Ch. 6: Class A Pharmacy Rules

Question 1

PIC

Answer 1

• 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

Question 2

Owner

Answer 2

• Responsibility for all administrative/operational functions of pharmacy
• Must consult with PIC/another pharmacist for establishing policies/procedures if not one themselves

Question 3

Pharmacist

Answer 3

• 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

Question 4

Pharmacist ONLY Duties (11)

Answer 4

1. Receiving verbal CS scripts
2. Interpreting Rx drug orders
3. Performing final check of dispensed Rx
4. Counseling
5. Assuring reasonable effort for obtain/record/maintain patient medical records
6. Interpreting med records and performing drug regimen reviews
7. Performing drug therapy management under protocol
8. Verifying CS received on invoices and initialing/dating invoices
9. Transferring/receiving transfer of CS
10. Selecting drug products (generic sub)
11. Administering immunizations (temporarily allowed for techs per COVID pandemic)

Question 5

Tech/Trainee

Answer 5

• Individuals working in pharmacies

- Provide nonjudgmental, technical services associated with dispensing of prescription drug order

Question 6

Tech/Trainee Duties (14)

Answer 6

1. Initiating/receiving refills
2. Initiating electronic transfers between common database pharmacies
3. Entering Rx data into computer
4. Taking stock bottle from shelf for Rx
5. Preparing/packaging drug orders
6. Affixing Rx/auxiliary labels
7. Reconstitution
8. Loading bulk drugs/prepackaged containers into automated counting/dispensing device (verified by pharmacist)
9. Bulk compounding
10. Compounding nonsterile drug orders after training
11. Compounding sterile products after training (Class A-S pharmacies)
12. Receiving oral Rx drug orders for dangerous drugs and reduce to writing
13. Transfer/receiving transfer of original Rx for dangerous drugs
14. Contacting provider for information regarding Rx

Question 7

Ratio

Answer 7

• 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

Question 8

Environment Standards

Answer 8

• 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

Question 9

Security Standards

Answer 9

• 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

Question 10

Temporary Absence of Pharmacist: On-site

Answer 10

• *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

Question 11

Temporary Absence of Pharmacist: Off-site

Answer 11

• 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

Question 12

Patient Counselings

Answer 12

• 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

Question 13

Drug Regimen Review (10)

Answer 13

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)

Question 14

Labeling Requirements for Dispensed Rx (15)

Answer 14

• 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**

Question 15

Notification of Safe CII Disposal

Answer 15

• 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

Question 16

Returning Undelivered Meds to Stock

Answer 16

• 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

Question 17

Equipment/Supplies

Answer 17

• 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

Question 18

Library

Answer 18

• 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

Question 19

Customized Patient Med Packages (Med Packs)

Answer 19

• 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

Question 20

Automated Counting Devices

Answer 20

• 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

Question 21

Automatic Pharmacy Dispensing Systems

Answer 21

• 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

Question 22

Automated Checking Device

Answer 22

• 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

Question 23

Records

Answer 23

• 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)

Question 24

Patient Med Records

Answer 24

• 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

Question 25

Computer System

Answer 25

- 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

Question 26

Transfer of Rx Orders

Answer 26

- 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