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Control substance, diversion prevention > Chapter 3 Control Substance & DEA Requirements > Flashcards

Chapter 3 Control Substance & DEA Requirements Flashcards

1
Q

It is defined as a set of rules, and principles that are written by some authority, and is applicable to a group of people,
is also provides a set of processes to deal with an issue, and how to solve it

A

What is law?

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2
Q

They are written on different levels, federal and state,
an individual must follow the federal and state laws unless state law is more restricted and does not have any conflict with federal law. In this situation, Individual must follow state law.

A

Laws are written on different levels:

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3
Q

What is one of the comprehensive of the federal laws in pharmacy practice?

A

It is the comprehensive drug abuse, prevention and control act of 1970

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4
Q

What is the CDAPCA?
What types of medication are define?

A

The comprehensive drug abuse, prevention and control act of 1970.

In 1970, Congress passed this law to fight illegal drug use, and requires all manufacture, distributor, and other members of pharmaceutical industry to have restricted control and record keeping fathers specific drugs that have potential to drug abuse and dependence. This type of medication are defined as controlled substance

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5
Q

The main part of CDAPCA title, II and III

A

Title II is known as the “ control substances Act” that focuses on the manufacturing, and distribution of control substance.
Title III, focused on importation, exploitation, and criminal forfeiture

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6
Q

According to CDAPCA, controlled substances, based on their potential for:

A

Abuse, medical use, and safety or dependency liability are divided into five schedules

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7
Q

The most dangerous schedule
There is no medical use, and have the highest potential for abuse and dependency, such as heroin, LSD, marijuana, Hashis, and crack cocaine

A

Schedule one

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8
Q

This still dangerous, and have a high potential for abuse and dependency, but they have medical use such as:
Cocaine.
Fentanyl.
Methadone.
Demerol
OxyContin.
Adderall
Ritalin

A

Scheduled ii

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9
Q

Do you have moderate potential for abuse and is used for treatment such : Tylenol with codeine, ketamine, anabolic, steroids, and testosterone

A

 Schedule III

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10
Q

Do you have low potential for abuse and dependency and used to treat the different diseases and conditions such as Xanax soma, Darvon, darvocet ,Valium, Ativan and Ambien

A

Schedule IV

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11
Q

Just have the lowest potential for abuse, and have medical you such as cough syrup with codeine llama till Lyrica para tolling and pseudoephedrine

A

Schedule V

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12
Q

What year did drug enforcement administration (DEA) was established to enforce the control substance laws in the United States

A

In 1973

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13
Q

What is a governmental agency and part of the department of justice?

A

The DEA

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14
Q

Who oversees the registration of individuals who are involved with control substances such as:

A

The DEA oversee the registration of individuals who are involved with controlled substance such as –
Manufactures.
Distributor.
Wholesalers.
Prescribers, such as physician, dentists, veterinarian pharmacist,
scientist, or who do research ,
hospital
In some states, nurse, practitioner, or physician assistant can prescribe controlled substance, and must register with the DEA

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15
Q

if one of the most common issue in the healthcare system is:

A

Controlled substance diversion

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16
Q

The outcomes can effect:

A

The patient
diverter
and organization

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17
Q

The patient who is affected by controlled substance divertion receives:

A

And under- dose of medication, and no relief of pain.

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18
Q

The health care worker involved with divertion might suffer from:

A

A lack of proper performance , harm to the patients, and increase risk of infection or contamination.
Medications errors

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19
Q

Another consequences of control substance diversion my cause the organization

A

The organization significant liability risk.

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20
Q

Strategies to control and prevent CS diversion is:

A

The responsibility of our organization, and must continue monitor and participation and healthcare workers

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21
Q

What is closed loop medication management?

A

It is a fully electronic operation system, where, in the prescriber use technology to enter their order and transfer the order to the pharmacy for verification, population, and dispensing. 

It is one of the most common strategies that many organization now try to apply in their activity to be able to decrease the risk of CS, diversion and medication error.

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22
Q

The area that organization tried to control due to higher chances of diversion are:

A

During procurement
During preparation an dispensing
During prescribing
During administration where is of the waste

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23
Q

To decrease the risk of CS diversion, there are many different strategies and management system. One of them is:

A

Closed-loop medication management
It is one of the common strategies that many organizations now try to apply in the activity to be able to decrease the risk of CS diversion and medication error

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24
Q

It is a fully electronic operation system, where in the prescriber use technology to enter the order and transfer the order to the pharmacy for vacation, operation, and dispensing.
Pharmacies are using Unidos package system to prepare the medication,
The administrator uses the barcode to identify the right patient, write medication, and write those and create the accurate documentation of administration.
This process is fully restricted, monitored with a lot of checked forward Dash balances of healthcare workers who have access to the medication during the process from beginning to end .

A

Doug close loop medication process

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25
Q

registration and renewal there are three common registration forms:

A

DEA form 224
DEA form 225
DEA form 363

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26
Q

This form is for compounding Control substance or narcotic treatment for what for what DEA form

A

DEA form 363

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27
Q

This form is for distributor, manufacture, exporter , importer, and researcher

A

DEA form 225

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28
Q

This form is for retail pharmacy, prescriber, hospital, or clinic, or teaching institution

A

DA form 224

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29
Q

How many years the registration must be renewed

A

Every three years

30
Q

For the renewal application, use the same registration form number with what letter following the number

A

A example DEA form 224a
Application must mail registration approximately 60 days before expiration date; otherwise, the application must inform the DEA office

31
Q

Registration and renewal. That.
Form 224 contains eight sections:

A

Section 1- applicant identification (name that your birth etc)
section 2 - business activity (such as retail pharmacy, prescribers, hospital or clinic or teaching, institution )
Section 3.- drug scheduled.
Section 4 - state license(s)
Section 5 - liability
Section 6 - exception, from application fee
Section 7- method of payment
Section 8 - application signature

32
Q

What is the reason tell requirement must have in order for a dispenses Control subtances?

A

The retail pharmacies that dispenses control system must have a valid DEA registration

33
Q

If the DEA registered and the person who operates they today’s activity of the pharmacy, such as ordering and dispensing, the controlled substance are not the same what does need to validate it?

A

A power of attorney must be used with two signatures to be validated and accepted. The record of record transaction with power of attorney must be kept for two years

34
Q

It is a person who receives controlled substance, acquired from another DEA registrant to return, unwanted, expired, or outdated, controlled substance to the manufacture, manufacture, agent, or disposal processes

A

Reverser distributor

35
Q

After register with DEA an application, receives the DEA number.
DEA numbers contains how many letter and how many numbers?

A

DEA number, containing a two letter prefix and seven digits which the last number is a check digit.

36
Q

A first of two- letter prefix of the DEA #
A—?
B—-?
C—?
M—?

A

A-for prescriber who start practicing before 1988
B- physicians and clinic
C- for specialists
M-mid-level practitioner, such as PA and nurse practitioner

37
Q

The second letter of a first to lead a prefix?

A

The second letter of the first two letter prefix is the last names initial of the prescriber

Then, for the following 6 digits, sum of the first, third and fifth, and sum of the second ,fourth, and sixth numbers and times it by 2.
Last at the first total and the second total. The last digit of the product must match the last digit of the DEA number.

38
Q

Ordering controlled substances
what DEA form must be used to order control substance?
And who is qualified to order DEA forms?

A

DEA form 222.
This form is used in the pharmacy to order the schedule controlled substance I and II
—only those who have a DEA license can order
— DEA forms he’s not used to order CSA schedule III, IV, and V and can we order directly from the supplier

39
Q

Ordering control substances
-To complete the form, all require area must be provided correctly such your as:

A

1-company’s name and address
2-order number and date
3-Name, number, and size of packages for each item ordered
4- DEA registration number and signature of the purchaser or his her attorney or agent

40
Q

Ordering controlled substances
-What is the maximum of different medication that can be ordered in one DEA form 222?

A

There is a maximum of 10 different medication that can be ordered in 1DEA form 222.
There is a restriction for only one item per line on the form.

41
Q

Ordering controlled substances
- what does Pharmacist need to complete at the bottom of the form to prevent fraud audition to order after completion of the order?

A

The pharmacy to complete the form must indicate the number of lines (number of items) ordered in the designated area at the bottom of the form, to prevent fraud, or additional to order after completion of the order

42
Q

Ordering control substances-
-how many copies of all the form must be submitted?

A

They are three copies:

The first and the second copy of the form must be submitted to the supplier and a third copy must stay in the pharmacy

43
Q

Where DEA form 222 must be file

A

DEA form 222 must be file separately from the other order
sometimes, the DEA inspector may ask for an unused DEA form, 222

44
Q

What is the close loop medication?

A

The close loop medication process is a fully electronic operation system, where in the prescriber uses technology to enter the order and transfer the order to the pharmacy for every vacation, preparation, and dispensing.
Pharmacies are using the unit those packaging system to prepare the medication chemistry to use the buckle to identify the right patient the right medication and the right dose and great day accurate documentation of the administration. This process is fully restricted, monitor with a lot of check/balances of healthcare workers, who have access to the medication doing the process from the beginning to the end.

45
Q

Which DEA form 222 must be used to order which of the drug class.?

A

Schedule I and II controlled substance

46
Q

Ordering control substances
What is CSOS?.

A

The pharmacy can order a Controlled Substances Diversion Prevention through that DEA controlled substance ordering system
The CSOS is a secure electronic transmission that allows the purchaser to order controlled substances online without using DEA form 222.
The electronic order is called DEA form 222

47
Q

What is the advantage of the CSOS?

A

1- reduction of error during the order.
2-allow more lines in a single order.
3-faster processes
4-reduces the inventory through more frequent orders and fewer items.

48
Q

Ordering controlled substances
What are the steps to use CSOS?

A

1-enrollment with CSOS through the DEA website
2-choose the application
I- registrant or DEA form 251
II- coordinator/ DEA form 252
III- power of attorney/ DEA form
253
3-upon approval, CSOS provides the registrant user name and password to lock in a secure system and order online
4-the registration is valid for three years or until DEA registration expired

49
Q

Ordering controlled substance
- what is DEA form 251 form for?

A

DEA form 251 is an application form wherein the applicant requested a CSOS certificate,
Application is a fillable form and contains
1-applicant information include first and last name, SSN, phone number, DEA, registration name, and other personalinformation.
2-applicant signature
3-notary acknowledge
After completing the form, the applicant must mail it to the DEA office .
 At the approval by the DEA, the DEA registrant has the authority to sign the application for DEA registration

50
Q

Ordering controlled substance
— what is DEA form 252 for?

A

DEA form 252 is used for de applicant to complete the role of CSOS, principal coordinator or alternate coordinator. The principal must serve as an organization primary recognize CSOS contact person with all day, duty, such as applications, renewal, or revocation for the DEA registration, there are two native coordinator is the secondary recognize CSOS contact the person for the organization, the principal, or the alternate coordinator will receive a CSOS administrative certificate, or a CSOS, power of attorney certificate. The duty of the principal or alternate coordinator includes verifying the identify and cover the Quetion of organization personnel, who applied for the CSOS certificate

51
Q

Ordering controlled substances.
DA form 252 contains six sections:

A

DEA form 252 contains six sections:
1-application information
2-applicant classification(principal, or alternative coordinator and certificate to be able to sign DA order for the identification D a registration)
3-applicant or notary signature4
4-DEA registrant affirmation of delegation of coordinator.
5-application signature.
6-notary acknowledgment

52
Q

Ordering control substances
What is DEA form 253 for?

A

DEA form 253 is for the power attorney (P0A) off the DEA registrant who wants a CSOS POA certificate.
The principal or alternate coordinator must confirm the identify and complication of the POA applicant, an individual who has a valid POA can Sign control substance order.

53
Q

Ordering controlled substances.
DEA form 253 contains three sections:

A

1-application information
2-application signature
3-DEA registrants or CSOS coordinator, affirmation of an applicant identify verification

54
Q

Destruction of controlled substances.
-doing the inventory check, if there are any expired or unwanted controlled substances, they must be taking out of the shelf, and inventory and pharmacy can process them in two ways:

A

1-send a medication to a reversed distributor
2-go through incendiary ration in the presence of two registrants
employees
3-for other alternative, the pharmacy should contact the DEA

55
Q

Destruction of controlled substances
-another way

A

-If the pharmacy has access to an authorized incinerator and wishes to destruct the expired or unwanted controlled substances, must have to Authorized employees, witnesses and complete the DEA form 41 the pharmacist must write a letter to DEA, explaining the situation and request permission to destroy the control substances. Then attach it to the DA form 41 Director of DEA form for one must be kept to at least two years

56
Q

Destruction of control substances
- Or

A

If the state board of pharmacy investigator witnesses, the destruction, the pharmacy does not need the approval from the DEA

57
Q

Destruction of control substances
-DA form 41 contain four sections:

A

1-section A: registrant must provide his/her registration number, name, and address indicated on the DEA registration
2-section B: registrant provides detail information regarding the item(s) that was destroyed such as name, NDC, batch number, mail return packages etc.
3-section C: contains information regarding method of destruction
4-section D: witnesses, information, signature, and date

58
Q

THEFT/LOSS report of controlled substances:

A

The DEA requires that the richest joint/pharmacy must report any significant loss/staff of controlled substances directly to the DEA office and the police department in the area of practice, within one business day or uncovering the
Lost or theft.

59
Q

Theft/loss, report of controlled substances
-DEA form 106 contains:

A

1-name, address, and DEA registration number of registrant.
2-date of theft/loss (date, discovered the loss)
3-type of theft , or lost, purchase value, any arm robbery, etc.
4-a detailed list of controlled substances that were lost or stolen. Should ask name, NDC strength, etc..
5-name and phone number of the police department in the area that was informed.
6-list of any identification codes, months, or label that pharmacy use.
7-if any DEA form 222

-The original copy must be kept in Pharmacy, two copies must be sent to DEA, and one copy to the state board of pharmacy, in Sam state, the pharmacy is required to send a copy of the local police department.

-DEA form 106 must be kept at pharmacy for a minimum two years

60
Q

Theft/lost report of listed chemical

A

-according to DEA guidelines, the pharmacy must already report any unusual, excessive, listed chemicals, or the disappearance or theft of listed chemicals to the DEA at the earliest possible time and complete or submit DA form 107 within the first 15 calendar days after becoming aware of the lost
-DEA form 107 must be submitted through the Da division secure network

61
Q

Theft/loss report of listed chemical:
-what does lDEA form 107 contains:

A

1-name, address, and contact information of the business
2-DEA registration number.
3-the date (or estimate date )that is unusual, excessive or disappearance of listed chemical, accurate or identified.
4-the name, quantity, and NDC number, if exists of the list chemical lost.
5-are the type of business conducted by the regulated person if he or she is not an DEA a registrant
6-description of day, and you should last disappearance of them this chemical

62
Q

Facing robbery/theft
- DEcA has some recommendations during robbery or theft:

A

-1-try to remain calm. Practiced the skill retraining and to be prepared for this situation and they arise.
2-do not make any shop or certain movement to aggravate the robber
3-follow the directions that were tall and try to avoid becoming a hero because the safety of the employer is more important than the store or products or cat register
4-try do not argue with Robert to agitate the situation
5-try to pay attention to the robbers, physical characteristics, such as height, weight, any specific, Mark, clothing
6-try do not touch anything to preserve the evidence

63
Q

Processing control substance :

A

The pharmacy technician is an important member of the pharmacy team who spent most of her or his time with the patient. Pharmacist ignition, must become familiar with the laws and regulations in the pharmacy practice, and understanding the guidelines concern to safe of practices

64
Q

Processing controlled substance:

A

The pharmacy technician must receipt and procedure related to control substances and how to handle prescription for these types of medication’s
— as we discussed earlier, the comprehension, drug abuse and prevention control act is the federal law that requires of pharmacy teams to follow except guard to monitor patient drug use, keep record and report any suspicious activities

65
Q

Processing control substances.
One area that pharmacy technician are directly involved in his process and control substance there are 9 steps:

A

1-the prescription of schedule I and schedule II must sign in ink
2-every schedule to medication must be written on a separate prescription blank
3-schedule II prescription must be written for legitimate legitimate medication reasons
4-prescription for schedule two drugs must be written, unless there is an absolute emergency, and only the pharmacist must accept the verbal order not a pharmacy technician. The pharmacy must receive the order within seven days.
5-prescriber can fax the schedule to control substance prescription, but the pharmacy must receive the written, signed prescription before dispensing medication to patient.
6-in three situations, faxed schedule to prescription are acceptable: space when prescribed for order, a compound, C2 for parenteral administration, long-term care, hospice orders.
7-no refill on schedule Ii, and for the schedule III to V ,there is a maximum of five refills in six months
8-all controlled , substances must be written by prescriber, who has a valid DEA number. (Sometimes the pharmacy technician must validate the DEA number.
9-all the required informatiosuch as the prescriber’s name address ,phone number ,patient name ,date prescription was issued drop name, strength and dosage for must be represent on the prescription

66
Q

Processing control substances
— after preparing the medication, the Controlled Substances, Diversion Prevention contain the following statement: the label shows:

A

CAUTION: federal law prohibit to the transfer of this drug to any person, other than the patient for whom it was prescribe

67
Q

Processing control substances
—-partial fill of schedule two controlled substances are allowed but..

A

But the remainder must be with the spend within 72 hours. If the pharmacy connect to spend the remainder, the pharmacist must notify the patient and request a new prescription.
—-schedule III to V can also be partially dispense and record it the same way as scheduled II controlled substances

68
Q

Processing control substances
— there are some schedule five controlled substances that I’m not legend drugs, and do not need a prescription and can be dispensed by Pharmacist to the patient with some limitations:

A

1- only licensed pharmacist can dispense them
2-no more than 240 ML of a control shift senses that contain a p.m. or 120 ML of any kind of substance can be dispensed ,within 48 hours ,to the same patient
3-no more than 48 dosage in units of a controlled substance that contain opium or 24 dosage units of any other control substances can be dispensed, within 48 hours, to the same patient
4-pharmacist must confirm that the patient is at least 18 years old.
5-Pharmacist must monitor and maintain a record of selling these products.
6-the record must contain this information: space the name, and address of the patient, the date of the dispense, the name, and quantity of each medication, and the same name, and initial of the Pharmacist
7-your pharmacy must keep the record for at least two years

69
Q

The combat of my amphetamine epidemic act:
-in 2006, come back up meth, amphetamine epidemic (CMEA) become a law. The retail pharmacy that dispenses also any over-the-counter list.-1 chemical (ephedrine’s, pseudoephedrine,
Phenylpropanolamine ), must follow CME law

A
70
Q

I come back up, but I amphetamines epidemic at;


A

Hey CMEA, created the list of non-prescription drugs, and it is called the schedule this chemical product, and mainly a cough and cold product. The pharmacy must follow the steps.:

71
Q

To come back up, methamphetamines, epidemic act:
— the CMEA creating the list of non-prescription drugs, and it is called a schedule is chemical product, manly, a cop and Coke product pharmacy must follow the 7 steps

A

1-desperate Muscat behind the counter, or in the lot having it pharmacy
2-the information of the purchaser must be verified by the pharmacy and should include Assam, address, and signature to the purchase in the logbook (electronic or paper logbook)
4-name of the products, the quantity, date, and time of purchase of this product might be Kevin de la Work.
5-hi employees, including pharmacy technician, must be trying to keep the record of this product, and a
record of training must be in Pharmacy.
6-purchase cannot find more than 3.6 g of pseudo ephedrine per day, 9 g within 30 days, and seven point gram Premier order.
7-at all the time of sale come out pharmacy person you must ask for identification card of the purchaser and record information in the logbook.
8-all non-liquid dosage, must be back up in blister package or with no more than dollars per person packs

72
Q

DEA 224
DEA 225
DEA 363
DEA 251

A

DEA 224 -for retail pharmacy, prescriber, Hospital, clinic
DEA 225 -distributor, manufacturing, expectation, importation , research
DEA 363- compound control
Substance, narcotic, treatment program.
DEA251 Regis tan for CSOS certification

Control substance, diversion prevention (12 decks)

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