Intravenous (IV) oxytocin is used antepartum to induce labor in patients with a medical indication, to stimulate or reinforce labor in selected cases of uterine inertia, and as an adjunct in the management of an incomplete, inevitable, or elective abortion. Used postpartum, IV oxytocin is indicated to produce uterine contractions during the expulsion of the placenta, and to prevent or control postpartum bleeding or hemorrhage. Therefore, oxytocin is needed in all obstetric care areas with consistency of practice amongst all provider types (e.g., anesthesia, obstetrics, midwives, perinatal nursing) whether using low doses for labor induction or augmentation, commonly measured in milliunits, or at higher doses to prevent or treat postpartum hemorrhage (PPH), commonly measured in units.

However, improper administration of oxytocin can cause hyperstimulation of the uterus, which in turn can result in fetal distress, the need for an emergency cesarean section, or uterine rupture. Multiple International Medication Safety Network (IMSN) member countries have identified that there are substantial risks involved with the use of oxytocin and have reported significant patient harm from related errors

Building a Response to Oxytocin-Related Errors

In a series of OxytocinSIG meetings held in 2022, IMSN members shared firsthand experience with a variety of risks, close calls, errors, and adverse events associated with the use of oxytocin. These included:

• Inappropriate/unnecessary use in labor induction in low-risk patient populations
• Lack of a standardized dosing regimen
• Confusion with look-alike and sound-alike medications
• Inappropriate use of brand names or unsafe abbreviations
• Non-standardized or non-centralized preparation of oxytocin infusions
• Use of multiple oxytocin infusion concentrations/preparations
• Insuficient monitoring of beyond-use dates of pre-prepared solutions
• Reliance on manually programmed infusion pumps without automated safeguards in place
• Mix-ups with infusion tubing
• Mix-ups with dosing/infusion rates
• Use/availability of oxytocin in the direct patient care area without appropriate orders and communication among healthcare providers

IMSN Oxytocin SIG Recommendations for Global Implementation of Safe Oxytocin Use Practices

These selected risk-reduction strategies include recommendations that can help avoid errors and significant patient harm related to the use of oxytocin through all phases of the medication-use process.

Implementing and moving forward

IMSN acknowledges that healthcare organizations in different parts of the world vary in the availability of technologies (e.g., electronic health records, infusion pumps, automated dispensing cabinets) and resources (e.g., central pharmacy compounding programs). While the recommendations may not all be achievable everywhere, organizations should work to identify those that can be implemented at each step of the medication-use process and consider the remaining recommendations as future goals to work towards.

• Continue to report errors involving oxytocin through your normal reporting programs and to the International Medication Error Reporting Portal, so that we may continue to evaluate the safe use of oxytocin and other medications around the world.
• Premixed solutions are currently not available globally except from outsourced compounding pharmacies in some countries. IMSN urges the global pharmaceutical industry to make premixed oxytocin solutions available everywhere, as soon as possible.

May 2023

During the fall of 2020, as the world waited in anticipation for the emergency use/conditional marketing authorization of COVID-19 vaccines, members of the International Medication Safety Network (IMSN) began to discuss safety issues that might impact global immunization roll out efforts with regard to the knowledge on vaccination errors already gathered by the IMSN.

Building a Response to the Different Types of Vaccine-Related Errors

In a series of CVSIG meetings in mid-2021, as vaccination campaigns rolled out, IMSN members shared firsthand experience with a variety of risks, near-misses, errors, and adverse events following immunization with COVID-19 vaccines on the basis of aggregated analysis by CVSIG members. These included issues with:

• screening (e.g., wrong age, patients with contraindicated conditions),
• storage (e.g., inappropriate storage temperature, confusion and mis-selection resulting from storage near other vaccines or monoclonal antibodies),
• preparation (e.g., serial errors for vaccines needing a two-step reconstitution process, diluent errors including incorrect diluent volume or no dilution, dosing errors including wrong dose, no dose, expired dose),
• administration (e.g., shoulder injury related to vaccine administration, wrong time interval for second dose or third dose, syringe and/or needle malfunction or misuse leading to underdose, wrong vaccine, wrong drug, wrong route of administration, accidental exposure),
• and monitoring (e.g., missed second or third doses).

In addition, the approach to errors has evolved over the course of COVID-19 vaccination campaigns (for example, intervals between doses, authorized ages, authorized doses, and recommended vaccines).

IMSN CVSIG Recommendations for Global Implementation of Safe COVID-19 Immunization Practices - January 2022

The recommendations follow the vaccine use process and address errors occurring during each stage.

Moving Forward: during the development of these recommendations, several topics were identified that will receive special attention from IMSN

• Promoting packaging vaccines in prefilled unit-dose syringes as a global standard
• Addressing issues related to COVID-19 vaccine safety for pediatrics as COVID-19 vaccines are being authorized for use in more countries
• Addressing risks during overlapping COVID-19 immunizations and other immunization campaigns
• Involving IMSN in review of a globally standardized schema and pathways for adverse events following immunization reporting

Mike will continue to be actively involved with ISMP part-time, working on newsletters and special projects close to his heart, continuing his quest for excellence in medication safety. He is an inspiration to us all, and we are delighted that he will continue to be available to ISMP. Rita will lead ISMP into a new era, as ISMP continues to provide sage guidance to influence companies, organizations, practitioners, and consumers who make, regulate, prescribe, dispense, administer, and receive medications, always focusing on the patient.

ISMP roots

As many know, the origin of ISMP is rooted in a monthly column entitled Medication Errors, that began in March 1975 in Hospital Pharmacy. The column grew from a conversation Mike had in 1974 with Neil Davis, both of whom were working at Temple University Hospital in Philadelphia. They were discussing a serious medication error that happened at a local hospital in which a prescriber had used an abbreviation, U for “units,” and a nurse had misread the handwritten U as a zero and administered 40 units of regular insulin to a patient instead of 4 units. The patient developed signs of severe hypoglycemia that required immediate treatment.

Dr. Davis, who was an editor of Hospital Pharmacy, suggested that the incident served as an opportunity for educating other healthcare professionals about this error-prone abbreviation. During the discussion, it became clear that much could be gained by publishing other medication errors that readers may be inclined to report in confidence to prevent patient harm and save lives. Thus, an idea was born and realized to create a national medication error reporting program that practitioners could use to confidentially report medication errors, which could then be shared anonymously with others for learning purposes. 

In 1977, Mike began a similar column for nurses in Nursing ‘77, and both the Hospital Pharmacy and Nursing ‘77 columns became leading features in the respective monthly journals. The columns prompted reports of errors from across the US, and Mike would often follow up with the practitioner to learn more about what had happened. Then Mike would share the deidentified error stories and provide error-prevention recommendations in the journal columns so others could proactively take action. Mike and Dr. Davis also began to interact with the US Food and Drug Administration (FDA), USP, The Joint Commission (TJC), and product manufacturers when important issues arose.

By 1990, Mike realized that his advocacy work for safe medication practices and products was a full-time calling that should be supported by a nonprofit organization. Shortly thereafter, ISMP was founded, and by 1994, the organization became the nation’s only 501c (3) nonprofit organization devoted entirely to preventing medication errors. Since then, ISMP has served as a vital force for progress in medication safety through its unyielding advocacy and the development of resources and learning opportunities for healthcare practitioners and consumers.

ISMP’s impact

ISMP has had a tremendously positive impact on patient safety, medication safety, and the practices of caregivers striving to provide quality and safe patient care, both across the US as well as internationally, including through ISMP sister organizations located in Brazil, Canada, and Spain, and as a founding member of the International Medication Safety Network (IMSN).

Along the way, ISMP has cultivated excellent relationships with other patient safety and professional organizations, accreditors, regulators, standards-setting organizations, and the medical products industry that allow us to share our recommendations with organizations so necessary changes can be made to prevent both product- and practice-related medication errors. For example, over the years, ISMP’s frequent interactions with FDA, USP, and the medical products industry have improved the safety of thousands of products, and have had a significant impact on labeling, packaging, and nomenclature guidances and standards. Additionally, ISMP’s collaboration with TJC, the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), professional organizations, and patient safety organizations has resulted in collaborative projects to advance our mutual goal of medication safety, as well as substantial changes in medication safety standards. Likewise, our recommendations to practitioners, healthcare providers, and organizations have also resulted in system- and practice-level changes. In fact, ISMP was among the first, if not the first, organization to recommend the following concepts to improve medication safety, many of which are widely implemented by healthcare providers and industry:

• Free flow protection for infusion pumps
• Removal of potassium chloride injection concentrate from patient care units
• VinCRIStine administration via a minibag instead of a syringe 
• Establishing a list of high-alert medications with layered error-reduction strategies
• Use of failure mode and effects analysis (FMEA) in healthcare
• Spotlighting Targeted Medication Safety Best Practices for Hospitals
• Employing a medication safety officer
• Maintaining a look-alike/sound-alike drug name list
• Maintaining a list of error-prone abbreviations that should never be used
• Use of tall man letters
• Calling infusion pumps with a dose error-reduction system (DERS) “smart pumps”

Throughout the years, there have been numerous times when ISMP has also brought together key stakeholders, sometimes for the first time, to discuss complex medication safety issues and create consensus-based best practices and/or action plans for organizations to implement. In some cases, ISMP has been a prickly thorn in the side, provoking important questions, challenging preexisting assumptions, exposing harmful medical products, and chipping away at the resistance to much needed system changes. At other times, ISMP has been a nurturing, healing shoulder to cry on when well-meaning and competent providers have inadvertently harmed a patient—because we are fallible human beings deeply troubled by our inability to “do no harm.”

But perhaps ISMP’s greatest contribution to healthcare has been giving a voice to health professionals who, in confidence, report errors to ISMP for altruistic reasons and/or share their ideas, observations, or questions with ISMP, without fear of even a disparaging thought. ISMP empowers others to give voice to their experiences because they trust ISMP and know their information will be used productively. Every idea, observation, question, or error report ISMP receives is carefully reviewed. Then ISMP healthcare professionals interact internally to apply their collective expertise to arrive at safety recommendations and then share compelling stories about medication errors and impactful change strategies. ISMP aims to draw national attention to medication safety problems, offers healthcare providers new ways of looking at problems, and inspires change.

Excerpted, with permission, from "2022 Ushers in the Beginning of a New Era at ISMP" January 13, 2022 Read on...