Lecture 3 - 7/7/2022 Flashcards

1
Q

Retail Sales limit on ephedrine, pseudoephedrine, PPA

A

No more than 3.6g/day or 9g/month

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2
Q

Mail order limit on ephedrine, pseudoephedrine, PPA?

A

No more than 7.5g of the 9g/month can be improved by private or commercial carrier or the postal service

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3
Q

Storage Requirements of CMEA

A

Keep behind the counter or locked cabinet where customers do not have access

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4
Q

Record keeping requirements of CMEA

A
  1. Sales of > 60mg must be recorded

2. Product name, Quantity sold, name & address of purchaser, date & time of sale, purchasers signature must be recorded

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5
Q

What is corresponding Responsibility

A

Responsibly for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, bur corresponding responsibility rests with the pharmacist who fills the prescription

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6
Q

Legitimate medical purpose

A

determined by professional judgment based on acceptable treatment in the US

prescription must be issued for legitimate medical purpose by a practitioner acting within the usual course of professional practice

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7
Q

Examples of non-legitimate medical purposes

A
  1. Methadone for maintenance/detoxification
  2. For fictitious patients
  3. Controlled Substance for general office-use – no, but exception is Vet practice**
  4. w/o a medical exam
  5. w/o medical reason for Controlled Substance
  6. High doses of a narcotic analgesic
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8
Q

PDMP

A

Prescription Drug Monitoring Programs

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9
Q

PDMP info

A
  1. Electronic monitoring of controlled substances ( CII-CV)…some states req Rx only drugs to also be reported ie. Gabapentin in MA
  2. States must participate in NABP PMP Interconnect
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10
Q

What is NABP PMP InterConnect

A

Allows for participating PMP’s to securely exchange perception data

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11
Q

NABP Red Flags

A
  1. Prescriptions for “cocktailed” medications
  2. Requests for early refills
  3. A large portion of prescriptions for controlled substances by one particular prescriber
  4. Doctors located 100 miles away from pharmacy
  5. Other pharmacists aren’t filling prescriptions from the particular prescriber
  6. Patients travel in groups to the pharmacy
  7. Requests to pay cash for prescriptions
  8. Patient presents multiple prescriptions for controlled substances from multiple prescribers (“doctor shopping”)
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12
Q

CS Record Keeping

A
  1. Registrant req to maintain inventory, a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant
  2. Requires that all inventory records be maintained at the registered location in a readily retrievable manner for at least 2 years
  3. Inventory records of C2s must be kept separate from all other controlled substances
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13
Q

CS Inventory Must include

A

Date of inventory
When it was taken
name of each controlled substance inventoried
Finished form of substance (ie 10mg tab)
Number of dosage units in container (ie 100 tab/btle)
number of containers (ie 4 100tab belts)
count of substance

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14
Q

CII inventory must be….

A

an actual physical count

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15
Q

CIII - CV inventory may be…

A

an estimated count or measure of contents unless the container holds more than 1,00 tabs/capsules then it has to be an exact count

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16
Q

What are the required inventories

A

Initial & Biennial

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17
Q

Initial Inventory

A
  1. taken when issued a DEA registration,
  2. an actual physical count of all controlled substances in registrant’s possession
  3. if there are no stocks of controlled substances on hand, the registrant should make a record showing a zero inventory.
  4. no requirement to submit a copy of the inventory to the DEA
  5. must be kept on file
18
Q

Biennial Inventory

A
  1. the registrant is required to take an inventory every two years (biennial)
  2. same required information as the initial inventory
  3. may be taken on any date which is within two years of the previous inventory date
  4. no requirement to submit a copy of the inventory to DEA
  5. must be kept on file
19
Q

Massachusetts Perpetual Inventory

A

247 CMR 9.01 (14)

  1. Pharmacist shall keep perpetual inventory of each controlled substance in C2 which pharmacist has received, dispensed, or disposed of in accordance with the law
  2. Must be reconciled atleast once every 10 days
20
Q

X-number or “DATA-waived” DEA Registration

A
  1. allows providers golding the registration to avoid DEA registration req for Narcotic treatment programs
  2. DEA number that is in addition to the prescriber’s DEA registration number
  3. Pharmacies need both for record keeping requirements under the Controlled substance Act
21
Q

DEA Form 106

A

Theft & Loss Reporting

22
Q

DEA Form 41

A

Registrant Record of Controlled substances Destroyed

23
Q

DEA Form CSOS

A

Electronic orders of controlled substances without supporting paper form 222

24
Q

Pharmacy Inspections Federal vs State

A

Federal: DEA needs permission or warrant (probable cause)

State: Board of pharmacy has authority to inspect without warrant or notice

25
Q

Why do we need Opioid Treatment Programs?

A

In usual course of professional practice, providers cant prescribe controlled substances to an addict to maintain or detoxify them

26
Q

What is the “3 - Day rule”

A

practitioner who is not separately registered as a narcotic treatment program can admin (but not prescribe) narcotic drugs to patient for the purpose of relieving acute withdrawal symptoms while arranging for the patients referral for treatment under the following conditions….

  1. not more than 1 days meds admin at time or given to pt
  2. Treatment cant be carried out for more than 72hrs
  3. 72hr period cannot be renewed or extended
27
Q

All practitioners who use narcotic drugs for treating opiate addiction must…

A

obtain a separate registration or a DATA 2000 Waiver

28
Q

Maintenance

A

The dispensing for a period of in excess of twenty-one days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.

29
Q

Detoxification

A

The dispensing for a period of time of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic-free state within such period of time

30
Q

Short Term Detoxification

A

< 30 days

31
Q

Long Term Detoxification

A

> 30 days but less than 180

32
Q

C2 that can be used for both treatment of severe pain and in detoxification/maintenance of addicts in OTP?

A

Methadone

33
Q

Methadone Info

A
  1. 40mg tab restricted to OTPS and not FDA approved for pain management
  2. cant be prescribed or dispensed for maintenance or detox of addicts in regular course of medical practice
  3. Pharmacy dispensing ONLY permitted for analgesic indication
34
Q

Drug used for treatment outside of OTP?

A

Buprenorphine, FDA approved for Opioid use disorders

35
Q

Who overseas treatment outside of OTP?

A

SAMHSA Center for Substance Abuse Treatment

36
Q

how to get waiver to practice opioid dependency treatment w/ approved buprenorphine medications

A
  1. Practitioner notify SAMHSA Center for Substance Abuse Treatment of intent to practice
  2. Notification of intent must be submitted to CSAT BEFORE initial dispensing or prescribing of opioid treatment
37
Q

Who is a qualified practitioner to apply for waiver?

A
Physicians
NPs
PAs
CNs
CRNAs
CNMs
38
Q

If qualified practitioners undertake required training, they can treat….

A

up to 100 patients using buprenorphine for OUD in the 1st year if they possess a waiver and meet certain conditions

39
Q

What conditions do practitioners need to meet?

A
  1. Holds board certification in addictive medicine or addiction psychiatry
  2. provides medication-assisted treatment in qualified practice setting
40
Q

Time required to apply for increase to treat 275 pts?

A

1 year at the 100pt limit, and meeting the required criteria can apply to increase

41
Q

What’s a qualified practice setting

A
  1. provides professional coverage for patient medical emergency when practice is closed.
  2. provides access to case-management services
  3. uses health info tech such as electronic health records
  4. registered for their state PDMP and in accordance with Federal & State Law
  5. accepts 3rd party payment
42
Q

Alternative Notice of Intent

A
  1. allows alternative NOI for those seeking to treat up to 30 pts
  2. they can forgo training req, certification to counsel & other services
  3. limited to treating no more than 30 pts at 1 time
  4. exemption only applies to prescription of C3,C4,C5 drugs or combo of drugs