Post-Marketing Surveillance in Medication Errors: the Naltrexone Case Study

In the realm of pharmaceuticals and healthcare, precision and safety are of paramount importance. Join us on an informative journey as we delve into the crucial aspects of post-market surveillance, medication errors, and the enlightening case of naltrexone.

At the Regulatory Division of Brandsymbol, our primary mission is to assess the potential for medication errors before a proprietary name gains approval. This meticulous evaluation process steers our methodology and ensures the seamless alignment of our Power of 3 Methodology with the rigorous standards set by regulatory agencies.

We also recognize that post-marketed surveillance is not just an additional safeguard but a fundamental component of our commitment to ensuring medication safety.

We recently had the privilege of attending an enlightening presentation by distinguished experts, CDR Jessica Voqui, PharmD., MS, RAC, and Sofanit Getahun, Pharm.D., BCPS. Their talk, “FDA Drug Topics: naltrexone Injection for Opioid Use Disorder – FDA’s Efforts to Reduce Medication Errors,” shed light on essential facets of medication error prevention, emphasizing its integral role throughout the product lifecycle. We’ve summarized these insights below, and you can explore the presentation slides here.

The Evolution of Medication Safety With Naltrexone

April 2006

Naltrexone was approved by the FDA to be marketed in the US. naltrexone is indicated for opioid dependence and alcohol dependence and is available as an intramuscular injection and an extended-release injectable suspension. The recommended frequency is every four weeks or once a month.

September 2022

The FDA approved updated labeling (including cartons and containers) on naltrexone due to medication errors.

Throughout the Product Life Cycle

Medication error surveillance continues during a product’s life cycle as the FDA’s Division of Medication Error Prevention and Analysis I, II (DMEPA I and DMEPA II) are involved in the premarket medication error prevention and Division of Mitigation Assessment and Medication Error Surveillance (DMAMES), a recent group that is part of the Office of Medication Error Prevention and Risk Management (OMEPRM) focus on post-market medication error pharmacovigilance, including signal management. Sources of medication errors include the FDA Adverse Event Report System (FAERS), Institute for Safe Medication Practices (ISMP), and/or other 3rd party agencies such as a drug company’s post-surveillance department. Monitoring activities may lead to labeling changes, package design updates, and a name change due to reported errors.

January 1, 2020 – May 1, 2021

The presentation discussed FAERS data collected from January 1, 2020, to May 1, 2021, regarding the drug, naltrexone, along with incorrect route of administration (n = 31 reports), inappropriate site of injection (n = 72 reports), and administration by a family member or caregiver (n = 3 reports).   One case described both incorrect route of administration and inappropriate site of product administration.


This “new safety information” ultimately led to the revised container label and carton label of naltrexone.

For example, the labeling on VIVITROL (naltrexone intramuscular injection) now includes the statement “FOR GLUTEAL INTRAMUSCULAR INJECTION ONLY” regarding ROUTE and SITE OF ADMINISTRATION.

In addition, VIVITROL carton labeling, front display panel, and container label have been updated.   Other changes include additional statements that are underlined and highlighted in yellow in the full prescription information intended to be visible to the healthcare professional.

The presentation ended with the following steps, which will help healthcare professionals avoid medication errors due to post-marketing drug safety practices.

  1. Read full prescribing information.
  2. Use proper injection techniques.
  3. Education Patients on Medication Risks
  4. Report Adverse Events to MedWatch

Our Mission

We have shared these highlights from the presentation as they embody the very essence of our industry. The FDA and the pharmaceutical sector are intertwined, learning from post-market monitoring activities and collaboratively instituting tangible changes based on newfound insights. It is a journey toward safer practices and improved patient care.

In this unfolding narrative of healthcare, we are not mere spectators but active contributors steadfast in our pursuit of making a meaningful difference. The tale of naltrexone and medication error prevention is a testament to the precision, dedication, and unity that propel our industry forward.