NYS Pharmacy Law Review

What RPh can NEVER ADD on a CS Rx

Patient NAME; Practitioner's Signature; Date Written; Drug NAME; Drug QUANTITY (Qty can be CHANGED with practitioner's authorization but NOT added)

What RPh can NEVER CHANGE on a CS Rx

Patient NAME; Practitioner's Signature; Date Written; Drug NAME

What RPh can ADD/CHANGE on a CS Rx

Patient ADDRESS; Patient SEX; Patient AGE

What RPh can ADD on a CS Rx WITH Practitioner's Authorization

Practitioner DEA#; Institutional DEA#/suffix; DIRECTIONS; CODE; MDD; Drug STRENGTH

What RPh can CHANGE on a CS Rx WITH Practitioner's Authorization

Practitioner DEA#; Institutional DEA#/suffix; DIRECTIONS; CODE; MDD; Drug STRENGTH; Drug QUANTITY (can be CHANGED but NOT added); Drug DOSAGE FORM (can be CHANGED but NOT added)

Is a controlled substance Rx for office use valid?

No, a controlled substance Rx for office use is NOT valid

What is Code A?

Code A: Anxiety/Panic Disorder (Up to 3 Months)

What is Code B?

Code B: Attention Deficit Disorder (Up to 3 Months)

What is Code C?

Code C: Chronic Debilitating Neurological Conditions such as a Movement Disorder or Exhibiting Seizure, Convulsive, or Spasm Activity (Up to 3 Months)

What is Code D?

Code D: Relief of Pain in patients suffering from conditions/diseases known to be Chronic or Incurable (Up to 3 Months)

What is Code E?

Code E: Narcolepsy (Up to 3 Months)

What is Code F?

Code F: Hormone Deficiency States in Males; Metastatic Breast Cancer in Women; Gynecologic Conditions that are Responsive with Anabolic Steroids or Chorionic Gonadotropin; Anemia and Angioedema (Up to 6 Months)

Can a 90-day Coded Controlled Substance Rx Include a Refill?

Yes, a 90-day Coded CIII-CV Rx can include ONE refill (Up to 6 months from date written).
Coded CII Rxs (and BZDs), however, CANNOT include ANY refills.

A CII Rx can be written for how many days and refills? (if no code on Rx)

A CII Rx can be written for a max of 30 days with ZERO refills.
Benzodiazepines (Federally CIV) and Anabolic Steroids (Federally CIII) are treated as a CII in NYS meaning that BZDs can be written for a max of 30 days with ZERO refills.

A CIII-CV Rx can be written for how many days and refills? (if no code on Rx)

A CIII-CV Rx can be written for a max of 30 days with a max of 5 refills (within 6 months of original written date).
Benzodiazepines (Federally CIV) and Anabolic Steroids (Federally CIII) are treated as a CII in NYS meaning that BZDs can be written for a

When is an Oral Emergency Supply allowed to be called in for a patient? (Controlled Substance)

When immediate administration is necessary (not administering can result in patient death); When no alternative treatment is available; No possible way to write an Rx

What do you do if Original Rx for Verbal CS Rx not received within 72 hours?

Pharmacist is obligated to contact the BNE (Bureau of Narcotic Enforcement) within 7 days, sign back of Rx, and stamp indicating cover not received.

Which Schedule of Controlled Substances allow a 30-day supply over the phone while the others are only a 5-day supply?

CIV Controlled Substances other than BZDs (i.e. Phenobarbital, "Z-Drugs", Narcolepsy drugs such as Provigil/modafinil or Nuvigil/armodafinil, Chloral Hydrate, etc.)

What schedule is butalbital?

C3

Can Office Administration or Nurses call in a Controlled Substance Rx?

No, ONLY the prescriber may call in the Controlled Substance Rx

How often must an inventory of Controlled Substances be taken?

Every 2 Years (Biennially)

True or False:
Schedule II inventories are exact counts
Schedule III, IV, and V inventories can be approximate counts

True

True or False:
A partial fill for a Schedule CII Rx can have the balance filled at any time.

False
It MUST be filled within 72 hours or the remaining balance is voided!

List the situations in which the partial filling/dispensing of a Schedule CII Rx is acceptable.

1) Unable to supply the full quantity for an emergency order
2) Patient is in a long-term care facility or RHCF (write "RHCF Patient" on Rx if partial filling)
3) Patient is terminally ill (write "Terminally Ill" on Rx if partial filling)

True or False:
The NAME on an Rx for EPT is not required for dispensing.

True
However, an effort must be made to obtain the name.

If you do not know the NAME of the patient for whom an EPT Rx is for, what do you put in place of it?

Either "EPT" or "Expedited Partner Therapy

How are prescriptions filed in NYS?

Three files:
Non-controlled Rxs; Schedule CII; Schedule CIII-CV

How long is a Syringe Rx good for?

A Syringe Rx is good for 2 Years.

What is Public Health Law 281?

Electronic Prescribing/E-scribing

True or False:
An electronic prescription is the original prescription and does not require a hard copy follow-up prescription.

True (E-scribing is recommended but is not yet mandatory until March 27, 2016; Veterinarians will not be required to e-scribe)

Are Benzodiazepines (BZDs) filed with CII or with CII-CV Rx records?

Although BZDs are issued and dispensed according to Schedule II regulations in NYS, the class of BZDs are listed as a Schedule IV controlled substance and therefore shall be filed with all the other CIII, CIV, and CV Rx records.

Are Syringes/Hypodermic Needles considered Controlled Substances?

Hypodermic needles and syringes are NOT scheduled as a controlled substance.

True or False:
A prescriber may issue a prescription for Hypodermic Needles/Syringes electronically (e-scribing).

True

True or False:
A pharmacist may transfer refills of a prescription for Hypodermic Needles/Syringes to another pharmacy.

True

True or False:
A Written or Electronic Rx for Hypodermic Needles/Syringes is not subject to quantity limitations.

True (No quantity limitation if patient has Rx)

The I-STOP legislation requires:
A) An RPh to access the PMP prior to dispensing a CS
B) A practitioner to access the PMP prior to prescribing a CS in Schedules II-V
C) A practitioner to access the PMP prior to prescribing a CS in Schedules II-IV (not nee

C) A practitioner to access the PMP prior to prescribing a CS in Schedules II-IV (not needed for V)

True or False:
Syringes containing Controlled Substances must follow all laws, rules, and regulations related to Controlled Substances.

True

EPT Prescriptions

- MUST include "EPT" in the body of the prescription above the name of the drug and dosage for ALL EPT prescriptions

EPT Counseling

- Sexual abstinence for 7 Days after treatment and until 7 Days after partner or partners have been treated.
- Complete STD/HIV Screening RECOMMENDED 3 MONTHS after treatment.

Wholesalers in NY re-register how often?

Every 3 Years (Triennially)

How many controlled substances are permissible in emergency medication kits in NYS nursing homes?

10 Controlled Substances

A pharmacist in NYS must maintain their records of continuing education for what period of time in case the NYS Board of Pharmacy audits them?

6 Years

In NYS, refill transfer records are maintained for how long a period of time?

5 Years (Just like any other Rx)

A pharmacist is appointed to the NYS Board of Pharmacy for what initial period of time?

5 Years

Internet pharmacies doing business in NYS must register how often?

Every 3 Years (Triennially)

How often is a NYS pharmacy responsible for updating the price list?
How often does BOP update?

Weekly
Yearly

The drug price lost covers the top ____ prescribed drugs

150

How many mandatory continuing education credits must a pharmacist acquire for each registration period for pharmacists in NYS?

45 (every 3 years, 23 must be live)

A pharmacist must have practiced pharmacy for how many years before they can apply for reciprocation to NYS?

1 Year

DEA pharmacy registration are renewed how often?

Every 3 Years (Triennially)

All medical devices must be what level of regulation?

Class 1

Label mix-up would be which level of recall?

Level 1 Recall

What color label must be on controlled substance?

Orange

In NYS, a pharmacy license must be renewed how often?

License is for life (no renewal)!
- However, registration is Every 3 Years (Triennially)

Within what period of time do you notify if you had a fire?

48 Hours

Within what period of time notify of change in supervision?

7 Days

What is the minimum # of pharmacists on the state board?

9 Pharmacists

Limited pharmacies register how often?

Every 3 Years (Triennially) just like normal pharmacies

Pharmacists in NYS are required to obtain how many hours of live CE?

23 Hours At Least (or more if you want)

Certified pharmacists can immunize if the patient is how old?

18 Years Old or Older

How many pharmacies can someone supervise?

Only ONE at a time!

Generic Substitution law requires picking from what?

Orange Book

NYS pharmacies that flood, must notify how quickly?

48 Hours (Just like for a fire)

In NYS, the area designated as a pharmacy must be

Not less than 300 sq. feet

In NYS, a nuclear pharmacy must have a compounding area

Not less than 100 sq. feet

How often must a consultant pharmacist review a long term care patient's file?

Every MONTH (Monthly)

How often can conditional license be renewed?

Zero Renewals

How long is a conditional license valid?

1 year

CDTM allows a pharmacist to...

Prescribe (not pain medications); Order Lab Tests

In NYS, how many hours of live law must pharmacist take?

Zero Hours of Live Law Required

Anabolic steroids are what schedule controlled substance?

CII

Emergency controls phoned in: original copy must be resented within?

72 hours

Emergency controlled substance medication orders must be countersigned by the prescriber within what period of time?

48 Hours

In NYS, PRN medication orders are valid for how long a period of time?

72 Hours (3 Days Max!)

In NYS, routine medication orders are valid for how long period of time?

Routine Orders are NOT VALID in NYS!

In NYS RHCFs, standing medication orders must be renewed how often?

30 Days (Same goes for Prisons)
- However, standing orders are only good for 7 Days in Hospitals

RHCFs are required to notify the vendor pharmacy within what period of time that the seal of an emergency medication kit has been broken?

Within 24 Hours!

Chorionic gonadotropins are what Schedule Controlled Substance?

CIII

What is the maximum number of refills a practitioner may authorize on a prescription for suboxone?

Up to 5 Refills (Within 6 Months of Date Rx Was Written)

Pharmacists in NYS are required to transmit controlled substance data to BNE by what date if waiver obtained?

By 15th of the Month

If no waiver, when must control info be sent to BNE?

within 24 hours

An emergency oral prescription for Phenobarbital is calling into the community pharmacy. The prescription is for 120 tablets with directions of 1 tablet four times a day. What is the maximum quantity the pharmacy can fill?

Quantity of 100 or a 30-Day Supply, Whichever is Less (Since Phenobarbital is a CIV)

True or False:
Optometrists may prescribe injectable drug products.

False (Only Topical Ophthalmic Meds)

Which of the following professionals may prescribe controlled substances utilizing the hospital's DEA number in NYS?

Interns and Residents

How much supply of medication can be dispensed from an ER?

24 hours

In NYS, how many PAs may a physician supervise in private practice?

2

In NYS hospitals, physician's assistant prescriptions for controlled substances must be countersigned by the supervising physician within what period of time?

No countersignature is required

What is the pharmacist to technician ratio in NYS?

1:2

Which of the following may a Nurse Practitioner prescribe?
I. Benzodiazepines
II. Anabolic Steroids
III. Standing orders for immunizations of influenza

I, II, and III (All of the Above)

In NYS, under what circumstances may a pharmacist partially fill a prescription for Lortab?
I. Patient requests a partial fill
II. Pharmacy has an insufficient quantity
III. Patient is terminally ill

I, II, and III (All of the Above)

Federally, pharmacies maintain prescription records for controlled substances for how long a period of time?

2 Years (5 Years for NYS)

Federally, what quantity of a schedule II controlled substance may an authorized prescriber issue in an emergency?

Quantity Sufficient to Treat the Emergency

For what period of time must a VA hospital pharmacy keep schedule II controlled substance orders on file for?

2 Years

Partial filling of schedule III controlled substance orders must be filled to completion within what period of time from date of issue?

6 Months from the Date of Issuance (Rx Written Date)

A patient who is enrolled in an Opioid Addiction Treatment Program that has been successful in the program for 2 years of continuous treatment is allowed to take home what amount of medication?

30 Doses

Short term detoxification applies what period of time?

30 Days

The NYS Office of Professional Discipline (OPD) investigates which of the following:
A) Individual
B) Facilities
C) Health Systems
D) All of the Above
E) None of the Above

A) Individual

The NYS OPD does what?

Investigates professional misconduct; Registers and inspects pharmacies; Investigates unlicensed practice

Emergency medication kits in NYS may contain:

24 hour supply of approved controlled substance medication

In NYS hospitals, which drugs require an administration sheet?

Schedule II Controlled Substances

What controlled substances are permissible on helicopters?

Fentanyl

Advanced Life Support vehicles maintain controlled substance administration records for what period of time from last administration?

5 Years

What action must pharmacies take when a non-scheduled drug becomes a scheduled drug?

- Add the drug to their controlled substance inventory and inventory the drug.
- Pull the prescription for the drug and void any refills for the drug that are no longer valid; advising the patient and the prescriber what action was taken.
- File the presc

Which of the following is(are) an example(s) of professional misconduct?
A) Diagnosing
B) Charged With a DWI
C) Allowing Technicians to Make OTC Recommendations
D) All of the Above

D) A, B, and C
A) Diagnosing
B) Charged With a DWI
C) Allowing Technicians to Make OTC Recommendations

In NYS, how many hours of CE on strategies and techniques to reduce medication and prescription errors?

3 Hours

In NYS, patient medication profiles must be maintained for what period of time?

5 Years

ACPE accredited continuing pharmacy education that is designated to be practice based must be a minimum of how minutes/hours?

15 Hours

Non-controlled prescriptions in NYS expire when?

There is No Expiration Date for Non-controlled Prescriptions in NYS

In NYS Private practice, a supervising physician may supervise a maximum of how many physician assistants?

4

What action must a pharmacy take if they do not receive a written follow up prescription to an emergency prescription called into a NYS pharmacy for a Schedule III controlled substance?

The pharmacy must stamp the back of the emergency prescription with a notation that the written follow up has not been received.

What is the max day supply on a C3 emergency rx?

5 days

Which professional does not have a duty to consult but may access the NYS Prescription Monitoring Program?

Pharmacist

How soon must immunizations be reported to NYSIIS if consent is given?

14 days

Can out of country Rx's be filled in NYS?

Yes, for non-controls

Emergency kit control requirements

24 hours supply for up to 10 CS, 3 being injectable
Can contain C2s

Name badges are required on duty. What info is required on them?

Name and title

Requirements for non-resident mail order availability by phone?

40 hours per week (no minimum number of days)

Is generic substitution permitted or mandated?

Mandated, unless DAW or patient requests brand
Substitution not required if RPH dispenses brand at generic price when generic unavailable

Can other drugs be written on same blank as controls?

No, control must be alone

Must report generic substitution of biologic to MD with _____ days

5 days

Special CE requirements for CDTM Pharmacists?

5 hours in their general area of practice

What can non-Phase Optometrists prescribe/use?

anesthetics, cyclopegics, myotics, mydriatics

Phase one?

Requires 300 hours clinical training
ABX, steroids, NSAIDS, antiallergy/decongestants, antivirals, artificial tears

Phase two?

Additional 100 hours training
Beta blockers, alpha agonists, and cholinergic agents

How much notice must BOP give of hearing?

15 days

Minimum hours for PIC?

30 hours (full time)
More than half if open less than 30 hours/week

How soon must BOP be notified of change in PIC?

7 days

Regulations for advertising?

Must explicitly state end of promotional period

If English is not primary language, what is applicant required to do?

take English language exam to demonstrate proficiency

Must notify BOP of change in address or name within _____ days

30 days

Preceptor requirements?

Must have 1 year experience and only supervise 1 FT intern or 2 PT interns

What is the intern to script ratio?

Pharmacy may employ 1 intern for every 5,000 annual scripts filled (or major fraction thereof)

What compounding tools are required in a pharmacy?

scale and weights sensitive to 6 mg, something to measure volumes 0.1 to 500 mL, and mortar and pestle

Age limits for vaccines?

18 and up, except 2 and up for flu

PharmD requirements for CDTM?

2 years of practice including one year of clinical practice
or
Residency completion
or
Board certification

What elements on label are "critical" and must be highlighted or emboldened?

Patient name
Drug name and strength
Directions

Rx blanks

NYS serialized and standardized form

Can PAs write controls?

Yes, 2-5

Limit of LPAs MD can supervise in private practice? How about SPAs?

4; 2

Limit of LPAs MD can supervise in hospital?

6

Max number of NPs MD can supervise in any location?

4

Max amount of medication in patient care area at any given time?

72 hour supply

If practitioner revoked, when must they return Rx blanks?

within 15 days

Can out of state Rx not on NYS blank be filled?

Yes, as long as it is not a controlled substance.

What are the requirements to be Executive Secretary or one of 9 RPH members of the BOP?

NY licensed RPh with 5 years experience

Who appoints Board members?

The regents on the recommendation of the commissioner (not the governor)

Can copies of prescriptions be given to a patient or provider for informational purposes?

Prescribers can be given any, but patients may only be given non-controls.

Can refills for c3-5s be transferred?

No

What is the minimum age to obtain pharmacist license?

21 years old

If a prescriber passes away, where may their prescription forms be returned?

BNE or NYSDOH

Practitioners should notify NYSDOH of lost prescription blanks in what time period?

Immediately

What prefix is contained on certification for immunizing pharmacists?

I

For a class 1 recall, pharmacies must make a reasonable attempt to notify patient by phone or mail within ___ days of initial notice?

3 days

If something is on the statewide formulary, does prescriber need PA to prescribe?

No

Define telehealth

Audio, fax, or electronic messaging only
"Telehealth" means the use of electronic information and communication technologies by telehealth providers to deliver health care services, which shall include the assessment, diagnosis, consultation, treatment, e

Define Telemedicine

Using two-way audiovisual communication while patient is at originating site but provider is at distant site.

Remote patient monitoring

Asynchronous monitoring of disease states via communication with patient

Who can order remote patient monitoring?

Physician, NP, or nurse midwife (NOT PAs)

What is max THC per dose of medical marijuana?

10 mg (also must contain within 90 and 110 percent of advertised level of THC and CBD)

What is required to be listed on label for generic substitution?

Generic name and manufacturer

What is a group of 8 or more pharmacies located in NYS and owned by the same corporate entity?

Covered Pharmacy

For controlled substances written on NYS blank, what is max d/s?

30 days (more must be electronic)

When is earliest a control can be refilled with MD authorization?

7 days early

Drugs repackaged for in-house use have what expiration?

12 months or 50% of manufacturer's, whichever is less.

Can controls be placed in customized medication packages?

No

Customized medication package expiration?

60 days

For a control written for greater than 30 d/s, how many refills can be used?

original fill plus one refill, regardless of how many are written

Can you fill a verbal prescription if MD does not specify whether generic substitution is permitted?

No, must be expressly stated on verbal prescriptions

If an electronicaly generated prescription is given to a patient to bring to pharmacy, can it be electronically signed?

No, once given to patient it becomes a written prescription, all of which must be manually signed. Same for faxes of electronically generated prescriptions.

Can certified techs do refill transfers or administer vaccines?

No, RPh and interns only

Prescriber must consult pdmp within ___ hours prior to prescribing C2-4

24 hours

Can there be samples of controls in NY?

No

Is electronic prescribing mandated for all prescriptions, regardless of control status?

Yes, unless waiver, veterinarian, out of state, failure of system, or emergency supply.

What is required to be documented on face of syringe/needle prescription upon dispensing?

Date and signature of pharmacist (not initials)

Within what time frame must a control prescription be delivered to the pharmacy?

within 30 days of written date

Can you sell syringes OTC?

Yes, can sell up to 10 to a purchaser at least 18 years old

Drug Donation

Can be done my most pharmacies, no REMS drugs. Third party intermediary can assist and does not need RPh to be involved

HIV post exposure prophylaxis (PEP)

Allows pharmacy to dispense 7 d/s with standing order, must refer to provider within 3 days

Prescription Registration Number

6 digit code, Required on all rxs not written by physician

Are faxed prescriptions allowed?

Yes, but cannot be a refill reminder sent by pharmacy that prescriber signs and faxes back.

How many interns can RPh supervise?

No limit (just need to be reasonable)

If MD dies, can you continue to refill rx?

No, patient-prescriber relationship is considered broken.

What specific, unsual item is required on verbal rx in NY?

Time rx is called in