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description Monograph

Validation and Counseling of Prescriptions for Controlled Substances and Opioids

Target Audience: Pharmacist

star star star star star_outline 4.0/5 based on 236 ratings
schedule 2.00 Contact Hours (0.20 CEUs)
category Pain Management/Opioids
local_activity Knowledge

Course Overview

Controlled substances may be prescribed to patients for legitimate medical purposes. However, controlled substances, such as opioids, may be misused. Patients must be assessed for the appropriate therapeutic use of controlled substances so that misuse, addiction, or dependence does not occur. To protect patients from the inappropriate use of controlled substances, clinicians must know the laws and rules related to the prescribing and dispensing of controlled substances. Clinicians in Florida must utilize the prescription drug monitoring program database and incorporate protocols for addressing and resolving problems recognized during a drug utilization review, as required by Florida law. Pharmacists are particularly situated to counsel patients with opioid prescriptions on the proper storage and disposal of controlled substances, standing orders for reversal agents, such as naloxone, and treatment resources for opioid physical dependence, addiction, or misuse.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Describe the laws and rules related to the prescribing and dispensing of controlled substances, including the Standards of Practice for the Filling of Controlled Substance Prescriptions and Electronic Prescribing in Florida (Fla. Admin. Code, Rule 64B16-27.831)
  • 2. Identify ways to ensure that access to controlled substances for all patients with a valid prescription includes assessment of prescriptions for appropriate therapeutic value, and pharmacist-initiated counseling of patients with opioid prescriptions
  • 3. Describe the use of the Prescription Drug Monitoring Program’s Database
  • 4. Identify the risk for controlled substance misuse, addiction, or dependence, and detection of prescriptions not based on a legitimate medical purpose
  • 5. Describe available treatment resources for opioid physical dependence, addiction, misuse, or abuse.
  • 6. Counsel patients about the proper storage and disposal of controlled substances and the available treatment resources for opioid physical dependence, addiction, or misuse
  • 7. Describe how to treat an opioid overdose, which includes reversal agents or standing orders for naloxone, including the Florida State Surgeon General’s Statewide Standing Order for Naloxone
  • 8. Describe protocols for addressing and resolving problems recognized during the drug utilization review, including but not limited to drug/drug interactions, side effects, and high-dose/low-dose guidelines

Faculty

Authors & Activity Planners
Pamela Sardo, Pharm.D., B.S.
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Pamela Sardo, Pharm.D., B.S. is a licensed pharmacist and Freelance Medical Writer at Sardo Solutions in Texas.
Steve Malen, PharmD, MBA
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Dr. Steve Malen graduated with a dual degree: Doctor of Pharmacy (PharmD) and Master of Business Administration (MBA) from the University of Rhode Island. Over his career, he has worked as a clinical pharmacist in the retail, specialty, and compounding sectors. He specialized and taught on topics from vaccines to veterinary compounding. Dr. Malen has also written a science fiction novel and taught and cofounded the concept of Patient Empowered Blockchain (P.E.B.). Currently, Dr. Malen continues to write, teach, and consult various companies in the healthcare sector.

I. Introduction

II. Controlled Substances Act and Other Regulations

A. Schedules of Controlled Substances
B. Stock Ordering of Controlled Substances
C. Storage, Recordkeeping, and Disposal of Controlled Substances
D. State-Level Scheduling and Regulations
E. Staying Up-to-Date

III. Drug Enforcement Administration (DEA)

IV. Prescription Drug Misuse

V. Prevention of Prescription Drug Misuse

A. Motivational Interviewing (MI) Techniques
B. Ensuring Appropriate Access
C. Legitimate Concerns or “Red Flags”
D. Basic Prescribing Best Practices
E. Basic Dispensing Best Practices
F. Implementation and Use of PDMPs
G. Florida State Prescription Drug Monitoring
H. Drug Diversion and Doctor Shopping

VI. Safe Prescribing of Opioids

A. Indications for Opioid Pain Treatment
B. Special Considerations for Opioid Dispensing

VII. Opioid Use Disorder and Pain Management

VIII. New FDA Class Label Change

IX. Summary

From September 13, 2025 through September 13, 2026, participants must:

  1. Read the "learning objectives" and "author and planning team disclosures"
  2. Study the section entitled "educational activity"
  3. Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be automatically uploaded to CPE Monitor®.

Faculty Planner Disclosure

The following individuals were involved in developing this activity: Steven Malen, PharmD, MBA, and Pamela Sardo, PharmD, BS. Pamela Sardo and Steven Malen have no conflicts of interest or financial relationships regarding the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.

Unlabeled Use Disclosure

The information provided in this course is general in nature and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice. Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits. Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only and such uses are not endorsed hereby. Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

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Accreditation

In support of improving patient care, RxCE.com is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.