Other settings

Question 1

Class 3 facilities include:

Answer 1

hospitals
nursing homes
adult care facilities

Question 1

Licensing and registration requirements for class 3 facilities?

Answer 1

• class 3 institutional dispenser license from the DOH
• register with the DEA

Question 2

Can class 3 facilities purchase stocks of CS?

Answer 2

yes, may purchase for inpatient use through an appropriately registered pharmacy.

Question 3

Can class 3 facilities administer CS?

Answer 3

only if there is a written order from an authorized practitioner

Question 4

May class 3 facilities dispense CS?

Answer 4

Not unless the facility has an on-site registered pharmacy licensed in NY

Question 5

Do class 3A facilities usually have a pharmacy on site?

Answer 5

No, typically these facilities contract with an outside pharmacy

Question 6

Can a 3A facility administer CS

Answer 6

Yes, can take temporary custody of a patients prescribed CS and assist with administration

all prescribed meds must be returned to the patient upon discharge

Question 7

Class 3A CS record keeping

Answer 7

daily running record of all prescribed controlled substances received

record administration of prescribed controlled substances

must be kept for 5 years

Question 8

3a CS security requirements

Answer 8

stationary, locked, double cabinet.

both cabinets must have key locked doors with separate keys

spring locks or combination locks are not acceptable

Question 9

Class 3a regulations for disposal of CS

Answer 9

Request for Approval of Disposal/Destruction of CS (DOH form 2340)
+
Controlled substance inventory form (DOH-166)

Name 2 individuals who will conduct disposal/ destruction (at least 1 must be a NYS licensed practitioner)

send to BNE before disposing of CS

Question 10

Class 3A licenses must promptly notify the BNE of any theft, loss, or possible diversion of CS. What form is used to do so?

Answer 10

DOH-2094
Loss of Controlled Substances Report

Question 11

DOH-4330

Answer 11

Application for license to engage in a CS activity

submitted to the BNE

Question 12

LTCF: who can administer medication?

Answer 12

Licensed physician
RPN
other licensed personnel
patient
patient’s caregiver

Question 13

A provider at a LTCF gives an oral order to administer CS from a sealed emergency kit. The prescriber must countersign a handwritten copy of the order within……

Answer 13

48 hrs

Question 14

LTCF: when an emergency med kit is unsealed does the facility must notify……

Answer 14

the pharmacy furnishing the med kit

Question 15

Can other personnel at a LTCF access medications without pharmacy staff present?

Answer 15

Yes, since in these facilities bulk stocks of controlled substances may be distributed within the institution to wards/floor stocks, etc.

pharmacy staff is not required to be present when a floor stock is accessed

Question 16

How long do LTCF who engage in multi-dose packaging or repackaging have to keep these records for?

Answer 16

5 years

Question 17

LTCF: expirations on repackaged meds

Answer 17

either 12 months, or 50% of the time remaining to the manufacturer exp date

whichever comes first

Question 18

LTCF CS storage requirements

Answer 18

separately locked, permanently affixed, compartments for storage of CS drugs and other drugs subject to abuse

exception: when facility uses single unit package drug distribution systems in which quantity stored is minimal and a missing dose can be readily detected

Question 19

Institutional dispensers:
C1-2 substances must be kept in either…..

Answer 19

A GSA class 5 rated steel cabinet or equivalent safe approved by the BNE
- if < 750 lbs it must be bolted or cemented to the floor.
- multiple position combination lock
- a relocking device
- steel plate that is at least 1/2 inch thick

A vault
- multiple position combination lock
- relocking device
- 1/2 inch thick steel door
- ceiling, floors, and walls should be no less than 8 inches of reinforced concrete

Question 20

C3 storage requirements for institutional dispencers

Answer 20

must be stored in a securely locked cabinet

may also be dispersed throughout the non-controlled stock

Question 21

in a LTCF, can patient specific CS be stored with the patient’s other meds in a locked cart or storage unit

Answer 21

Yes but only up to 72hrs supply

Question 22

Nuclear pharmacy: RPh special requirements

Answer 22

• certified as a nuclear pharmacist by BOP-specialties
  OR
• 200 contact hours of instruction in nuclear pharmacy + 500 hrs of clinical nuclear pharmacy training under a certified nuclear pharmacist, residency, etc

Question 23

Nuclear pharmacy: facility requirements

Answer 23

basic requirements of normal pharmacy +
- laminar flow hood
- dose calibrator
- exhaust hood & filter system
- chromatography apparatus
- materials for determining pH
- scintillation detection system
- microscope
- separate, secured area for storage and dispensing radioactive drugs if non-radioactive drugs are also handled at the facility

Question 24

Remote pharmacy: Licensure requirements

Answer 24

language dose not indicate that remote services/telepharmacy are allowable
- hospitals require pharm services ON THE PREMISES

But…. its a bit foggier in other settings such as residential facilities

Basically be licensed and if out of state follow OOS mail order requirements
- register as non-resident facility
- 1 resident agent (doesn’t need to be an RPh)

Question 25

Medical offices: Which type of prescriber can receive/store meds?

Answer 25

any prescriber allowed to prescribe meds is also allowed to dispense them

Question 26

Medical offices: Which type of providers can administer meds?

Answer 26

RPNs may possess and administer drugs and devices pursuant to a non-patient specific regimen prescribed by a licensed physician or NP

Question 27

Medical offices: Who may receive Rx samples and distribute to patients

Answer 27

• licensed practitioners
• hospital pharmacies
• other health care entities upon written request of a licensed prescriber
  NOT retail pharmacies

Question 28

Medical offices: can CS be distributed as samples?

Answer 28

No.

Exception: Research / instructional activities / chemical analysis

Question 29

Medical offices: Can prescribers dispense prescriptions?

Answer 29

Yes, may supply up to a 72hr supply of Rx meds (including CS)

Exceptions to the 72hr limit:
- pt lives 10 miles or more from a pharmacy
- meds are dispensed at no charge to patients
- medical emergency
- drug is compounded by prescriber
- oncology/AIDS protocol

Prescribers may then dispense up to a
- 30 day supply of CS
- 3 month supply of chorionic gonadotropin
- 6 month supply of anabolic steroid

must follow same reporting rule as pharmacists
must submit data to BNE within 72hrs

Question 30

Medical offices: labeling requriements

Answer 30

drug dispensed must be labeled with
- prescribers name/address
- Pt name & address
- name of drug
- strength
- directions
- date of delivery

Question 31

Medical offices: logging requirements

Answer 31

patients record should be annotated to reflect dispensing of drug with:
- drug name
- drug quantity
- dose
- directions
- # of refills

Question 32

Medical offices: can pharmacies supply offices?

Answer 32

wording unclear…

Question 33

Correctional facilities: can CFs operate an on-site pharmacy?

Answer 33

yes, must be supervised by a licensed RPh

must keep stock and dispensing records, medication profiles on all inmates receiving Rxs

Question 34

Correctional facilities: may healthcare personnel administer injectable medications to inmates?

Answer 34

Injectable meds must be administered to inmates by a member of the healthcare staff

if a facility doctor approves, inmates may self-admin some SQ medications under direct visual supervision of a registered RPN, this approval must be documented

Question 35

Veterinary/ animal dispensing rules

Answer 35

similar to physician

Question 36

ER/Urgent Care dispensing rules

Answer 36

See hospital/institutional