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
19
Q
Class C Records
A
- ALL must be maintained for 2 years and supplied within 72 hours if requested
- CII must be separated from other records
- CIII-V must be separate or readily retrievable
- Outpatient pharmacy records must be maintained under Class A rules
- Patient records must be maintained for each patient
- Computer system must be able to product hardcopy printouts of audit trails related to drug distribution of facility
20
Q
Inclusions on Audit Trail
A
- Patient name/room number or identifier
- Prescribing physician
- Drug name/strength/dosage form
- Quantity
- *Must be provided within 72 hours of request**
21
Q
Class C Pharmacies in Freestanding Ambulatory Care Surgical Centers (C-ASC) (7)
A
- If full-time pharmacist, drugs withdrawn reviewed within 72 hours for CS and once per calendar week for DD
- If part-time/consultant, review withdrawn meds at least once every calendar week pharmacy is open
- Perpetual inventories of all controls
- Invoices of DD/CS must be dated/initialed by person receiving drugs and pharmacist verifies their entry in perpetual inventory with their initials
- Pharmacist must conduct audit by randomly comparing distribution records with med orders at LEAST Q30d
- Postoperative drugs may only be supplied to patients admitted to ASC from approved drug list
- Drugs must be prepacked and max of 72h supply
22
Q
Class B Pharmacies
A
- Nuclear pharmacies
- Also regulated by Texas Department of State Health Services through Radiation Control Program
- Radioactive Material License
23
Q
Authorized Nuclear Pharmacists
A
- Must be Board of Pharmaceutical Specialties (BPS) Certified Nuclear Pharmacist OR
- Complete 700 hours of structured education program with 200 hours didactive (Approved by TDSHS) and 500 supervised experience
24
Q
Nuclear Pharmacist:Tech
A
- Max of 1:6
- No more than 3 trainees
25
Nuclear Pharmacy Rules
- Policy/procedure manual required
- Federal DOT regulations must be met
- Refills of radioactive Rx aren't allowed
- Prep of sterile radiopharmaceuticals must meet sterile compounding requirements (special exemptions/exceptions for certain provisions that can't be met in nuclear pharmacy)
26
Outer Radioactive Container Label (13)
1. Name/address/phone of pharmacy
2. Date dispensed
3. Directions of use
4. Prescription number
5. Name of patient if known or "for physician use" if not
6. Radiation symbol
7. "Caution/Danger-Radioactive Material"
8. Name of radiopharmaceutical or abbreviation
9. Amount of radioactivity in millicuries/microcuries/bequerels and corresponding time that applies to activity IF different from requested calibration date/time
10. Initials/identification code of prep person and pharmacist checking product
11. Liquid => volume in mL
12. Requested calibration/time
13. Expiration date/time
27
Inner Radioactive Container Label
1. Standard radiation symbol
2. "Caution/Danger-Radioactive Material"
3. Name of radiopharmaceutical or abbreviation
4. Prescription number
28
Class D Clinic
- Facility/location other than physician's office where limited types of DD/devices are stored, administered, provided, dispensed to outpatients of clinic
- DD/Devices must be restricted to those listed/approved for clinic
29
Class D License
- Copy of Class D pharmacy policy/procedure is part of license application
- Formulary is also part of application
30
Class D PIC
- Employed or under written agreement as consultant
- May be PIC for any number of clinics
- Responsibilities: continuous supervision of all carrying out pharmacy-related provision of drugs, documented on-site visits, formulary development
31
Class D Supportive Personnel
- Responsible for provision of drugs
| - Acts according to written policies, procedures, and completion of drug label
32
Class D Formulary MAY Include...
- Anti-infective
- Musculoskeletal drugs
- Vitamins
- OB/gynecological drugs
- Serums, toxoids, vaccines
33
Class D Formulary may NOT Include
- Nalbuphine (Nubain)
- Drugs for erectile dysfunction
- CS
34
Class D Expanded Formulary
- May petition TSBP for expanded formulary if serving at least 80% indigent patients
- May provide for other drugs based on documented objectives in clinic (NEVER drugs specified as not allowed)
35
Expanded Formulary Requirements
- Require supportive personnel to be nurses/practitioners
- Policies/procedures for drugs that require special monitoring
- Retrospective drug regimen reviews of random clinic patient sample on quarterly basis
- IF antipsychotics provided, therapy must be initiated by physician of clinic that shall monitor ongoing therapy AND patient examined at LEAST yearly by physician
36
Class D Provision of Drugs
- Drugs are prepackaged properly labeled
- Drugs provided to patient by supportive personnel who completes label with patient information, directions of use, date of provision, and provider
- Patient counseling shall be provided w/ provision
- IF using expanded formulary, only nurses or physicians can provide drugs
- Store/provide samples of DD on formulary supplied to clinic's physician from a manufacturer
37
Class D Drug Label Requirements
- Name/address of clinic
- Name/strength of drug
- Quantity
- Lot number/expiration date
- Directions of use
- Appropriate ancillary labels
38
Class D Dispensing Drugs
- DD may only be dispensed by pharmacist in Class D
| - Must be pursuant to prescription drug order
39
Class D Supversion
- PIC, consultant pharmacist, or staff pharmacist must personally visit clinic AT LEAST monthly
- Clinics operated by state/local government or funded by government may petition TSBP for alternative visiting schedule
40
Class E Pharmacy
- Nonresident (not located in Texas) pharmacies
- Primary business is to dispense drug/device under prescription order and deliver to Texas resident
- May also process prescription drug order or perform other pharmaceutical service for Texas resident
41
Class E Pharmacy Rules
- Must have a license in good standing in home state
- PIC (ONLY) of pharmacy must have a Texas license
- Must provide dispensing orders within 72 hours of request
- Unless compliance would violate pharmacy/drug laws/rules in state, then must comply with TSBP Rules
- Patient counseling required for all new Rx (can be written info about med with statement of where to call to contact a pharmacist)
- IF compounding sterile products, must be E-S license
42
Class F Pharmacy
- Freestanding Emergency Medicine Facility that is licensed by TDSHS to provide emergency care to pts
- Must have one PIC who is employed/contracts for a part-time/consultant basis
43
Class F Operational Standards (10)
- Pharmacy and storage area of Rx drugs must be enclosed and lockable
- Only individuals authorized by PIC can enter pharmacy can access storage areas for drugs
- Locked storage for CII
- Only designated nurses/practitioners may remove drugs from pharmacy for immediate therapeutic need of patient in pharmacist absence
- Full-time pharmacist will verify withdrawal of CS within 72 hours of withdrawal (once/calendar week for DD)
- Part-time/consultant will verify withdrawals at least once every calendar week pharmacy is open
- Perpetual inventory of CS verified once per calendar week pharmacy is open
- Initial/date invoices with CS/DD by person receiving, pharmacist shall initial/review date once verified that these were entered into perpetual inventory
- Max 72h supplies of prepackaged meds for outpatient use; label completed by practitioner/supervised nurse
- Retrospective random drug regimen review conducted at LEAST Q31d to verify proper usage of drugs
44
Class G Pharmacy
- Issued to facility with primary purpose of processing Rx/medication drug orders on behalf of another pharmacy, HC provider, or payor
- No max ratio pharmacists:techs
45
Class G CANNOT...
- Possess Drugs
- Store Drugs
- Dispense Drugs
46
Class G CAN...
- Receive/interpret/clarify Rx/med orders
- Data entry/transfer
- Performing drug regimen reviews
- Obtaining refills/substitution authorizations
- Verifying accurate Rx entry data
- Interpreting clinical data for PA for dispensing
- Performing therapeutic interventions
- Providing drug info concerning patient's prescription
