CS J Flashcards
Q
A
Narcotic Addict Treatment Act of 1974:
Goal for FDA & HHS & DEA
Practitioners
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)
Where can opioids approved for treatment of opioid addiction be stored?
Clinics with detox units/ narcotic addict treatment clinics (only approved drugs for opioid addiction)
Unless clinic is also registered as a dispenser
Who can dispense opioid addiction drugs at clinics to addicts?
Physician
RN, LPN under supervision of the physician
Physician must be trained
Narcotic addict patient treatment plan
-What drugs approved to use
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)
Can you dispense methadone to a patient that comes into the hospital from a car crash and is addicted?
Yes bc their addiction is their secondary problem and not primary
In what situation can you dispense methadone
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)
Who can order and administer CS for narcotic addict treatment
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
Drug Addiction Treatment Act of 2000:
What did it allow
What drug is approved
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
Buprenorphine
What sched.
Use
How many refills
How many days supply
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
What drugs are used for induction and maintenance therapy?
Buprenorphine:
only be used for induction to avoid precipitating withdrawal symptoms.
Buprenorphine & naloxone:
only be used for maintenance therapy.
Requirements for physician to prescribe, administer, dispense narcotic addiction
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.
Does the identity of narcotic addict treatment patients need to be reported by physician?
Yes, patient names to BNE (HIPAA exempt)
Buprenorphine treatment: Physician training (patient numbers)
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”
Comprehensive addiction and recovery act of 2016: Provisions
[federal]
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.)
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)
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.
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?
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
Prescription Pain Medication Awareness Program
-who needs to take it?
-How many hours is the course? How often do you renew?
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
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?
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
Acute Pain: definition
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
Can a vendor pharmacy dispense methadone to a nursing home (class 3a facility) for Medication Assisted Treatment?
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
Can a vendor pharmacy dispense Suboxone to a nursing home (class 3a facility) for Medication Assisted Treatment?
Yes. The federal drug addiction treatment act of 2000 allows a practitioner to prescribe, administer & dispense a CS approved by FDA for narcotic treatment
Does the supervising doctor’s name need to be on a controlled substances prescription written by a resident?
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.
Treatment of Heroin and Opioid Addictions
What has to be given by pharmacists to patient with their prescription
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
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
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
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
