CS F

Question 1

Q

Answer 1

A

Question 2

What controlled substances can be filled?

How many systems are allowed

Answer 2

Schedule 2

Schedule 3,4,5 c(including benzos)

Non controlled (including syringes and needles)

Question 3

NYS practitioners have to be registered with ____ to receive ONYSRx’s

Answer 3

BNE (even if they prescribe only non-controlled substances)

Question 4

Who needs a DEA number to register or order ONYSRx?

Answer 4

Non-practitioners (Practitioners not required)

Question 5

Who can issue ONYSRx’s?

Answer 5

Registered practitioners (BNE)

Facilities duly registered with the department to be issued ONYSRx

Practitioners working for these facilities (staff practitioner)

Renew registration every 2 years

Question 6

Diversion of drugs

Answer 6

Possession, delivery or use of a drug or a prescription by a person in a manner not specifically authorized by law.

Question 7

Do all prescriptions written in NYS have to be issued upon an ONYSRx

Answer 7

Yes! Controlled and non-controlled

Question 8

Identity of person picking up/ delivering prescription

Answer 8

pharmacy shall make a good faith effort to verify the identity of any person accepting delivery or a dispensed prescription for a controlled substance by requiring such person, if unknown to the pharmacy, to present appropriate identification.

Question 9

Who can use issued ONYSRX’s

Answer 9

ONYSRx’s may only be used by the practitioner to whom they are issued

ONYSRx’s issued to a facility

Staff practitioners may use but must imprint or stamp their name.

Question 10

ONYSRx’s:
Time

Facility close

Practitioner dies

Answer 10

ONYSRx’s are valid only for a limited time

Forms must be returned to BNE

Responsibility of the estate or lawful designee to return forms to BNE

Question 11

ONYSRx’ forms:
Safety
Whose responsibility is it?

When to report to BNE?

What needs to be recorded?

How do forms need to be treated when they are not in use?

What to do if a practitioner is fired?

Answer 11

Adequate safeguards against: Loss, Destruction, Theft, Unauthorized use/diversion of drugs due to unauthorized use

Responsibility of the practitioner and registered facility

Practitioners shall immediately notify the department: loss, destruction, theft or unauthorized use, failure to receive official New York State prescription forms within a reasonable time after ordering them from the department.

Record of all forms received

Record forms assigned to practitioners

System requiring security of the forms when not in use

System to surrender forms if practitioner is terminated from the facility

System whereby the facility has a reserve quantity of ONYSRx’s

Question 12

Practitioner stickers on ONYSRx

Answer 12

Stickers of any kind (patient name, drug name, prescriber name etc) not allowed anymore

Can pharmacists use sticker? Yes of patient’s info

Question 13

Is photocopy of ONYSRx required?

Answer 13

No if at min. The PR keeps the name of CS & Quantity in chart

Question 14

How long do ONYSRxs records need to be kept for?

Answer 14

5 years (HIPAA)

Question 15

How must quantity prescribed & no. of refills be stated on prescription?

Answer 15

Must be indicated in numerical AND written word form

Question 16

How must prescriptions be written for controls for ONYSRx? Days supply, refills

Answer 16

Schedule 2, anabolic steroids, benzodiazepines

Only 1 Rx per blank

Not transferable

Cannot be refilled

Max 30 days supply (cannot fill if prescription exceeds 30 days)

No refills

Question 17

7 day rule

Answer 17

The amount of drug must be used up so there is only a 7 day supply left

Question 18

Multiple prescriptions of C2 Federal: Conditions

Answer 18

May issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:

Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.

The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.

The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.

The issuance of multiple prescriptions is permissible under applicable state laws.

NYS SAYS NO!

The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and Code of Federal Regulations, as well as any additional requirements under state law.

Question 19

Exceptions to 30 day rule: conditions

Answer 19

30 day/ up to 3 months (condition codes A to E)

30 day/ up to 6 months (codes F)

Condition or code must be on face of prescription

No refills

Must write for/ fill entire quantity at once

Partially fill a prescription with a code on it: Not allowed except for hospice or nursing home

Question 20

Code A, B, C, D, E, F

Answer 20

Code A: Panic Disorders

Code B: ADHD

Code C: Chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity

Code D: Relief of pain in patients suffering from diseases known to be chronic and/ or incurable

Code E: Narcolepsy

Code F: Hormone deficiency states in males, gynecologic conditions that are responsive to treatment w/ anabolic steroids or chorionic gonadotropin, metastatic breast cancer in women, anemia, angioedema

Question 21

Endorsement of ONYSRx

Answer 21

Signature of prescriber

His/ her signature

The date of filling

No. of prescription under which it is recorded in the pharmacy prescription file

Substitution law: pharmacists can substitute without informing the patient.

Quantity if different

Question 22

Emergency administration/ prescription (sched. 2, anabolic steroids, benzodiazepines): conditions

Answer 22

Immediate administration

No appropriate alternative

Not possible for PR to present written Rx to patient prior to dispensing

All 3 of these conditions must qualify

Quantity prescribed and dispensed does not exceed 5 day’s supply

Any amount beyond 5 days must have a new written Rx

Must reduce oral order to writing (memoranda)

(F = immediately)

Contain all the required information of written RX except signature of PR.(F)

“Telephone Order”

Memoranda is filed with Schedule II file (if a CII) or in the Schedule III, IV,V file if a benzodiazepine

RPH indicates on FACE of Telephone order: RPH’s signature

Date filled

Serial Number of RX

Substitution law

Quantity if different

Prescriber must within 72 hours: deliver an original ONYSRx to RPH covering oral order.

EXACTLY COVER

ONYSRx or electronic follow up must conform to all other legal

Requirements: must have statement: “Authorization for emergency dispensing”

Question 23

Emergency administration/ prescription (sched. 2, anabolic steroids, benzodiazepines): follow up

Answer 23

If you receive follow up:
RPH endorses original

Date of delivery

RPH signature

DEA number of pharmacy

Attaches original to telephone order in the Sch II file or III, IV V file.

Must transmit the information to the BNE.

Only the PR may phone in for emergency authorization. NOT AGENT!

Question 24

DEA Rules Federal Only CS Drugs - NYS Noncontrol

Answer 24

May dispense what the physician wrote for. Verbal/fax you may dispense what the physician wrote for

To cover the emergency situation:

Must sign, date

File in II file

NO Refills

Follow up must occur within 7 days

Must be inventoried at the time of initial scheduling.

Note: It may go on NYS Scheduling at any time.
Practitioner may give samples

Nurse (or agent) may phone in the prescription

Federal Controlled
ONLY CII’s

Dronabinol oral solution (Syndros)

Olicerdine (Olinvyk)

CIII’s

Perampanel (Fycompa)

CIV

Alfaxalone (Alfaxan)

Brexanolone (Zulresso)

Eluxadoline (Viberzi)

Lemborexant (Dayvigo)

Locaserin (Beviq)

Solriamfetol (Sunosi)

Suvoresant (Belsomra)

CIV Benzodiazepine

Remimazolam (Byfavo)

CV

Brivaracetam (Briviact)

Cenobamate (Xcopri)

Lasmiditan (Reyvow)

Question 25

Prescription for any quantity of condition codes: how must they be prescribed

Answer 25

Must be either a written Rx or an e-Rx

Cannot be verbal