Lecture 3 - 7/7/2022

Question 1

Retail Sales limit on ephedrine, pseudoephedrine, PPA

Answer 1

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

Question 2

Mail order limit on ephedrine, pseudoephedrine, PPA?

Answer 2

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

Question 3

Storage Requirements of CMEA

Answer 3

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

Question 4

Record keeping requirements of CMEA

Answer 4

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

Question 5

What is corresponding Responsibility

Answer 5

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

Question 6

Legitimate medical purpose

Answer 6

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

Question 7

Examples of non-legitimate medical purposes

Answer 7

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

Question 8

PDMP

Answer 8

Prescription Drug Monitoring Programs

Question 9

PDMP info

Answer 9

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

Question 10

What is NABP PMP InterConnect

Answer 10

Allows for participating PMP’s to securely exchange perception data

Question 11

NABP Red Flags

Answer 11

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”)

Question 12

CS Record Keeping

Answer 12

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

Question 13

CS Inventory Must include

Answer 13

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

Question 14

CII inventory must be….

Answer 14

an actual physical count

Question 15

CIII - CV inventory may be…

Answer 15

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

Question 16

What are the required inventories

Answer 16

Initial & Biennial

Question 17

Initial Inventory

Answer 17

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

Question 18

Biennial Inventory

Answer 18

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

Question 19

Massachusetts Perpetual Inventory

Answer 19

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

Question 20

X-number or “DATA-waived” DEA Registration

Answer 20

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

Question 21

DEA Form 106

Answer 21

Theft & Loss Reporting

Question 22

DEA Form 41

Answer 22

Registrant Record of Controlled substances Destroyed

Question 23

DEA Form CSOS

Answer 23

Electronic orders of controlled substances without supporting paper form 222

Question 24

Pharmacy Inspections Federal vs State

Answer 24

Federal: DEA needs permission or warrant (probable cause)

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

Question 25

Why do we need Opioid Treatment Programs?

Answer 25

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

Question 26

What is the "3 - Day rule"

Answer 26

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

Question 27

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

Answer 27

obtain a separate registration or a DATA 2000 Waiver

Question 28

Maintenance

Answer 28

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.

Question 29

Detoxification

Answer 29

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

Question 30

Short Term Detoxification

Answer 30

< 30 days

Question 31

Long Term Detoxification

Answer 31

> 30 days but less than 180

Question 32

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

Answer 32

Methadone

Question 33

Methadone Info

Answer 33

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

Question 34

Drug used for treatment outside of OTP?

Answer 34

Buprenorphine, FDA approved for Opioid use disorders

Question 35

Who overseas treatment outside of OTP?

Answer 35

SAMHSA Center for Substance Abuse Treatment

Question 36

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

Answer 36

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

Question 37

Who is a qualified practitioner to apply for waiver?

Answer 37

``` Physicians NPs PAs CNs CRNAs CNMs ```

Question 38

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

Answer 38

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

Question 39

What conditions do practitioners need to meet?

Answer 39

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

Question 40

Time required to apply for increase to treat 275 pts?

Answer 40

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

Question 41

What's a qualified practice setting

Answer 41

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

Question 42

Alternative Notice of Intent

Answer 42

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