Ch. 6: Class A Pharmacy Rules Flashcards
1
Q
PIC
A
- Each Class A has one employed full-time
- Generally limited to PIC at one Class A unless two pharmacies aren’t open at the same time or for an emergency time period lasting a max of 30 days (work at least 10 hours at each pharmacy)
- Responsibilities: legal pharmacy operations, educating/training pharm techs
2
Q
Owner
A
- Responsibility for all administrative/operational functions of pharmacy
- Must consult with PIC/another pharmacist for establishing policies/procedures if not one themselves
3
Q
Pharmacist
A
- Responsible for supervising techs/trainees - can be electronic if immediate communication and other requirements met
- Dispensing pharmacist (final check) must ensure drugs are dispensed safely/accurately UNLESS computer system can identify other pharmacist involved in different steps of dispensing process
4
Q
Pharmacist ONLY Duties (11)
A
- Receiving verbal CS scripts
- Interpreting Rx drug orders
- Performing final check of dispensed Rx
- Counseling
- Assuring reasonable effort for obtain/record/maintain patient medical records
- Interpreting med records and performing drug regimen reviews
- Performing drug therapy management under protocol
- Verifying CS received on invoices and initialing/dating invoices
- Transferring/receiving transfer of CS
- Selecting drug products (generic sub)
- Administering immunizations (temporarily allowed for techs per COVID pandemic)
5
Q
Tech/Trainee
A
- Individuals working in pharmacies
- Provide nonjudgmental, technical services associated with dispensing of prescription drug order
6
Q
Tech/Trainee Duties (14)
A
- Initiating/receiving refills
- Initiating electronic transfers between common database pharmacies
- Entering Rx data into computer
- Taking stock bottle from shelf for Rx
- Preparing/packaging drug orders
- Affixing Rx/auxiliary labels
- Reconstitution
- Loading bulk drugs/prepackaged containers into automated counting/dispensing device (verified by pharmacist)
- Bulk compounding
- Compounding nonsterile drug orders after training
- Compounding sterile products after training (Class A-S pharmacies)
- Receiving oral Rx drug orders for dangerous drugs and reduce to writing
- Transfer/receiving transfer of original Rx for dangerous drugs
- Contacting provider for information regarding Rx
7
Q
Ratio
A
- Pharmacist:Tech (including trainees) in Class A may be 1:6 as long as max trainees are 3
- If more than 3 trainees, ratio must be 1:3
8
Q
Environment Standards
A
- Clean, orderly
- Sink with hot and cold water, exclusive of bathroom
- If serving public, counseling area for confidentiality
- Appropriate lighting/temperature
- Designated area for flammable products
9
Q
Security Standards
A
- Prescription department must be locked to restrict unauthorized access
- Method of locking cannot be duplicated
- Min: basic alarm system with off-site monitoring and motion detectors
- PIC can authorize other individuals to enter for non-dispensing activities but record must be kept of who entered site when pharmacist wasn’t present
- Written policies/procedures for security
10
Q
Temporary Absence of Pharmacist: On-site
A
- *Only applied if one pharmacist on duty - goes on break/eats**
- At least one tech remains in pharmacy
- Pharmacist must remain on premises
- Notice must be posted that pharmacist is on break
- Techs can process orders/refills but they can’t be dispensed until pharmacist returns and verifies tech actions
- Intern must act as tech when pharmacist is absent
- Patients can pick up previously filled/verified scripts
11
Q
Temporary Absence of Pharmacist: Off-site
A
- Department must close if pharmacist leaves premises - techs must leave pharmacy
- May deliver previously verified meds within 2 hours of pharmacy closing
- Must maintain record of date, Rx number, name/phone number, and signature of person’s Rx delivered
- Must meet same requirements if delivered to patient’s home
- If using automated dispensing/delivery device, not restricted to 2 hour rule
12
Q
Patient Counselings
A
- Mandatory if picking up new Rx order (not same strength/dosage form in past year)
- Information provided based on pharmacist’s clinical judgement and deemed significant
- Verbal and written info must be provided; electronic okay if requested by patient and request documented
- Pharmacy must document initials/ID code of pharmacist providing counseling on script or in computer
- Must include “Written information about this prescription has been provided to you. Please read this information before you take the medication. If you have any questions concerning this prescription, a pharmacist is available during normal business hours to answer those questions at (phone#)” - in English AND Spanish if delivered
- Only pharmacist can verbally give drug info to patient and answer Rx questions; non-pharmacist personnel/computer cannot ask screening questions to limit pharmacist interaction
13
Q
Drug Regimen Review (10)
A
Required for all prescriptions (new/refill):
- Known allergies
- Rational therapy-contraindications
- Reasonable dose/route of administration
- Reasonable directions of use
- Duplication of therapy
- DDI
- Drug-food interactions
- Drug-disease interactions
- ADR
- Proper utilization (over/underutilization)
14
Q
Labeling Requirements for Dispensed Rx (15)
A
- Name/address/phone number of pharmacy
- Prescription number (at least 10 font, Times Roman)
- Date Dispensed
- Name of prescriber
- Name of pharmacist signing drug order (if applicable)
- Name of patient or animal’s owner
- Instructions for use (at least 10 font, Times Roman)
- Quantity dispensed
- Appropriate ancillary instructions
- CII-IV: “Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed.”
- “Substituted for brand name/prescribed” if generic sub
- Name/strength of drug (10 font, Times Roman) - can be omitted per doctor instruction
- BUD: 1 year from day dispensed or manufacturer Exp.
- “Do not flush unused medications or pour down sink or drain” on label or written information with Rx UNLESS recommended to flush by FFDA
- *Not required if institutionalized, max 90-DS**
15
Q
Notification of Safe CII Disposal
A
- Unless exempt, pharmacy that dispenses CII must provide patient with notification of safe disposal for CS including locations where CII are accepted
- In lieu of list, can provide address to website by the Board with database of these locations
- Can be provided electronically if patient requested electronic info and this is documented
- Exemptions: pharmacy is registered “authorized collector” with DEA OR provides mail-in pouch/chemicals to render meds unusable at pickup
16
Q
Returning Undelivered Meds to Stock
A
- Prescriptions that have not been picked up/delivered may be returned to pharmacy’s stock for dispensing
- Pharmacist must evaluate quality/safety of returned Rx
- Cannot be mixed in with manufacturer original container and original label is removed to prevent discloser of PHI
17
Q
Equipment/Supplies
A
- Data processing system (computer and printers)
- Refrigerator
- Child-resistant, light-resistant, light, and (if applicable) glass containers
- Prescription, poison, and other applicable labels
- Metric/apothecary weight and measure conversion charts
- Class A prescription balance, if compounding
18
Q
Library
A
- Can be hard copies or electronic
- Laws and Rules: TPA/rules, Texas Dangerous Drugs Act/rules, Texas CS Act/rules, Federal CS Act/rules
- At least one current general drug information reference; includes drug interaction info
- General reference on vet drugs if dispensed there
- Basic antidote information and phone number for closest, regional poison control
19
Q
Customized Patient Med Packages (Med Packs)
A
- Need consent of patient, can provide customized med pak where container holds 2+ prescribed, oral dosage forms
- Designed so each container is labeled with day and/or time to take each drug
- Must have prescription number for med pak and separate Rx numbers for each drug
- BUD: 1 year from dispensing or earliest Exp date from any of the meds in pak
20
Q
Automated Counting Devices
A
- Type of automated device/system in Class A pharmacy
- Must be calibrated/verified on routine basis
- Records of loading device must be maintained
- Pharmacist must verify/sign that the system if properly loaded prior to use
21
Q
Automatic Pharmacy Dispensing Systems
A
- Type of automated device/system in Class A pharmacy
- System must have been tested to dispense accurately
- Must operate according to written QA program which requires continuous monitoring/tests at LEAST Q12mo or when upgrade/change is made to system
- Must operate under written policies/procedures
- Recovery plan for disasters/other interruptions
- Stocked by pharmacist or under supervision of pharmacist
- Pharmacist must check final product after fill/before dispensing or verify bulk stocked drugs and accuracy of data entry for Rx in system
22
Q
Automated Checking Device
A
- Type of automated device/system in Class A pharmacy
- Checks after dispensing but before delivery that correct drug/strength have been labeled with correct label or correct patient
23
Q
Records
A
- All shall be maintained for 2 years (hard copies)
- CII shall be separate from the rest
- CIII-V, other than prescriptions, shall be maintained separately/readily attainable (“readily attainable” meaning asterisked/redlined/identified from other items)
24
Q
Patient Med Records
A
- Required for all NEW patients
- Must provide for immediate retrieval of information for previous 12 months to conduct drug regimen review
- PIC must ensure reasonable effort to obtain: name/address/phone number of patient, age/gender of patient, known allergies/reactions, other drugs being used, pharmacist’s comments on relevant drug therapy, and a list of all prescription drug orders dispensed to patient by pharmacy in last 2 YEARS
25
Q
Computer System
A
- Must be backed up at least monthly
- Must maintain information purged from computer for 2 years from date of final data entry
- Must produce daily hardcopy printouts within 72 hours of when prescriptions were dispensed
- Each pharmacist who dispensed/filled Rx from printout shall sign/date within 7 days of dispensing
- Pharmacy can maintain a logbook instead of hardcopy printout, but computer must be able to produce an audit trail within 72 hours
- Each time a modification/change/manipulation is made to a record documentation of this will be recorded in computer system including who performed the action
- Must maintain unique initials/ID codes for pharmacy workers to track who acted in different phases of dispensement - kept for 7 YEARS from date of transaction
26
Q
Transfer of Rx Orders
A
- May be completed verbally or by fax (NO CS for techs)
- Can be electronic if requirements are met
- CS transfers only allowed once unless share database
- DEA/TSBP do not permit pharmacy transfers of CS received but not filled at original pharmacy (unless electronic for all parts)
- Rx must be voided once transferred out (write VOID if manual)
- Individual cannot refuse to transfer med and transfer must be completed within 4 business HOURS of request
- Electronic transfer of multiple/bulk Rx is permitted
