Law 2 Exam 1

Cautions: Federal Law prohibits on which schedules of medication

2, 3, 4

When does the prescription exp time start

day after it was written

schedules where an authorized agent of a prescriber can make changes

3,4,5,6

schedules where only the prescriber can change it

2

changes on a C2 an authorized agent can make

address

family member prohibition on which schedule

2

Federal Controlled Substances Act

▪ Creates a closed system via registration

▪ Establishes national uniformity

▪ Enforced by DEA

CI drugs

▪ Includes hallucinogenics, some opiates, methaqualone,

and unapproved GHB

CII drugs

▪ Includes opium and many other opiates (including

products containing hydrocodone); cocaine; stimulants

such as amphetamine and methamphetamine;

depressants such as amobarbital, glutethimide,

secobarbital, and pentobarbital

out of state CII last for

5 days

CIII drugs

▪ Also includes certain stimulants, anabolic steroids,

dronabinol, ketamine, paregoric, and GHB approved

by the FDA

C-IV Drugs

▪ Includes narcotic drugs such as dextropropoxyphene;

depressants such as alprazolam, chloral hydrate,

barbital, benzodiazepines; stimulants such as

diethylpropion, phentermine; tramadol

C-V Drugs

▪ Includes antitussives containing codeine and

antidiarrheals containing an opiate

DEA registration for manufacturers and distributors

every yer

DEA reg for dispenses

every 3 years

a pharmacy can distrubute how much of their drugs before having to be reg as a distributor

5%

dispenser registration form

224

Methadine fir treatment only

40mg

Which of the following is an example of a Schedule II Narcotic Controlled Substance?

Xanax

Ritalin

Percocet

Lyrica

Percocet

Which of the following is an example of a Schedule II Non-Narcotic Controlled Substance?

Ritalin

Percocet

Ativan

Tramadol

Ritalin

Tylenol with Codeine #3 is an example of a Schedule ___ Controlled Substance.

II

III

IV

V

III

Secobarbital capsules is an example of a Schedule ___ Controlled Substance.

II

III

IV

V

II

Secobarbital suppository dosage form is an example of a Schedule ___ Controlled Substance.

II

III

IV

V

III

Diazepam 10 mg is an example of a Schedule ___ Controlled Substance.

II

III

IV

V

IV

Amoxicillin 500mg capsules is an example of a Schedule ___ Controlled Substance, under Massachusetts law.

III

IV

V

VI

VI

Which of the following statements is false about DEA Registration.

Manufacturers must register with the DEA if they manufacture controlled substances.

Distributers must register with the DEA annually.

Manufacturers must register with the DEA every 3 years.

Dispensers must register with the DEA every 3 years.

Manufacturers must register with the DEA every 3 years.

Under the federal Controlled Substance Act, which of the following is not considered an Individual Practitioner?

Physicians

Dentists

Veterinarians

Hospital

Hospital

Which of the following terms is defined as "To deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term "distributor" means a person who so delivers a controlled substance or a listed chemical."

Dispense

Distribute

Manufacture

Administer

Distribute

Which of the following terms is defined as "To deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery. "

Dispense

Distribute

Manufacture

Administer

Dispense

Which of the following terms is defined as "The direct application of a controlled substance to the body of a patient or research subject by 1) a practitioner or (in their presence) by their authorized agent, or 2) the patient or research subject at the direction and in the presence of the practitioner, whether such application is by injection, inhalation, ingestion, or any other means."

Dispense

Distribute

Manufacture

Administer

Administer

A Mid-level practitioner's DEA registration would begin with the letter __.

A

B

F

M

M

Which of the following statements is false about Methadone.

Used for severe pain outside of narcotic treatment programs

Legal to prescribe or dispense as an antitussive

Manufacturers voluntarily restricted 40mg methadone tablets to Opioid Treatment Programs (OTP).

It is a Schedule II Controlled Substance.

Legal to prescribe or dispense as an antitussive

The Combat Methamphetamine Epidemic Act of 2005 and Methamphetamine Prevention Act of 2008 places restrictions on OTC drugs used to manufacture methamphetamine. Which of the following statements is false?

The law limits the sale of no more than 3.6 g of ephedrine, pseudoephedrine (PSE), or phenylpropanolamine (PPA) base to a single purchaser per day.

The products may be stored in a manner that customers have direct access to the products.

No consumer may purchase more than 9 g of ephedrine, pseudoephedrine (PSE), or phenylpropanolamine (PPA) base within a 30-day period.

No consumer may purchase more than 7.5 g of ephedrine, pseudoephedrine (PSE), or phenylpropanolamine (PPA) base within a 30-day period by mail order.

The products may be stored in a manner that customers have direct access to the products.

Under Massachusetts Board of Registration in Pharmacy Policy 2018-01, which of the following elements of a new Schedule II prescription may NEVER be changed and would require a new prescription?

patient's address

directions for use

drug strength

prescriber's signature

prescriber's signature

Under Massachusetts Board of Registration in Pharmacy Policy 2018-01, which of the following elements of a new Schedule II prescription may be changed after consultation with the prescriber?

Prescriber's signature

Patient's name

Drug strength

Controlled substance prescribed

Drug strength

Under Massachusetts Board of Registration in Pharmacy Policy 2018-01, if a Schedule II prescription is missing the patient's address, the pharmacist may add the address without contacting the prescriber.

True

False

True

A Massachusetts pharmacy receives an out-of-state prescription for Morphine 30 mg tablets. From which of the following states may the prescription NOT be filled?

New York

Connecticut

New Hampshire

California

California

A Massachusetts pharmacy receives an out-of-state prescription for methylphenidate 10 mg tablets from a New Jersey prescriber. How many days does the pharmacy have to fill the prescription?

5 days

Resident pharmacies

Those in MA

Non resident pharmacies

Those outside of MA

NPI is used for

Insurance billing

(Vets don't get one)

Is DOB required on a script?

No, but it's "best practice"

90 day supply on controlled substances

Stimulants, testosterone, drugs for OUD, implantable infusion pumps

Do you need a diagnosis on the script for ADHD, ADD, or narcolepsy?

No

What is allowed on a CIII-VI script?

Can talk to Dr/agent

No need for partial fill language

DEA not needed

VI need MA controlled substance registration

Changes to the day supply

Changes you can make on a CII script

After consult with Dr:

Date of issue

Dr. address

Directions

Dosage forms

Strength and quantity

Add DEA

partial fill language

Can add pt address with our doctor if omitted

Can change pt address with Dr./agent consult

Changes you can't make on a script (you need a new script)

Name

Controlled substance prescribed

Dr. Name

Dr. Signature

Earliest date to be filler (CII only)

Can you get CV robitussion without a script

According to federal law yes

Mid-level practitioner's DEA numbers start with the letter "__"

M

Distributers DEA starts with

P or R

Information required on CS scripts

Date of issuance (no predate or post date)

Full name and address of patient, drug name, strength, dosage form, and quantity prescribed; directions for use; name, address, and registration number of practitioner

Must be signed on the day of issuance

Written in ink, indelible pencil, or typed and manually signed

Before filing a CS

must contain written or typed name or initials of dispensing pharmacist, the date dispensed, and the units or volume dispensed

CII prescription must be

Written and signed by prescriber

CMS required ERX for med Dw

Can partial fill up to how many days after CII is written

30

Or 60 if LTCF

If pharmacy can't supply a full fill, how long do they have to partial it before it's void

72 hours

CIII-V

May be written, faxed, electronic, or oral

IPs may administer or dispense without a script

Can a practitioner call in more refills for a CIII/IV orally?

Yes

Records in CS need to be kept for

2 yeats

Labeling of CS partial

Date of filling if CII and date of initial filling if another schedule

Refills should be labeled with initial filling and date of dispensing

Must have statement prohibiting transfer of drug

Labeling not applicable if for institutionalized patient

CS can be transferred how many times

Once or no limit (if using a shared electronic record system)

DEA allows a retail pharmacy in I transfer a II-V ERx to another pharmacy for initial dispensing

One time

Central filling pharmacies

Can't accept Rxs directly from patient or practitioner or deliver Rx directly to patient or practitioner

PDMP

State pdmp has to transmit to the state a record of dispensed CS for a patient

A LTCF with ADS

Needs a separate DEA registration at LTCF location

Distributions made to a ADS do not count towards the 5% limit that would require a separate registration as a distributor

Dispensing from LTCF emergency kits

Prescriber must issue the script to the pharmacy and the pharmacy must authorize nurse dispense from the kit

3 types of records involved with CS

Inventory

Drugs received

Drugs dispersed

Kept for 2 years

Inventory

Prior to beginning business end every 2 years, inventory of all CS on hand

Newly scheduled drugs must be inventoried on days of scheduling

Exact amount of CI and CIIs needed

Estimated amount for all other schedules is ok

Records of receipt

Invoices and 222

Date of receipt needs to be recorded

Records of dispersal

Rxs, record books, 222, invoices, records of disposal, theft, loss, etc

Distribution from pharmacy to practitioner

Invoice for C3-5

222 for C2

Total number of dosage units distributed to another registrant can't be more than 5% of total units if CSs distributed and dispensed in a year

Nonprescription Schedule V Sales

▪ In some states, C-V products may be sold without Rx,

provided:

▪ Dispensing done only by a pharmacist

▪ No more than 8 oz of an opium-containing product or 4 oz

of any other CS may be dispensed to the same purchaser

within a 48-hour period (some states have stricter

requirements).

▪ The purchaser is at least 18 years of age.

▪ The purchaser furnishes suitable identification.

▪ The sale is recorded in a bound record book with all

required information.

Disposal or Destruction

▪ Must request/document via a DEA Form 41 (available

online) and completed with required information.

▪ "Blanket authorization" may be allowed for hospitals.

▪ A registrant may also transfer CSs to a reverse

distributor.

▪ Reverse distributor to use DEA Form 41

Records of Theft or Loss

▪ A registrant must notify the DEA within 1 day of

discovery of any "theft or significant loss" of any CS

(should also notify police and most likely required to

notify state board of pharmacy).

▪ A registrant must complete Form 106, which is available online.

Records Required of Individual Practitioners

▪ Must keep records of CSs they dispense, but not of

those they prescribe.

▪ Need not keep records of CSs they administer unless

the IP regularly engages in dispensing or administering

and charges patients.

▪ A record must be kept of CSs administered in the

course of maintenance or detoxification of treatment of

addiction.

▪ May administer or dispense CS without Rx.

DEA Form 222

▪ Required for any distribution of C-I or C-II drugs.

▪ Forms are serially numbered and issued with name,

address, and registration number of registrant,

authorized activity, and schedules registrant is

authorized to handle.

Execution of Form 222

▪ Number of last line completed must be noted on each

form

▪ The form must contain required information. The NDC

number is optional (supplier must enter it).

▪ Must be signed and dated by authorized person.

▪ The purchaser, upon receipt of order, must record

number of containers received of each item and date

received.

▪ Partial order fills by supplier must be completed within

60 days.

▪ Errors, alterations, or erasures generally not permitted

Single-Sheet DEA Form 222

▪ The purchaser sends the original completed form to

the supplier after making and retaining a copy.

▪ The supplier would then keep the original form and

inform DEA of the purchase via ARCOS or by sending

a copy of Form 222.

Electronic Order System (CSOS)

▪ May be used instead of Form 222

▪ The purchaser can order any drug.

▪ The registrant must obtain a digital certificate for each

DEA-registered location.

Power of Attorney (POA)

▪ Required to allow person other than one who signed

registration to execute Form 222

▪ Whenever registrants distribute C-I or C-II drugs

among themselves,

they must execute a Form 222

following proper procedure.

▪ If an unfilled order form is lost,

the purchaser must

execute another together with a statement noting the

serial number of the lost form, date of lost form, and

that the CSs were not received.

▪ Must maintain copy of second order form and lost

order form with statement

▪ The copy of the statement must be sent with original

form to the supplier.

▪ If forms stolen or lost other than in transmission, must

notify DEA and provide serial numbers of missing

forms; if found, DEA must be notified immediately.

▪ Executed Form 222s must be

maintained separately from all other records and retained for 2 years.

▪ A copy of the single-sheet DEA Form 222 must be kept at the registered location.

▪ The supplier always keeps the original DEA Form 222.

A Massachusetts community pharmacy needs to order oxycodone 10 mg tablets from its wholesaler. Which of the following is required under federal law?

A written prescription from the pharmacy manager

DEA Form 222 or a CSOS electronic order

An invoice signed by a pharmacist

A Massachusetts Controlled Substance Registration (MCSR) application

DEA Form 222 or a CSOS electronic order

A physician writes a prescription for hydromorphone in the physician's own name so the physician can keep the medication in the office for future patient use. Which statement is correct?

The prescription is valid if the physician holds a DEA registration.

The prescription is valid if less than a 30-day supply is prescribed.

The prescription is invalid because prescriptions cannot be used to obtain controlled substances for office stock.

The prescription is valid if the pharmacist documents the purpose.

The prescription is invalid because prescriptions cannot be used to obtain controlled substances for office stock.

A physician instructs a medical assistant to prepare an electronic Schedule III prescription for testosterone. The physician reviews and signs the prescription before transmission.

Is this permissible?

No, only the physician may prepare prescriptions.

No, an agent may not be involved in any controlled substance prescription.

Yes, provided the physician authorizes and signs the prescription.

Yes, but only for Schedule V medications.

Yes, provided the physician authorizes and signs the prescription.

A pharmacist receives a Schedule II prescription that is missing the prescriber's DEA number.

Under Massachusetts Joint Policy 2018-01, what may the pharmacist do?

Refuse the prescription immediately

Add the DEA number without consulting the prescriber

Change the patient name

Change the drug prescribed

Add the DEA number without consulting the prescriber

A pharmacist receives a Schedule II prescription with the wrong patient listed.

According to Massachusetts Joint Policy 2018-01, what must occur?

Pharmacist may correct the patient name

Pharmacist may correct after consulting the prescriber

A new prescription is required

Pharmacist may correct if documentation is retained

A new prescription is required

Which of the following is required on a Massachusetts prescription under 105 CMR 721?

Prescriber DEA number on every prescription

Patient Social Security number

Date of issuance

Pharmacist signature

Date of issuance

A hospitalized patient receives an order for IV morphine entered into the hospital electronic medical record.

How is this order best classified?

Outpatient prescription

Medication order intended for institutional administration

DEA Form 222 order

Schedule II inventory transfer

Medication order intended for institutional administration

According to Massachusetts Policy 2024-05, which prescription may be issued and filled for up to a 90-day supply if otherwise lawful?

Oxycodone for chronic pain

Hydromorphone for acute pain

Methylphenidate for ADHD

Morphine sulfate for postoperative pain

Methylphenidate for ADHD

A pharmacist receives a Schedule II prescription for methylphenidate. The quantity written is illegible. The pharmacist contacts the prescriber, who confirms the intended quantity.

Under Massachusetts Joint Policy 2018-01, what may the pharmacist do?

Change the quantity after consultation with the prescriber

Refuse the prescription because quantity may never be changed

Change the quantity without contacting the prescriber

Dispense the pharmacist's estimated quantity

Change the quantity after consultation with the prescriber

Which practitioner may issue a controlled substance prescription under federal law?

Any individual employed in a healthcare facility

Any licensed pharmacist

An authorized practitioner licensed to prescribe controlled substances and properly registered or exempt from DEA registration requirements

Any nurse employed by a physician

An authorized practitioner licensed to prescribe controlled substances and properly registered or exempt from DEA registration requirements

A pharmacist receives a Schedule III prescription that contains all required information except the date written.

Under Massachusetts Joint Policy 2018-01, what may occur?

The pharmacist must always refuse the prescription

The date may be added if omitted after consultation with the prescriber

The pharmacist may create any reasonable date

The date can never be added

The date may be added if omitted after consultation with the prescriber

Which Schedule II prescription remains subject to the Massachusetts 30-day quantity limitation under Policy 2024-05?

Buprenorphine for opioid use disorder

Testosterone

Methylphenidate for ADHD

Oxycodone for chronic pain

Oxycodone for chronic pain

A pharmacist receives a Schedule II prescription for oxycodone. The prescriber calls and states hydromorphone was intended.

Under Massachusetts Joint Policy 2018-01, what is required?

Pharmacist may simply change the drug name

Pharmacist may change the medication if documented

A new prescription is required

Pharmacist may substitute any equivalent opioid

A new prescription is required

A pharmacist receives a Schedule II prescription for amphetamine salts. The prescription contains all required information except the prescriber's address.

Under Massachusetts Joint Policy 2018-01, what may the pharmacist do?

Add the prescriber's address after consulting the prescriber

Refuse the prescription because the address may never be added

Substitute the pharmacy address

Dispense the prescription without documenting the omission

Add the prescriber's address after consulting the prescriber

A Schedule III prescription is presented without a patient address.

Which action is permitted under Massachusetts Joint Policy 2018-01?

The pharmacist may add the patient address if omitted

The pharmacist must obtain a new prescription

The prescription must be voided immediately

The pharmacist may substitute the pharmacy address

The pharmacist may add the patient address if omitted

A pharmacist receives a printed Schedule II prescription containing all required information except the prescriber's signature.

According to Massachusetts Joint Policy 2018-01, what is required?

The pharmacist may sign on behalf of the prescriber

The signature may be added by a medical assistant

A new prescription is required

The pharmacist may document verbal authorization

A new prescription is required

A Massachusetts Schedule VI prescription is presented without the prescriber's Massachusetts Controlled Substances Registration (MCSR) number.

What is permitted?

The pharmacist may add the MCSR number without consulting the prescriber

A new prescription is required

The pharmacist may create a temporary MCSR number

The prescription may not be dispensed

The pharmacist may add the MCSR number without consulting the prescriber

A prescriber issues multiple Schedule II prescriptions for a patient to provide a legitimate course of therapy over several months.

Which statement is most accurate?

Federal law always prohibits multiple Schedule II prescriptions

Schedule II prescriptions may never exceed a 30-day supply in aggregate

Federal law permits issuance of multiple Schedule II prescriptions when regulatory requirements are met and the total quantity prescribed may never exceed a 90-day supply in aggregate.

Massachusetts law requires conversion to Schedule III medication

Federal law permits issuance of multiple Schedule II prescriptions when regulatory requirements are met and the total quantity prescribed may never exceed a 90-day supply in aggregate.