Cont. Ch 4 Flashcards
1
Q
Physician Administration/Dispensing of Dangerous Drugs
A
- Physicians generally not allowed to dispense in Texas
- Exceptions: 72-hour supply of dangerous drug in office dispensement to meet immediate therapeutic needs, certain rural areas where there isn’t a pharmacy to dispense dangerous drugs to patients and be reimbursed for cost, and vets
2
Q
Impaired Pharmacists/Student Program (PRN)
A
- Pharmacist and students who have alcohol or drug impairment can enter into tx and monitoring through Professional Recovery Network (PRN)
- Enter voluntarily => not reported to TSBP as long as they follow recommendations
- Can also be placed into program as part of discipline
- Any Board order by TSBP for impairment is confidential
- Program partially funded by surcharge on all pharmacy/pharmacist licenses (pays for evaluation, not tx)
3
Q
Peer Review Program
A
- Peer review committee may be set up by pharmacy owners/associations to evaluate QoC from pharmacies by evaluating errors/near errors or other quality issues
- Statute provides legal protection of peer review documents in civil litigation
- Setting up committee is voluntary; however, some pharmacies may be mandated to establish committee as part of a disciplinary action against pharmacy license
4
Q
Reporting Professional Liability Claims
A
- Insurer who provides professional liability insurance to pharmacist/techs/pharmacies must report any claim that ends in injury/death filed against them to TSBP
- If one of these claimed is received by individual who doesn’t have liability insurance, must report to TSBP themselves
- Initial report required within 30 days of receiving claim notice and follow-up report within 105 days after disposition (settlement, judgement, etc.)
5
Q
Tech/Trainee Registration
A
- Must be registered as pharmacy tech/trainee prior to beginning work in pharmacy
- Trainee license valid for two years, not renewable
- Initial registration as tech requires passing Board-approved certification exam, but maintaining certification is not required for renewal of registration
- Renewal of registration requires 20 CE Q2y including 1 hour of Texas law
6
Q
Tech Ratios
A
- Class A is 1:6 pharmacists:trainees/techs in Class A pharmacy… max of 3 trainees
- No ratio in Class C and G pharmacies
7
Q
Tech Training
A
- Pharmacy techs and trainees must complete training conducted by PIC as outlined in pharmacy tech training manual
- Specific requirements can be found on TSBP website
- PIC must document their training
8
Q
CE for Techs
A
- Techs are required to complete 20 contact hours of CE Q2y
- 1 hour must be Texas law
- Acceptable forms of CE are same as pharmacists (include courses for pharm. tech. training program)
- Those who maintain certification are considered to have met CE requirements and aren’t subject to audit by TSBP
- Sep 2020 - Sept, 1 2022: must completed 1 human trafficking course
9
Q
Immunization/Vaccinations
A
- Requires written protocol with physician
- Services to patient under 14 yo may only be provided if referred by physician (exception: flu shot for child >7 yo without established physician-pt relationship)
- Can only be given at pharmacy or location provided in protocol (not residence unless nursing home/hospital)
- Immunization certification required BLS, 20 hours of CDC training, and 3 hours of CE Q2y related to immunizations/vaccines
- Must notify physician who issued protocol within 24 hours and patient’s physician within 14 days
10
Q
DTM Under Protocol
A
- Pharmacist may perform DTM as authorized under written protocol
- Includes getting med histories, getting assessment procedures (vitals), ordering related labs, and implementing/modifying drug therapy as detailed in protocol
- Any other drug therapy related act delegated by physician
11
Q
Pharmacists can sign prescription order for dangerous drug (NO CS) if…
A
- Delegation follows a diagnosis, initial assessment, and drug therapy order by physician
- Pharmacist practices in federal HC AND that facility has bylaws that permit medical staff to delegate a pharmacist the management of a patient’s drug therapy
12
Q
DTM Written Protocols
A
- Must identify supervising physician and pharmacist permitted with DTM
- Must identify types of DTM decision a pharmacist can make
- Must state activities pharmacist shall follow in performing DTM
- State mechanism/time schedule for pharmacist to report to physician
13
Q
DTM CE Requirements
A
- Must report to TSBP before performing DTM
- Complete at least 6 hours of CE related to drug therapy
14
Q
DTM Supervision
A
- Physician must review protocol and any deviations from protocol annually (min.)
- Physician must have physician-pt relationship with each pt
- Physician must be geographically located to be physically present daily
- Must receive periodic status reports as defined in protocol
- Physician must be telecommunicatively available to consult
15
Q
DTM Records
A
- Kept for 2 years
- Must keep copy of written protocol and any pt-specific deviations from protocol
- Must document ALL interventions
- Must review protocol annually
16
Q
Inventory Requirements
A
- PIC responsible for ensuring all inventories done
- Inventories must be maintained in pharmacies, filed separately, available for inspection x2years
- Inventories include all stock “on hand” of CS (includes expired meds)
- Persons taking inventory and PIC shall sign/date inventory and indicate time it was taken
- Signature of PIC/date of inventory notarized within 3 business days (not including initial/change of PIC)
- PIC responsible for each exact count of CII and estimated counts of CIII-V (container hold <1000 pills)
- CII shall be listed separately
- Perpetual inventories must be reconciled on date of annual inventory
17
Q
Required Inventories
A
- Initial inventory (on opening day of business, if no CS then record 0)
- Annual inventory of CS - Texas requirement
- Change of ownership for A/C/F pharmacies: take on date of change of ownership (acts as closing and initial inventories respectively)
- Change of PIC in A/C/F pharmacies
18
Q
Perpetual Inventories
A
- Class C must maintain perpetual inventories of CII
- Class C ambulatory care facilities and Class F must maintain perpetual inventories for all CS
- All pharmacies must maintain perpetual inventories for CS in remote locations
19
Q
Closing a Pharmacy
A
- 14 days prior to closing, PIC must notify DEA and post a closing notice for customers stating name/address/phone number of pharmacy acquiring their records
- Closing Day: PIC must perform closing inventory, transfer prescription records, and remove all signs that indication pharmacy location
- After closing: within 10 days, PIC must provide written notice to TSBP of actual closing date, pharmacy license, statement of inventory completion, manner that dangerous drugs/CS were transferred/disposed of, and where records were transferred to
- If registered with DEA for CS, must send notification to DEA with statement that pharmacy closed, their DEA registration certificate, and any unused, voided DEA 222 forms
20
Q
Remote Pharmacy: Emergency Med Kits
A
- Allows pharmacy within 20 miles of facility to provide pharmaceutical services via emergency kit (nursing/mental/vet homes)
- Application to TSBP required before performing services
- If only used as an emergency kit, DEA registration not required
- Access to kit limited to pharmacists/HC personnel employed by facility
- Contents determined by consulting pharmacist, PIC of facility, medical director, and director of nursing
- Stocking must be done by consultant pharmacy staff unless barcodes/microchips/tech used to ensure requirements are met
- Record must be maintained of all drugs sent/returned (keep separate from other records)
- Perpetual inventory of all CS! Inventory these the same day the consultant pharmacy is inventoried
21
Q
Remote Pharmacy: Automated Pharmacy Systems
A
- Allows Class A/C to provide services to homes/jails via an automated pharmacy system
- DEA registration required if CS stored there (for remote location in consulting pharmacy name)
- TSBP application required beforehand
- Pharmacist may supervise operation of system electronically and provide authorization to release initial dose after receiving valid drug order
- Must meet labeling requirements
- Must be packaged in original manufacturer container or be prepackaged at consultant pharmacy
- Stocking done by pharmacy staff unless system uses removable cartridges/containers/etc.
- Record maintained for all drugs sent/returned and kept separate
- Perpetual inventory of all CS! Inventory these the same day the consultant pharmacy is inventoried
22
Q
Remote Pharmacy: Telepharmacy
A
- System that monitors the dispensing of Rx drugs and provides related drug use regimen/counseling services electronically using audio/video/image capture
- Two types: Remote HC Sites and Remote Dispensing Sites
- Slightly different rules for each
23
Q
Telepharmacy: Remote HC Sites
A
- Class A or C can provide telepharmacy services for rural health clinics, HC centers for medically underserved populations, federally qualified HC centers, and HC centers in medically underserved areas or where HC professional shortage occurs
- Cannot dispense in that area if a Class A or C pharmacy is already located in the same community (excluding federally qualifying HC centers) - within 22 miles
24
Q
Telepharmacy: Remote Dispensing Sites
A
Class A ONLY can provide remote dispensing by a pharmacy tech IF:
- Remote dispensing site is defined as a location licensed as a telepharmacy by provider pharmacy to store/dispense drugs (dangerous/CS too)
- Staffed by pharmacy tech under continuous supervision of provider pharmacy
- Pharmacy techs at remote dispensing site have at least 1 year working retail (within last 3 years) and completed Board-certified training program on proper telepharmacy use
- Included in pharmacist:tech ratio at provider pharmacy and CANNOT compound except for reconstitution
- Max of 2 remote dispensing site per provider pharmacy
25
Other Remote Dispensing Site Rules
- May not be located within 22 miles of another Class A pharmacy (another can open later within this range and still stay open)
- No CII meds
- If dispensing avg>125 scripts per day, must apply to be a Class A pharmacy
- Provider pharmacist must make monthly dispensing site visits to reconcile perpetual inventory of CS
26
Additional Rules of Remote Dispensing/HC Sites
- Need DEA registration if plan to store CS at remote location
- Drugs dispensed through remote site may only be delivered to patient at that site
- Max of 2 remote sites
- Application to TSBP needed before providing services
- Perpetual inventory for CS that are inventoried on the same day as the main pharmacy
- Original Rx records kept at remote site with provider pharmacy having electronic access to them
27
Remote Pharmacy: Automated Dispensing/Delivery Systems
- Allows Class A and C pharmacies to provide pharmacy services via remote dispense/delivery site
- Mechanical system that dispenses/delivers scripts to patients at remote site and maintains transaction records
- Delivery sites must be board approved - submit application and renew Q2y w/ provider pharmacy's license
- Comply with CS registration if dispensing CS
- Counseling received remotely via direct link audio/video by pharmacist with patient records prior to release of new meds (pharmacist must always be available)
28
Security of Dispense/Delivery Systems
- Must be locked and have security system including camera to document who picked up scripts
- Access to system is limited to pharmacy staff (supervised by pharmacist) and stocking on machine must be supervised by pharmacist
- Shall operate per written QA/procedures/protocol which ensures continuous supervision of automated system
- Establish mechanisms to test accuracy of automated dispensing at LEAST Q6mo or whenever upgrade/change to system is made (document!)
29
Destruction of Dispensed Dangerous Drugs/CS: HC facilities/nursing homes
Consultant pharmacist destruction requires:
- Inventory
- Destruction so human consumption is unfit and complied with all state/federal regulations
- Witnessed by peace officer, agent of board, Texas Health Service (human/health or state health), OR two persons from facility (admin, director of nursing, or a licensed nurse)
30
Destruction of Dangerous Drugs/CS: Waste Disposal Service
- Inventory required
- Drugs placed in sealed container in presence of witness (same as dispensed destruction)
- Destroyed in manner that unfit for human consumption and complied with all state/federal regulations
- Waste disposal provides proof of destruction to facility
- IF destroying CS, must follow DEA rules for destruction
31
Destroying Drugs Returned to Pharmacy
- Destroyed in manner that unfit for human consumption and complied with all state/federal regulations
- Document date of destruction, name/address of dispensing pharmacy, name/strength of drug, and signature of pharmacist
- Collect CS under DEA destruction rules
32
Destruction of Stock Drugs
- Texas Board pharmacist can destroy stock drugs if destroyed in manner that unfit for human consumption and complied with all state/federal regulations
- Records of destruction not required
- Destroy stock CS by DEA rules
33
Drug Recalls
- Requires PIC to have policies/procedures for handling recalled
- Ensures recalled drug has been removed from inventory within 24 hours of recall notice
34
Return of Rx Drugs
- Unlawful to accept Rx drugs that have been dispensed for purposes of resale
- Exception for certain Rx dispensed to nursing homes
- Separate rule for returning from "will call" bin
35
Prescription Pick-up Locations
- No person/firm/business may participate in picking up prescriptions from locations other than a pharmacy licensed by the Board (solicited/picked up/collected)
- Pharmacy may pick up a prescription from residence/office of provider, home/work place of patient, or hospital/medical facility where patient is getting tx (at request of patient)
36
Delivering Prescription Drugs
- May delivery to office of provider for dangerous drugs/single dose of CS administered in office to patient
- Patient's home
- Place of employment if patient is present
- Hospital/medical facility where patient is getting tx
37
Pharmacy Balance Registration/Inspection
- Balance is required if pharmacy performs nonsterile compounding
- Must be registered with TSBP and shall be inspected for accuracy by the board
38
Pilot/Demonstration Projects
- Specifies procedures to be followed to apply for approval of research/demonstration project
- Used for innovative applications in pharmacy
- TSBP may waive a rule to allow the pilot project but NOT the law
39
Professional Responsibility of Pharmacists/Telemedicine
- Requires pharmacist to exercise professional judgement with respect to accuracy/authenticity of prescription and perform verification PRN
- Ensure all CS/dangerous drugs are dispensed for legitimate medical purpose in usual course of practice
- No prescriptions from the internet (needs min. one in-person exam), can be from telemedicine appointment EXCEPT for abortifacients, other drugs that terminate pregnancy, and tx of chronic pain with CS
40
Nontherapeutic Dispensing
- Pharmacist may NOT dispense a script if they have reason to suspect that order was issued in absence of valid patient-prescriber relationship
- Not required for STD tx of patient's family member or partner if illness is determined to be a pandemic per CDC, WHO, or Governor's office
- TSBP has list of factors relevant to preventing nontherapeutic dispensing
- Shall NOT dispense script if known fraudulent/forged
41
Centralized Prescription Dispensing
Allows outsourcing of Class A/C dispensing to another Class A/C/E pharmacy IF
- Under common ownership or have written agreement
- Share common database/tech to share info
- Provide notice to patients or sign in pharmacy
- Label should include name of outsourcing pharmacy and unique identifier of central pharmacy
- DEA doesn't allow central fill pharmacy to deliver CS but TSBP allows dangerous drugs to be delivered
42
Centralized Drug/Med Order Processing
Allows Class A/C/E pharmacy to outsource script/order processing to another Class A/C/E pharmacy IF
- Under common ownership or have written agreement
- Share common database/tech to share info
- Provide notice to Class A/E patients that central processing be used (one time notice/sign)
43
Satellite Pharmacy
- Not typically considered satellite pharmacy if hospital pharmacy
- Allows Class A/C to operate satellite location not licensed separately
- Rx dropped off at satellite are sent to A/C pharmacy to be filled which are then sent back to satellite to be picked up and counsel provided
- Exception to prohibition of Rx pickup locations
- No bulk prescription drugs allowed to be stored in satellite
