Pharmacy Law Exam 3- Part Ii

Front 1

When must a prescription for a CS be dated and signed?

Back 1

On the date when issued

Front 2

What items must a CS prescription contain? (6)

Back 2

The patient’s full name and address; the practitioner’s full name, address, and DEA number;
drug name/strength/dosage form; quantity prescribed; directions for use; number of refills
authorized (if any)

Front 3

May a physician have a nurse or secretary prepare a CS prescription for his/her signature?

Back 3

yes

Front 4

May a physician have a nurse or secretary sign a CS prescription for her/him?

Back 4

no

Front 5

Read “Construction of Valid DEA Registration Numbers for Practitioners”. If the first number of the DEA Registration Number is an “A” then you know that the number was issued prior to 1985 to a physician, dentist, veterinarian or other practitioner. What would be the first letter if the number was issued after 1985 to a physician, dentist, veterinarian or other practitioner?

Back 5

B or F

Front 6

What would the first letter be if the number was issued to a mid-level practitioner, such as a nurse practitioner?

Back 6

M

Front 7

What is the significance of the second letter of the DEA Registration Number?

Back 7

It is almost always the first letter of the registrant’s last name

Front 8

When an individual practitioner who does not have their own registration number, such as an intern or resident, is working as an agent of a hospital prescribes a controlled substance what number do they use?

Back 8

have to use hospital's DEA + internal code

Front 9

Under what contingency will the DEA issue an individual DEA Registration Number to a Mid-level practitioner?

Back 9

The authority granted by the state in which they are licensed

Front 10

To be valid, a prescription for a controlled substance must ___________________________________________ by a practitioner

Back 10

must be issued for a legitimate medical purpose

Front 11

Fill in the blank: To be valid, a prescription for a controlled substance must be issued by a practitioner __________________________________________ of professional practice.

Back 11

acting in the usual course of professional practice

Front 12

The practitioner is responsible for the proper prescribing and dispensing of controlled substances. However, the pharmacist who dispenses the prescription has a __________________________________________.

Back 12

corresponding responsibility

Front 13

What is the legal status of a prescription not issued in the usual course of the prescribing physician’s professional practice?

Back 13

invalid

Front 14

When may a Schedule II prescription be given orally by the prescriber to the pharmacist?

Back 14

in an emergency

Front 15

How long after a Schedule II prescription has been written is it still valid, according to federal law?

Back 15

There is no federal time limit, but the pharmacist must determine that the prescription is still
needed by the patient

Front 16

You receive a prescription for a Schedule II controlled substance. The date on the prescription is three months ago. What is the minimum you must do to decide if the prescription is still valid?

Back 16

Determine if the prescription is still needed by the patient

Front 17

Under federal law what is the maximum number of doses for which a Schedule II CS can be written?

Back 17

There is no express federal limit, but the amount dispensed must be consistent with the
requirement that a prescription for a controlled substance be issued only for a legitimate
medical purpose

Front 18

What is the maximum number of refills that a prescriber can put on a Schedule II CS prescription?

Back 18

0

Front 19

You receive a Schedule II prescription by fax. No emergency exists and none of the exceptions are met in this case. Can you fill the prescription and If so under what conditions?

Back 19

Yes, as long as the original prescription is presented to the pharmacist and verified against
the facsimile at the time of dispensing

Front 20

You receive a telephone call from a physician who wants to give you a prescription for a Schedule II drug over the phone. Can you fill the prescription and if so under what circumstances?

ok we know it's only under emergencies...what 3 conditions constitute a bona fide emergency

Back 20

Yes, in a bona fide emergency situation, meaning that the immediate administration of
the drug is necessary for proper treatment of the intended ultimate user, that no
alternative treatment is available, and it is not possible for the prescribing practitioner
to provide a written prescription for the drug at this time

Front 21

The doctor on the telephone tells you this is an emergency and he/she gives you an oral prescription for a Schedule II Drug. He/she asks you how long he/she has to send a signed, written prescription according to federal law. What answer do you give the doctor?

Back 21

within 7 days

Front 22

The doctor who gave you the oral Schedule II failed to provide you with a signed, written prescription as required by law. What must you now do?

Back 22

Notify the local DEA Diversion Field Office

Front 23

The DEA grants three exceptions to the fax prescription rule for Schedule II CS prescriptions. What are they?

Back 23

1. Practitioners prescribing a schedule II narcotic CS to be compounded for direct
administration to a patient by parenteral, IV, IM, SQ, or intraspinal infusion
2. Practitioners prescribing schedule II CS for residents of long term care facilities (LTCF)
3. Practitioners prescribing a schedule II narcotic CS for a patient enrolled in a hospice care
program which is licensed by the state

Front 24

Schedule III through V prescriptions may be refilled under federal law, but there are limits as to number of times and for how long. What are the maximum number of refills that can be put on a Schedule III, IV and V prescription and what is the maximum length of time within which it can be refilled?

Back 24

Schedules III and IV: no more than five (5) times within six (6) months after the date of issue
Schedule V: as authorized when a prescription is issued or if renewed by a practitioner

Front 25

A patient asks for a refill on a prescription he/she has for a Schedule V CS drug. Can you refill the prescription without calling the doctor?

Back 25

Yes, if there are refills authorized on the prescription

Front 26

You refill a prescription for a Schedule III drug. This is the first of five refills and the Rx is 30 days old. What information must you enter on the back of the prescription when you refill it?

[Actually the computer is probably programmed correctly and will automatically record the needed information, but assume for this answer that the computer has not yet been invented].

Back 26

The dispensing pharmacist’s initials, the date the prescription was refilled, and the amount
of drug dispensed on the refill

Front 27

Under federal law a pharmacy is permitted to use a computer to store and record information on prescription refills of CS. Who is responsible for verifying and documenting that the refill date entered into the computer system is correct?

Back 27

The pharmacist

Front 28

Your pharmacy’s computer system is down. You are presented a Schedule III prescription to refill. What do you do?

Back 28

The pharmacy must have a back-up procedure to document in writing refills of schedules III
or IV controlled substances. This procedure must ensure that refills are authorized by the
original prescription, that the maximum number of refills has not been exceeded, and that all
required data is retained for online entry as soon as possible

Front 29

You receive a faxed prescription for a Schedule III drug. May you fill it and if so under what circumstances?

Back 29

Yes, the facsimile is considered to be equivalent to the original prescription as long as the
practitioner has manually signed the prescription

Front 30

The federal law allows that only a practitioner can prescribe controlled substances and
that this authority cannot be delegated to anyone else. You receive a telephone prescription
for a Schedule IV CS from a doctor’s nurse. Can you fill the prescription and if so under
what circumstances?

Back 30

Yes, as long as it meets DEA requirements

Front 31

You receive a call from an independent pharmacy in another town asking for refill information on a Schedule IV prescription. There are refills and time left on the Rx. Under federal law can you transfer prescription information to the other pharmacy for the purpose of refilling the prescription and if so under what circumstances? (3)

Back 31

Yes, but only on a one-time basis. Transfers must be communicated directly between two
licensed pharmacists and the transferring pharmacist must:
1. Write the word VOID on the face of the invalidated prescription or record information
that the prescription was transferred on an electronic system
2. Record on the reverse of the invalidated prescription the name, address, and DEA number
of the pharmacy to which it was transferred and the name of the pharmacist receiving the
prescription

Front 32

You work for a chain pharmacy that has real time, online sharing capabilities. How
many CS refills will federal law allow you to transfer to another of the chain’s pharmacies?

Back 32

Up to the maximum refills permitted by law and the prescriber’s authorization

Front 33

In addition to the information required on a noncontrolled substance prescription, what
other statement is required to be on a Rx for a controlled substance?

Back 33

prescription: need DEA and manual signature

CAUTION: Federal law prohibits the transfer of this drug to any person other than the
patient for whom it was prescribed

Front 34

In a bona fide emergency, a practitioner may telephone a Schedule II prescription to the pharmacy. The pharmacist may dispense if he follows these rules: List the five requirements.

Back 34

1. The drug prescribed/dispensed must be limited to the amount needed to treat the
patient during the emergency period
2. The prescription order must be immediately reduced to writing by the pharmacist and
must contain all information except for the practitioner’s signature
3. If the prescribing practitioner is not known to the pharmacist, he/she must make a
reasonable effort to determine that the oral authorization came from a registered
individual practitioner
4. The prescribing practitioner must provide a written, signed prescription for the
prescribed controlled substance within 7 days after authorizing
5. For electronic prescriptions, the pharmacist must annotate the record of the electronic
prescription with the original authorization/date of the oral order

Front 35

You are filling a Schedule II prescription, but you find you only have enough tablets for ½ of the amount prescribed. The patient asks you to give her the tablets that you have and order in the rest. What three rules do you have to keep in mind when you partially fill a Schedule II Rx?

Back 35

The pharmacist must note the quantity supplied on the front of the written prescription and
the remaining portion may be dispensed within 72 hours of the first partial dispensing. If
not, the pharmacist must notify the prescribing practitioner and no further quantity may be
dispensed beyond 72 hours without a new prescription

Front 36

Federal law contains an exception for Long Term Care Facilities (LTCF) and Schedule II prescriptions allowing the pharmacist to partially fill a Schedule II Rx, including giving single dosages, and fill the remaining quantities as needed. The same rule applies for terminally ill patients. There are special rules, however. Name three special rules for partially filling Schedule II prescriptions for LTCF patients and terminally ill patients.

Back 36

1. A prescription for a schedule II controlled substance may be filled in partial quantities
to include individual dosage units for patients of a LTCF or with a terminal diagnosis
2. The pharmacist must record on the prescription whether the patient is “terminally ill”
or an “LTCF patient”
3. Schedule II prescriptions for patients in an LTCF or terminally ill patients are valid for
a period not to exceed 60 days from the issue date unless sooner terminated by
discontinuance of the medication
4. phramacist has to mark on back of rx the qt left...

Front 37

Does the DEA currently permit a prescription received via the internet to be filled?

Back 37

no

Front 38

You are in the pharmacy and a doctor e-mails you a prescription for a Schedule IV drug.
What do you have to do before filling the Rx? (3)

Back 38

1. Ensure that you have previously dispensed to the patient a controlled substance other
than by means of the internet and pursuant to the valid prescription of a practitioner
2. Contact the practitioner who issued the original prescription at the request of that
individual to determine whether the practitioner will authorize the issuance of a new
prescription for that individual for the controlled substance
3. The practitioner, acting in the usual course of professional practice, determines there is a
legitimate medical purpose for the issuance of the new prescription

Front 39

Under federal law Schedule V drugs do not require a prescription and may be sold over the counter subject to special rules. What are these special rules? (6)

Back 39

1. Such dispensing is made only by a pharmacist
2. Not more than 240mL (8oz) or 48 units of any CS containing opium nor more than
120mL (4oz) or 24 units of any other CS may be dispensed at retail to the same
purchaser in any given 48-hour period
3. The purchaser is at least 18 years of age and able to furnish suitable ID if unknown to
the pharmacist
4. A bound record book for dispensing of CS is maintained by the pharmacist which
contains the name/address of the purchaser, name/quantity of the CS, date of each
purchase, and name or initials of the dispensing pharmacist
5. The prescription is not required for distribution or dispensing of the substance
pursuant to any federal, state, or local law
6. Central fill pharmacies may not dispense CS at the retail level to a purchaser

Front 40

What statement does the DEA make in the Pharmacists Manual regarding fear of
pharmacists when dispensing CS for patients with intractable pain?

Back 40

A pharmacist should not hesitate to dispense them when a prescription indicates they
are for a legitimate medical purpose

Front 41

You are working in a pharmacy and you receive a call from a pharmacy located across
the town from you. The pharmacist asks if he/she can purchase 5 tablets of a Schedule II
drug to complete a prescription for a patient. Your pharmacy is not registered as a
distributor. Under federal law can you sell him/her the 5 tablets? (4 conditions)

Back 41

Yes, as long as:
1. The pharmacy is registered under the CSA to dispense controlled substances
2. The distribution is recorded by the distributing practitioner and receipt is recorded by
the receiving practitioner
3. The pharmacy documents the transfer on DEA Form 222 or the electronic equivalent
4. The total number of dosage units of all controlled substances distributed by the
pharmacy does not exceed 5% of all controlled substances dispensed by the
pharmacy during a calendar year

Front 42

how to calculate whether a DEA number checks

Back 42

A sample DEA number would be: AB1234563. The Algorithm is:
· Add digits 1, 3 and 5. write down the answer
o In the example: 1 + 3 + 5 = 9
· Add digits 2, 4 and 6 and multiple the sum time two. Write the answer
o In the example: 2 + 4 + 6 = 24
· Add together the two answers.
o In the example: 9+ 24 = 33
· The last digit of the DEA number should be the same as the last digit in the final
sum obtained.
o In the example: AB1234563 the number checks

Front 43

657 IAC 10.21 deals with controlled substances prescription requirements. When must controlled substance (CS) prescriptions be dated and signed?

Back 43

on date of issue

Front 44

A CS prescription must bear what information? (13)

Back 44

a) Full name of the patient
b) Address of the patient
c) Drug name
d) Drug strength
e) Drug dosage form
f) Quantity prescribed
g) Directions for use
h) Prescriber’s name
i) Prescriber’s address
j) Prescriber’s DEA registration number
k) Legibly printed, typed, or hand-printed name of the prescriber
l) Prescriber’s written or electronic signature

date of issue

Front 45

Who may sign a CS prescription?

Back 45

The individual prescribing practitioner

Front 46

What does the term “a corresponding liability rests upon the pharmacist” [see10.21(1)] mean?

Back 46

The pharmacist is responsible, as well as the prescriber, for ensuring that the controlled
substance prescription is legitimate and has been prepared correctly and for a legitimate
medical purpose in the usual course of practice

Front 47

What must the pharmacist do when he or she receives a Schedule II CS prescription from a patient the pharmacist does not know, written by a prescriber the pharmacist does not know? (2)

Back 47

Verify the authenticity of the prescription with the individual practitioner or the
prescriber’s agent and

document the manner in which the prescription was verified and
include the pharmacist’s name or unique identifier

Front 48

What must be included on a CS prescription written by an intern in addition to all regular
requirements, the hospital’s registration number and the prescriber’s signature? (2)

Back 48

a) Special internal code number assigned by the hospital and
b) Stamped or legibly printed name of intern, resident, or foreign physician

Front 49

On a schedule II Cs prescription, what three items may not be changed

Back 49

a) Patient’s name
b) Controlled substance prescribed (except for generic substitution) and
c) Name or signature of the prescriber

Front 50

on schedule II CS rx, what 5 items may be changed and under what circumstsances (2)

Back 50

1) Drug strength/dosage form
2) Drug quantity
3) Directions for use
4) Date the prescription was issued and
5) The prescriber’s address or DEA registration number

but only after
consultation with the prescriber or prescriber’s agent and documentation of such
consultation

Front 51

Under Iowa rules, may a pharmacist in charge destroy controlled substances by themselves?

Back 51

no

Front 52

What CS schedule must you maintain a perpetual inventory for?

Back 52

schedule II

Front 53

How often must an inventory of controlled substances be taken? How long must the record of that inventory be maintained?

Back 53

Inventory of CS should be taken at least annually. Records must be maintained for at least 2
years following the date of inventory

Front 54

For what products must there be an actual exact count or measure? (3)

Back 54

For all substances listed in schedule I and II, and for all solid oral and injectable
hydrocodone-containing products


schedule III and IV- if more than 100 ct