Coming Soon to Your Pillbox: FDA Approves Tablet with Digital Ingestion Tracking System
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Discuss what addition to aripiprazole has recently been approved by the FDA and key elements in the black box warning 2. List common side effects commonly seen with aripiprazole
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Jan 25 2023, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine 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.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
On November 14, 2017, the FDA announced its approval of the first drug in the U.S. with a digital ingestion tracking system. Aripiprazole tablets can now be prescribed that contain an ingestible sensor, embedded in the pill, that records that the medication was taken. Aripiprazole is used to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and depression in adults. The pill’s sensor sends a message to a wearable patch. The patch then sends the information to a mobile application that allows patients to track the ingestion of the medication on their smart phone. Caregivers and physicians will be able to access the information through a web-based portal with patient consent. It has not yet been demonstrated that patient compliance will improve with this product.
The tracking system comes with a black box warning due to concerns related to increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis. • Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors. • The safety and effectiveness of ABILIFY MYCITE have not been established in pediatric patients.
In addition, clinical trials for aripiprazole identified common side effects such as nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. The patch associated with the sensor mechanism may result in skin irritation.
This tracking technology raises concerns about privacy and data security in this era of almost daily security breaches. Sensitive medical information could be accessed by unauthorized persons. Forced medication compliance as a condition for release from inpatient psychiatric treatment is also a potential threat to personal autonomy. There are limited circumstances under which an adult can be forced to take psychiatric medication. Is an adult who “consents” to medication monitoring by a digital tracking pill as a condition of release from inpatient psychiatric treatment really giving voluntary consent to treatment?
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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