EXAM 3 Rules of the Board Pt4 1140-04

Question 1

Know the definitions

Answer 1

check 1140-01
know the definitions referring to institutional settings

Question 2

What does an institutional setting look like?

Answer 2

-short-term and acute care emphasis

Hospital and associated clinics;
Developmental disability center;
Inpatient psychiatric center;
Sub-acute care facility; and
University health center

Question 3

What is not considered an institutional setting (anymore)?

Answer 3

LTFCs

they used to be in that category

Question 4

What is an Alternate or alternative infusion pharmacy practice site?

Answer 4

Parenteral, enteral, and respiratory therapies provided to patients in a non-institutional setting

-think home infusion outside of an institutional setting

Question 5

Name the personnel in an institutional setting.

Answer 5

-PIC -> designees (techs or other pharmacists)
-Pharmacists
-Institutional Consultant Pharmacists (often they are employed by the hospital and not external consultants)

Question 6

Who is considered supportive personnel?

Answer 6

-Techs (Techs:RPh ratio does apply): 6:1
-Interns
-Other

Question 7

What are the physical requirements of an institutional setting?

Answer 7

-Area
-need hot and cold water
-Equiment and materials
-Storage
-alcohol and flammable (kept separately)
-Security: if the pharmacist is absent, then close and lock the pharmacy

Question 8

Does a pharmacist need to review an order EVERY time before dispensing to a patient in an institutional setting?

Answer 8

in general YES, a pharmacist shall review it before dispensing

-may be reviewed in a timely manner (the verification can be skipped, ex: emergency)

-keep records or Rx orders for 2 years

Question 9

How long should Rx orders be kept in an institutional setting?

Answer 9

2 years
just like in community pharmacy

Question 10

Which 4 pieces of information need to be on the label of a drug in an institutional setting?

Answer 10

-Name and location (room number, floor, wing) of the patient
-Name and strength of the drug

Question 11

Regarding the Distribution of the drug, what needs to be established to oversee drug dispensing?

Answer 11

-audit trail (follow the drug through the system)

-Rx order recorded in the med profile
-Date of the Rx order
-Name and dosage form of the drug
-Dose and administration frequency

Question 12

Are medical carts required in an institutional setting?

Answer 12

NO

-if they are used, the board requires policies and a systematic manner in using them (ex: who has access) -> PIC is responsible

-using unit dose and using separate bins for each patient is recommended by the board

Question 13

What needs to be documented when using a controlled substance from a floor stock?

Answer 13

Drug:
Name, strength, and dosage form

Administered: date, time, and quantity/dose

ID: patient, prescriber, and personnel who is administering

Question 14

How are controlled substances destroyed?

Answer 14

if it is non-patient specific (not assigned to a patient yed) -> destroyed by a board-approved vendor or agent

-if the drug is assigned to a patient:
can be destroyed with an authorized personnel and a witness (usually nurse and pharmacist)

Question 15

What should be on the record of destructed controlled drugs in an institutional setting?

Answer 15

-ID of the patient
-Drug: name, strength, dosage form, and quantity
-Destruction: date, method, and ID of witness
-kept for 2 years

Question 16

How should C-II be stored in an institutional setting?

Answer 16

Double-locked in a safe

Question 17

When can emergency kits be used in an institutional setting?

Answer 17

policies must exist for:
-Drugs otherwise unobtainable for immediate use
-PIC/medical/nursing staff approve contents
-Sealed
-the expiration date of the earliest expiring drug
(clearly marked)
-Securely stored to prevent unauthorized access
-Only those authorized may use
-Contents of kit should be made known

-Drugs must be properly labeled (manufacturer packaging or repackaged)
-need valid order to use contents
-Pharmacy shall be notified when kit is opened →
pharmacy restocks

Question 18

Home Care Kits

Answer 18

-Kept at home, for use by healthcare professionals for emergencies!!!

-IV maintenance medications (NS, heparin flushes)
-Anaphylaxis prevention (diphenhydramine, epi)
-Other injectables
-No controlled substances listed

Question 19

Does the use of home kits require an order from the pharmacy?

Answer 19

Yes, requires an order and notification from the pharmacy

Question 20

What happens with drugs and devices that are discontinued, outdated, defective, or deteriorated in an institutional setting?

Answer 20

need to be returned to the pharmacy site and destroyed

-also when worn, illegible, or have missing labels

Question 21

When might a drug that was returned to the pharmacy be reused?

Answer 21

-in unit dose packaging
-unopened commercially
-prepackaged containers
-meets all federal and state board standards for product integrity

Question 22

If a patient was discharged from an institutional setting, how should the drug vial be labeled?

Answer 22

like if it was an outpatient
-the institutional rules don’t apply when they are discharged and take meds home

-if the patient leaves by absence (decide to leave):
Dispensed according to institution’s policies and procedures

Question 23

What are the rules for drugs that patients bring with them into an institutional setting?

Answer 23

-administered based on medical or Rx order
-Drug must be properly identified before administration

if not used:
-Returned to an adult member of the patient’s family or locked up returned to the patient at discharge per facility policy

Question 24

How should an institutional facility act if the pharmacist is not absent?

Answer 24

-Pharmacist must be on call 24/7

-After Hours Drug Provision (a lot like an EDK)
-Outside of the Pharmacy Practice Site
-Rx drugs accessible to authorized personnel
-Prepackaged not to exceed 72-hour period
-Monthly inventory

-Record of accessing required
-Verify Rx orders in a timely manner

Question 25

What is the appropriate approach if a drug is not contained in the “after-hours drug provision” in the absence of a pharmacist?

Answer 25

-need emergency access to the institutional pharmacy practice site by designated personnel (+ authorized employee or security guard)

-Documentation
Date and time of removal
Patient ID and location
Drug name, strength, dosage form, and quantity
Signature of personnel and accompanying witness
Kept for 2 years

-medication order needs to be verified in a timely manner

Question 26

How much of a drug can be removed from a Pharmacy Practice site in an institutional setting if the pharmacy is not absent?

Answer 26

the amount needed plus 1 dose until the pharmacy reopens

Question 27

What is the appropriate approach for an absent pharmacist in an alternate infusion pharmacy?

Answer 27

These patients may receive home infusions

-Policies and procedures in place to ensure patients receive medical or Rx orders 24/7

-Pharmacist must be on call during all absences

Question 28

What are the requirements for automated dispensing systems in an institutional setting?

Answer 28

-Device and method of operation requires board
approval
-Designated pharmacist is accountable for the system
-Other individuals may be authorized to stock
-Requires training to access
-Only allowed to stock items related to the care of
patients

Question 29

What needs to be documented when removing drugs from an automated dispensing system and how long should it be kept?

Answer 29

-Date/time
-Drug info: Name, strength, formulation, and quantity
-Patient identification
-Identification of authorized person removing

-keep for 2 years

-PIC is responsible for access codes and policies involving other healthcare providers

Question 30

Can a facility have automated dispensing devices (ADD) allowed outside of the institutional setting?

Answer 30

Yes
-must be registered and licensed with the board
-PIC is responsible
-prepacked cartridges must be loaded at the pharmacy
-Techs can take to ADD if use bar code technology to load
-controlled substances are allowed if allowed federally

Question 31

When is it allowed to dispense drugs in an Emergency Room?

Answer 31

-only after a medical or Rx order has been issued and recorded in ER and labeled appropriately
-Dispensed by physician or ER nurse or certified PA

Question 32

How much can be dispensed only when done by providers other than a physician in an emergency room for outpatient use?

Answer 32

12 hr supply or
smallest available packaging for multiple-dose therapy (ophthalmic, topical, otic)

-so the physician can dispense more than a 12 hr supply

Question 33

How often must an inspection take place in an institutional or alternate setting?

Answer 33

Monthly

by the PIC (can also be inspected by pharmacists or even techs)
-refers to drugs/devices/floorstuck/ med rooms/emergency drug kits
-test reagents, disinfectants stored properly, no outdated drugs, drugs are labeled properly…
-keep records for 2 years
-there are 13 listed inspection areas (read through it at 1140-04-.18