist members (and members' spouses) of TSBP cannot be what?

1. A lobbyist on behalf of a profession regulated by the Board

2. An officer, employee, or paid consultant to a Texas trade association in the healthcare field

Public members (and members' spouses) of TSBP cannot be what?

1. Registered, certified, or licensed by an occupational regulatory agency (e.g., nurse, physician)

2. Employed by or participate in the management of a business or other entity regulated by the Board or receiving funds from the Board

3. An owner or person who controls more than a 10% interest in a business or other entity regulated by the Board or receiving funds from the Board

4. An officer, employee, or paid consultant to a Texas trade association in the healthcare field

Appointment and Terms of Office for TSBP members

- appointed by the governor with advice and consent of the Senate

- appointed for a 6-year term

- may not serve more than 2 consecutive full terms

TSBP powers, duties, and rulemaking authority: how does the Board regulate the practice of pharmacy?

- issuing and renewing licenses

- determining and issuing standards for recognizing and approving degree requirements of colleges of pharmacy

- specifying and enforcing the requirements for practical training including internship

- regulating the training, qualifications, and employment of pharmacist interns and pharmacy technicians

True or False: TSBP regulates drug wholesalers

False - they are regulated by the Texas Department of State Health Services

True or False: TSBP regulates pharmaceutical manufacturers' representatives

False - does not have the authority

True or False: there is grace period when renewing a pharmacist license for the protection of your legal practice.

False - no grace period; if you fail to renew your license on time, you cannot legally practice

A person may not use the title "Registered Pharmacist" (R.Ph.) or similar words unless what?

the person is licensed to practice pharmacy in Texas

Licensure by Examination Qualifications

1. At least 18 years old

2. Completed internship

3. Graduated and received professional practice degree

4. Passed NAPLEX and MPJE

5. Has not had pharmacist license in another state restricted, suspended, revoked, or surrendered

A person who is enrolled or plans to enroll in school to become a pharmacist or a pharmacy technician or who, prior to taking an examination for licensure, has reason to believe they may be ineligible due to a conviction or deferred adjudication for a felony or misdemeanor offense may request what?

a criminal history evaluation letter

Licensure by Examination: Retake Procedures

1. if an applicant fails the NAPLEX or MPJE, they may retake each examination 4 additional times (5 total)

2. after 5 attempts, an applicant must meet additional requirements, including additional coursework, before being allowed to take the exams again

Licensure by Reciprocity Requirements

- must provide proof of initial licensure by examination and that current license or any other licenses have not been suspended, revoked, cancelled, surrendered, or otherwise restricted

- must pass the Texas MPJE (score of 75)

*Texas allows a pharmacist to reciprocate their license from a state where a pharmacist obtained their license by examination or reciprocity

Pharmacist Intern definition

a student intern, a resident intern, or an extended intern who is participating in a Board-approved internship program

Student Intern definition

an individual registered with the Board who is enrolled in the professional sequence of a COP/SOP and is participating in the Board approved internship program

Student intern designation expires if the person does what?

- ceases enrollment at an accredited COP/SOP

- fails NAPLEX and/or Texas MPJE

- fails to take NAPLEX and/or Texas MPJE within 6 calendar months after graduation

Resident Intern definition

an individual registered with the Board who has graduated from a COP/SOP and is completing an accredited residency program

Extended Intern definition

an individual registered with the Board who is no longer a student intern and other individuals in specific circumstances such as foreign pharmacy graduates or those seeking reissuance of a pharmacist license

Goals and Objectives of Internship

- Goal: 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 Texas

- Objectives: provide drug products; communicate with patients about prescription drugs; communicate with patients about non-prescription drugs, devices, dietary supplements, diet, nutrition, traditional non-drug therapy, complementary and alternative therapies, and diagnostic aids; communicate with healthcare professionals; practice as part of the patient's interdisciplinary healthcare team; maintain professional ethical standards; compound; retrieve and evaluate drug information; manage general pharmacy operations; participate in public health, community service, or professional activities; demonstrate scientific inquiry

Pharmacist interns may perform any duty of a pharmacist, provided they are working under the supervision of whom?

a pharmacist registered as a preceptor or a healthcare professional preceptor

*healthcare professional preceptor may be a physician, dentist, podiatrist, veterinarian, APRN, or PA in Texas or another state; or a pharmacist in a state other than Texas but not licensed in Texas who is serving as an instructor for a Texas COP/SOP-based internship program and who is recognized by a Texas COP/SOP to supervise and be responsible for the activities and functions of a pharmacist intern

True or False: intern duties may include supervising technicians and signing documents that require a pharmacist's signature

False

When not working under the supervision of a preceptor, an intern functions as what?

a pharmacy technician (must have completed the pharmacy's technician training program) but does not count in any ratio of pharmacy techs to pharmacists

Intern Hour Requirements

ACPE dictates 300 hours of IPPE and 1440 of APPE

*an intern cannot receive credit for more than 50 hours per week

Preceptor Requirements

- current, active pharmacist license that has not been disciplined

- at least 1 year of experience or 6 months of residency training

- complete 3 hours of preceptor training through an ACPE course and complete 3 hours of training every 2 years

- may only supervise one intern, however the 1:1 ratio does not apply to student interns who are part of a Texas COP/SOP program (supervision must be direct for dispensing activities and general for other activities)

True or False: there is no ratio for preceptors supervising pharmacist interns as a part of a Texas COP/SOP program

True

Licenses shall be renewed after how much time?

annually or biennially (TSBP now renews biennially)

Licenses expire on the _________ day of the assigned month.

last day of the assigned month (birth month)

If a license is expired for less than ___ days, the licensee may renew by paying a renewal fee that is equal to _________ times the renewal fee and report the required hours of CE.

1. less than 90 days

2. one and one-half times

If a license is expired for more than 90 days but less than ___ year(s), the licensee may pay a renewal fee equal to ____ times the renewal fee and report the required number of CE hours.

1. less than 1 year

2. two times

True or False: if one's license has been expired for more than 1 year, the license cannot be renewed.

True - alternatives for reexamination required

Inactive License Status

- pharmacists not actively practicing pharmacy can place their license in inactive status

- cannot practice and still must pay the license renewal fee

- to activate license, must pay a fee and meet specific CE requirements

*a pharmacist with an inactive license is not required to report any CE hours at the time of renewal

To renew a pharmacist license, a pharmacist must complete at least ____ contact hour(s) of CE during the preceding license period (2 years), and at least ___ hour(s) must be related to Texas pharmacy law and rules

1. 30 hours (3.0 CEUs)

2. 1 hour (0.1 CEU)

With each license renewal, a pharmacist must have completed a __________________ prevention course approved by the Texas Health and Human Services Commission, and a list of approved courses is posted on ___________________________.

1. Human Trafficking prevention course

2. the commission's website

*this is a requirement for all licensed healthcare professionals and is not part of the 30 contact hours requirement (would only count if it is an ACPE-accredited course)

Not later than the _____ anniversary of becoming licensed to practice pharmacy, a pharmacist must have completed at least ____ contact hour(s) related to approved procedures of prescribing and monitoring controlled substances.

1. first anniversary

2. 2 contact hours

*newly licensed pharmacists must complete this requirement within one year of obtaining their license

_____ uses Continuing Education Units (CEUs) to accredit courses, but ______ (and nearly every organization) refers to CE contact hours; one contact hour equals _____ CEU

1. ACPE

2. TSBP

3. 1 hour = 0.1 CEU

Methods of Obtaining CE: successfully completing during the preceding license period ____ contact hour course(s) for each year of their license period, which is part of the professional degree program (accredited by ______) in a college of pharmacy

1. a 1 contact hour course

2. accredited by ACPE

*this would include people in a nontraditional PharmD program

Methods of Obtaining CE: taking and passing the ___________ examination as a pharmacist during the preceding license period, which shall be equivalent to _____ hour(s) of CE.

1. NAPLEX

2. 30 contact hours

In addition to ACPE-accredited courses, TSBP allows what methods for obtaining CE?

1. courses that are part of a COP professional degree program

2. CPR course (1 hour)

3. ACLS courses leading to initial certification (12 hours)

4. ACLS courses leading to recertification (4 hours)

5. attending a TSBP meeting (3 hours)

6. participating in a TSBP appointed Task Force (3 hours)

7. attending programs presented by the TSBP

8. an Institute for Safe Medication Practices Medication Safety Self-Assessment (3 hours)

9. a certain Board of Pharmaceutical Specialties certification examination (3 hours)

10. programs accredited by Accreditation Council for Continuing Medical Education as Category 1 CME

CE records must be kept for ___ years

3 years

*only records that TSBP requires to be kept for 3 years; most other records are required to be kept for 2 years

CPE Monitoring Service

- joint effort of ACPE and NABP which allows pharmacists to electronically track pharmacist CE from ACPE-accredited providers

- pharmacists should set up an NABP e-profile at NABP's CPE Monitor website and obtain an e-profile ID; e-profile ID should be provided when obtaining CE from an ACPE-accredited provider

True or False: a separate pharmacy license is required for each location and only one pharmacy license may be issued to a location.

True

True or False: if a hospital is operating a Class A (community) pharmacy under its Class C (institutional) license, it is not required to have a Class A license.

True

*it must follow Class A rules for the outpatient pharmacy including the Class A ratio of pharmacy techs to pharmacists

Qualifications and Requirements for a Pharmacy License Application: signature of the __________, notarized signature of the __________, an approved credit application from a __________, a sworn disclosure statement, and business information documents.

1. signature of the PIC

2. notarized signature of the owner

3. approved credit application from a primary drug wholesaler

An on-site inspection is required prior to issuing a pharmacy license; when can TSBP waive this requirement?

the applicant holds another active pharmacy license in the state or for another good reason

Any pharmacy that compounds sterile products cannot be licensed by ______ until the pharmacy has been inspected by _______.

1. TSBP

2. TSBP

A pharmacy that fails to engage in the business as described in the application for a license within _____ month(s) of the date of issuance of the license is subject to disciplinary action.

6 months

True or False: a pharmacy license is transferable if there is a change of location or change of name.

False - not transferable; pharmacy must file a new application and return the old license

*TSBP issues an amended license and the previous license number does not change

For a pharmacy change of location, TSBP must be notified in writing at least _____ day(s) before the change.

30 days

TSBP is prohibited by law from adopting rules regarding ratios of pharmacy technicians to pharmacists in Class _______ pharmacies.

Class C

Generically Equivalent Drug definition

a drug that is pharmaceutically equivalent and therapeutically equivalent

Pharmaceutically Equivalent Drugs definition

drug products having identical amounts of the same active chemical ingredient in the same dosage form

Therapeutically Equivalent Drugs definition

pharmaceutically equivalent drugs that when administered in the same amounts will provide the same therapeutic effect, identical in duration and intensity

Interchangeable Drug definition

a biological product that is designated as biosimilar and therapeutically equivalent to another product approved by the FDA

The Texas statute refers to biological product designation as equivalent in the FDA __________ Book, but the publication FDA uses for therapeutic equivalency evaluations for biologicals is the FDA _________ Book.

1. Orange Book

2. Purple Book

Permissive Substitution - a pharmacist may dispense a generically equivalent drug or interchangeable biological product if what?

1. the product costs less than the brand name prescribed

2. the patient does not refuse the substitution

3. the prescriber has not prohibited substitution by a dispensing directive

A practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product on a written prescription by doing what?

writing across the face of the prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary"

True or False: two-line prescription forms, check boxes, or other notations on an original written prescription drug order which indicate "substitution instructions" are valid methods to prohibit substitution.

False - a pharmacist may substitute on these types of written prescriptions

True or False: the dispensing directive on written prescriptions may be preprinted, rubber-stamped, or otherwise reproduced on the prescription.

False - not permitted

A practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product on a verbal prescription by doing what?

verbally specifying "brand necessary" or "brand medically necessary"

On an electronic or verbal prescription for a __________ patient, the practitioner must also mail or fax a written prescription with the written dispensing directive to the pharmacy within ______ day(s).

1. Medicaid patient

2. 30 days

A practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product on an electronic prescription by doing what?

noting "brand necessary" or "brand medically necessary" on the electronic prescription

True or False: for out-of-state, Canadian, or Mexican practitioners or practitioners in federal facilities, the prescription must authorize substitution.

True

No later than ____ day(s) after dispensing a biological product substituted for the prescribed product, the dispensing pharmacist or designee shall communicate to the ________________ the specific product provided to the patient, including the name of the product and what else?

1. 3 days

2. prescribing practitioner

3. manufacturer and NDC number

*this can be done by making an entry into a medical records system or prescription claim system that is accessible to the prescriber

For drugs listed in "Approved Drug Products with Therapeutic Equivalents (the FDA __________ Book), the pharmacist may only substitute ____ rated drugs; biological products must be listed as _____________ in the FDA __________ Book.

1. Orange Book

2. "A" rated drugs

3. interchangeable

4. Purple Book

*for drugs not listed in the FDA Orange Book, the pharmacist may use professional discretion

* biological e.g., Semglee (insulin glargine-yfgn) for Lantus (insulin glargine)

For generic drug substitution and interchangeable biological products, the prescription label must include __________________ or __________________ where 'Brand Name' is the name of the actual product prescribed.

"Substituted for Brand Prescribed" or "Substituted for 'Brand Name'"

Requirements for Substitution of Dosage Form

- must contain the identical amount of the active ingredient as the dosage prescribed

- not an enteric-coated or timed-release product

- does not alter clinical outcomes

Display of Pharmacy License Requirements

- pharmacies shall display pharmacy license in public view

- Class A and C pharmacies must display the word "pharmacy" or a similar word or symbol in front of the pharmacy if they serve the public

- a pharmacy shall make available to the public on request proof that each pharmacist, pharmacist intern, tech, and tech trainee holds the appropriate license or registration

True or False: you are allowed to make copies of your original license, renewal certificate, and your "pocket license" card.

False - you may only copy your "pocket license" card

A pharmacist may exercise professional judgement in refilling prescriptions for drugs, other than CIIs, without authorization of the prescriber if what?

1. Failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering

2. Either a natural or manmade disaster has occurred that prohibits the pharmacist from being able to contact the prescriber, or the pharmacist is unable to contact the prescriber after reasonable effort

3. The quantity of the prescription drug dispensed does not exceed a 72-hour display

4. If the governor declares a disaster and if notified by TSBP, the pharmacist may dispense a 30-day supply

5. TSBP permits dispensing the entire unit-of-use products such as PO contraceptives, inhalers, and ophthalmic solutions

The pharmacist informs the patient at the time of dispensing that the refill is being provided without the prescriber's authorization - what happens next?

1. pharmacist informs the patient that the authorization of the prescriber is required for future refills

2. pharmacist informs the practitioner of the emergency refill at the earliest reasonable time

3. pharmacist maintains a record of the emergency refill containing the information required to be maintained on the prescription

4. pharmacist labels the refill as a prescription

True or False: the rules can be applied to emergency refills for CIII-V prescriptions.

True

Auto-Refill Program Requirements

- patients must affirmatively indicate that they wish to enroll in such a program, and the pharmacy shall document such indication

- patients must have the option to withdraw at any time

- may be used for refills of dangerous drugs and CIV-Vs

*CII-IIIs may not be dispensed by an auto-refill program

A pharmacist may dispense up to a 90-day supply of a dangerous drug from a prescription that specifies for a lesser amount if what?

1. the total quantity dispensed does not exceed the total prescribed (including refills)

2. the patient consents to the dispensing

3. the physician has been notified electronically or by telephone (afterwards)

4. the drug is not a psychotropic drug

5. the patient is at least 18 years old

A pharmacist shall report to the Texas Department of State Health Services any unusual or increased prescription rates or trends that may be caused by _______________, _______________, or _______________________.

bioterrorism, epidemic, or pandemic disease

*treating respiratory or GI complaints (including antibiotics) and OTC products to treat respiratory or GI complaints or fever

A pharmacist may administer epinephrine through an ____________ in an emergency. After administering the epinephrine, what shall the pharmacist do?

1. an autoinjector

2. pharmacist shall ensure 911 is called and the patient is evaluated by emergency medical personnel

3. pharmacist must report such administration to the patient's PCP within 72 hours from the time of administration

*law provides liability protection for the pharmacist

True or False: pharmacies are allowed to dispense epinephrine autoinjectors to various entities based on prescriptions without requiring a patient name.

True

*and in some cases asthma medication

A physician or person who has been delegated prescriptive authority (APRN or PA) may issue an order for an epinephrine auto-injector to be stored at specific types of entities; the order must contain what?

1. name and signature of the prescribing physician or other person

2. name of the entity to which the order is issued

3. quantity to be obtained and maintained under the order

4. date the order was issued

Prescriptions for epinephrine autoinjectors may be dispensed by a pharmacy pursuant to a valid prescription without requiring the name or any other identifying information of the user for what entities?

law enforcement agencies, day care centers, child care facilities, day camps or youth camps, private or independent institutions of higher education, amusement parks, restaurants, sports venues, youth centers, and any other entity designated by rule of the Texas Health and Human Services Commission

Prescriptions for epinephrine autoinjectors and asthma medication may be dispensed by a pharmacy pursuant to a valid prescription without requiring the name or any other identifying information of the user for what entities?

school districts, open-enrollment charter schools, and private schools

________________ is required to report a change of pharmacist name or address to TSBP within ________ day(s).

Pharmacist within 10 days

_______________ is required to report a change of pharmacist employment to TSBP within ________ day(s).

Pharmacist within 10 days

______________ is required to report the permanent closing of the pharmacy to TSBP within ________ day(s) after closing.

Pharmacy within 10 days after closing

______________ is required to report the change of pharmacy ownership to TSBP within _____ day(s) and new license required.

Pharmacy within 10 days

____________ is required to report the change of pharmacy location to TSBP with new license filed at least _____ day(s) prior to change

Pharmacy files 30 days prior to change of location

______________ is required to report the change of pharmacy name to TSBP with new license filed at least ____ day(s) prior to change

Pharmacy files 10 days prior to change of name

______________ is required to report the change of managing officers or partnership/corporation to TSBP within ____ day(s)

Pharmacy reports within 10 days

______________ is required to report the change of PIC to TSBP within _____ day(s)

Incoming PIC within 10 days