ONYSRx

Question 1

ONYSRx Prescriptions rule and exceptions

Answer 1

All prescriptions written in New York must be on an Official New York State Prescription (ONYSRx).

Exceptions:
Prescribers not practicing in NYS.

Clinics/hospitals on federal land (VA, military installations, Indian reservations).

Nursing homes: Use a patient-specific prescription form.

Question 1

ONYSRx Features and Signature

Answer 1

ONYSRx must include:
A touch-sensitive security feature.
A bar code.
A serial number.

Prescriptions must contain the signature of the prescriber (not “electronically signed”).

Question 2

Non-Controlled Drug Prescription Requirements

Answer 2

Written prescriptions for non-controlled drugs must:
Be written in indelible pencil, ink, or typewritten.
Contain the patient’s name, address, and age.
Include the date written, drug name, strength, quantity, and directions for use.
Include the prescriber’s name, address, telephone number, profession, registration number, and signature.

Question 3

Information the Pharmacist CANNOT Change or Add on Rx

Answer 3

Drug Name: Cannot be changed without a new prescription, except for generic substitution.
Prescriber’s Name: Cannot be changed or corrected.
Signature: Cannot be added or corrected; must always be signed by the prescriber.
Date Written: Cannot be changed, altered, or added if missing (must contact the prescriber for a new prescription).

Question 4

Information the Pharmacist CAN Add or Change (with confirmation if needed)

Answer 4

Patient’s Address: Can be added or corrected.
Patient’s Age/Date of Birth: Can be added or corrected.

Strength of the Drug: Can be added or corrected if the
strength is missing but clearly implied (e.g., only one strength exists for that drug).

Quantity of the Drug: Can be added if missing or adjusted if it is consistent with the prescribed directions (e.g., number of days supplied for a chronic medication).

Directions for Use: Can be clarified or added if missing.

Prescriber’s Address: Can be added.
Prescriber’s Telephone Number: Can be added.

Prescriber’s Profession (e.g., MD, NP, PA): Can be added if missing.

Question 5

One Drug Per Blank Rule (s6810[7])

Answer 5

Each prescription form in New York must contain only one drug.
No prescription form can authorize the dispensing or compounding of more than one drug.

Question 6

Pharmacist’s Role in One Drug Per Blank

Answer 6

If a prescription contains more than one drug, the pharmacist must verify with the prescriber which drug(s) should be dispensed.
If the prescriber cannot be reached, the pharmacist may dispense the noncontrolled drug but not controlled substances.

Question 7

Exceptions to One Drug Per Blank Rule

Answer 7

Article 28 Facilities: General hospitals, nursing homes, RHCFs.
Mental Health Hospitals and Developmental Centers.
Inpatients: More than one noncontrolled substance can be written on a single medical order or patient-specific prescription form.

Question 8

Example Scenario: One Drug Per Blank

A prescription with Lantus U100 insulin and diabetic syringes on one blank:

Answer 8

You would need to contact the prescriber to verify which item to dispense.

Question 9

RPh Responsibilities for Written Prescriptions

Answer 9

When receiving a written prescription, the pharmacist must:

Initial or sign.

Add the date.

Record the RX number (serial number).

Record the brand or generic name and manufacturer if applicable.

These notations should not interfere with the original details.

Question 10

Filing Prescriptions

Prescriptions must be filed by:

Answer 10

Numerical order (RX number), or
Date for ready retrieval.

Question 11

Pharmacy Intern Responsibilities for written prescriptions

Answer 11

Pharmacy interns must:
Add their initials or signature to the prescription.
The supervising pharmacist must also initial or sign.
This is typically placed on the front of the prescription.
Interns may complete these tasks electronically.

Question 12

E-Prescribing Rules

Answer 12

Mandatory for all prescriptions in New York (as of March 27, 2016).
Requirements for electronic prescriptions are the same as ONYSRx.
Prescriptions must be processed through a DEA-approved system.
If prescriptions are scanned into the system, there is no need to pull paper copies for refills.

Question 13

Electronic Prescribing for Pharmacies

Answer 13

Pharmacists may:
Sign electronically.
Take verbal orders electronically.
Make notations on prescriptions electronically.
Only practitioners can send electronic prescriptions.

Question 14

Electronic Prescribing Application Requirements

Answer 14

PRs must use an electronic prescribing (EP) application that meets DEA requirements.
The prescription must:
Conform to the Controlled Substances Act (CSA).
Be valid, with no functions disabled when signed.

Question 15

Hard Token for Electronic Prescribing

Answer 15

A hard token is a cryptographic key stored on a secure device (e.g., USB drive, smart card).

To sign a prescription, the practitioner must authenticate using two of the following:
Something they know (password or challenge question).
Something they are (biometric data).
Something they have (device like a hard token).

Question 16

Electronic Prescribing Exceptions

Answer 16

Veterinarians.

Out-of-state prescriptions.

Temporary technological failures.

Waivers granted to PRs.

Impracticality affecting patient health (up to 5-day controlled substance supply).

Federal institutions (e.g., VA, Indian Reservations, military bases).

PRs issuing < 25 prescriptions per year.

Question 17

Commissioner of Health Blanket Waivers (Effective Until October 31st, 2024)

Answer 17

Waivers apply to written ONYSRx or oral prescriptions for:
Complicated directions or those longer than 140 characters.
Compounded prescriptions or infusions.
Prescriptions with FDA-required elements.
Expedited Partner Therapy (EPT) or Collaborative Drug Management.
Public health emergencies and opioid antagonists.

Question 18

Pharmacy Application (PHA) Requirements (§1311.100)

Answer 18

The PHA can only accept an electronic prescription if:
The PHA meets DEA application requirements.
The prescription complies with all laws and regulations.

Question 19

PHA Security Standards (§1311.205)

Answer 19

The PHA must meet DEA security standards, such as:
FIPS 140-2 Security Level 1.
Must use ASAP 4.2 software, which distinguishes between when the prescription was filled and when it was picked up.

Question 20

Digital Signature Verification (§1311.205)

Answer 20

The PHA must verify the practitioner’s digital signature, signed with the practitioner’s private key and transmitted securely.

Question 21

Prescription Data Recording and Retention (§1311.200)

Answer 21

The PHA must be able to record and retain:
Full DEA number of the private practitioner, or
Institution’s DEA number and specific internal practitioner code.
Allow for the addition of the number of units dispensed, date dispensed, and dispenser’s initials.

Question 22

Retrieving Controlled Substance Prescriptions (§1311.205)

Answer 22

The PHA must be able to retrieve controlled substance prescriptions by:
Practitioner name, Patient name, Drug name, and Date dispensed.
Data must be downloadable into a database or spreadsheet.

Question 23

If the pharmacist receives a written or verbal prescription that was originally transmitted electronically:

Answer 23

The pharmacist must check records to ensure the electronic version was not dispensed.
If both were received, one must be marked as void.

Question 24

Handling Paper or Verbal Rx Sent to Another Pharmacy

Answer 24

Contact the other pharmacy to determine if it was dispensed.
If the electronic prescription was not dispensed, it should be marked void, and the paper version can be filled.
If the electronic prescription was dispensed, the paper version must be marked void.

Question 25

Making Notations on Electronic Prescriptions

Answer 25

Any notations must be made and retained electronically.
The prescription and any annotations should be kept in the electronic record and must not be printed and rescanned.

Question 26

How Long to Keep Patient Records

Answer 26

NYS BOP: 5 years.
BNE: 5 years.
HIPAA: 6 years.
Medicaid: 6 years.
Medicare: 10 years (Medicare Part D).

Question 27

Verbal Prescription Requirements (§ 6810[4])

Answer 27

Verbal prescriptions must contain the same information as written prescriptions, except for the prescriber’s signature.
A common source of medication errors due to misinterpretation.

Question 28

Noncontrolled Drugs: Verbal Prescription

Answer 28

Verbal prescriptions for noncontrolled drugs can be phoned in by the prescriber’s agent.
Nursing homes may follow special procedures for verbal prescriptions.

Question 29

Pharmacist Responsibilities for Verbal Prescriptions

Answer 29

The pharmacist must indicate:
Signature or initials of the pharmacist who received the prescription.
The prescription number, date, time, and name of the person who phoned it in.
Signature or initials of the pharmacist who filled the prescription.

Question 30

Verbal Orders in Nursing Homes

Answer 30

Verbal orders are allowed in nursing homes if warranted by circumstances.
Orders must be countersigned by the prescriber within 48 hours. If not signed, the order is terminated.

Question 31

Controlled Substances Verbal Orders

Answer 31

Verbal orders for controlled substances must be phoned in directly by the prescriber.
An agent (e.g., a nurse) cannot phone in controlled substances.

Question 32

Fax-to-Fax Prescriptions

Answer 32

Faxed prescriptions must be written on ONYSRx forms and signed by the prescriber.
Faxed prescriptions are allowed for both controlled and noncontrolled substances.

Question 33

Refill Authorization

Answer 33

Prescriptions may be refilled if refills are authorized on the original or via oral order.

The pharmacist must indicate:
Date of refill.
Initials of the pharmacist.
Amount dispensed (if different).

Question 34

Oral Authorization for Refills

Answer 34

Pharmacists may take oral authorization for refills of noncontrolled drugs from the prescriber.
There is no limit on the number of refills authorized this way.

Question 35

Partial Filling

Answer 35

A partial fill is dispensing fewer dosage units than prescribed.
It is allowed as long as the total dispensed does not exceed the total prescribed amount.

Question 36

Who Can Dispense Medications?

Answer 36

Pharmacists, Pharmacy Interns (under supervision), and Practitioners can dispense medications.
Practitioners can also dispense samples of medications.

Question 37

Returning Unclaimed Prescriptions

Answer 37

Unclaimed prescriptions must be reviewed periodically in the will-call section.

Medications may be returned to inventory, but not to the original stock bottle.

Only a pharmacist can determine if the medication can be safely returned.

The medication can be used at the next possible opportunity within a few months.

Question 38

Practitioner Dispensing Limits (Section 6807)

Answer 38

Practitioners may dispense a maximum of a 72-hour supply.
Exceptions include:
Prescribers 10+ miles from a pharmacy.
Medications dispensed for free.
Hospitals or clinics.
Veterinarians.
Emergency cases or compounded medications.

Question 39

Who Can Request Drug Samples?

Answer 39

Only licensed practitioners can request samples.
Samples can be sent to hospital pharmacies or healthcare entities at the request of a licensed practitioner.

Question 40

Drug sample requests must include

Answer 40

Practitioner’s name, address, signature.
Drug identity and quantity.
Manufacturer name.
Date of request.
Written receipt from the recipient upon delivery.

Question 41

Hospital pharmacies can manage samples but must

Answer 41

Store samples separately.
Keep copies of written requests from practitioners.
Use original packaging when dispensing samples.

Question 42

Community Pharmacies and Samples

Answer 42

Community pharmacies are not allowed to have prescription drug samples.
Controlled substance samples are prohibited in New York State.

Question 43

Coupons for Controlled Substances

Answer 43

Coupons may be used for non-controlled and controlled substances, per specific guidelines.