Ch. 7: Other Classes of Pharmacy Flashcards
1
Q
Class C Pharmacy Personnel
A
- Facilities with 101+ beds shall be under continuous on-site supervision of a pharmacist when department is open
- =<100 beds services of pharmacist or consultant pharmacist part time; on site at least once Q7d
- If institution has outpatient site, must have a pharmacist at that site and meet all Class A rules (including pharmacist:tech ratio)
2
Q
Class C PIC
A
- Pharmacist must be accessible in all Class C pharmacies at all times even if over phone/pager/list of number to reach them
- 101+ beds must have one full-time PIC that is only PIC at that pharmacy (cannot serve Class A/B pharmacy)
- =< 100 beds must have a PIC who is employed/under contract as a consultant… max of three facilities or total of 150 beds (can be 101+ and =< 100 facilities as long as max is 150 beds)
3
Q
Class C PIC Responsibilities (5)
A
- Assuring the legal operation of pharmacy
- Appropriate level of pharmaceutical care services
- Ensuring drugs/devices are prepared and distributed safely/accurately
- Participating in development of a formulary for the facility
- Supervising system to ensure maintenance of effective controls Rx drug diversion
4
Q
Class C Pharmacists
A
- Responsible delegated acts of techs/trainees
- Distributing pharmacist checks medication prior to distribution to ensure safe/accurate meds UNLESS computer system can record/identify each pharmacist involved in prep process
- Includes drug regimen review, data entry verification, distribution, prep, and labeling
5
Q
Class C Techs: 101+ Beds (8)
A
- Prepackaging/labeling unit-dosed and multiple dosed meds
- Preparing/packaging/compounding/labeling Rx scripts
- Compounding nonsterile/sterile (C-S only) after appropriate training
- Batch compounding/preparation
- Distributing route orders for stock supplies in patient areas
- Entering med orders/drug distribution info into computer
- Loading unlabeled drugs into automated compounding/counting devices
- Accessing automated med supply systems
6
Q
Class C Techs: =< 100 Beds (4) + Present Pharmacist Supervision
A
- Prepackaging and labeling unit-dose and multiple-dose package
- Bulk compounding or batch preparation
- Loading unlabeled drugs into automated compounding or drug dispensing system
- Compounding medium/high-risk sterile preps after training (C-S only)
7
Q
Class C Techs: =< 100 Beds (5) + Physical/Electronic Pharmacist Supervision
A
- Prepare/package/compound/label Rx drugs from med orders
- Distributing routine orders for stock supplies to patient areas
- Entering med orders/drug distribution info into computer system
- Accessing automated supply systems
- Compounding nonsterile/low-risk sterile compounds (C-S only)
8
Q
Special Class C Rules
A
- No pharmacist/tech ratio
- Special rules apply to rural hospitals
- Tech-Check-Tech: if ongoing clinical program in place, a tech may check another tech’s (NOT TRAINEE FOR EITHER) work regarding filling floor stock and unit-dose distribution systems IF orders were reviewed by pharmacist previously
9
Q
Rural Hospitals
A
- Defined as 75>= beds AND located in county with population of <50,000 OR designated as critical access hospital/referral center/sole community hospital
- If practitioner orders drug/device while pharmacist is not on/pharmacy is closed; a nurse/practitioner may withdraw med from pharmacy in sufficient quantity to complete order
- Withdrawal must be verified and drug review performed within 7 days of withdraw
10
Q
Rural Hospitals: Techs (5)
A
- *If pharmacist isn’t on duty; NOT allowed for trainees**
- Entering medication orders/drug distribution information into computer
- Preparing/packaging/labeling Rx drugs from med orders if licensed NP or pharmacist verifies accuracy electronically before administration
- Filling med carts used in rural hospitals
- Distributing routine orders for stock supplies
- Accessing/restocking automated med supply cabinets
11
Q
Absence of Pharmacist
A
Facilities with full-time pharmacists when closed:
- Designated nurse/practitioner may remove drugs for patient immediate therapeutic needs
- Record of withdrawal must be made which is verified ASAP (max 72 hours after)
IF facility has part-time/consultant pharmacist, same rules as above PLUS:
- Pharmacist shall performed drug regimen review within 96 hours if average census >10 days or within 7 days if average =< 10 days
- If using floor stock distribution, must verify withdrawal no later than 7 days afterwards with same rules as above
12
Q
Class C Library Requirements
A
- *Electronic or hard copies**
- Current copies of TPA/rules, Texas Dangerous Drug/CS Acts/rules, Federal CS Act/rules
- Drug interaction references
- General drug information reference
- Injectable drug products reference
- Basic antidote info/phone number of nearest poison control center
- Metric/apothecary weight/measure conversion chart
13
Q
Class C Operational Standards
A
- Formulary required
- Prepackaging of drugs allowed for distribution within facility or another Class C facility under common ownership (recordkeeping requirements)
- Written policies/procedures for drug distribution systems required
- Drug regimen review must occur on prospective basis on-duty and retrospective if off-duty (within 72 hours if full-time; 96 hour/7day requirements if part-time/consultant per census rules)
- Floor stock records must be reviewed by pharmacist at LEAST Q30d
- Perpetual CII inventory required
14
Q
Class C Emergency Rooms
A
- If pharmacist on-duty any drugs dispensed or outpatient use (including ED) must be verified by pharmacist
- If off-duty, conditions must be met to dispense dangerous drugs/CS to patient
- Pharmacist shall verify contents of ED drug list records at least once Q7d
15
Q
ED Dispensing of DD/CS w/o Pharmacist
A
- Only drugs on emergency room drug list can be provided
- Quantities shall not exceed 72h supply
- Drugs are prepackaged by pharmacy department and at time of delivery the label is completed by practitioner/nurse
- Pharmacist shall verify contents of ED drug list records at least once Q7d
16
Q
Labeling on ED CS/DD Supplied w/o Pharmacist
A
- *Completed by practitioner/nurse**
- Name/address/phone of facility
- Date supplied
- Name of practitioner
- Name of patient
- Directions for use
- Unique identifier number (script number)
- Brand/generic name and strength of med
- Quantity supplied
17
Q
Class C Automated Compounding/Counting Devices
A
- Must be calibrated/tested for accuracy
- May be loaded by pharmacy tech but must be verified by pharmacist prior to use
18
Q
Class C Automated Med Supply Systems
A
- Include robotic systems and nurse unit-based storage like Pyxis/Omni-Cell
- Must be tested/verified for accuracy
- Must operate per written QA program which requires continuous monitoring and tests for accuracy AT LEAST Q6mo OR when upgrade/change made to system
- Must operate under written policies/procedures
- May be restocked by tech if meds were checked by pharmacist prior to restocking or system uses machine-readable product identifiers like barcodes
- Pharmacist must have a written plan for recovery from disaster/situation that disrupts automated system
