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Hospital Pharmacy > Controlled substances > Flashcards

Controlled substances Flashcards

1
Q

A set of general or permanent rules that are
published in the Federal Register by the federal
government.

A

CODE OF FEDERAL REGULATIONS (CFR)

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2
Q

CODE OF FEDERAL REGULATIONS (CFR) is divided into

A

50 titles

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3
Q

Also known as the Comprehensive Drug Abuse
Prevention and Control Act of 1970

A

CONTROLLED SUBSTANCES ACT (CSA)

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4
Q

the federal government’s drug policy
governing the manufacturing, importation,
possession, and distribution

A

CSA

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5
Q

A non-profit organization with the mission of
enhancing patient safety through education,
collecting and analyzing adverse drug events,
disseminating medication safety information,
collaborating with healthcare organizations, and
conducting research.

A

INSTITUTE OF SAFE MEDICATION PRACTICES

(ISMP)

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6
Q

A set of written REQUIREMENTS dictated by an
organization

A

POLICIES AND PROCEDURES

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7
Q

provides the foundation for the written
procedural instructions in an organization

A

PROCEDURES

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8
Q

A legal document that allows another person to
act on your behalf.

A

POWER OF ATTORNEY AUTHORIZATIONS

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9
Q

An order that automatically discontinues a
medication based on pre-established parameters.

A

STOP ORDER

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10
Q

An order that changes the dose of a medication

A

TAPER ORDER

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11
Q

T/F: In tape order, the dose is either progressively decreased or
increased based on pre-established parameters

A

true

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12
Q

A national program designed for the voluntary
reporting, categorizing, and expert data analysis
of medication errors and adverse drug reactions.

A

UNITED STATES PHARMACOPEIA (USP) – ISMP
MEDICATION ERRORS REPORTING PROGRAM

(USP-MEDMARX)

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13
Q

(JCAHO 2004)

A

MANAGEMENT OF CONTROLLED SUBSTANCES

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14
Q

The principal federal law regulating controlled
substances is the

A

Controlled Substances Act
(CSA).

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15
Q

Controlled Substances Act
(CSA) is also known as the

A

“Title II of the
Federal Comprehensive Drug Abuse Prevention and
Control Act of 1970”,

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16
Q

Controlled Substances Act
(CSA) is under title ____ United States
Code, starting at Section ________”

A

21; 801

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17
Q

the
federal entity charged with ENFORCING and
IMPLEMENTING CSA.

A

Drug Enforcement Administration (DEA)

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18
Q

T/F: The Controlled Substances Act is applied only in the
USA.

A

T

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19
Q

an act instituting the comprehensive dangerous
drugs act of 2002

A

RA 9165

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20
Q

PH counterpart of CSA

A

RA 9165

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21
Q

comprehensive dangerous
drugs act of 2002 (repealing republic act no. 6425) is also known as

A

dangerous drugs act of
1972,

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22
Q

E.O. No. 218

A

(Comprehensive Dangerous
Drugs Act of 2002)

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23
Q

The comprehensive version of the list of Dangerous Drug commonly used in the PH can be seen
on the

A

Dangerous Drugs Board Website

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24
Q

T/F: Drug Scheduling in the US is different from the one
in the Philippines

A

T

25
Q

has designated controlled substances, specially
opiates in several dosage forms (IV, transdermal,
and oral preparations) as High Alert Medications.

A

Institute of Safe Medication Practices (ISMP)

26
Q

T/F: Data obtained shows that medication errors
involving controlled substances were among the
most frequently reported.

A

T

27
Q

selection of medicines is
performed by the

A

Pharmacy and Therapeutics
Committee.

28
Q

When any controlled substance medication is
considered for inclusion onto a formulary, a _____________ of the medication is conducted.

A

detailed
evaluation

29
Q

useful when evaluating the
controlled substances for formulary addition and prior to procurement and distribution within a health
system.

A

Use of Failure Mode and Effects Analysis (FMEA)

30
Q

must be filled up to procure drug products;

A

DEA Form 224

31
Q

Renewal of DEA Form 224 is every

A

3 years

32
Q

T/F: The procurement for Schedule II requires the use of
DEA Form 222, aside from the license to procure.

A

T

33
Q

PH counterpart of Procurement

A

S3 License - renewed
annually

34
Q

Philippine counterpart
of DEA Form 222

A

Local Order Permit Form

35
Q

T/F: Local Order Permit Form is downloadable on
the PDEA Compliance Service website.

A

T

36
Q

allow for
an audit trail of complete and accurate documentation of the controlled substances from
procurement to administration to patient.

A

Health Integrated System (HIS)

37
Q

Records of inventory in the United States must be maintained
for ________ in paper or electronic format to be
readily retrievable.

A

2 years

38
Q

Requirements in the Philippines:

A

-DD logbook
-S3 license to procure
-Local order Permit Form
-Recording Schedule
-Yellow Prescription

39
Q

PHILIPPINE COUNTERPART - INVENTORY AND RECORDING

A

Dangerous Drug Logbook –
Submitted report semi-annually (every 6 months), kept for 1 year

40
Q

Federal requirements for physical security for
controlled substances require that the medications
be in a _______________, __________ to deter theft and diversion

A

“securely locked, substantially
constructed cabinet”

41
Q

Greatly enhance the process of controlled
medication distribution within health systems in both
patient safety and inventory control.

A

AUTOMATED STORAGE AND DISTRIBUTION DEVICES

42
Q

t/f: When controlled substances need to be disposed of
due to expiration, damage, or for other quality
reasons, they must be segregated and
inventoried separately from all other drugs.

A

T

43
Q

A company that disposes expired medications (a
reverse distributor) may be contacted for controlled
substances, as long as that distributor is registered
with the _______

A

DEA

44
Q

PHILIPPINE COUNTERPART - DISPOSAL

A

PDEA, DD logbook

45
Q

T/F: Prescription does not cover medication orders
that are written for the purpose of being
dispensed for immediate administration to a
patient in hospital setting

A

T

46
Q

Facsimile of Schedule II Substances prescriptions
has been authorized by

A

DEA since 1994.

47
Q

T/F: This authorization is allowed if an original
prescription is presented at the time of actual
dispensing of the controlled substances.

A

T

48
Q

Exceptions to this requirement for an original
prescription are for medication orders to home
intravenous infusions for ___________, ______________

A

pain therapy, patients in
long-term care facilities

49
Q

Facsimile prescriptions for Schedule III-V
substances are authorized _________ (with/without) the requirement
for an original prescription to be presented at the
time of dispensing.

A

without

50
Q

Steps in DD prescription

A

Doctor prescribe DD, must have S2 -> Nurse makes online request, fill up Form -> Pharmacist will review PDEA form -> pharmacist will give the Administration Sheet
for documentation of the dangerous drug.

51
Q

THREE FACTORS IN THE SCRUTINY OF
CONTROLLED SUBSTANCES

A
  1. Federal and state laws and regulations
  2. Patient Safety
  3. Complexity of Pharmacotherapy
52
Q

used as a tool to study the use of controlled
substances throughout the medication-use system
or to focus on one particular process of the system.
It can also enhance patient safety, ensure
compliance with regulation and laws and improve
patient outcomes

A

medication utilization (MUE)

53
Q

Provides opportunity to improve the quality of the
patient care through appropriate use of controlled
substances.

A

CLINICAL PRACTICE GUIDELINES

54
Q

No accepted medical use with a lack of accepted
safety and high abuse potential; medications within
this schedule may not be prescribed, dispensed, or
administered for medical use

A

Schedule I

55
Q

High abuse potential with severe psychological or
physical dependence; however, these medications
have an accepted medical use and may be
prescribed, dispensed, or administered

A

Schedule II

56
Q

Abuse potential less than Schedules I or II but more
than Schedule IV medications; abuse may lead to
moderate or low physical dependence or high
psychological dependence

A

Schedule III

57
Q

Abuse potential less than Schedule III but more than

Schedule V medications

A

Schedule IV

58
Q

Medications with the least potential for abuse among the controlled substances

A

Schedule V

Hospital Pharmacy (6 decks)

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