CONTROLLED SUBSTANCE

MANAGEMENT

CHAPTER 8
GABBUAT, GALICIA, GANTE,
GONZALES, ISON

Introduction

The approach used in examining the

management of controlled substances in
the
health-system
environment
is
medication-use system.
Allows systematic examination within an
organization
from
selection
and
procurement through storage, inventory
management, dispensing, administration,
surveillance and system evaluation.

Introduction
Factors that influence the need for health-system
pharmacist involvement in controlled substances
management:
1. Pharmacists must ensure that all federal and
state law and regulations are obeyed;
. Controlled Substance Act (CSA) principal federal
law regulation
- Title II of the Federal Comprehensive Drug
Abuse Prevention and Control Act of 1907, under Title
21 United States Code, starting at Section 801.

Introduction

Drug Enforcement Administration (DEA)

federal entity charged with enforcing and
implementing the CSA
. Main mission: to work in concert with
state agencies and other federal
agencies to prevent the diversion of
controlled substances for illicit reasons
. Provides informative manual targeted for
pharmacists

Introduction

DEA is able to carry out its mission through

regulations contained in the Code of
Federal Regulations (CFR) a set of
general or permanent rules that are
published in the Federal Register by the
federal government that is divided into 50
titles encompassing executive departments
and agencies covering broad areas subject
to federal regulation.

Introduction

Factors that influence the need for health-system

pharmacist involvement in controlled substances
management:

2. Pharmacists need to ensure that controlled

substances are used safely with minimal medication
errors resulting in adverse patient outcomes; and
3. Pharmacists must ensure that controlled substance
are used appropriately to achieve optimal health for
patients.

Patient Safety

Institute of Safe Medication Practices (ISMP)

specifically opiates in several dosage forms as high alert
medications
medication errors that involves controlled substances
have greater risk of causing negative outcomes for
patients
results from medication errors reported nationally
through the USP-ISMP Medication Errors Reporting
Program (USP-MEDMARX)
insulin being the first in medication errors followed by
morphine that cause patient morbidity

Complexity of Pharmacotherapy

Can lead to negative health outcomes for

patients
New formulations of older agents like
morphine in sustained release forms or in
novel administration forms can lead to
therapeutic problems

Selection of Controlled
Substances

Formulary
When controlled substance medication is
considered for inclusion onto a formulary, a
detailed evaluation of the medication is
conducted safety, efficacy, toxicity,
potential for adverse events and abuse and
pharmacoeconomics

Selection of Controlled
Substances

Criteria considered:
Location where controlled substance will be stored
Storage requirements for controlled substances
Physical security requirements at the location to ensure federal or state
standards are met
Appropriate stocking levels
Authorized access to medication by health care staff
Requirement for any prescribing restrictions based on providers scope
of practice
Incorporation of controlled substances into any prescribing or clinical
guidelines
Specific medication ordering requirements by prescriber
Health care staff and patient education requirements on the use of the
controlled substances
Any new policies and procedures that need to be addressed with the
addition of controlled substances

Selection of Controlled
Substances
Risk Assessment
Failure Mode and Effects Analysis (FMEA)
useful when evaluating the controlled
substances for formulary addition, prior
procurement and distribution
- examines potential for failures by
identifying, classifying and assessing impact
of failures

Selection of Controlled
Substances
Risk Assessment
Failure Modes any errors or defects in a
process, design or item especially those
affect the patients
Effects
Analysis

studying
the
consequences of those failures
*A critical analysis of the process can identify
risk reduction strategies to enhance patient
safety

Procurement of Controlled
Substances
Federal Registration Requirements

The health-systems pharmacy must be registered

with the Drug Enforcement Agency (DEA)
The registration is required to be renewed every 3
years with both the initial and renewal involving
fees
The pharmacist in charge of the health system
pharmacy needs to acquire a complete
understanding of federal requirements for
procurement and processes with the medicationuse systme

INVENTORY AND STORAGE

MANAGEMENT
Inventory and Record
Requirements
The pharmacist
must assure compliance with the
regulations pertaining to accountability and
documentation.

Inventory System allow for an audit trail of complete

and accurate documentation of the controlled
substances.

Certain records must be maintained for 2 years, in

either paper or electronic format to be readily available.

RECORDS TO BE MAINTAINED:
Official order forms (official record of receipt and sale)
Power of Attorney (sign for DEA order forms)
Receipts and invoices
Initial inventory (CFR requires the date and time of the
initial inventory; name of the drug, strength, and dosage
forms; number of units or volume and total quantity)
Biennial Inventory (conducted following the initial inventory.
Every two years)
Records of controlled substance distribution and
dispensing records (prescription)
Records, if needed, relating to theft or loss
Inventory of controlled substances surrendered for
disposal
Records of any transfers
DEA registration certificate

INVENTORY AND STORAGE

MANAGEMENT
Physical Security and Storage

Federal requirements for physical security securely

locked in a substantially constructed cabinet to
defer theft and diversion.
We can consider the following for security measures:
Locked cabinet with minimal stock levels and limited
access
Detection devices and alarm systems

FACTORS TO CONSIDER IN DETERMING THE LEVEL

OF SECURITY REQUIRED:
Location of the storage site
Level of activity of the storage site

Quantity of controlled substances to be stored at the

site
Dosage form of controlled substances handled at the
storage site
Level of physical security that the container provides
Policies and procedures for restricting access to the
storage site
Adequacy of electronic detection and alarm systems
Amount of unsupervised access and, or potential for
unsupervised access and procedures
Amount of oversight of health care staff
Audit capability and inventory
Review of applicable state laws and regulations and
institutional policies and procedures

INVENTORY AND STORAGE

MANAGEMENT
Automated Storage and
Distribution
Devices
Automated Storage
and Distribution
- enhance the
process of controlled medication distribution within health
systems
Devices - permit better inventory control (electronic
documentation of all controlled medication use)

User identification of access to the storage devices

-provides an audit trail if any discrepancies of records
occur
American Society of Health System Pharmacists
- overview of considerations for requirements in
automated storage and distribution devices

INVENTORY AND STORAGE

MANAGEMENT
Disposal of Controlled Substance
Medications

Reasons for disposal:

due to expiration, damage or for other quality control
reasons
Must be segregated and inventoried separately from all
other drugs.
CODE OF FEDERAL REGULATION (CFR)
inventory details: inventory date, drug name, strength and
dosage form, total quantity (volume or number of units),
reason for disposal, if it is capable to be used for
manufacturing other controlled medications.
Reverse Distributor
company that disposes of expired medications

Ordering and Dispensing of

Controlled Substances

Medication Orders covered under the

Title 21 CFR, Section 1300. It defines a
prescription as a means of ordering
medication is intended to be dispensed for
a patient who is the ultimate user.
This regulation does not cover medication
orders that are written for the purpose of
being dispensed for immediate
administration

Ordering and Dispensing of

Controlled Substances
Electronic Prescribing
- With the advent of physician computer
order-entry and the strong movement within
health systems across the nation to adopt this
technology, both federal and and state laws
and regulations will need to address the
electronic transmission of medication orders
in the absence of paper

Ordering and Dispensing of

Controlled Substances

The vendor must have a

current copy of your DEA
license on file.
The drug can only be
shipped to the address on
your license.
Shipment tracking must be
used.
Once you take possession of
the substance, you are
responsible for its handling.
Schedules I & II require an
order form

Administration of Controlled
Substances

3 Primary factors requiring increased

scrutiny of controlled substances
Attributable to federal and state laws and
regulations
Patient safety
Complexity of pharmacotherapy

Patient Safety

Pharmacist must take an active role in

working primarily with the nursing staff to
reduce the risk of controlled substances
diversion at the point of administration

Complexity of Pharmacotherapy

Contributory to the environment of

increasing the potential for medication
errors, with multiple medications and
dosage forms, medications with look-a-like
and sound-a-like names, and the increased
utilization of infusion devices.

Risk Reduction Strategies

Minimizing medication errors prior to

administration on patient care units

Evaluation of Controlled Substances

Medication Utilization Evaluation

(MUE) Program

Examining utilization of controlled

substances within the health system
Examines the utilization of a medication
and its effects on patient outcomes
Can be a tool to study the use of controlled
substances throughout the medication
system or to focus on one particular
process of the system

Evaluation of Controlled Substances

Controlled Substances Surveillance
Program

Controlled substances medications

that have various potential for abuse
and diversion within medical system
This program focuses on controlled
substances diversion and subsequent
abuse
Required program that every pharmacist
must actively engaged in

Evaluation of Controlled Substances

Clinical Practice Guidelines

Provides the opportunity to improve the

quality of patient care through
appropriate use of controlled substances
Theses guidelines are part of any MUE
program that strives to ensure
appropriate utilization of medication
Can also be used as a tool in a
controlled substances surveillance
program

Processes within the Medication

Use System

It is of vital importance that policies and

procedures for controlled substances
management be developed and instituted
within the organization. This is because of
the following:
Risks associated with controlled
substances are too great to allow much
flexibility in the process
Poses real risks to patients

 A pharmacists career is at risk if he or

she is careless in handling or recording

substances
Being lax with ones responsibility in
managing controlled substances is one of
the quickest ways to get fired from a
pharmacy

Policies and Procedures

Vital tool in the management of a pharmacy in

a health system.
Evident in the management of controlled
substances
Needs to address the entire medication
system which includes the following:
Selection
Procurement and Storage
Ordering
Distribution and Preparation

Policies and Procedures

Administration and Monitoring

essential to address the entire
medication management system

Controlled Substance
Management in the Philippines

Philippine Drug Enforcement Agency (PDEA)

Is the lead anti-drug law enforcement-agency,
responsible for preventing, investigating and
combating any dangerous drugs,
controlled precursors and essential
chemicals within the Philippines.
Is the implementing arm of the Dangerous Drugs
Board (DDB).

The agency is tasked with the enforcement of the

penal and regulatory provisions of Republic
Act No. 9165 (R.A. 9165), otherwise known as
the Comprehensive Dangerous Drugs Act of
2002.

Controlled Substance
Management in the Philippines
Dangerous Drug Board (DDB)
is the policy-making and strategy-

formulating body in the planning and

formulation of policies and programs on
drug prevention and control. PDEA and
DDB are both under the supervision of
the Office of the President.

Controlled Substance Management

in the Philippines
The following are questions as answered by
the DDB:

What is drug abuse?

Drug abuse exists when a person continually uses a

drug other than its intended purpose. This continued
use can lead to drug addiction and dependency.

What is drug addiction?

Drug addiction refers to the behavioral condition where

an individuals need to obtain and use (especially, selfadminister) drugs becomes a strong fixation.

What is drug dependence?

Drug dependence describes the state when
an individual is dependent upon the drug for
normal physiological functioning.

Controlled Substance
Management in the Philippines

Can dangerous drugs be prescribed for

therapeutic purposes?

A licensed practitioner could prescribe, administer, or

dispense dangerous drugs for therapeutic purpose to
a person diagnosed and treated for a condition
resulting in intractable pain provided that this
diagnosis and treatment have been documented in
the practitioners record. The prescription cannot
exceed 100 dosage units or a 31-day supply,
whichever is higher.

What is Annex Form A and how shall it

be used?

The Annex Form A can be used by pharmacists

in hospitals and similar institutions to keep
records of dangerous drugs dispensed in the inpatient wards. Only a licensed pharmacist or a
licensed practitioner in a dispensary of an
institution shall issue a requisition for dangerous
drugs or drug preparations.

Controlled Substance
Management in the Philippines

Can a person travelling to the Philippines be allowed to

bring in dangerous drugs or drug preparations for their
medical use/treatment?
International travelers are allowed to carry quantities of
dangerous drugs or drug preparations for their medical use
and treatment, provided that they have the following
documents:
Original copy of a Certification from the attending

physician that the patient needs the drug for the

medication.
Specific dates of arrival and departure from the

Philippines.
Original copy of prescription issued by the duly licensed

attending physician/ doctor.

Controlled Substance
Management in the Philippines
The following are examples of Board
Regulations by DDB:
Series 2015

Controlled Substance
Management in the Philippines
Series 2014

Quiz
1. Any errors or defects in a process, design or
item especially those that affect patients.
A. Failure Modes
B. Effects Analysis
C. Critical Analysis
2. It is the principal federal law regulation.
A. DEA
B. CFR
C. CSA

Quiz
3. It is useful when evaluating the controlled substances for
formulary addition and prior to procurement and distribution
within health system
A. Medication Utilization Evaluation
B. Failure Mode and Effects Analysis
C. Institute of Safe Medication Practice
4. Any errors or defects in process, design, or item,
especially those that affect the customer
A. Stop orders
B. Effect analysis
C. Failure modes

Quiz
5. It enhances the process of controlled
medication distribution health systems
A. Devices
B. Automated storage and distribution
C. User identification
6. Certain records must be maintained by?
A. 2 years
B. 4 years
C. 3 years

Quiz
7. It is a Vital tool in the management of a
pharmacy in a health system.
Medication Use Systems
B. Policies and Procedures
C. Administration and Monitoring

A.

8. It is the lead anti--drug law enforcement agency

in the Philippines.
A. Dangerous Drug Board (DDB)
B.
Office of the President
C. Philippine Drug Enforcement Agency (PDEA)

Quiz
9. It is contributory to the environment of increasing the
potential for medication errors, with multiple medications and
dosage forms, medications with look-a-like and sound-a-like
names, and the increased utilization of infusion devices.
A. Complexity of Pharmacotherapy
B. Patient Safety
C. Risk Reduction Strategy
10. This program focuses on controlled substances diversion
and subsequent abuse
A. Patient Safety
B. Medication Utilization Evaluation (MUE) Program
C. Controlled Substances Surveillance Program