Controlled substances Flashcards by Kim Grace

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

CODE OF FEDERAL REGULATIONS (CFR)

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CODE OF FEDERAL REGULATIONS (CFR) is divided into

50 titles

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

CONTROLLED SUBSTANCES ACT (CSA)

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

CSA

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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.

INSTITUTE OF SAFE MEDICATION PRACTICES

(ISMP)

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A set of written REQUIREMENTS dictated by an
organization

POLICIES AND PROCEDURES

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provides the foundation for the written
procedural instructions in an organization

PROCEDURES

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

POWER OF ATTORNEY AUTHORIZATIONS

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

STOP ORDER

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An order that changes the dose of a medication

TAPER ORDER

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

true

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

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

(USP-MEDMARX)

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(JCAHO 2004)

MANAGEMENT OF CONTROLLED SUBSTANCES

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The principal federal law regulating controlled
substances is the

Controlled Substances Act
(CSA).

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Controlled Substances Act
(CSA) is also known as the

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

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

21; 801

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the
federal entity charged with ENFORCING and
IMPLEMENTING CSA.

Drug Enforcement Administration (DEA)

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

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an act instituting the comprehensive dangerous
drugs act of 2002

RA 9165

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PH counterpart of CSA

RA 9165

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

dangerous drugs act of
1972,

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E.O. No. 218

(Comprehensive Dangerous
Drugs Act of 2002)

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

Dangerous Drugs Board Website

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

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

Institute of Safe Medication Practices (ISMP)

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

selection of medicines is performed by the

Pharmacy and Therapeutics Committee.

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

detailed evaluation

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

Use of Failure Mode and Effects Analysis (FMEA)

must be filled up to procure drug products;

DEA Form 224

Renewal of DEA Form 224 is every

3 years

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

PH counterpart of Procurement

S3 License - renewed annually

Philippine counterpart of DEA Form 222

Local Order Permit Form

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

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

Health Integrated System (HIS)

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

2 years

Requirements in the Philippines:

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

PHILIPPINE COUNTERPART - INVENTORY AND RECORDING

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

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

“securely locked, substantially constructed cabinet”

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

AUTOMATED STORAGE AND DISTRIBUTION DEVICES

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

DEA

PHILIPPINE COUNTERPART - DISPOSAL

PDEA, DD logbook

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

Facsimile of Schedule II Substances prescriptions has been authorized by

DEA since 1994.

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

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

pain therapy, patients in long-term care facilities

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.

without

Steps in DD prescription

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.

THREE FACTORS IN THE SCRUTINY OF CONTROLLED SUBSTANCES

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

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

medication utilization (MUE)

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

CLINICAL PRACTICE GUIDELINES

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

Schedule I

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

Schedule II

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

Schedule III

Abuse potential less than Schedule III but more than Schedule V medications

Schedule IV

Medications with the least potential for abuse among the controlled substances

Schedule V