CS J Flashcards

(27 cards)

1
Q

Q

A

A

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2
Q

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

Practitioners

A

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)

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3
Q

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

A

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

Unless clinic is also registered as a dispenser

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4
Q

Who can dispense opioid addiction drugs at clinics to addicts?

A

Physician

RN, LPN under supervision of the physician

Physician must be trained

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5
Q

Narcotic addict patient treatment plan

-What drugs approved to use

A

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)

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6
Q

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

A

Yes bc their addiction is their secondary problem and not primary

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7
Q

In what situation can you dispense methadone

A

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)

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8
Q

Who can order and administer CS for narcotic addict treatment

A

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

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9
Q

Drug Addiction Treatment Act of 2000:
What did it allow

What drug is approved

A

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

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10
Q

Buprenorphine
What sched.

Use

How many refills

How many days supply

A

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

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11
Q

What drugs are used for induction and maintenance therapy?

A

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

Buprenorphine & naloxone:
only be used for maintenance therapy.

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12
Q

Requirements for physician to prescribe, administer, dispense narcotic addiction

A

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.

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13
Q

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

A

Yes, patient names to BNE (HIPAA exempt)

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14
Q

Buprenorphine treatment: Physician training (patient numbers)

A

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”

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15
Q

Comprehensive addiction and recovery act of 2016: Provisions

[federal]

A

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.)

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16
Q

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)

A

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.

17
Q

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?
A

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

18
Q

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

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

A

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

19
Q

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?

A

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

20
Q

Acute Pain: definition

A

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

21
Q

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

A

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

22
Q

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

A

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

23
Q

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

A

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.

24
Q

Treatment of Heroin and Opioid Addictions

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

A

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

25
Letter to practitioners 2/13/2019 Opioid prescribing for addiction treatment: cannot prescribe if? Does not apply to?
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
26
NYS Opioid Stewardship Act: Goal What does it do? What does it not include? Records:
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
27
Opioid Excise Tax: Who pays? How much? How long do sale records need to be kept for? Report Tax does not include
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