MPJE: DEA Pharmacists Manual

Define Schedule I

Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment

Define Schedule II

Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.

Define Schedule III

Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

Define Schedule IV

Substances in this schedule have a low potential for abuse relative to substances in schedule III.

Define Schedule V

Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

What is a schedule listed chemical product (SLCP)?

Any product that contains ephedrine, pseudoephedrine, or phenylpropanolamine

What is DEA Form 224 used for?

Initial registration of a new pharmacy with the DEA

What is DEA Form 224a used for?

Pharmacy registration renewal

Why is it imperative to notify the DEA if the physical address of the pharmacy changes?

The 224 form will only be sent to the address they have on file once it comes time to renew DEA registration for a pharmacy

What is DEA Form 224b used for?

Affidavit for Renewal of Retail Chain Pharmacy Registration

(pharmacy registration renewal for a chain of corporately owned)

How often does a pharmacy need to renew its registration with the DEA?

Every three years

When is the earliest a pharmacy can renew their DEA registration?

No more than 60 days prior to their current registration's expiration date

T/F: corporations that own or operate a chain of pharmacies may submit a single DEA registration renewal

True, along with a Retail Pharmacy Registration Affidavit for Chain Renewal (DEA form 224b)

A pharmacy transferring ownership must notify the DEA at least _______ days prior to the transfer

14 days

With names, addresses, and registration numbers of both parties, weather the business is moving, and the date of the proposed transfer of CS's will take place

What are the five scenarios where the DEA can revoke, suspend, or deny registration?

A finding that the registrant has:

1. Materially falsified any application filed

2. Been convicted of a felony relating to a controlled substance or a List I chemical

3. Had their state license or registration suspended, revoked, or denied

4. Committed an act which would render the DEA registration inconsistent with the public interest

5. Been excluded from participation in a Medicaid or Medicare program

Practitioners operating within a hospital (may / may not) use the hospital's DEA registration number to write for controlled substances

Practitioners operating within a hospital may use the hospital's DEA registration number as long as they are acting within their scope of practice and uses a unique, internal code to use at the end of the registration number

T/F: Federal government practitioners who prescribe CS's are exempt from DEA registration requirements

True, the requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase controlled substances

Which of the following can be an employee of a DEA registrant who has access to controlled substances:

a. Someone who has been convicted of a felony offense related to CS's

b. Someone who has been denied a DEA registration

c. Someone who has had a DEA registration revoked

d. Someone who has surrendered a DEA registration for cause

e. None of the above

e. None of the above

What is DEA Form 106 used for?

Reporting theft and/or loss

All records related to controlled substances must be

maintained and be available for inspection for a minimum of ____ years

Two years

T/F: C-II records can be combined with C-III, C-IV and C-V records if state law permits

False, C-II records must always be kept separate and easily accessible from other records, including those of other CS's

A registered practitioner does not need to keep a record of the patients that they prescribe CS's for, with the exception of one situation. What is that situation?

When the CS's are being used for narcotic detoxification or maintenance treatment

T/F: a registered practitioner must keep a record of patients that they administer CS's to

False, the only patient registries that need to kept are for patients who get CS's dispensed directly to them or when a practitioner prescribes or administers a CS for narcotic detoxification

However, this becomes true if the practitioner directly charges separate fees for the CS's administered

A CS inventory must be done every ____ years and records of the inventory must be retained on site for _____ years

Two years; Two years

What six pieces of information must be included in a CS inventory?

1. If inventory was taken at beginning or close of business (for the day?)

2. Names of CS's

3. Dosage form/strength of CS's

4. Units per commercial package (tabs/bottle)

5. Number of commercial packages on-hand

6. Disposition of products

When disposing of CS's, C-II's should always be transferred via the ________, while C-III-IV-V compounds may be transferred via ________.

DEA form 222; invoice

The DEA requires that any prescription for a CS contain, at minimum, what information?

1. drug name

2. strength

3. dosage form

4. quantity prescribed

5. directions for use

6. number of refills (if any) authorized

7. date of issue

8. prescriber signature

9. patient's full name and address

10. prescriber's full name, address, and DEA#

According to the DEA, who can write prescriptions for CS's?

Physicians, dentists, podiatrists, and veterinarians

Other mid-level practitioners qualify as well if they meet certain requirements

Mid level practitioners can write prescriptions for CS's if they are....

1. Authorized to prescribe controlled substances by the jurisdiction where they are licensed to practice

2. Registered with DEA or exempted

3. An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered provided that additional requirements as set forth in the CFR are met.

T/F: there are no specific federal limits to quantities of drugs dispensed via a prescription for a CS within a 30 day time frame

True

T/F: a prescription for a C-II can never be given over verbal order

False, prescriptions for emergency supplies can be given verbally

T/F: There is no federal time limit within which a C-II prescription must be filled after being signed by the practitioner

True

T/F: there are certain circumstances where prescriptions for C-II medication can contain refills

False, C-II's can never be refilled

The records involving the transfer of controlled substances must be kept readily available by the pharmacy for _____ years for inspection by the DEA

Two Years

How are C-II products transferred between pharmacies or distributors?

The receiver issues a DEA 222 form to the registrant transferring the drugs

How are C-IIIs, C-IV's or C-V's transferred?

The transfer must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer

If a pharmacy goes out of business or is acquired by a new pharmacy, how are its CS's transferred?

-A complete inventory must be taken on the day of transfer

-This inventory serves as the final inventory for the closing pharmacy and the initial inventory for the purchaser and records of it need to be kept for two years

-A DEA 222 form is issued from the buyer to the seller of the C-II's

A pharmacy transferring CS's back to a supplier must maintain a written record showing what information?

1. The date of the transaction.

2. The name, strength, dosage form, and quantity of the controlled substance.

3. The supplier or manufacturer's name, address, and registration number.

DEA 222 forms are the official record for any C-II's

What is a DEA registered reverse distributor?

A designated distributor of CS's that is authorized to collect and destroy controlled substances

What form is sent to a pharmacy wishing to send in their unused C-II's to a reverse distributor?

DEA form 222

What is a DEA 41 form?

Registrants Inventory of Drugs Surrendered

Submitted by DEA reverse distributors when CS's have been destroyed

Who submits DEA form 41 when CS's are given to a reverse distributor for destruction?

a. the pharmacy

b. the reverse distributor

c. each must submit a copy

d. DEA form 41 is not used for destroying CS's

b. the reverse distributor

Can a DEA 41 form be used to transfer controls between pharmacies?

No, this is only used by reverse distributors when inventory is surrendered to them or when a pharmacy receives a shipment of broken, damaged, or spilled CS's

Can a known felon be employed in a pharmacy or other establishment that has access to controlled substances?

No if the crime was related to substances

However, there is a waiver that can be filled out that details the crime, the extent to which they have access to CS's, and other details

A registrant must not employ in a position which allows access to controlled substances any person who________, or who, at any time, has ____________.

A registrant must not employ in a position which allows access to controlled substances any person who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause

For cause: surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil, or criminal action

How long does a pharmacy have to report a significant loss or theft of CS's to the DEA and local police?

One business day

Who must be notified in the event of a theft of CS's? How?

1. The DEA --> in writing within one business day then also file DEA Form 104 (if an investigation confirms the loss)

2. The local police

What is considered a "significant loss" of CS's?

The burden of responsibility is on the registrant (aka the pharmacy) to identify what is a significant loss

What happens if a pharmacy finds a loss of CS's that they determine not to be significant?

They should place a record of the occurrence in a theft and loss file for future reference

Who is responsible for reporting in-transit loss of CS's? How?

The supplier reports it if it never reaches its destination and the purchaser reports it if it is lost after it has been signed for

It is reported using DEA Form 104

Who reports in-transit losses of CS's from a central fill pharmacy?

The central pharmacy when the loss occurs during delivery using a contracted courier

The retail pharmacy when the loss occurs during retrieving the CS's by way of a contracted courier

It is reported using DEA Form 104

How is a shipment of "broken, damaged, or spilled" CS's reported?

On DEA Form 41

Does breakage or spillage constitute loss of CS's?

No

When is a robbery of CS's considered a federal investigation?

1.The replacement cost of the controlled substances taken is $500 or more.

2.Interstate or foreign commerce was involved in the execution of the crime.

3.A person was killed or suffered significant bodily injury as a result of the crime.

Records for _______'s must be kept separately from records for ________'s, ________'s, and ________'s

CII's must be separate from records for CIII's, CIV's, and CV's

All records and inventories of schedules III, IV, and V controlled substances must be maintained in such a form that the information required is readily retrievable from the ________________.

Ordinary business records

What are the records that must be kept by a pharmacy (10 things)?

1. Executed and unexectuted DEA 222 Forms

2. Power of attorney authorization forms

3. Invoices for all C-III, C-IV, and C-V

4. All inventory records

5. Records of CS's distributed (returns, sales to other pharmacies)

6. Records of CS's dispensed

7. Records of CS's transferred

8. DEA 41 and 106 Forms, if applicable

9. DEA registration certificate

10. CMEA logbook

A registrant may maintain shipping and financial records (but not _______________) at a central location rather than the registered location

Executed official order forms

What are the two formats by which a pharmacy can keep paper records?

Format 1:

1. A file for schedule II controlled substances dispensed.

2. A file for schedules III, IV and V controlled substances dispensed.

3. A file for all noncontrolled drugs dispensed.

Format 2:

1. A file for all schedule II controlled substances dispensed.

2. A file for all other drugs dispensed (noncontrolled and those in schedules III, IV and V).

(If this method is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high unless they are also maintained electronically and able to be separated)

When doing a CS inventory, when must an exact count of C-III, C-IV, and C-V drugs be taken?

When a container holds more than 1000 tablets

T/F: An exact count of all CS's is to be done with each mandated inventory

False, an exact count of C-II's is required but for all other CS's an estimate can be done for all drugs in containers holding less than 1000 tabs or caps

Inventory records of _________ must be kept separate from all other controlled substances

C-II's

After initial inventory, how often must a pharmacy complete a subsequent inventory? Is this inventory submitted to the DEA?

Every two years

No, it is for the registrant's records only

Is a pharmacy's initial inventory submitted to the DEA?

No

What can be ordered using a DEA 222 form?

C-I and C-II substances

Does a pharmacy still have to use a DEA 222 form if a drug is not a C-II federally, but is a C-II according to state law?

Yes if their state requires the use of a 222 form for all C-II's, they should always go by whichever law is more strict in this case

How does a pharmacy get DEA 222 forms?

By indicating they need blanks on their initial registration (form 224), by finding them online, by requesting them from their local office, or by requesting them (by phone) from DEA headquarters

Each book of DEA Form 222 consists of ___ sets of forms

Seven

When receiving C-II's, the pharmacist must document how many packages were received and the date on copy number ________ of DEA from ______

Copy 3 of Form 222

Can a supplier reject a C-II order if there is an erasure marking on it?

Yes

A pharmacist receives a shipment of MS Contin 30mg tablets. He ordered 3 containers of 100 tabs on his 222 form but received 10 containers of 30 tabs instead. The NDC is the same except for the last two digits. Is it still okay to accept this from his supplier?

Yes:

DEA policy does not preclude the substitution of identical products differing in packaging size from those initially ordered, provided that the actual quantity received does not exceed the amount initially ordered and that the National Drug Code number reflected is that of the actual product shipped.

What's the difference between cancelling and voiding a 222 order form?

The pharmacy can cancel all or part of a 222 order

The supplier can void all or part of a 222 form

What is power of attorney to sign?

Any registrant (pharmacy) may authorize one or more individuals to obtain and execute DEA Forms 222 by granting a power of attorney to each such individual.

They do not necessarily have to be located at the registrant's location

What happens if a DEA 222 order form is stolen or lost?

It should be reported immediately to the DEA Diversion field office. If a form was lost after submitting it to the supplier, a new form should be filled out and a written statement prepared stating that the drugs were not received which includes the original order from serial number

They will require the serial number of each stolen or lost form; or if a whole book was stolen, then the approximate date the forms were received

What is the CSOS?

Controlled Substance Ordering System

CSOS users must obtain a _________ for electronic ordering since it employs Public Key Infrastructure (PKI) technology

A CSOS digital certificate

Why would an electronic order form for C-II's be rejected?

1. The required data fields have not been completed.

2. The order is not signed using a digital certificate issued by DEA.

3. The digital certificate used has expired or been revoked prior to signature.

4. The purchaser's public key will not validate the digital certificate.

5. The validation of the order shows that the order is invalid for any reason.

What are the requirements for a prescriptions written for a controlled substance?

1. Patient's full name and address

2. Prescriber's full name and address

3. Drug name, strength, and dosage form

4. Quantity

5. Directions

6. Refills, if any

7. Date written

8. Hand-signed in ink

9. Prescriber DEA registration number

Can a nurse or secretary write prescriptions on behalf of a prescriber?

Yes, as long as it is still hand signed by the prescriber and this practice conforms with all other laws

Who can prescribe CS's?

Any physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:

1. Authorized to do so by their jurisdictional laws

2. Registered with the DEA or exempt

3. An agent of a healthcare institution acting within the normal course of practice

Can a prescriber write a prescription for the purpose of general dispensing to patients in his/her office?

No

T/F: an order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is an invalid prescription

True

Can a pharmacist who deliberately ignores a questionable prescription and dispenses a CS be prosecuted for negligence?

Yes, this is a felony offense

T/F: When a prescription is received electronically, the prescription and all required annotations must be stored electronically.

True, this was bolded and italicized

What should a pharmacist do if they receive a written Rx for a CS that indicates it was already sent electronically to another pharmacy?

Contact the pharmacy; if it has been dispensed then void the written Rx

Prior to October 1985, DEA registration numbers for physicians, dentists, veterinarians, and other practitioners started with the letter(s)...

A

After October 1985, DEA registration numbers for physicians, dentists, veterinarians, and other practitioners started with the letter(s)...

B or F

DEA registration numbers issued to mid-level practitioners begin with the letter(s)...

M

The second letter of a DEA number should usually match what?

The first letter of the practitioner's last name

When can a mid-level practitioner, intern, or other employee of a hospital use the hospital DEA number to write prescriptions in lieu of an individual number (5 requirements)?

1. They are acting within their role at the hospital

2. State law allows it

3. The hospital has verified that they are allowed to prescribe, dispense, or administer CS's within the state

4. Dispensing, prescribing and administering is in their usual course of practice

5. The hospital allows it and has given them a unique identifier suffix to use at the end of the hospital's DEA number

The requirement of registration is waived for any official of the ___________________, who is authorized to administer, dispense, or prescribe

U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons

This does not mean they can produce or distribute CS's

Can nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, euthanasia technicians, nursing homes, and homeopathic physicians register with the DEA to prescribe, dispense and administer CS's?

It depends on state laws in the jurisdiction they practice in

These are all "mid-level" practitioners

T/F: here is no federal time limit within which a C-II prescription must be filled after being signed by the practitioner

True

Can a practitioner issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a C-II?

Yes, if...

-Each Rx is on a separate blank

-The prescriber is acting within their scope

-There are earliest fill-dates on all Rx's

-Doing this will not create risk for abuse

-It is allowed under state law

Normally, can a C-II be dispensed from a faxed prescription?

Only if the original is presented and verified against the fax at the time of dispensing, there are a few exceptions to this though

When can a C-II prescription be accepted via fax?

-The patient presents the original at time of dispensing

-It is for a sterile compound for direct administration to the patient

-It is for a LTCF patient

-It is for a hospice patient

Very Important Flash Card

How can prescriptions for C-III, C-IV and C-V drugs be communicated?

-Written

-Verbal

-Electronic

-Fax

A C-III or C-IV prescription may only be refilled up to ______ times within ______ months after the date of issue.

Five times in six months

After five refills or after six months, whichever occurs first, a new prescription is required

Are there limits on refills for C-V prescriptions?

No, there are no federal or state limits on number of refills for C-V's

A CS can be refilled off of an electronic record if it meets what requirements?

-It prints out hard copies of each day's CS refills which the pharmacist then verifies and signs

-The printout is provided to the pharmacy within 72 hours of the refill being dispensed

-The system has a backup procedure in case of outages or interruptions

Or, instead of a printout, a logbook or file is kept whereby the pharmacists working that day acknowledge that all CS refills have been reviewed