Institutional law II

Question 1

What’s a “Dangerous drug”?

Answer 1

Essentially any prescription drug (human or Vet),
including those exempt narcotics (CV) and those intended for administration via injection to an orifice other than oral.

Question 2

What’s an adulterated drug?

Answer 2

1. Improper Physical conditions of the drugs, environment in which they were manufactured, anything unsanitary
   

Question 3

What’s a Misbranded drug?

Answer 3

◦ It’s dispensed without a prescription/valid order
◦ OTC without proper labeling
◦ Improper refills
◦ False advertising
◦ Wrong drug dispensed
◦ Improper directions for use
◦ Drugs that do not have some type of ID, code, or marking that identifies them

Question 4

Order for drug requirement?

Answer 4

-Name of patient
-Name, strength, and dosage form of drug -Directions for use, including route of
administration
-Date prescribed -Prescribers positive ID

Question 5

Dispensing must be validated by?

Answer 5

◦ Dispensing and DUR processes must be completed/validated by the RPh

Question 6

how is Drug “dispensed” by RPh in Institutional setting?

Answer 6

◦ Release drug via automated machine or physically

dispensed and delivered from the main pharmacy

Question 7

who approves I.S systems and automation?

Answer 7

All I.S. systems and automation must be approved by the OSBP

Question 8

what is the original prescription order in E-system?

Answer 8

Positive ID and approved system enables electronic order

to be considered the ORIGINAL ORDER.

Question 9

can we leave drug supply outside of the pharmacy? if yes what is the requirement?

Answer 9

◦ P&P’s in place which:

Question 10

who is responsible for Drug security and Control for the institution?

Answer 10

mainly R.P.

in conjunction with multi-disciplinary team, responsible for P&P’s re: legal distribution of drugs

Question 11

what is Contingency Drug Stock?

Answer 11

Contingency stock are those drugs required to meet

the therapeutic needs of the patients when a R/Ph. Is unavailable

Question 12

what is Emergency Drug Stock?

Answer 12

Emergency stock are those drugs required to meet immediate needs to save or sustain life in an emergency (crash carts)

Question 13

in case of the absence of a licensed pharmacist, how do we get drugs to patient?

Answer 13

may be obtained from Contingency stock

Question 14

who can have access to Contingency Stock?

Answer 14

By licensed health care professionals authorized to administer within their scope

Question 15

Contingency Stock storing requirement?

Answer 15

1. Locked cabinet or
   2..Other enclosure constructed/located outside of the
   pharmacy
2. Area must be sufficiently secure to deny access, without
   obvious damage to unauthorized persons

Question 16

what does RP do to ensure security of Contingency Stock?

Answer 16

1. Designate who can have access
2. Proper labeling, packaging and quantities to cover need
   while pharmacy closed
3. Provide Procedures to prevent diversion and ensure
   accountability, ex: name and positive ID of who obtained rx.
4. Drugs included in stock
5. Including inspection of inventory to ensure proper use and restock of supply

Question 17

in case of emergancy who can have access to the pharmacy?

Answer 17

=Policy and Procedures from RP include:

Question 18

What is a drug sale?

Answer 18

Sale or sell include “Any delivery, barter, exchange, gift or offer” made by any person whether as principle proprietor, agent or employee

Question 19

Institutions buying drugs from wholesaler requirement?

Answer 19

1. Furnish a copy of their TDDD license to the wholesaler
   

Question 20

what is TDDD?

Answer 20

terminal distributor of dangerous drugs license

Question 21

what is WDDD?

Answer 21

wholesale distributor of dangerous drugs license

Question 22

What’s the difference between TDDD and WDDD?

Answer 22

TDDD: dispense to patient
WDDD: sell drugs to TDDD/pharmacy

Question 23

labeling requirement for Inpatient unit dose meds?

Answer 23

1. Name of drug
2. Route of administration if other than oral
3. Strength (volume)
4. Lot number (control number) and expiration date
5. Manufacturer or re-packager
6. Special storage conditions

Question 24

Labeling requirement for IV bags (Inpatient)?

Answer 24

1. Patient name
2. Name and amount of parental solution
3. Name and amount of the drug(s) added
4. Expiration date
5. Name and address of the institution pharmacy
6. Cautionary statements

Question 25

Labeling requirement for IV bags (Outpatient)

Answer 25

1. Name and address of pharmacy
2. Patient name
3. Prescriber
4. Directions and route of administration
5. Date of Dispensing
6. Any cautions (federal caution)
7. Name and amount of parental solution
8. Name and amount of the drug(s) added
9. Quantity of drug dispensed if appropriate
10. Expiration date
11. Storage conditions

Question 26

Labeling requirement for Outpatient?

Answer 26

◦ Name and address of dispenser
◦ Directions
◦ Name of Patient (species and owner’s name)
◦ Name of prescriber
◦ Date of dispensing
◦ Cautions (not auxiliary labels) Federal Caution Statement ◦ Rx number (serial number)
◦ Drug name and strength
◦ Quantity

Question 27

bedside label for patient in hospital?

Answer 27

Inpatient at bedside-same as outpatient label!

Question 28

labeling requirement for Small container

Answer 28

1. Rx number

2. Patient name