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Duties, Dates, open, close, remote sites, etc

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Pharmacy Intern objectives: 1-5 1. providing drug products 2. communicating with pts about prescriptions 3. communicating with pts about non-prescription drugs, devices, dietary supplements, diet, nutrition, traditional non-drug therapy, complementary and alternative therapies, and diagnostic aids 4. communicating with healthcare professionals 5. practicing as part of the pt's interdis. team
Pharmacy Intern objectives: 6-11 6. maintaining professional ethical standards 7. compounding 8. retrieving and evaluating drug information 9. managing general pharmacy operations 10. participating in public health, community service, or professional activities 11. demonstrating scientific inquiry
Internship hours: Board rules dictate the # of internship hours required for licensure is the # of hours required by ACPE which is ___ hours of IPPE and ____ hours of APPE 300; 1440 * cannot receive credit for more than 50 hours per week; hours may be used for the purpose of licensure for no longer than 3 years from the date the internship was completed
Preceptor requirements 1. current, active pharmacist license 2. at least 1 year of exp. or 6 mo of residency training 3. completed 3 hours of preceptor training through ACPE 4. completed 3 hours of preceptor training every 2 years 5. not have a disciplined license 6. may also be other healthcare providers (physicians, dds, vets, or other pharmacists in other states 7. may only supervise 1 intern; 1:1 ratio does not apply to student interns part of a Tx college/school of pharmacy program
TSBP license renewal is ______ biennially; expiring on the last day of the assigned month (birth month) <90 days of expiring--> 1.5x the renewal fee and report the required hours of CE > 90 days expired--> 2x the renewal fee and report the required hours of CE > 1 year expired--> license cannot be renewed
CE (continuing education) : Pharmacist must complete 30 contact hours of CE which equals how many CEUs or (continuing education units)? 3.0 CEU *complete during the preceding license period (2 years)
CE (continuing education) hour requirements: at least 1 contact hour (0.1 CEU) must be related to? Texas pharmacy laws and rules
CE (continuing education) hour requirements: No later than the first anniversary of becoming licensed to practice pharmacy, a pharmacist must have completed at least 2 contact hours of CE related to? approved procedures of prescribing and monitoring controlled substances *one-time requirement for newly licensed pharmacists only
CE (continuing education) hour requirements: With each license renewal, pharmacists must also complete a? human trafficking prevention course as required in section 116.002 of the Texas Occupations Code *course approved by Texas Health and Human Services Commission (HHSC) *new pharmacists are not exempt from this requirement for their first renewal
1 contact hour equals? 0.1 CEU (continuing education units)
Other methods for obtaining CE's under approved programs in TSBP include? 1. completing courses that are part of the professional degree program of a college of pharmacy 2. CPR course (1h) 3. ACLS course for initial certification (12h) 4. ACLS recertification (4h) 5. Attending a TSBP meeting (3h) 6. participating in a TSBP appointed Task Force (3h) 7. attending programs presented by TSBP 8. completing institute for safe medication practices medication safety self assessment (3h) 9. passing specialty certifications (3h) 10. ACCME (CME) *keep CE record for 3 years ⭐️
On a verbal rx for a medicaid pt, the practitioner, must also ___ or ___ a written prescription with the written dispensing directive to the pharmacy within ___ days mail or fax; 30 days *same applies for an E-script
For Out-of-State, Canadian, Mexico prescriptions, or practitioners in a federal facility MUST authorize _______ (rather than prohibit it) substitutions
Communicate with the prescribe no later than ___ days after dispensing a biological product given to the pt including the name of product, manufacturer or NDC 3 days *notification is only required if the biological product dispensed has been substituted form the prescribed product
Substitution of Dosage form: A pharmacist may dispense, with the pt's consent and notification to the prescriber, a dosage form of a drug product different from that prescribed (tablet/capsule/liquid). Requirements are? 1. must contain the identical amount of the active ingredient as the dosage prescribed 2. is not an enteric-coated or timed-release product 3. does not alter clinical outcomes
Emergency refills--> refilling a rx for a drug (other than a C-II) without authorization of the prescriber requirements? 1. failure to refill may lead to therapeutic interruption or pt suffering 2. natural/man-made disaster prohibiting contact with the provider 3. quantity does not exceed 72-hr supply 4. Governor declares disaster and if notified by TSBP, pharmacist may dispense 30-day supply 5. TSBP permits dispensing entire unit-of-use products (oral contraceptives, inhaler, ophthalmic solutions
Emergency refills patient notification: pharmacist notifies patient at time of dispense that refill is provided without provider authorization and that its required for future refills and that: 1. the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time 2. maintains record of emergency refill containing info required to be maintained on a script 3. pharmacist labels the refill as a prescription *can also be applied to emergency refills for Schedule III-V since Texas rules allow this
Auto-refill programs may be used for refills of dangerous drugs and Schedule ___ and ____ CS. Schedule II and III may not be dispensed by an auto-refill program IV and V *Thanks Tx
Impaired pharmacists/pharmacy student programs: alcohol or drug impairment can enter into treatment and monitoring through the? Professional Recovery Network (PRN) *only for pharmacist and pharmacy interns; not for technicians or trainees
Impaired pharmacists/pharmacy student programs: If entering voluntarily, they are not reported to? TSBP *as long as they follow through with PRN's recommendations; could also be placed as part of a disciplinary process by TSBP and Board orders remain confidential
Impaired pharmacists/pharmacy student programs: Funded by and covers? partially funded by a surcharge on all pharmacy and pharmacist licenses. Funds only pay for evaluation of participants and do not cover cost for treatment
Peer review programs evaulate the? quality of care in pharmacies by reviewing errors or near errors or other quality issues *can be voluntary or mandated (as a result of a medication error)
Professional liability insurance insurers must report to _____ any claim filed against a pharmacist, technician, or pharmacy related to care that results in injury or death. TSBP *no liability insurance? report it yourself to TSBP *initial report is required w/in 30 days of receiving the claim notice; follow-up report is required w/in 105 days after disposition (settlement, dismissal, judgment) of the claim
Pharmacy Technicians and Trainee: Requirements 1. Registered prior to beginning work 2. trainee registration is valid for 2 years and is not renewable 3. techs require passing a Board-approved exam, but maintaining certification is not required for renewal of registration 4. Renewal of registration requires 20h of CE (every 2 years) including 1 hour of Texas laws and rules
Pharmacy Technicians and Trainee: Ratio in a Class A? Ratio in Class C or G pharmacies? 1. 1:6 as long as maximum number of pharmacy tech trainees is 3 2. No ratio in Class C and Class G pharmacies
Pharmacy Technician: For renewals after 08/31/2020 and before 09/01/2022--> a pharmacy technician must have completed a? human trafficking prevention course approved by the Texas Health and Human Services Commission
Miscellaneous Texas Pharmacy Act Provisions and TSBP rules: Immunizations and vaccinations requires? written protocol with a physician
Immunzations may not be provided to patients under age ____ unless the pt has been referred by a physician 14; *except that a pharmacist may administer an influenza vaccination to a pt over the age of 7 without an established physician-patient relationship
Immunizations may only be given at a pharmacy or location provided in the protocol; cannot be provided wher pt resides except for ____ ____ or _____ nursing homes or hospitals
Immunization/Vaccine pharmacist certification requires an ACPE-approved course that includes? 1. Basic cardiac life support certification 2. 20h of CDC training 3. 3h of CE every 2 years relating to disease states, drugs, and administration of immunizations or vaccines
Immunization/Vaccine Notifications: notify physician who issued the protocol within ___ hours of administration; PCP notified within ____ days of administration 24h; 14 days
PREP Act expanded ability of pharmacists, interns, and technicians to provide additional services during the COVID-19 pandemic regardless of state law such as? 1. administer COVID-19 vaccines, influenza, childhood vaccines (3yo-18yo), administering COVID-19 diagnoistic tests, and ordering and administering COVID-19 therapeutics *preempted any state laws
Authority to administer childhood vaccines to children age 3yo-18yo w/o a pt-specific order or referral under the PREP Act has ____ expired *may only administer pursuant to a pt-specific order
Although Texas law still does not allow pharmacy technicians to administer any vaccines, they can currently provide? When was the PREP Act extended to? Covid-19 and influenza vaccines under the PREP Act; 12/29/2029
Pharmacist can sign a prescription drug order for a dangerous drug (not a controlled substance) if: 1. delegation follows a diagnosis, initial pt assessment, and drug therapy order by the physician 2. Pharmacist practices in a federally qualified health center (FQHC), hospital, hospital-based clinic, or an academic healthcare institution 3. FQHC or site listed above in which the pharmacis practices has bylaws and a medical staff policy that permits a physician to delegate to a pharamcist the mgmt of a pt's drug therapy
A prescription drug order "signed" by a pharmacist may be ____ to a pharmacy but may not be issued _____. faxed; verbally
Notification and CE requirements with DTM protocol for a pharmacist: Must notify TSBP prior to engaging in DTM; Must complete at least 6h of CE annually related to drug therapy; Physician myst review protocol and any deviations from protocol at least annually
There is no limit to the number of ________ for whom a pharmacist may perform drug therapy mgmt and there is no limit to the number of ______ with whom a physician can enter into a protocol physicians; pharmacists
Required inventory dates include: 1. if on opening day there are no CS, then the pharmacist should record zero 2. annual inventory of CS required in Texas in contrast to the DEA every 2-yr requirement 3. Change of ownership of Class A, A-S, C, C-S, or F pharmacy - taken on day of change of ownership - constitutes the closing inventory for seller and the initial inventory for buyer
Perpetual inventories required for Class C and C-S for Schedule II CS. Class C (ASC) and Class F must maintain a perpetual inventory for ____ CS and any CS stored at a _______ location ALL; remote
Class A and A-S are not required to maintain a ______ inventory of all CS (other than those stored in remote pharmacy locations). perpetual
Many Class C and Class C-S keep a perpetual of all CS but are only required to do so for ______ ___ drugs Schedule II
Prior to closing: At least ____ days prior to closing, the PIC must notify ___ and post a closing notice informing pts of the name, address, and telephone # of the pharmacy acquiring the records 14; DEA
On closing day, PIC must take a ______ inventory and transfer prescription drug order files and pt medication records. Remove all signs that indicate the location is a pharmacy closing
After closing: Within ____ days after closing, the PIC must provide to _____ a written notice of the actual date of closing, the pharmacy license, a statement that an inventory was conducted according to TSBP Rule 291.17; how dangerous drugs and CS were transferred or disposed of and name and address of new place 10; TSBP
After closing: If pharmacy is registered to possess CS, a notification must be sent to a _____ ____ ____ explaining that the pharmacy has closed, along with the DEA registration certificate and any unused DEA Forms ____ which have been voided DEA Divisional Office; 222
A pharmacy may _______ close for lack of a PIC for no more than ____ days. Notify the Board of the closing; and either reopen within ____ hours under the supervision of a new PIC temporarily; 30 *if the 48h cannot be met, the pharmacy must start the process to permanently close the pharmacy
Delivery of prescription drugs: TSBP sets standards for the delivery of rx drugs by a pharmacy licensed by the Board as a Class? A, A-S, E, or E-S
Delivery of prescription drugs: what is a common carrier? A person or entity who hold out to the general public a willingness to provide transportation of property from place to place for compensation in the normal course of business
Delivery of prescription drugs: Examples of a common carrier are? US Mail, FedEx, UPS
Delivery of prescription drugs: What is a contract carrier? A person or entity who provides to industrial customers, pursuant to the terms of a bilateral agreement, the transportation of property for compensation in the normal course of business.
Delivery of prescription drugs: Standards: The pharmacy is responsible for any problems in the delivery of a rx drug by a ____ _____ contract carrier
Delivery by unmanned aircraft services (i.e. drones) may deliver rx drugs, excluding ____ _____ and _____ _____ preparations, by use of a common or contract carrier at the request of the pt or pt's agent in accordance with the ______ and ____ controlled substances; sterile compound; manufacturer; USP (United States Pharmacopeia
All deliveries: Counseling Information: Pharmacy shall comply with the requirements for pt counseling for delivered scripts found in _____ rule 291.33 (1)(F) TSBP
All deliveries: Compromised delivery: If a pharmacist determines a prescription drug is in any way compromised during delivery, the pharmacy shall ______ the drug or arrange for the drug or to be replaced, Replace *either by promptly replacing the drug or contact the provider to arrange the drug to be dispensed to the pt by a pharmacy of their choosing
Deliveries: maintain records for ___ years on the folowing events: when an rx is sent and delivered to the pt or agent; and pt _____ regarding compromised deliveries, which may be documented in the pt profile 2 years; complaints
TSBP recognizes 4 types of remote pharmacy proactices in which drugs may be stored and/or dispensed from locations where a pharmacist is NOT present. These include: 1. Emergency Medication Kits at nursing homes 2. Automated Pharmacy Systems for routine dispensing of drugs at certain healthcare facilities (including nursing homes) 3. Telepharmacy Systems used for dispensing drugs at remote dispensing sites and certain remote healthcare sites 4. Automated Dispensing and Delivery Systems at locations outside a pharmacy
Summary of TSBP Rule: Remote Pharmacy Services using an Emergency medication Kit: This rule allows a Class __ or __ or a Class __ pharmacy located within ___ miles of a facility to provide pharmacy services to facilities licensed under Health and Safety Code Chapter 242 (Convalescent/Nursing homes and related institutions A; C; E; 20 miles * or Chapter 252 (intermediate Care Facilities for Individuals with an Intellectual Disability) using an EMK as outlined in the Texas Pharmacy Act
Summary of TSBP Rule: Remote Pharmacy Services using an Emergency medication Kit: It also allows a US department VA pharmacy or other ______ operated pharmacy to provide pharmacy services using an EMK at an institution licensed under Chapter 242 that is a ______ ____ ____ ____ Federally; Texas State Veterans Home *an application to TSBP is required before providing these services
Summary of TSBP Rule: Remote Pharmacy Services using an Emergency medication Kit: DEA Rule 1301.27 (b) requires automated dispensing systems in LTCF to be registered with ____ DEA *if automated system is being used solely as an emergency kit and not dispensing CS, DEA registration is not required
Contents of an Emergency Medication Kit shall be determined by the ______ _______, PIC of the provider pharmacy, medical director, and Director of Nursing and shall be limited to those drugs necessary to meet the resident's emergency medication needs Consulting Pharmacist
Summary of TSBP Rule: Remote Pharmacy Services: maintain record of all drugs sent to and returned from the remote location and should be kept ______ from the records of the ________ pharmacy and from other remote site records separately; provider *maintain a perpetual inventory of all CS for each remote location and each remote location's CS must be inventoried on the SAME DAY as the provider pharmacy's inventory
Summary of TSBP Rule: Remote Pharmacy Services using Automated Pharmacy Systems: Drugs maintained only in an ____ ____ _____; if CS are stored and dispesed from automated systems at remote locations a ____ ______ must be obtained from the remote location in the name of the providing pharmacy Automated System; DEA registration * an application to TSBP is required prior to providing these services
Summary of TSBP Rule: Remote Pharmacy Services: A pharmacist may supervise operation of the system _____, and shall control all operations of the APS and approve the release of the ___ ___ after receiving a valid prescription drug order electronically; initial dose
Summary of TSBP Rule: Remote Pharmacy Services: Drugs used in an Automated Pharmacy System must be in the _____ _____ container or be __- ____ in the provider pharmacy original manufacturer's; pre-packaged
Summary of TSBP Rule: Remote Pharmacy Services: Using Telepharmacy Systems definition? system that monitors the dispensing of rx drugs and provides for related drug use regimen and pt counseling services by an electronic method, which includes audio/video, still image capture, and store and forward
What are 2 types of remote sites that may use telepharmacy systems? Remote Healthcare Sites Remote Dispensing Sites
Remote Healthcare Sites: Class A or C pharmacy may provide pharmacy services using a telepharmacy system at the following remote healthcare sites: 1. Rural Healthcare Clinics 2. Health centers (service medically underserved populations) 3. Federally qualified health centers 4. Healthcare facilities located in a medically underserved area or health professions shortage area as defined by HHS
A pharmacy may NOT provide remote pharmacy services at a remote healthcare SITE if a Class A or Class C pharmacy that dispenses rx drug orders to outpatients is located in the _____ _____ same community *rule does not apply to telepharmacy systems at federally qualified health centers (FQHC); *Community defined by the Board as within 10 miles if not in a metropolitan statistical area; *Remote Dispensing Sites have more restrictive rules (within 22 miles
Remote Dispensing Sites: A Class A pharmacy (but not a Class C pharmacy) may provide _____ ____ at remote dispensing sites STAFFED by a pharmacy technician telepharmacy services
Telepharmacy systems at Remote Dispensing Sites have the following additional requirements that are NOT required for telepharmacy systems at Remote Healthcare Sites: (1) 1. defined as a location licensed as a telepharm authorized by provider pharmacy through a telepharm system to store and dispense drugs and devices including dangerous drugs and CS - staffed by on-site technician - tech must have worked at least 1 year at retail during the past 3 years and complete Board-approved program of telepharmacy system - tech is included in pharmacist:tech ratio; may not perform extemporaneous sterile/non-sterile compounding but can prepare commercial products
Telepharmacy systems at Remote Dispensing Sites have the following additional requirements that are NOT required for telepharmacy systems at Remote Healthcare Sites: (2) (3) 2. may not be located within 22 road miles of a Class A pharmacy. If one opens within milage restriction AFTER a remote dispensing site is operating and may continue to operate *a provider pharmacy may provide pharmacy services at no more than 2 remote dispensing sites 3. may not dispense C-II
Remote Dispensing Sites (4): If a Remote Dispensing Site dispenses an average of more than _____ prescriptions each day the site is open (calculated annually), it must apply for a Class __ license 125; A
Remote Dispensing Site: (5): A pharmacist from the provider pharmacy must make at least ______ on-site visits to a remote dispensing site and must _______ the perpetual inventory of CS to the on-hand count at a remote dispensing site monthly; reconcile
Remote Healthcare Sites & Remote Dispensing Sites: (1). If CS are to be stored at the remote location, a ____ registration must be obtained for the remote location DEA
Remote Healthcare Sites & Remote Dispensing Sites: (2): Drugs dispensed at a remote site through a telepharmacy system may only be delivered to the _____ at the remote site patient; *provider pharmacy may not supervise more than 2 remote sites and requires application to TSBP before providing services *inventory on same-day as provider pharmacy's inventory *original rx records kept at remote sites shall have electronic access to those records at provider pharmacy
Remote Pharmacy Services: Automated Dispensing and Delivery Systems definition is a mechanical system that dispenses and delivers rx drugs to pts at remote delivery sites and maintains related transaction information *could include prepackaged from provider pharmacy or bulk drug doing packaging, dispensing, and delivery
Remote Pharmacy Services: Automated Dispensing and Delivery Systems may only be provided at Board approved remote delivery sites and application be submmited to the board and renewed every __ years with the provider pharmacy license 2
A pharmacy providing services through an automated dispensing and delivery system at a remote delivery site shall operate according to a written program and procedures which require 1. continuous supervision of the automated dispensing and delivery system 2. Establishes mechanisms and procedures to routinely test the accuracy of the system at a minimum of every 6 months**
Destruction of drugs dispensed to pts in healthcare facilities or institutions (nursing homes) via Consultant Pharmacist to make it unfit for human consumption and disposed in compliance with all state and federal requirements. Destruction is witnessed by? A peace officer or agent of the Board, Texas HHS, Texas State Health Services, or 2 of the following persons from the facility (administrator, director of nursing, or a licensed nurse
Destruction of drugs dispensed to pts in healthcare facilities or institutions (nursing homes) via Waste Disposal in compliance with all state and federal environmental laws and rules. Requirements? Placed in sealed container in presence of witness with tamper-resistant tape containing signature of consulting pharmacist kept in secure area until transfer record date of transfer, person picking up, name and address of waste disposal service, and employee signature of wast disposal service provide proof of destruction
Destruction of Stock Drugs: Records of destruction are ____ required NOT
TSBP Rule: Drug Recall--> requires PIC to remove from inventory within ___ hours of notice of the recall 24
TSBP Rule: Return of Prescription drugs--> it is unlawful to accept rx drugs that have been dispensed for purposes of ______. Exception? Resale; exception for certain prescriptions dispensed to nursing home pts; separate rule for returning undelivered rx or rx from a "will-call" bin to stock
TSBP Rule: Prescription Pick Up Location: No person, firm, or business establishment whereby rx are solicited, collected, picked up, or _____ to be picked up from any location other than a pharmacy licensed by the Board advertised *exception is use of an automated dispensing and delivery system as provided in the remote pharmacy rules *pt may also request pick up at office/home of prescriber, residence or place of employment of pt or hospital or medical care facility where pt is receiving treatment
Federal Law: Only allows a pharmacy to deliver a CS prescription for a specific pt to a prescriber's office if it is to be administered by ____ or _____ for maintenance or detoxification treatment; CS administered no later than ___ days after the date of receipt of the CS by the practitioner injection; implant; 14
Class A prescription balance/analytical balance must be registered with _____ and shall be inspected for accuracy by the Board. Accuracy verified by the pharmacy every ___ months TSBP; 12
Centralized Prescription Dispensing (TSBP): Allows Class __, __, or __ pharmacies to outsource rx drug orders dispensing to another A, C, or E pharmacy (Central Fill). Conditions include? A, C, E - common ownership or written contract or agreement - share common database to allow access to information - provide notice to pts or a sign in the pharmacy - include name of outsourcing pharmacy and unique identifier - DEA does not allow delivery of CS but TSBP allows dangerous drugs directly to pt
Satellite pharmacies are? TSBP Rule allows Class A or C pharmacy to operate a satellite location that is not separately licensed. Rx are dropped off and sent to A or C to be filled then sent back where pt picks up rx and counseling is provided as required
Satellite pharmacies: No ____ prescription drugs are allowed to be stored in a satellite pharmacy Bulk
Created by: Xander635
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