Other settings Flashcards
Class 3 facilities include:
hospitals
nursing homes
adult care facilities
Licensing and registration requirements for class 3 facilities?
- class 3 institutional dispenser license from the DOH
- register with the DEA
Can class 3 facilities purchase stocks of CS?
yes, may purchase for inpatient use through an appropriately registered pharmacy.
Can class 3 facilities administer CS?
only if there is a written order from an authorized practitioner
May class 3 facilities dispense CS?
Not unless the facility has an on-site registered pharmacy licensed in NY
Do class 3A facilities usually have a pharmacy on site?
No, typically these facilities contract with an outside pharmacy
Can a 3A facility administer CS
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
Class 3A CS record keeping
daily running record of all prescribed controlled substances received
record administration of prescribed controlled substances
must be kept for 5 years
3a CS security requirements
stationary, locked, double cabinet.
both cabinets must have key locked doors with separate keys
spring locks or combination locks are not acceptable
Class 3a regulations for disposal of CS
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
Class 3A licenses must promptly notify the BNE of any theft, loss, or possible diversion of CS. What form is used to do so?
DOH-2094
Loss of Controlled Substances Report
DOH-4330
Application for license to engage in a CS activity
submitted to the BNE
LTCF: who can administer medication?
Licensed physician
RPN
other licensed personnel
patient
patient’s caregiver
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……
48 hrs
LTCF: when an emergency med kit is unsealed does the facility must notify……
the pharmacy furnishing the med kit
Can other personnel at a LTCF access medications without pharmacy staff present?
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
How long do LTCF who engage in multi-dose packaging or repackaging have to keep these records for?
5 years
LTCF: expirations on repackaged meds
either 12 months, or 50% of the time remaining to the manufacturer exp date
whichever comes first
LTCF CS storage requirements
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
Institutional dispensers:
C1-2 substances must be kept in either…..
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
C3 storage requirements for institutional dispencers
must be stored in a securely locked cabinet
may also be dispersed throughout the non-controlled stock
in a LTCF, can patient specific CS be stored with the patient’s other meds in a locked cart or storage unit
Yes but only up to 72hrs supply
Nuclear pharmacy: RPh special requirements
- 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
Nuclear pharmacy: facility requirements
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
