The Role of Prescription Digital Therapeutics in Medical Practice

Pharmacist CEU
Contact Hours: 2.0 (0.2 CEUs)

Course Summary

Prescription digital therapeutics are a part of telehealth and are being integrated into clinical practice. Digital therapeutics can be prescription or non-prescription. Prescription digital therapeutics may help close treatment gaps when used to treat and manage chronic medical conditions and mental or behavioral disorders. Prescription digital therapeutics in the clinical setting require knowledge of government regulations and familiarity with the available applications and products. Pharmacy teams may contribute to integrating prescription digital therapeutics into practice and collaborating with other healthcare professionals.

Course Objectives

Define prescription digital therapies (PDTs) and distinguish them from non-prescription devices

Identify the uses of PDTs in healthcare

Identify how to integrate PDTs into patient care and management

I. Introduction

II. Definition of Prescription Digital Therapeutics

III. PDTs Compared to Traditional Therapeutics

IV. Regulating Prescription Digital Therapeutics

A. SaMD Framework Used to Regulate PDTs
B. Breakthrough Devices Program

V. Clinical Trials and Evidence for PDTs

A. The CONVOKE Clinical Trial
B. Concerns with PDT Clinical Trials

VI. Clinical Conditions and PDT Products

FDA-Approved PDTs

VII. Challenges and Barriers to Using Digital Therapeutics

A. Digital Therapeutics and the Clinician-Patient Relationship
B. Safety and Efficacy of Digital Therapeutics
C. Systemic Barriers to Using PDTs in Clinical Practice

VIII. Pharmacy Role in PDTs

IX. The Future of PDTs

A. Future Directions in PDT Regulation
B. Artificial Intelligence and Machine Learning
C. Will PDTs Cause Pharmacy Teams to be Bypassed

X. Summary

How to Earn Credit:
To earn credit for this course, participants must:
  1. Read the course objectives and faculty planner disclosure
  2. Read the course material
  3. Complete the post-test with a minimum score of 70% and complete the course evaluation form.
  4. Results are automatically submitted 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 or any of the individuals involved in the development of this activity.

Unlabeled Use Disclosures

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 LLC. LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

Computer Hardware/Software Requirements

Please ensure the device you plan to use meets these requirements and specifications:

  • Operating System: Windows 7,8,10, or 11 /Mac OS X 10.9 or later/iOS/Android
  • Supported Browsers: Microsoft Edge, Firefox, Google Chrome, Safari, Opera
  • A connection to the internet
  • For Live Webinars or Conferences: GoToWebinar application for iOS, Android, Mac, or PC. You cannot 'call into' a live conference.

  • Target Audience: Pharmacist
  • Contact Hours: 2.0 (0.2 CEUs)
  • Activity Release Date: 5/21/2024
  • Activity Expiration Date: 5/21/2027
  • Activity Type: Knowledge
  • UAN: 0669-0000-24-056-H01-P
  • Topic: Disease State Management/Drug Therapy
  • CeBroker Number: 20-954023


Steve Malen, PharmD, MBA



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