Your Pharm Aid

This article contains a roundup of brief updates in the pharmacy world.

iPledge Risk Evaluation and Mitigation Strategy (REMS) Update

The iPledge REMS is a shared, centralized system for prescribers, patients, and pharmacies to manage isotretinoin-associated embryo-fetal toxicity.

While most family medicine providers don’t prescribe isotretinoin for acne, we’re sharing the update for awareness in the event that patients ask.  Effective, February 9, 2023, patients may complete pregnancy tests at home during and after treatment.  Testing during and after therapy no longer needs to be conducted in a medical setting.  Pre-treatment testing does still need to be completed in clinic or another medical setting. 

Patients who cannot become pregnant must be counseled prior to enrollment in iPledge, and prescribers should reinforce counseling points throughout the program. However, the requirement for monthly documentation of this counseling in the REMS system has been removed.

A summary of the February 9 iPledge REMS update, as well as a catalog of previous updates and future updates is available here. 

Splitting Suboxone Tablets or Film

Pharmacies are receiving communications from pharmacy benefit auditors seeking recoupment for claims submitted with directions to split Suboxone tablets or film products.  As a result, pharmacies may be calling to request new orders for full dosage units.  Prescribers may avoid this by prescribing these dosage forms in full tablets or films only.

Dexcom G7 15-Day App Changes

Patients using a Dexcom receiver (instead of a smartphone) and switching from the traditional Dexcom G7 10-day continuous glucose monitor (CGM) sensors to the new G7 15-Day sensors will need to update the firmware for the receiver device.  A desktop or laptop computer and USB cable are necessary to complete the firmware upgrade.

A step-by-step guide for how to complete the receiver firmware update is available at dexcom.com.

The Dexcom smartphone app is compatible with the new G7 15-Day sensors. 

Based on the wealth of beneficial evidence for A1C reduction, hypoglycemia reduction, adherence, treatment satisfaction, behavioral change and overall improvement in quality of life for persons with diabetes, the 2026 ADA Standards of Care highlighted and elevated the important role of CGM in diabetes care with updated recommendations:

• When to recommend: At the onset of diabetes and anytime thereafter for persons on:
  • Insulin therapy
  • Noninsulin therapy that can cause hypoglycemia
  • Any treatment where CGM helps with management
• Frequency: (If feasible/affordable)
  • As close to daily as possible, with uninterrupted access
  • Periodic use to adjust medication or lifestyle
• Clinician Education reminders:
  • Skin reactions: Assess and Address contact dermatitis from adhesive reactions (irritant and/or allergic)
  • Interfering substances/factors can affect accuracy (see table)

Excellent resources to compare available CGMs:

• Danatech CGM Comparison Tool
• AACE CGM toolkit

The table below includes the 2 most commonly prescribed personal CGM systems:

1. Libre 3 PLUS:
   1. New Apple Watch Feature – allows notifications on the watch instead of the phone
   2. Libre Assist – to support dietary education and behavior change. Based on a photo of a meal, the assist gives a predicted impact on glucose levels, with suggestions to help lower the impact.
   3. OTC version: Lingo CGM (see table below)
2. The Dexcom
   1. Expanded sensor duration (15 days instead of 10 days) – requires a new prescription for the “G7 15 day”

On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System (AEMS), reported to be a new unified platform designed to modernize how adverse events related to medical products are collected, analyzed, and shared.

The AEMS is a centralized database that aggregates adverse event reports submitted by clinicians, patients, manufacturers, and other stakeholders for FDA-regulated products. These include drugs, biologics, vaccines, medical devices, cosmetics, foods, tobacco products, and veterinary products. The platform allows these reports to be analyzed and searched through a single interface and public dashboard.

The FDA described the new AEMS database as a major modernization initiative intended to improve transparency and strengthen post-marketing surveillance. FDA Commissioner Marty Makary, MD, MPH stated that the agency’s prior systems were “outdated and fragmented and made important data difficult to access.”

Previously, the FDA processed roughly six million adverse event reports annually across multiple separate databases.  The FDA mentioned searching individual databases was made difficult due to poor user interfaces; they feel the new system will help to correct this.

Key advantages of the AEMS database includes:

• Real-time data availability vs. the previous systems that would release data quarterly.

• Improved transparency and accessibility, allowing health care providers, researchers, and the public to query adverse-event data directly. 

Limitations of the AEMS database includes:

• A report in the database does not prove causation.

• Duplicate and incomplete reports may be found in the system.

• Submission of a report does not mean it’s been confirmed nor that the product caused or contributed to an event.

• Occurrence rates cannot be established with reports found in the database.

AEMS consolidates several “legacy” adverse-event reporting databases that previously operated independently across different FDA centers. These include:

• FDA Adverse Event Reporting System (FAERS) – drug, biologic, and cosmetic adverse event reports

• Vaccine Adverse Event Reporting System (VAERS) – vaccine safety reports (co-managed with the Centers for Disease Control and Prevention)

• Adverse Event Reporting System (AERS) – animal drug and animal food reports

Additional databases scheduled for migration to AEMS by May 2026 include:

• Manufacturer and User Facility Device Experience (MAUDE) – medical device reports

• Human Foods Complaint System (HFCS) – food and dietary supplement reports

• Center for Tobacco Products Adverse Event Reporting System (CTPAE) – nicotine/tobacco product reports

Once the transition is complete, these legacy systems will be decommissioned, leaving AEMS as the FDA’s single adverse-event data platform.

As with prior FDA adverse-event databases, the presence of a report in AEMS does not establish causation, and reports may contain incomplete or duplicate information. The data should therefore be interpreted as signals that require clinical evaluation and, when necessary, more formal and extensive study.

The launch of AEMS represents a significant change in how data is reported by the FDA.  By consolidating multiple databases into a real-time, searchable platform, the FDA hopes to strengthen post-marketing safety monitoring and increase transparency around adverse events.