CS J

Question 1

Q

Answer 1

A

Question 2

Narcotic Addict Treatment Act of 1974:
Goal for FDA & HHS & DEA

Practitioners

Answer 2

Required FDA & HHS to establish specific treatment standards & protocols to treat ppl who are addicted to opioid

DEA must establish security standards for CS

Narcotic treatment programs

Practitioners are required to obtain approval to work in detox units (FDA & DEA)

Question 3

Where can opioids approved for treatment of opioid addiction be stored?

Answer 3

Clinics with detox units/ narcotic addict treatment clinics (only approved drugs for opioid addiction)

Unless clinic is also registered as a dispenser

Question 4

Who can dispense opioid addiction drugs at clinics to addicts?

Answer 4

Physician

RN, LPN under supervision of the physician

Physician must be trained

Question 5

Narcotic addict patient treatment plan

-What drugs approved to use

Answer 5

Patients must first undergo “maintenance treatment” (“methadone maintenance”) for a specific period of time to keep addict from having severe psychological or physical withdrawal symptoms.

Patient then undergoes “detoxification treatment” (maintenance to abstinence)
Addict is slowly given decreasing doses of narcotic to become drug free
Two drugs approved for use: Methadone Levo-alpha-acetlymethadol (LAAM)

Question 6

Can you dispense methadone to a patient that comes into the hospital from a car crash and is addicted?

Answer 6

Yes bc their addiction is their secondary problem and not primary

Question 7

In what situation can you dispense methadone

Answer 7

Emergency medical treatment unrelated to abuse

Bona fide patient suffering from an incurable and fatal disease

Patient who is aged, infirm, or suffering from serious injury or illness (withdrawal would endanger the life or impede or inhibit the recovery of such person)

Question 8

Who can order and administer CS for narcotic addict treatment

Answer 8

Must be ordered by a practitioner

Dispensed or administered by a practitioner or his/her designated agent

interim treatment for an addict on a waiting list for admission to an authorized maintenance program.

as part of a regimen designed and intended to withdraw a patient from addiction to controlled substances.

Administered by a practitioner or RN

Question 9

Drug Addiction Treatment Act of 2000:
What did it allow

What drug is approved

Answer 9

Allows “office-based” physicians to prescribe drugs in Schedules III, IV and V for opioid addiction

Only buprenorphine is approved by the FDA at this time.

Prior to DATA, only had methadone clinics

Question 10

Buprenorphine
What sched.

Use

How many refills

How many days supply

Answer 10

Sched. 3 fed & NYS

Use:

Buprenorphine is a narcotic analgesic used to treat opioid addiction.

Naloxone is used for complete or partial reversal of opioid depression.

severe withdrawal symptoms when abused intravenously in opioid dependent patients.

5 refills

Up to 30 days supply

Question 11

What drugs are used for induction and maintenance therapy?

Answer 11

Buprenorphine:
only be used for induction to avoid precipitating withdrawal symptoms.

Buprenorphine & naloxone:
only be used for maintenance therapy.

Question 12

Requirements for physician to prescribe, administer, dispense narcotic addiction

Answer 12

Must have a DEA number already assigned to them

Physician must register with the Substance Abuse and Mental Health Administration (45 day review period)

Notification sent back to the DEA which, if physician is accepted will assign another DEA number beginning with “X” with same numbers

DEA notifies the Department of Health Bureau of Narcotic Enforcement & Office of Alcohol and Substance Abuse Services (OASAS)

Physician fills out joint application

Physician receives a certificate from OASAS

Special registration from BNE to prescribe buprenorphine

A physician must register with the department every two years to provide such treatment

Such registration will be provided at no cost.

Question 13

Does the identity of narcotic addict treatment patients need to be reported by physician?

Answer 13

Yes, patient names to BNE (HIPAA exempt)

Question 14

Buprenorphine treatment: Physician training (patient numbers)

Answer 14

Physicians may see 30 patients initially

Must have training

8 hours of training

Physicians may see up to 100 patients

After one year w/ DEA number with “X”

Question 15

Comprehensive addiction and recovery act of 2016: Provisions

[federal]

Answer 15

Physicians may now have up to 275 patients

Must have 100 patients prior

Be practicing in a qualified practice setting

Additional credentials

Board certified in addiction medicine or psychiatry by American Board of Addiction Medicine or

American Board of Medical Specialties

Certified by: American Society of Addiction Medicines

Availability of naloxone in pharmacies

Law enforcement carrying naloxone

NP’s and PA’s for buprenorphine prescribing

They must have 24 hours of training Incentivize states to address opioid epidemic

Partial filling of CII’s (Not allowed by NYS yet.)

Question 16

DATA 2000: Physicians who are not separately registered as a narcotic treatment program or certified as a waivered DATA 2000 physician (have no X number)

Answer 16

Allowed to treat patients undergoing withdrawal (emergency situation)

Can prescribe up to 3 days supply of opioids

Not more than one day’s medication may be administered or given to a patient at one time

Not more than one day’s medication may be administered or given to a patient at one time

The 3-day period cannot be renewed or extended.

Question 17

Office of Alcoholism & Substance Abuse Services (OASAS) allows immediate access of CS without prior authorization

• Which CS?
• conditions?
• Insurance? How many days supply? Copay?
• prior authorization for managed care providers?

Answer 17

Buprenorphine

Immediate access without prior authorization

Emergency condition

Substance use disorder

Acute symptoms of severe pain or expectation of severe pain which may result in:

Placing the patient in serious jeopardy Serious impairment to such person’s bodily functions

Serious dysfunction of any bodily organ or part of such person

Serious disfigurement of such person

Every insurance policy must provide for prescription drugs for the treatment of a substance use disorder shall include immediate access, without prior authorization, to a 5-day emergency supply of prescribed medication associate with the management of opioid withdrawal and/or stabilization

Subject to copay or coinsurance

No additional copays/coinsurance

When patient is prescribed up to a 30-days supply in the same 30-day period in which they received the emergency 5-days supply

Managed care providers shall not require prior authorization for an initial or renewal prescription for buprenorphine or injectable naltrexone for detoxification or maintenance treatment of opioid addiction unless the prescription is for a non- preferred or non-formulary form of the drug

Question 18

Prescription Pain Medication Awareness Program
-who needs to take it?

-How many hours is the course? How often do you renew?

Answer 18

Practitioners must take course work in pain management, palliative care and addiction

Every licensed practitioner (that prescribes controls) that treats humans

Every practitioner that has their own DEA number

Every medical resident using the facility’s DEA number

3 hours, renew every 3 years

Question 19

Practitioner administering and dispensing

What cannot be prescribed to an addict or habitual user

Who can administer

Can they prescribe CS to an addict for acute pain? If yes, for how many days?

What if the patient has the same pain when they come back for subsequent consultations?

Answer 19

No CS II, III, IV, V can be prescribed (unless buprenorphine in compliance with DATA 2000)

May not prescribe any anabolic steroids or chorionic gonadotropin except for medical use

Must obtain informed consent by the patient or caregiver if patient is unable to give consent

May designate an agent to administer under their direction and supervision

Yes, but may not prescribe more than a 7 days supply of CS II, III, IV [NYS Law]

Same pain: The practitioner may issue an appropriate refill or new opioid Rx or any other drug

Question 20

Acute Pain: definition

Answer 20

Pain resulting from disease, accidental or intentional trauma or other cause, that the practitioner reasonably expects to last only a short period of time

Not chronic pain

Not cancer pain

Not hospice or end-of-life care

Not palliative care practices

Question 21

Can a vendor pharmacy dispense methadone to a nursing home (class 3a facility) for Medication Assisted Treatment?

Answer 21

No. Methadone can never be dispensed pursuant to a prescription for substance use disorder. The class 3a facility must make arrangements w/ the patient’s OASAS approved opioid treatment program

The facility will have to bring the patient to the OTP daily for their treatment or make arrangements through OASAS & the OTP for the patient to receive their methadone

Question 22

Can a vendor pharmacy dispense Suboxone to a nursing home (class 3a facility) for Medication Assisted Treatment?

Answer 22

Yes. The federal drug addiction treatment act of 2000 allows a practitioner to prescribe, administer & dispense a CS approved by FDA for narcotic treatment

Question 23

Does the supervising doctor’s name need to be on a controlled substances prescription written by a resident?

Answer 23

No. Interns, residents, or foreign physicians may prescribe CS under the DEA no. of the institution & the code no. assigned to them by the institution. The prescription does not need to be transmitted or written w/ the supervising practitioners name or DEA no.

Question 24

Treatment of Heroin and Opioid Addictions

What has to be given by pharmacists to patient with their prescription

Answer 24

Educational materials must be dispensed by pharmacies & need to explain to patients

Explain dangers of abuse, risk for addiction, warning signs for addiction

Available alcohol and drug addiction treatment resources

Proper disposal guidelines for unused prescription controlled substances

Handouts provided to pharmacies

Registered by NYS

Must be given at the time of dispensing with any controlled substance

May be given electronically to the consumer if they request

On OASAS website

Order form

Question 25

Letter to practitioners 2/13/2019
Opioid prescribing for addiction treatment:

cannot prescribe if?

Does not apply to?

Answer 25

No opioids shall be prescribed to a patient initiating or being maintained on opioid treatment for pain which has lasted more than three months or past the time of normal tissue healing, unless the medical record contains a written treatment plan that follows generally accepted national professional or governmental guidelines..

Does not apply to: cancer patients, hospice patients, other end-of-life care, patients whose pain is being treated as part of palliative care practices

Question 26

NYS Opioid Stewardship Act:
Goal

What does it do?

What does it not include?

Records:

Answer 26

To battle the opioid crisis

Requires manufacturers, distributors, and importers licensed in NYS as of 1/1/2017 to report transactions of opioids going back to 1/1/2017

Must report all opioids sold or distributed to or within NYS to the NYS BOH BNE

Payments from each manufacturer and distributor

Does not include dispersing

Includes intra-company transfers

Must pay a ratable share to opioid stewardship fund each fiscal year (each manufacturer or distributor, sell or distribute opioids in NYS)

Does not include:
controlled substances surrendered to reverse distributors or donated to recipient entities or third party intermediaries pursuant to unused RX drug donation and redispensing programs.

Total stewardship program: To support programs operated by the NYS Office of Alcoholism and Substance Abuse Services (OASAS)
Opioid treatment, recovery, prevention and education

Support PMP

Records:
Manufacturer and distributor must provide detailed records to the state.

Including the total number of morphine milligram equivalents (MME’s) sold or distributed: Not including Buprenorphine, Morphine, Methadone

Does not include opioids manufactured and sold

or distributed outside of NYS.

Does not include entities pursuant to Article 32 of mental hygiene law or Article 40 of PBH.

Fines $1,000/day up to $1M per incident

Effective July 1, 2018 through June 30, 2024

Question 27

Opioid Excise Tax:
Who pays?

How much?

How long do sale records need to be kept for?

Report

Tax does not include

Answer 27

¼ to ½ cents per MME (morphine milligram equivalents)

Must be paid by the registrant making such first sale and shall accrue to at the time of sale

Not paid by insurance

Not paid by patient

All sales slips, invoices and other statements from any sale of opioids must be retained for a period of 6 years

Report

Each registrant must file an annual report to NYS: N, A, P, DEA, NYS registration #

Name, address, and DEA # of the entity to whom sold

Date of the sale of the opioid

Gross receipt total in dollars

Name and NDC of opioid

containers and strengths

Total # MME

Any other elements

Tax does not include:
Opioids made in NYS but sold to out of state

Sold to mental health services

Buprenorphine, methadone, morphine