Pharmacy Law Exam 3- Controlled Substances

Front 1

The Pharmacists Corresponding Responsibility for controlled substances- what does law state about pharmacist and practitioner responsibility?

Back 1

An rx for a CS to be effective must be issued for a legit medical purpose by an individual practitioner acting in usual course of his professional practice.

Correspopnding responsibility rests with pharmacist who fills the rx!

Front 2

can pharmacist be indicted for filling rx that he should have identified as fake?

Back 2

yes

Front 3

IF a pharmacy goes out of business or is acquired by a new pharmacy, what responsibility does the pharmacy have in disposing of its controlled substances?

Back 3

it may transfer the controlled substances to another pharmacy, supplier, manufacturer or distributor registered to dispose of controlled substances.

Front 4

To transfer Schedule II substances, the receiving registrant must do what

Back 4

must issue an Official Order Form (DEA Form-222, U.S. Official Order Forms - Schedules I & II) to the registrant transferring the drugs

Front 5

CS form info

Back 5

name of supplier
street address
date
quantity of packages
package size
name of the drug
# lines completed
then store's info

Front 6

photos on website of CS shit

Back 6

--

Front 7

DEA form numbers to know

Back 7

DEA form -222- order forms to transfer schedule II substances (not sure who sends it)

Front 8

On the day the controlled substances are transferred to another store- (transferring all meds due to closing store)- what must you do? (2)

Back 8

complete inventory must be taken which documents drug name/dosage form/str/qt/date transferred

DEA Form 222 must be prepared to document transfer

Front 9

complete inventory when transferring all controlled substances must contain what (5)

Back 9

drug name, dosage form, strength, quantity, and date transferred.

Front 10

complete inventory serves what purpose (2)

Back 10

This inventory will serve as the final inventory for the registrant going out of business and transferring the controlled substances. It will also serve as the initial inventory for the registrant acquiring the controlled substances.

Front 11

DEA recommends that any pharmacy seeking to dispose of controlled substances do what?

Back 11

first contact the nearest DEA Diversion Field Office (see Appendix K) for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA

Front 12

A pharmacy registrant … must not employ …anyone who...(2)

any exceptions?

Back 12

anyone who has been convicted of a felony relating to controlled substances, or … has had an application for DEA registration denied, revoked, or surrendered for cause.

However, pharmacies desiring to employ an individual who meets this definition may request an exception

Front 13

if theft or loss of CS- what must you do (3)

Back 13

notify DEA (phone/fax/written), local police

he said something about the board...

also complete DEA form 106

Front 14

loss must be ______ in order to report to DEA?? listen again. that doesn't sound right

Back 14

significant? said we need to know.

Front 15

Controlled Substance Registrant Protection Act of 1984 provides for the federal investigation of pharmaceutical thefts and robberies if...(3)

Back 15

1.Replacement cost of the controlled substances taken is $500 or more, OR
2.A registrant or other person is killed or suffers "significant" bodily injury during the robbery or theft of a controlled substance.
3.Interstate or foreign commerce is involved in planning or executing the crime.

otherwise usually delegate to state police

Front 16

burgling pharmacies results in...what 3 negative effects

Back 16

property loss, serious injury to professionals and bystanders, and trafficking which serves to fuel the drug abuse problem.

Front 17

Inventory Requirements for CS- what is required, where it needs to be maintained and for how long, and whether it needs to be separated from other inventory

Back 17

complete and accurate list of all by actual physical count (C-II).

• maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection.
• inventory of Schedule II controlled substances must be kept separate from those for all other controlled substances

Front 18

bienniel inventory test question

Back 18

read test question carefully regarding whether you need to submit to DEA the biennial inventory?? (41:00)

Front 19

biennial inventory- when to take (2)

submit to DEA?

Back 19

Following the initial inventory, take a biennial inventory (every two years),
•taken on any date which is within two years of the previous inventory date.
•no requirement to submit to DEA!!!!!! be careful of this

Front 20

Schedule II vs. III, IV, V- how to count

Back 20

•Schedule II - actual physical count.
•Schedules III, IV and V - estimated count may be made.

Front 21

when must an actual physical count be performed for bienniel inventory

Back 21

An actual physical count must be made if the container holds more than 100 (changed) dosage units and has been opened

Front 22

When a drug not previously controlled is scheduled, how do you handle its inventory

Back 22

the drug must be inventoried as its schedule as of the effective date of scheduling.

Front 23

inventory of drugs for destruction or no longer saleable: what constitutes this group (3) and does it need to be inventoried

Back 23

(1)damaged, defective, or impure and is awaiting disposal,
(2)held for quality control purposes, or
(3)maintained for extemporaneous compoundings, must be inventoried

Front 24

which schedule drugs are ordered with DEA form 222

Back 24

Only Schedule I and II controlled substances are ordered with a DEA Form-222.

Front 25

When ordering Schedule II substances, the pharmacist is responsible for filling whats parts of the form (4)

Back 25

the number of packages,
•the size of the package and
•the name of the item
-then signed/dated by person authorized to sign a registration application (see power of attorney to sign an official order form?? IDK If pharmacist signs this?)

Front 26

when items are received (schedule II) pharmacist must document what and where

Back 26

must document on the purchaser’s copy (copy 3) the actual number of packages received and the date received.

Front 27

Power of Attorney to Sign an Official Order Form: who is allowed to initiate these forms? How many people/location of such individuals can they authorize to have power of attorney?

who needs to sign form

Back 27

Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute Official Order Forms by granting a power of attorney to each such individual.

The power of attorney must be signed by the same person who signed the most recent application for registration or renewal registration, as well as the individual being authorized to obtain and execute Official Order Forms.

Front 28

When the pharmacist has not received a shipment what must they do

Back 28

contact the supplier to determine whether the original DEA Form-222 was received.

Front 29

If the original order form is determined to have been lost or stolen what must pharmacist do (4)

Back 29

must complete a second order form so the supplier can fill the original order.

prepare a statement which includes the first order form’s serial number and date, and verify that the drugs ordered were never received.
•Attach a copy of the statement to the second order form that is sent to the supplier.
• keep a copy of the statement with copy 3 from the first and second order forms.

Front 30

Schedule III-V Substances: the pharmacy (registrant) must keep what records and record what on it? how must these records be maintained?

Back 30

must keep a receipt (i.e., invoice or packing slip) on which they record the date the drugs were received and confirm that the order is accurate. These receipts must be maintained in a readily retrievable manner for inspection by the DEA.

Front 31

Rx requirements to be able to dispense CS (for pharmacist)

what is/isn't a prescription

Back 31

a pharmacist must know the requirements for a valid prescription which are described in this section. A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription.)

Front 32

signature on controlled substance rx (or all rx i think...) must be from...

Back 32

cannot be signed by prescriber's agent: must be signed by prescriber

Front 33

legit rx must contain these 7 items

Back 33

•A prescription - dated and signed on the date when issued.
• the patient’s full name and address,
• practitioner’s name, address, and registration number.
• drug name, strength, dosage form
quantity prescribed
directions for use, and number of refills.

Front 34

if oral rx is not permitted...what must be done instead

Back 34

Where an oral prescription is not permitted, a prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner

Front 35

can someone else other than doctor prepare rx for signature?

Back 35

An individual (i.e., secretary or nurse) may be designated to prepare prescriptions for signature. The practitioner is responsible

Front 36

who has to be registered by DEA? (TEST QUESTION)

Back 36

who has to be registered by DEA? anyone who deals with controlled substances EXCEPT pharmacists

Front 37

A prescription order for a controlled substance may be issued only by...6 professions + 2 conditions

Back 37

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

–Authorized to prescribe controlled substances by the jurisdiction in which he/she is licensed to practice; and
–Registered with DEA or exempted from registration (i.e., Public Health Service and Bureau of Prison physicians).

Front 38

Prior to October 1, 1985, DEA registration numbers for physicians, dentists, veterinarians and other practitioners started with the letter

New registration numbers issued after that date begin with the letters

Back 38

A

B & F.

Front 39

Registration numbers issued to mid-level practitioners begin with the letter

Back 39

M

Front 40

The first letter of the registration number is followed by...

Back 40

the first letter of the registrant’s last name. (e.g., J for Jones or S for Smith), and then a computer generated sequence of seven numbers

Front 41

practioner's use of hospital DEA: when they can use it...? (5)

reqs for internal codes (last 3 tailing digits on a hospital DEA)

Back 41

--- (1:12)

1.in the usual course of professional practice;
2.The practitioner is authorized to do so by the state;
3.The hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state;
4.The practitioner acts only within the scope of employment in the hospital or institution;
5.The hospital or institution authorizes the practitioner to dispense or prescribe (See example of a specific internal code number below);


A current list of internal codes and the corresponding individual practitioners is to be kept by the hospital or other institution

Front 42

exceptions to DEA registration requirement (2)

how do they deal with controlled substance prescribing? (what to use in lieu)

Back 42

if you practice in public health service, or prison- do not require DEA numbers for internal distribution

Such officials must specify their agency and service identification number of the issuing official in lieu of DEA number on any rx of CS. The service ID number is SSN???? WTF

Front 43

DEA Registration Requirement for Military Personnel (if any)

military physicians issuing rx must do what

Back 43

The requirement for registration is waived for military physicians who prescribe, dispense, or administer, but do not procure or purchase, controlled substances in the course of official duties.

Military physicians issuing prescriptions must indicate the branch of service or agency and the service identification number in lieu of the registration number required on prescriptions. Such prescriptions may be filled off base at community pharmacies.

Front 44

mid level prescribers and CS prescribing- allowed?

Back 44

Mid-level practitioners (MLP) are registered and authorized by the DEA and the state in which they practice to dispense, administer and prescribe controlled substances in the course of professional practice

Front 45

examples of MLBs

Back 45

health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, veterinarian euthanasia technicians, nursing homes and homeopathic physicians.

Front 46

Purpose of ISsue slide

Back 46

TEST

Front 47

to be valid, an RX for CS must be issued for...(TEST) (3)

Back 47

legit medical purpose

by a practitioner acting in the usual course of sound professional practice.
•The practitioner is responsible for the proper prescribing and dispensing of controlled substances.

Front 48

corresponding responsibility of CS lies with... (TEST)

Back 48

corresponding responsibility rests with the pharmacist who dispenses the prescription.

Front 49

rx that is not a valid CS prescription

Back 49

An order for controlled substances which purports to be a valid prescription, but is not issued in the usual course of professional treatment, or for legitimate and authorized research,

Front 50

The individual who knowingly dispenses such a purported prescription, as well as the individual issuing it, will be subject to

Back 50

criminal and/or civil penalties and administrative sanctions

Front 51

A prescription may not be issued for what purpose (stated explicitely in purpose of issue)

Back 51

may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients. Therefore, a prescription written for office stock or "medical bag" use is not valid

Front 52

schedule II substances require what type of rx and what must be on it

Back 52

Schedule II substances require a written prescription which must be signed by the practitioner.

Front 53

time limit for filling after doc writes it

Back 53

There is no time limit when a Schedule II prescription must be filled after being signed by the physician (by FEDERAL law; however IA law has 6 mo limit). However, the pharmacist must determine that the prescription is still needed by the patient (e.g., a narcotic prescription filled several weeks after being written.)

Front 54

qt limit for schedule 2?

Back 54

no not by feds

Front 55

Emergeny rx- schedule II requirements (4)

Back 55

1.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 prescribing practitioner’s signature.
3.If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner, by verifying the practitioner’s telephone number with that listed in the directory and by making other good faith efforts to insure proper identity.
4.Within seven days prescribing written, signed prescription - written on its face "Authorization for Emergency Dispensing." If they do not then it is pharmacists duty to report DEA/board that they did not provide it.

on face of rx you should write "For emergency"

Front 56

reporting responsibilities of lack of provision of written rx for emergency Schedule II fill and consequences (2)

Back 56

By law the pharmacist must notify the nearest DEA Diversion Field Office if the prescriber fails to provide a written prescription within seven days.
•If the pharmacist fails to do so, his/her authority to dispense without a written prescription will be void.

Front 57

what must RPh do with the subsequent written rx for the oral emergency schedule II fill

Back 57

dispensing pharmacist must attach this written prescription to the oral prescription.

Front 58

partial dispensing laws- what Rph can/can't do and timeline

Back 58

•The pharmacist may partially dispense a prescription for a Schedule II if unable to supply the full quantity
•pharmacist notes the quantity supplied on the front of the written prescription (or on a written record of the emergency oral prescription).
•The remaining portion may be dispensed within 72 hours
•if cannot be dispensed within the 72-hour period, the pharmacist must notify the prescribing practitioner.
•No further quantity may be supplied beyond the 72 hours, except on a new prescription.

Front 59

LTC/terminally ill: if partially filling what does pharmacist have to notate on rx (4)

Back 59

For each partial filling, the pharmacist must note - date the prescription was partially filled, the quantity dispensed, the remaining quantity and the identification of pharmacist

Front 60

Schedule III-V Controlled Substance Prescriptions: form of rx

Back 60

A pharmacist may dispense a Schedule III, IV, or V controlled substance having received either a written prescription signed by a practitioner, a facsimile of that prescription transmitted by the practitioner or his/her agent to the pharmacy, or an oral prescription made by an individual practitioner. The pharmacist must promptly reduce the oral prescription to writing, including all required information

Front 61

Partial Dispensing III - V: can pharmacist do it? conditions?

Back 61

The pharmacist may partially dispense a prescription for a Schedule III-V controlled substance if the pharmacist notes the quantity dispensed and initials the back of the prescription order. The partial dispensing may not exceed the total amount authorized in the prescription order. The dispensing of all refills must be within the six month limit.

Front 62

skipped next long slide

Back 62

---

Front 63

The purchaser at a retail outlet for sched V must be at least what age

Back 63

at least 18 years of age.

Front 64

sched V: what is required to purchase

Back 64

For the retail purchase of a Schedule V controlled substance, every customer the pharmacist does not know should be required to provide suitable identification, including proof of age, where appropriate.

Front 65

record keeping system required for sched V drugs

Back 65

A Schedule V bound record book is maintained which contains the name and address of the purchaser, name and quantity of controlled substance purchased, date of each sale, and initials of the dispensing pharmacist. This record book must be maintained for a period of two years from the date of the last transaction entered in such record book, and it must be made available for inspection and copying by officers of the United States, as authorized by the U.S. Attorney General.

Front 66

can dispense sched V without rx if??? idk this slide?

Back 66

Other federal, state or local law does not require a prescription.

Front 67

Delivery of CS to Persons in Another Country

Back 67

Controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals in another country without proper authorization. Any such delivery or shipment is an export under the CSA

Front 68

Emergency Kits for Long Term Care Facilities

Back 68

basically..separate entity for rules

The DEA has issued a policy statement which provides individual state licensing and regulatory boards with general guidelines for establishing specific rules concerning controlled substances used in emergency kits at Long Term Care Facilities. For a copy of this policy statement, see Guidelines for Emergency Kits in Long Term Care Facilities

Front 69

The Narcotic Addict Treatment Act of 1974- what is it, what's it do (3)

Back 69

law that governs the use of narcotics and the treatment of addiction in the United States. In addition, the law designates which government agencies have responsibility for narcotic treatment programs, defines the terms "maintenance" and "detoxification," and explains who has to register to treat patients for drug dependence.

Front 70

record keeping/security requirements for narcotic treatment programs vs. normal CS prescriptions

Back 70

There are separate recordkeeping and security requirements for Narcotic Treatment Programs.

Front 71

Use of Methadone Outside a Narcotic Treatment Program-conditions

Back 71

A practitioner may prescribe methadone or any other narcotic to a narcotic addict for analgesic purposes. However, a practitioner may not prescribe methadone or any other narcotic medication solely for the treatment of a patient's narcotic addiction.

Front 72

Narcotics for Patients with Terminal Illnesses or Intractable Pain requirements for legitimacy

Back 72

These drugs have legitimate uses and a pharmacist should not hesitate to dispense them when a prescription indicates they are for a legitimate medical purpose

CSA does not define what exactly this means...

Front 73

Combat Methamphetamine Epidemic Act of 2005: what pharmacy needs to do to be able to dispense List 1 shit (3)

Back 73

THERE'S ONE SLIDE I DIDN'T GO OVER- has limits for when you need to recordkeep.

if you have DEA registration, you're fine.

but if you're going to sell List 1 shit, you have to comply with recordkeeping and reporting reqs in CMEA 2005

This includes documentation of receipts/sales of threshold amounts of these drugs.

Front 74

know quantity limits for sudafed

Back 74

-

Front 75

penalties upon conviction if violating CSRPA???? provisions (3)

for burglary/robbery

for use of dangerous weapon

if death results

Back 75

1.Conviction of burglary or robbery - maximum $25,000 fine and/or 20 years imprisonment.
2.Conviction for use of a dangerous weapon - maximum $35,000 fine and/or 25 years imprisonment.
3.If death results - maximum $50,000 fine and/or life imprisonment.

Front 76

Recordkeeping requirements (2)

Back 76

Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, distributed, dispensed or otherwise disposed of. All records of controlled substances must be maintained for two years.
•List I Chemicals

Front 77

5% rule on exam- what is it

Back 77

total number of dosage units dispensed (to other DEA registrants?) during a calendar year, if at any time it exceeds 5 % OF WHAT??? of total dosage units of CS, the pharmacy is also required to register as a distributor

Front 78

USPS mailing requirements for CS

Back 78

U.S. Postal Service regulations permit mailing any controlled substances, provided that they are not outwardly dangerous or of their own force could cause injury to a person’s life or health, if the following preparation and packaging standards are met:

no indication on outside of package that it contains a CS

Front 79

ways to file CS shit (3)

Back 79

1) three separate files
2) two separate files (II vs. everything else + C)
3) two separate files: II-V CS all in one file, everytihng else in a file. Must have red C on III, IV, V