TSBP Flashcards

Question

Dispensing of Opioid Antagonist by Pharmacist

Answer 1

* Opioid antagonist--Any drug that binds to opioid receptors and blocks or otherwise inhibits the effects of opioids acting on those receptors. * (1) A pharmacist may dispense an opioid antagonist under a valid prescription, including a prescription issued by a standing order, to: * (A) a person at risk of experiencing an opioid-related drug overdose; or * (B) a family member, friend, or other person in a position to assist a person described by subparagraph (A) of this paragraph. * (2) A prescription dispensed under this section is considered as dispensed for a legitimate medical purpose in the usual course of professional practice. * (3) A pharmacist who, acting in good faith and with reasonable care, dispenses or does not dispense an opioid antagonist under a valid prescription is not subject to any criminal or civil liability or any professional disciplinary action for: * (A) dispensing or failing to dispense the opioid antagonist; or * (B) if the pharmacist chooses to dispense an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist.

Answer 2

* Physician supervision shall be considered adequate if the delegating physician: * (1) is responsible for the formulation or approval of the physician's order, standing medical order, standing delegation order, or other order or protocol and periodically reviews the order or protocol and the services provided to a patient under the order or protocol; * (2) has established a physician-patient relationship with each patient under 14 years of age and referred the patient to the pharmacist; except a pharmacist may administer an influenza vaccination to a patient over seven years of age without an established physician-patient relationship; * (3) is geographically located so as to be easily accessible to the pharmacist administering the immunization or vaccination; * (4) receives, as appropriate, a periodic status report on the patient, including any problem or complication encountered; and * (5) is available through direct telecommunication for consultation, assistance, and direction.

Answer 3

* (1) Pharmacists may only administer immunizations or vaccinations pursuant to a written protocol from a physician authorizing the administration. * (2) Pharmacists may administer immunizations or vaccinations to a patient **under 14 years** of age **only upon a referral from a physician who has an established physician-patient relationship with each patient**. However, a pharmacist may administer an **influenza vaccination** to a patient **over seven years** of age without an established physician-patient relationship. * (3) Pharmacists may administer immunizations or vaccinations under written protocol of a physician within a pharmacy or at any other location specifically identified in the written protocol. Such other location may not include where the patient resides, except for a licensed nursing home or hospital. * (4) The authority of a pharmacist to administer immunizations or vaccinations may not be delegated. * (5) Pharmacists may administer immunizations and vaccinations only when a licensed health-care provider authorized to administer the medication is not reasonably available to administer the medication. For the purpose of this section, "reasonably available" means those times when the licensed health-care provider is immediately available to administer the immunization or vaccine and is specifically tasked to do so. * (6) Under the provisions of the National Vaccine Injury Compensation Program (NVICP), the health-care provider under whose authority a covered vaccine is administered (i.e., the physician issuing the written protocol) must maintain certain information in the patient's permanent record. In order for the physician to comply with the provisions of the NVICP, the pharmacist shall provide the physician with the information specified in notification of administration * (7) Before preparing an immunization or vaccine and between each patient contact, the pharmacist shall cleanse his or her hands with an alcohol-based waterless antiseptic hand rub or shall wash his or her hands with soap and water. If gloves are worn, the pharmacist shall change gloves between patients. * (8) The pharmacist shall comply with all other state and federal requirements regarding immunizations or vaccinations.

Answer 4

* (1) Drugs (immunizations and vaccinations) administered by a pharmacist under the provisions of this section shall be in the legal possession of: * (A) a pharmacy, which shall be the pharmacy responsible for drug accountability, including the maintenance of records of administration of the immunization or vaccination; or * (B) a physician who shall be responsible for drug accountability, including the maintenance of records of administration of the immunization or vaccination. * (2) Drugs shall be transported and stored at the proper temperatures indicated for each drug. * (3) Pharmacists while actively engaged in the administration of immunizations or vaccinations under written protocol, may have in their custody and control the drugs for immunization or vaccination that are identified in the written protocol and any other dangerous drugs listed in the written protocol to treat adverse reactions. * (4) After administering immunizations or vaccinations at a location other than a pharmacy, the pharmacist shall return all unused prescription medications to the pharmacy or physician responsible for the drugs.

Answer 5

* (1) A pharmacist engaged in the administration of immunizations or vaccinations shall provide notification of the administration to: * (A) the physician who issued the written protocol within 24 hours of administering the immunization or vaccination; and * (B) the primary care physician of the patient, as provided by the patient or patient's agent, within 14 days of administering the immunization or vaccination. * (2) The notifications required in paragraph (1) of this subsection shall include the: * (A) name and address of the patient; * (B) age of the patient if under 14 years of age; * (C) name of the patient's primary care physician as provided by the patient or patient's agent; * (D) name, manufacturer, and lot number of the vaccine administered; * (E) amount administered; * (F) date the vaccine was administered; * (G) site of the immunization or vaccination (e.g., right arm, left leg, right upper arm); * (H) route of administration of the immunization or vaccination (e.g., intramuscular, subcutaneous, by mouth); and * (I) name, address, and title of the person administering the immunization or vaccination. * Every record, including notifications, required to be made under this section shall be kept by the pharmacist administering the immunization or vaccination and by the pharmacy when in legal possession of the drugs administered. Such records shall be available for at least two years from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.

Answer 6

* (1) Pharmacists may administer epinephrine through an auto-injector to a patient in an emergency situation. * (2) The authority of a pharmacist to administer epinephrine through an auto-injector may not be delegated. * (3) Epinephrine administered by a pharmacist under the provisions of this section shall be in the legal possession of a pharmacist or the legal possession of a pharmacy which shall be the pharmacy responsible for drug accountability, including the maintenance of records of administration of the epinephrine. * Limitation on liability. * (1) A **pharmacist** who in good faith administers epinephrine through an auto-injector **is not liable** for civil damages for an act performed in the administration unless the act is willfully or wantonly negligent. * (2) A pharmacist **may not receive remuneration** for the administration of epinephrine through an auto-injector but **may seek reimbursement for** the cost of the epinephrine **auto-injector**. * (3) The administration of epinephrine through an auto-injector to a patient **does not constitute the unlawful practice of any health care profession.** * Notifications. * (1) A pharmacist who administers epinephrine through an auto-injector to a patient shall **report** the use **to** the patient's **primary care physician**, as identified by the patient, **as soon as practical**, but in no event more than **72 hours** from the time of administering the epinephrine. * (2) **Immediately**, **after** administering the epinephrine auto-injector, the pharmacist shall ensure that **911 is called** and the patient is evaluated by emergency personnel for possible transfer to the nearest emergency department for additional evaluation, monitoring, and treatment. * (3) The notifications required in paragraph (1) of this subsection shall include the: * (A) name of the patient; * (B) age of the patient if under 8 years of age; * (C) name and manufacturer of the epinephrine auto-injector; * (D) date the epinephrine was administered; * (E) name and title of the person administering the epinephrine; and * (F) name, address, and telephone number of the pharmacy.(f) * Records. * (1) The notification required to be made under this section shall be kept by the pharmacy and such **records** shall be available for **at least two years** from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies. * (2) The notification may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided: * (A) the records maintained in the alternative system contain all of the information required on the manual record; and * (B) the data processing system is capable of producing a hard copy of the record upon request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

Answer 7

* (1) Individuals who are **not registered** with the Board may **not be employed** as or perform the duties of a pharmacy technician or pharmacy technician trainee. * (2) Individuals who have **previously** applied and **registered as a pharmacy technician**, regardless of the pharmacy technician's current registration status, **may not register as** a pharmacy technician **trainee.** * (3) Individuals who **apply and are qualified for both** a pharmacy technician trainee registration and a pharmacy technician registration **concurrently** will **not be considered for** a **pharmacy technician trainee registration**. * (b) Registration for pharmacy technician **trainees**. An individual **may register** as a pharmacy technician trainee **only once** and the registration **may not be renewed**. * (1) Each applicant for pharmacy technician trainee registration shall: * (A) **have** a high school or equivalent **diploma (e.g., GED)**, **or** be **working to achieve** a high school or equivalent diploma. For the purposes of this subparagraph, an applicant for registration may be working to achieve a high school or equivalent diploma **for no more than two years**; * (B) **complete the Texas application for registration** that includes the following information: * (i) name; * (ii) addresses, phone numbers, date of birth, and social security number; and * (iii) any other information requested on the application. * (C) **meet all requirements** necessary in order for the Board to access the **criminal history record information,** including submitting **fingerprint** information and paying the required **fees**. * (2) Once an applicant has successfully **completed all requirements** of registration, and the board has determined there are **no grounds to refuse** registration, the applicant will be **notified of registration** as a pharmacy technician trainee and of his or her pharmacy technician trainee **registration number.** * (3) Pharmacy technician trainee registrations **expire two years from the date of registration** or upon issuance of registration as a **registered pharmacy technician,** whichever is earlier. * (c) Initial registration for pharmacy technicians. (1) Each applicant for pharmacy technician registration shall: * (A) **have** a high school or equivalent **diploma (e.g., GED),** or be **working to achieve** a high school or equivalent diploma. For the purpose of this clause, an applicant for registration may be working to achieve a high school or equivalent diploma **for no more than two years**; and * (B) either have: * (i) taken and **passed a pharmacy technician certification examination** approved by the board and have a current certification certificate; or * (ii) been **granted an exemption** from certification by the board as specified in §297.7 of this title (relating to Exemption from Pharmacy Technician Certification Requirements); and * (C) complete the Texas application for registration that includes the following information: * (i) name; * (ii) addresses, phone numbers, date of birth, and social security number; and * (iii) any other information requested on the application. * (D) meet all requirements necessary in order for the Board to access the **criminal history record** information, including submitting **fingerprint** information and paying the required **fees**; and * (E) pay the **registration fee** specified in §297.4 of this title (relating to Fees). * (2) Once an applicant has successfully **completed all requirements** of registration, and the board has determined there are **no grounds to refuse** registration, the applicant will be **notified of registration** as a registered pharmacy technician and of his or her pharmacy technician **registration number**. If the pharmacy technician applicant was **registered as a pharmacy technician trainee** at the time the pharmacy technician registration is issued, the **pharmacy technician trainee registration expires.**

Answer 8

* (1) All applicants for renewal of a pharmacy technician registration shall: * (A) **complete the Texas application for registration** that includes the following information: * (i) name; * (ii) addresses, phone numbers, date of birth, and social security number; * (iii) 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; and * (iv) any other information requested on the application. * (B) **pay the renewal fee** specified in §297.4 of this title; and * (C) complete **20 contact hours of continuing education per renewal period** as specified in §297.8 of this title (relating to Continuing Education). * (2) A pharmacy technician registration expires on the last day of the assigned expiration month. * (3) As specified in §568.004 of the Act, if the completed application and renewal fee are not received in the board's office on or before the last day of the assigned expiration month, the person's pharmacy technician registration shall expire. An expired registration shall be renewed according to the following schedule. * (A) If a pharmacy technician registration has **expired for 90 days or less**, the person may become registered by making application and paying to the board a renewal fee that is **equal to one and one-half times the renewal fee** for the registration * (B) If a pharmacy technician registration has been expired for **more than 90 days but less than one year**, the person may become registered by making application and paying to the board a renewal fee that is equal to **two times the renewal fee** for the registration * (C) If a pharmacy technician registration has expired for **more than one year**, the pharmacy technician **may not renew** the registration and **must complete the requirements for initial registration** as specified in subsection (c) of this section. * (4) After review, the board may determine that paragraph (3)(C) of this subsection does not apply if the registrant is the subject of a pending investigation or disciplinary action.(e) An individual may use the title "**Registered Pharmacy Technician" or "Ph.T.R." if the individual is registered as a pharmacy technician in this state.**

Answer 9

* (a) Pharmacy technician **trainee**. The fee for registration shall be **$55 for a two-year registration**. * (b) Pharmacy technician. * (1) **Biennial Registration**. The board shall require biennial renewal of all pharmacy technician registrations provided under Chapter 568 of the Act. * (2) Initial Registration Fee. The fee for **initial registration shall be $83** for a two-year registration. * (3) Renewal Fee. The fee for **biennial renewal shall be $80** for a two-year registration.

Answer 10

* (a) A person designated as a **pharmacy technician trainee** shall be **registered with the board prior to beginning training** in a Texas licensed pharmacy. * (b) A person may be **designated** as a pharmacy technician **trainee** **for no more than two years** and the **requirements for registration** as a pharmacy technician must be **completed within the two year period**.

Answer 11

* (a) Pharmacy **technicians and** pharmacy technician **trainees** shall **complete initial training** as **outlined by the pharmacist-in-chrge** in a training manual. Such training: * (1) shall meet the requirements of subsections (d) or (e) of this section; and * (2) may not be transferred to another pharmacy unless: * (A) the pharmacies are under common ownership and control and have a common training program; and * (B) the pharmacist-in-charge of each pharmacy in which the pharmacy technician or pharmacy technician trainee works certifies that the pharmacy technician or pharmacy technician trainee is competent to perform the duties assigned in that pharmacy. * (b) The **pharmacist-in-charge** shall **assure** the continuing **competency** of pharmacy technicians and pharmacy technician trainees through in-service education and training to supplement initial training. * (c) The **pharmacist-in-charge** shall **document** the **completion** of the training program and certify the competency of pharmacy technicians and pharmacy technician trainees completing the training. A written **record** of **initial and in-service training** of pharmacy technicians and pharmacy technician trainees shall be maintained and contain the following information: * (1) name of the person receiving the training; * (2) date(s) of the training; * (3) general description of the topics covered; * (4) a statement that certifies that the pharmacy technician or pharmacy technician trainee is competent to perform the duties assigned; * (5) name of the person supervising the training; and * (6) signature of the pharmacy technician or pharmacy technician trainee and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training of pharmacy technicians and pharmacy technician trainees. * (d) A person who has **previously completed** the training program outlined in subsection (e) of this section, **a licensed nurse, or physician assistant is not required to complete the entire training program outlined** in subsection (e) of this section **if the person is able to show competency** through a **documented assessment of competency**. Such competency assessment may be conducted by personnel designated by the pharmacist-in-charge, but the **final acceptance of competency** must be **approved by** the **pharmacist-in-charge**. * (e) Pharmacy technician and pharmacy technician trainee training shall be outlined in a training manual. Such training manual shall, at a minimum, contain the following: * (1) written procedures and guidelines for the use and supervision of pharmacy technicians and pharmacy technician trainees. Such procedures and guidelines shall: * (A) specify the manner in which the pharmacist responsible for the supervision of pharmacy technicians and pharmacy technician trainees will supervise such personnel and verify the accuracy and completeness of all acts, tasks, and functions performed by such personnel; and * (B) specify duties which may and may not be performed by pharmacy technicians and pharmacy technician trainees; and * (2) instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians and pharmacy technician trainees in the pharmacy: * (A) Orientation; * (B) Job descriptions; * (C) Communication techniques; * (D) Laws and rules; * (E) Security and safety; * (F) Prescription drugs: * (i) Basic pharmaceutical nomenclature; * (ii) Dosage forms; * (G) Drug orders: * (i) Prescribers; * (ii) Directions for use; * (iii) Commonly-used abbreviations and symbols; * (iv) Number of dosage units; * (v) Strengths and systems of measurement; * (vi) Routes of administration; * (vii) Frequency of administration; and * (viii) Interpreting directions for use; * (H) Drug order preparation: * (i) Creating or updating patient medication records; * (ii) Entering drug order information into the computer or typing the label in a manual system; * (iii) Selecting the correct stock bottle; * (iv) Accurately counting or pouring the appropriate quantity of drug product; * (v) Selecting the proper container; * (vi) Affixing the prescription label; * (vii) Affixing auxiliary labels, if indicated; and * (viii) Preparing the finished product for inspection and final check by pharmacists; * (I) Other functions; * (J) Drug product prepackaging; * (K) Written policy and guidelines for use of and supervision of pharmacy technicians and pharmacy technician trainees; and * (L) Confidential patient medication records. * (f) Pharmacy technicians and pharmacy technician trainees compounding non-sterile pharmaceuticals shall meet the training and education requirements specified in the rules for the class of pharmacy in which the pharmacy technician or pharmacy technician trainee is working. * (g) Pharmacy technicians and pharmacy technician trainees compounding sterile pharmaceuticals shall meet the training and education requirements specified in the rules for class of pharmacy in which the pharmacy technician or pharmacy technician trainee is working.

Answer 12

* (a) Drugs dispensed to patients in health care facilities or institutions. * (1) Destruction by the **consultant pharmacist**. The consultant pharmacist, if in good standing with the Texas State Board of Pharmacy, **is authorized to destroy dangerous drugs dispensed to patients in health care facilities or institutions**. A consultant pharmacist **may destroy controlled substances** as allowed to do so by federal laws or rules of the Drug Enforcement Administration. **Dangerous drugs may be destroyed provided the following conditions are met**. * (A) A written agreement exists between the facility and the consultant pharmacist. * (B) The drugs are inventoried and such inventory is verified by the consultant pharmacist. The following information shall be included on this inventory: * (i) name and address of the facility or institution; * (ii) name and pharmacist license number of the consultant pharmacist; * (iii) date of drug destruction; * (iv) date the prescription was dispensed; * (v) unique identification number assigned to the prescription by the pharmacy; * (vi) name of dispensing pharmacy; * (vii) name, strength, and quantity of drug; * (viii) signature of consultant pharmacist destroying drugs; * (ix) signature of the witness(es); and * (x) method of destruction. * (C) The signature of the consultant pharmacist and witness(es) to the destruction and the method of destruction specified in subparagraph (B) of this paragraph may be on a cover sheet attached to the inventory and not on each individual inventory sheet, provided the cover sheet contains a statement indicating the number of inventory pages that are attached and each of the attached pages are initialed by the consultant pharmacist and witness(es). * (D) The drugs are destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements. * (E) The actual destruction of the drugs is **witnessed** by one of the following: * (i) a commissioned **peace officer**; * (ii) an **agent of** the Texas State **Board** of Pharmacy; * (iii) an **agent** of the **Texas Health and Human Services Commission**, authorized by the Texas State Board of Pharmacy to destroy drugs; * (iv) an **agent** of the **Texas Department of State Health** Services, authorized by the Texas State Board of Pharmacy to destroy drugs; or * (v) any **two individuals** working in the following capacities at the facility: * (I) **facility administrator**; * (II) **director of nursing**; * (III) **acting director of nursing**; or * (IV) **licensed nurse**. * (F) If the actual **destruction** of the drugs is conducted at a **location other than the facility or institution**, the **consultant pharmacist and witness(es)** shall **retrieve the drugs** from the facility or institution, **transport, and destroy the drugs at such other location.** * (2) **Destruction by a waste disposal service**. A consultant pharmacist **may utilize a waste disposal service to destroy dangerous drugs** dispensed to patients in health care facilities or institutions. A consultant pharmacist **may destroy controlled substances as allowed** to do so by federal laws or rules of the Drug Enforcement Administration. **Dangerous drugs may be transferred to a waste disposal service** for destruction provided the following conditions are met. * (A) The waste disposal service is in compliance with applicable rules of the Texas Commission on Environmental Quality and United States Environmental Protection Agency relating to waste disposal. * (B) The drugs are inventoried and such inventory is verified by the consultant pharmacist prior to placing the drugs in an appropriate container, and sealing the container. The following information must be included on this inventory: * (i) name and address of the facility or institution; * (ii) name and pharmacist license number of the consultant pharmacist; * (iii) date of packaging and sealing of the container; * (iv) date the prescription was dispensed; * (v) unique identification number assigned to the prescription by the pharmacy; * (vi) name of dispensing pharmacy; * (vii) name, strength, and quantity of drug; * (viii) signature of consultant pharmacist packaging and sealing the container; and * (ix) signature of the witness(es). * (C) The **consultant pharmacist seals the container of drugs in the presence of the facility administrator and the director of nursing or one of the other witnesses** listed in paragraph (1)(E) of this subsection as follows: * (i) **tamper resistant tape is placed on the container** in such a manner that any attempt to reopen the container will result in the breaking of the tape; and * (ii) the **signature of the consultant pharmacist** is placed **over this tape** seal. * (D) The **sealed container** is maintained **in** a **secure area** at the facility or institution **until transferred** to the waste disposal service by the consultant pharmacist, facility administrator, director of nursing, or acting director of nursing. * (E) A **record of the transfer** to the waste disposal service is maintained and **attached to the inventory** of drugs specified in subparagraph (B) of this paragraph. Such record shall contain the following information: * (i) date of the transfer; * (ii) signature of the person who transferred the drugs to the waste disposal service; * (iii) name and address of the waste disposal service; and * (iv) signature of the employee of the waste disposal service who receives the container. * (F) The **waste disposal** service shall **provide** the facility with **proof of destruction** of the sealed container. Such proof of destruction shall contain the date, location, and method of destruction of the container and shall be attached to the inventory of drugs specified in subparagraph (B) of this paragraph. * (3) Record retention. **All records** required in this subsection shall be **maintained** by the consultant pharmacist at the health care facility or institution for **two years** from the date of destruction.

Answer 13

* A **pharmacist** in a pharmacy **may accept and destroy dangerous drugs** that have been previously dispensed to a patient and **returned to a pharmacy by the patient or an agent of the patient.** A pharmacist **may accept controlled substances** that have been previously dispensed to a patient as allowed by federal laws of the Drug Enforcement Administration. The following procedures shall be followed in destroying dangerous drugs. * (1) The dangerous drugs shall be destroyed in a manner to **render the drugs unfit for human consumption** and **disposed of in compliance with all applicable state and federal requirements**. * (2) **Documentation** shall be maintained that includes the following information: * (A) name and address of the dispensing pharmacy; * (B) unique identification number assigned to the prescription, if available; * (C) name and strength of the dangerous drug; and * (D) signature of the pharmacist.

Answer 14

* (a) Definition of stock. "Stock" as used in these sections means **dangerous drugs or controlled substances** which are **packaged in the original manufacturer's container**. * (b) Disposal of stock dangerous drugs. A **pharmacist**, licensed by the board, is **authorized to destroy stock dangerous drugs** owned by a licensed pharmacy if such dangerous drugs are destroyed in a manner to **render the drugs unfit** for human consumption and **disposed of in compliance with all applicable state and federal requirements**. * (c) Disposal of stock controlled substances. A **pharmacist**, licensed by the board, **shall dispose of stock controlled substances** owned by a licensed pharmacy in accordance with procedures authorized by the Federal and Texas Controlled Substances Acts and sections adopted pursuant to such Acts.

Answer 15

All **inventory records** and **forms of disposed drugs** shall be maintained **for two years** from the **date of transfer, disposal, or destruction** and be available for inspection by an agent of the board, Texas Department of Public Safety, Drug Enforcement Administration, or any other agent authorized to inspect such records.

Answer 16

* (a) A **practitioner** may order official prescription forms from the board only if the practitioner is **registered by the DEA to prescribe a Schedule II** controlled substance. * (b) The **board** is the sole **source** for the **official prescription forms**. * (c) This subsection applies only to an **institutional practitioner** who is employed by a hospital or other training institution. An institutional practitioner **authorized by a hospital or institution to prescribe a Schedule II** controlled substance under the DEA registration of the hospital or institution may order official prescription forms under this section if: * (1) the practitioner prescribes a controlled substance in the usual course of the practitioner's training, teaching program, or employment at the hospital or institution; * (2) the appropriate state health regulatory agency has assigned an institutional permit or similar number to the practitioner; and * (3) the hospital or institution: * (A) maintains a current list of each institutional practitioner and each assigned institutional permit number; and * (B) makes the list available to another registrant or a member of a state health regulatory or law enforcement agency for the purpose of verifying the authority of the practitioner to prescribe the substance. * (d) An **advanced practice registered nurse** or **physician assistant** operating under a prescriptive authority agreement pursuant to Texas Occupations Code, Chapter 157 **may order official prescription forms** under this section if authority to prescribe has been delegated by a physician. Upon **withdrawal** of the delegating **physician's authority** such **forms are void** and **must be returned** to the board.

Answer 17

* (1) Except as provided by subsection (e) of this section, a **practitioner,** as defined in the TCSA, §481.002(39)(A), **must issue a written prescription for a Schedule II** controlled substance only **on an official Texas prescription form** or through an **electronic prescription that meets all requirements of the TCSA**. This subsection also applies to a prescription issued in an emergency situation. * (2) A practitioner who issues a **written prescription** for any quantity of a **Schedule II** controlled substance must complete an **official prescription form**. * (3) A practitioner **may issue multiple written prescriptions** authorizing a patient to receive **up to a 90-day supply** of a **Schedule II** controlled substance provided: * (A) each prescription is issued for a **legitimate medical purpose** by a practitioner acting in the usual course of professional practice; * (B) the practitioner provides **written instructions on EACH prescription**, other than the first prescription if the practitioner intends for that prescription to be filled immediately, **indicating the earliest date on which a pharmacy may dispense** each prescription; and * (C) the practitioner concludes that **providing the patient with multiple prescriptions** in this manner **does not create an undue risk** of diversion or abuse. * (4) A **schedule II** prescription must be **dispensed no later than 21 days after the date of issuance** or, if the prescription is part of a multiple set of prescriptions, issued on the same day, no later than **21 days after the earliest date** on which a **pharmacy may dispense** the prescription as indicated on each prescription. * (e) **Advanced practice registered nurses or physician assistants** may only use the **official prescription forms** issued **with their name**, address, phone number, and DEA numbers, **and** the **delegating physician's name** and DEA number.

Answer 18

* (1) A **practitioner,** as defined in the TCSA, §481.002(39)(A), (C), (D), **may use prescription forms and order forms through individual sources**. A practitioner may issue, or allow to be issued by a person under the practitioner's direction or supervision, a Schedule III through V controlled substance on a prescription form for a valid medical purpose and in the course of medical practice. * (2) Schedule **III through V** prescriptions **may be refilled up to five times within six months after date of issuance**. * (c) Electronic prescription. A practitioner is permitted to issue and to dispense an **electronic controlled substance prescription only in accordance with the requirements of the Code of Federal Regulations**, Title 21, Part 1311.(d) Controlled substance prescriptions **may not be postdated**. * (e) **Advanced practice registered nurses or physician assistants may only use the official prescription forms** issued **with their name**, address, phone number, and DEA numbers, **and** the **delegating physician's name** and DEA number.

Answer 19

* (a) An official prescription form is **not required** for a medication order written **for a patient who is admitted to a hospital at the time the medication order is written and dispensed.** * (1) A practitioner may dispense or cause to be dispensed a Schedule II controlled substance to a patient who: * (A) is admitted to the hospital; and * (B) will require an emergency quantity of a controlled substance upon release from the hospital. * (2) Under paragraph (1) of this subsection, the controlled substance: * (A) may only be dispensed in a properly labeled container; and * (B) may **not be more than a seven-day supply or the minimum amount needed** for proper treatment of the patient until the patient can obtain access to a pharmacy, **whichever is less**. * (b) Subsection (a) of this section applies to a patient who is admitted to a hospital, including a patient: * (1) admitted to: * (A) a general hospital, special hospital, licensed ambulatory surgical center, surgical suite in a dental school, or veterinary medical school; or * (B) a hospital clinic or emergency room, if the clinic or emergency room is under the control, direction, and administration as an integral part of a general or special hospital; * (2) receiving treatment with a Schedule II controlled substance from a member of a Life Flight or similar medical team or an emergency medical ambulance crew or a paramedic-emergency medical technician operating as an extension of an emergency room of a general or special hospital; or * (3) receiving treatment with a Schedule II controlled substance while the patient is an inmate incarcerated in a correctional facility operated by the Texas Department of Criminal Justice or a correctional facility operating in accordance with the Health Services Plan adopted by the Texas Commission on Jail Standards. * (c) Subsection (a) of this section applies to an animal admitted to an animal hospital, including an animal that is a permanent resident of a zoo, wildlife park, exotic game ranch, wildlife management program, or state or federal research facility. * (d) An official prescription form is **not required** in a **long-term care facility** (LTCF) if: * (1) an individual administers the substance to an inpatient from the facility's medical emergency kit; * (2) the individual administering the substance is an authorized practitioner or an agent acting under the practitioner's order; and * (3) the facility maintains the proper records as required for an emergency medical kit in an LTCF. * (e) An official prescription form is not required when a therapeutic optometrist administers a topical ocular pharmaceutical agent in compliance with: * (1) the Texas Optometry Act; and * (2) a rule adopted by the Texas Optometry Board under the authority of the Texas Optometry Act.

Answer 20

* (a) Upon **receipt** of a properly completed **prescription form**, a dispensing pharmacist must: * (1) if the prescription is **for a Schedule II** controlled substance, **ensure the date** the prescription is presented **is not later than 21 days after the date of issuance**; * (2) if **multiple prescriptions** are issued by the prescribing practitioner **allowing** up to a **90-day supply** of Schedule II controlled substances, **ensure each prescription** is **neither dispensed prior to the earliest date** intended by the practitioner **nor dispensed beyond 21 days from the earliest date** the prescription may be dispensed; * (3) record the date dispensed and the pharmacy prescription number; * (4) indicate whether the pharmacy dispensed to the patient a quantity less than the quantity prescribed; and * (5) if issued on an official prescription form, record the following information, if different from the prescribing practitioner's information: * (A) the brand name or, if none, the generic name of the controlled substance dispensed; or * (B) the strength, quantity, and dosage form of the Schedule II controlled substance used to prepare the mixture or compound. * (b) The **prescription** presented for dispensing is **void**, and a **new prescription is required**, if: * (1) the prescription is for a Schedule II controlled substance, 21 days after issuance, or 21 days after any earliest dispense date; or * (2) the prescription is for a Schedule III, IV, or V controlled substance, more than six months after issuance or has been dispensed five times during the six months after issuance.

Answer 21

* (a) **Not later than the next business day** after the date **a controlled substance** prescription is **dispensed**, a pharmacy must **electronically submit to the board** the following data elements: * (1) the prescribing practitioner's DEA registration number including the prescriber's identifying suffix of the authorizing hospital or other institution's DEA number when applicable; * (2) the official prescription form control number if dispensed from a written official prescription form for a Schedule II controlled substance; * (3) the board's designated placeholder entered into the control number field if the prescription is electronic and meets the requirements of Code of Federal Regulations, Title 21, Part 1311; * (4) the patient's name, date of birth, and address including city, state, and zip code; or such information on the animal's owner if the prescription is for an animal; * (5) the date the prescription was issued and dispensed; * (6) the NDC # of the controlled substance dispensed; * (7) the quantity of controlled substance dispensed; * (8) the pharmacy's prescription number; and * (9) the pharmacy's DEA registration number. * (b) A pharmacy must **electronically correct dispensing data** submitted to the board **within seven business days** of identifying an omission, error, or inaccuracy in previously submitted dispensing data.

Answer 22

* (a) If a **pharmacy dispenses** a controlled substance **pursuant to an orally or telephonically communicated prescription** from a practitioner or the practitioner's designated agent, the **prescription must be promptly reduced to writing**, including the information required: * (1) by law for a standard prescription; and * (2) by law and this subchapter for an official prescription, if issued for a Schedule II controlled substance in an emergency situation. * (b) After **dispensing a Schedule II controlled substance pursuant to an orally or telephonically communicated prescription**, the dispensing pharmacy must: * (1) **maintain the written record** created under subsection (a) of this section; * (2) **note the emergency** nature of the prescription; * (3) upon receipt from the practitioner, **attach the original official prescription to the orally** or telephonically communicated prescription; and * (4) **retain both documents** in the pharmacy records. * (c) A pharmacy that dispenses **Schedule III, IV, or V controlled substances pursuant to an orally or telephonically communicated prescription** must inform the prescribing practitioner in the event of an emergency refill of the prescription. * (d) All **records** generated under this section must be **maintained for two years** from the date the substance was dispensed.

Answer 23

* The pharmacy is responsible for documenting the following information regarding a modified prescription: * (1) date the change or adding of information was authorized; * (2) information that was authorized to be added or changed; * (3) name of the prescribing practitioner granting the authorization; and * (4) initials or identification code of the pharmacist.

Answer 24

* (a) A Schedule II controlled substance prescription issued by a practitioner in another state not on the board's official prescription form may be dispensed if: * (1) the practitioner is authorized by the other state to prescribe the substance; * (2) the pharmacy has a plan approved by and on file with the board allowing the activity; and * (3) the pharmacy processes and submits the prescription according to the reporting requirements approved in the plan. * (b) The pharmacy may dispense a prescription for a Schedule III through V controlled substance issued by a practitioner in another state if the practitioner is authorized by the other state to prescribe the substance.

Answer 25

* (a) An unused official prescription form is invalid and the practitioner or another person acting on behalf of the practitioner must return the unused form to the board with an appropriate explanation not later than the 30th day after the date: * (1) the practitioner's license to practice, DEA number is canceled, revoked, suspended, denied, or surrendered or amended to exclude the handling of all Schedule II controlled substances; or * (2) the practitioner is deceased. * (b) An individual who is an institutional practitioner must return an unused official prescription form to the administrator of the hospital or other training institution upon completion or termination of the individual's training at the hospital or institution. The administrator must return an unused official prescription form to the board not later than the 30th day after the date the individual completes or terminates all training programs. * (c) No individual may continue to use an official prescription form issued under an institutional practitioner's DEA number or similar number after the individual has been properly and individually licensed as a practitioner by the appropriate state health regulatory agency.

Answer 26

* (a) A practitioner, as defined in the TCSA, §481.002(39)(A), (C), and (D), may use prescription forms ordered through individual sources or through an electronic prescription that includes the controlled substances registration number issued by the United States Drug Enforcement Administration and meets all requirements of the TCSA. * (b) If a written prescription form is to be used to prescribe a controlled substance the dispensing practitioner must be registered with the DEA under both state and federal law to prescribe controlled substances.

Answer 27

* (a) Accountability. A practitioner who obtains from the board an official prescription form is accountable for each numbered form.( * b) Prohibited acts. A practitioner may not: * (1) allow another practitioner to use the individual practitioner's official prescription form; * (2) pre-sign an official prescription blank; * (3) post-date an official prescription; or * (4) leave an official prescription blank in a location where the practitioner should reasonably believe another could steal or misuse a prescription. * (c) While not in use. While an official prescription blank is not in immediate use, a practitioner may not maintain or store the book at a location so the book is easily accessible for theft or other misuse. * (d) Voided. A practitioner must account for each voided official prescription form by sending the voided form to the board.( * e) Types of forms. Forms may be single or multiple copy forms as provided by the board. * (f) Faxed forms. Faxed official prescription forms will be accounted for as in the TCSA, §481.074(o).

Answer 28

* (a) Report lost forms. Not later than close of business on the day of discovery, a practitioner must report a lost or stolen official prescription form to: * (1) the local police department or sheriff's office in an effective manner; and * (2) the board. * (b) Recovery report. Not later than close of business on the day of recovery of an official prescription form previously reported lost or stolen, a practitioner must, before using the recovered form, notify: * (1) the local law enforcement agency to which the matter was originally reported; and * (2) the board. * (c) Replacement/lost form. Not later than the close of business on the day that an official prescription is replaced or reported lost, with or without a replacement, the prescribing practitioner, or designated agent, shall report to the board the following: * (1) patient name, address, date of birth or age; * (2) all drug information; and * (3) official prescription form control number.

Answer 29

* (a) Effective September 1, 2019, a pharmacist **before dispensing an opioid, benzodiazepine, barbiturate, or carisoprodol** for a patient shall consult the Texas Prescription Monitoring Program (PMP) database to **review the patient's controlled substance history**. The dispensing pharmacist of a prescription shall be responsible for the review of the PMP database prior to dispensing the prescription, unless the pharmacy has designated another pharmacist whose identity has been recorded in the pharmacy's data processing system as responsible for PMP review. * (b) The duty to **consult the PMP database** as described in subsection (a) of this section **does not apply** in the following circumstances: * (1) the prescribing individual practitioner is a veterinarian; * (2) it is clearly **noted** in the prescription record that the patient has a diagnosis of **cancer or is in hospice care**; or * (3) the **pharmacist is unable to access the PMP** after making and documenting a good faith effort to do so. * (c) If a pharmacist uses pharmacy management systems that integrate data from the PMP, a review of the pharmacy management system with the integrated data shall be deemed compliant with the review of the PMP database as required under §481.0764(a) of the Texas Health and Safety Code and in subsection (a) of this section. * (d) Pharmacists and pharmacy technicians acting at the direction of a pharmacist may only access information contained in the PMP as authorized in §481.076 of Texas Controlled Substances Act. A person who is authorized to access the PMP may only do so utilizing that person's assigned identifier (i.e., login and password) and may not use the assigned identifier of another person. Unauthorized access of PMP information is a violation of Texas Controlled Substances Act, the Texas Pharmacy Act, and board rules.

Answer 30

* a pharmacist **may dispense a generically equivalent drug or interchangeable biological** product if: * (1) the generic drug or interchangeable biological **product costs the patient less** than the prescribed drug product; * (2) the **patient does not refuse** the substitution; and * (3) the **practitioner does not certify** on the prescription form that a specific prescribed **brand is medically necessary** as specified in a dispensing directive described in subsection (c) of this section. * (b) Prescription format for written prescription drug orders. * (1) A written prescription drug order issued in Texas may: * (A) be on a form containing a single signature line for the practitioner; and * (B) contain the following reminder statement on the face of the prescription: "A generically equivalent drug product may be dispensed unless the practitioner hand writes the words 'Brand Necessary' or 'Brand Medically Necessary' on the face of the prescription." * (2) A pharmacist may dispense a prescription that is not issued on the form specified in paragraph (1) of this subsection, however, the pharmacist may dispense a generically equivalent drug or interchangeable biological product unless the practitioner has prohibited substitution through a dispensing directive in compliance with subsection (c)(1) of this section. * (3) The prescription format specified in paragraph (1) of this subsection does not apply to the following types of prescription drug orders: * (A) prescription drug orders issued by a practitioner in a state other than Texas; * (B) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or * (C) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment. * (4) In the event of multiple prescription orders appearing on one prescription form, the practitioner shall **clearly identify to which prescription(s) the dispensing directive(s) apply.** If the practitioner does not clearly indicate to which prescription(s) the dispensing directive(s) apply, the **pharmacist may substitute on all prescriptions** on the form. * When a **prescription is issued** for a brand name product that has **no generic equivalent** product, the pharmacist must dispense the brand name product. If a **generic equivalent** or interchangeable biological product **becomes available**, a **pharmacist may substitute** the generically equivalent or interchangeable biological product **unless the practitioner** has **specified on the initial prescription** that the brand name product is medically necessary. * If the **practitioner has prohibited substitution** through a dispensing directive in compliance with this subsection, a **pharmacist shall not substitute** a generically equivalent drug or interchangeable biological product **unless the pharmacist obtains verbal or written authorization** from the practitioner, notes such authorization on the original prescription drug order, and notifies the patient * Written prescriptions: A practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product for a brand name drug product by **writing** across the face of the written prescription, **in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."** * dispensing directive specified in this paragraph **may not be preprinted, rubber stamped, or otherwise reproduced** on the prescription form. * A practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. **Two-line prescription forms, check boxes, or other notations** on an original prescription drug order which indicate "substitution instructions" **are not valid methods to prohibit** substitution, and a pharmacist may substitute on these types of written prescriptions. * Verbal prescriptions: must verbally indicate brand medically necessary and pharmacist will reduce to writing. * If prescription is reimbursed by medical assistance program (medicare): * Practitioner must verbally indicate brand necessary AND mail or fax written prescription with directive to pharmacy **within 30 days******

Answer 31

* Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners. * (A) The dispensing directive specified in this subsection does not apply to the following types of prescription drug orders: * (i) prescription drug orders issued by a **practitioner in a state other than Texas**; * (ii) prescriptions for dangerous drugs issued by a **practitioner in the United Mexican States or the Dominion of Canada**; or * (iii) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment. * (B) A **pharmacist may not substitute** on prescription drug orders identified in subparagraph (A) of this paragraph **unless the practitioner has authorized substitution** on the prescription drug order. If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product **unless**: * (i) the **pharmacist obtains verbal or written authorization** from the practitioner (such authorization shall be noted on the original prescription drug order); or * (ii) the pharmacist **obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas**, in which the prescription drug order was issued. The following is applicable concerning this documentation. * (I) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order. * (II) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file. * (III) Such documentation shall be updated yearly.

Answer 32

* **Not later than the third business day after the date of dispensing a biological product**, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescribing practitioner the specific product provided to the patient, including the name of the product and the manufacturer or national drug code number. * (b) The communication must be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy benefit management system or a pharmacy record, which may include information submitted for the payment of claims, that a pharmacist reasonably concludes is electronically accessible by the prescribing practitioner. Otherwise, the pharmacist or the pharmacist's designee shall communicate the biological product dispensed to the prescribing practitioner, using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication is not required if: * (1) there is no interchangeable biological product approved by the United States Food and Drug Administration for the product prescribed; or * (2) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.

Answer 33

* (a) The determination of the drug product to be substituted as authorized is the professional responsibility of the pharmacist, and the pharmacist may not dispense any product that does not meet the requirements of the Texas Pharmacy Act. * (b) Pharmacists shall use as a basis for the determination of generic equivalency or interchangeability the most recent edition or supplement of the United States Food and Drug Administration's references (e.g., the Orange Book or Purple Book). * (c) Pharmacists. For drugs not listed in the Orange Book, pharmacists shall use their professional judgment to determine generic equivalency. * (d) Pharmacists shall use Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication, to determine biosimilarity to or interchangeability with a reference biological product.

Answer 34

Drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendial or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium

Answer 35

Pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.

Answer 36

A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

Answer 37

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

TSBP Flashcards

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