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

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.

With the goal of sharing experience and learning from member countries to address COVID-19 vaccine safety issues, the IMSN Executive Committee formed the IMSN COVID-19 Vaccine Safety Interest Group (CVSIG) in February 2021. The two primary objectives of the initiative were to address issues encountered by members during global vaccine rollout and to create a guiding document of experience-based safety recommendations.

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.

These safety recommendations were developed based on the collective experience and learning from IMSN member countries and should be considered for implementation in global COVID-19 immunization efforts. For a complete copy of the IMSN CVSIG Recommendations for Global Implementation of Safe COVID-19 Immunization Practices, click here.

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

ISMP Announces Leadership Transitions

In January 2022, an era of unwavering leadership for the Institute for Safe Medication Practices (ISMP) comes to an end, as Michael R. Cohen, a persistent advocate for medication safety, has stepped down as President of ISMP. Mike will continue to support ISMP’s critical lifesaving work as President Emeritus, and Rita K. Jew, a respected and worthy successor, has been appointed as the new ISMP President (to learn more about Rita, click here).

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...

What is IMSN bringing to you in terms of medication safety?

For World Patient Safety Day, 17 September 2021, WHO urges all stakeholders to “Act now for safe and respectful childbirth!” with the theme “Safe maternal and newborn care”.

Considering the significant burden of harm women and newborns are exposed to due to unsafe care, this year’s World Patient Safety Day is dedicated to the need to prioritize and address safety in maternal and newborn care, particularly around the time of childbirth, when most harm occurs. This is especially important in the context of disruption of health services due to the COVID-19 pandemic, which has further compounded the situation.

Among safety measures during pregnancy, childbirth and the immediate postnatal period, medication safety is a key component.

Medication during childbirth and the immediate postnatal period

A medication error can threaten a mother during childbirth, especially in the case of epidurals, infusions or invasive procedures. These risks are mainly related to the operating conditions, preparation and administration of injectable drugs. Some of these medication safety issues are well known to cause harmful and fatal errors in mothers and neonatal patients despite knowledge of repeated occurrence and warnings.
The risk of medication errors is increased in pediatrics and neonatology for many reasons: lack of pediatric formulations, dosage forms and guidelines; confusion between adult and pediatric formulations; confusion among concentrations of oral liquids; look-alike packaging and confusion with drug names; multiple dosing styles; calculation errors; measuring devices; nonstandard concentrations and dilutions; preparation of IV admixtures; IV administration of enteral fluids, etc.

Mother and newborn are more often together on the same delivery unit, same room, having stored their medications together in the same storage area. That has led to mix-ups, such as giving mother hepatitis B vaccine instead of the birth dose intended for the newborn, a common error, and methylergometrine to the newborn instead of the mother. Another problem is identification of mother and newborn since the baby may not yet have a name and may be given same last name as the mother.

"A medication error in a child is often compounded by the need for additional calculations to determine the dose. Many medicines prescribed for children are only available as adult dose forms. Sometimes complex manipulations are necessary to prepare doses for very small babies. Ideally, small doses for intravenous administration should be prepared centrally in the pharmacy. Staff prescribing or giving drugs in paediatrics and neonatology should demonstrate competence in calculation skills."

in “Building a Safer NHS for Patients: Improving Medication Safety” UK NHS; January 22, 2004, p.77.

Many of the resources provided by the International Medication Safety Network (IMSN) are applicable to medication safety during childbirth and the postpartum period for both mothers and newborns.

IMSN Global Targeted Medication Safety Best Practices

The International Medication Safety Network (IMSN) promotes risk-reduction strategies, called the Global Targeted Medication Safety Best Practices, to inspire and mobilize widespread, international adoption of consensus-based best practices for specific medication safety issues that continue to lead to harmful and deadly medication errors. In particular during childbirth and the postpartum period, it is the case for concentrated injectable electrolytes, such as magnesium or potassium; mix-ups between IV and peridural medicine, such as tranexamic acid, local anesthetics; vaccines extemporaneous preparation, etc. Among others, see as example:

IMSN advocacy to improve medication safety at a global level

The International Medication Safety Network issues recommendations to regulators, pharmaceutical industry and healthcare providers in several domains such as medication error reporting and learning, unsafe medicines naming, labeling and packaging, etc. In particular for both mothers and newborns, it is the case of liquid form dosing preparation, inadequate measuring devices, and also various types of vaccination and medication errors including mix-ups between mothers and newborn. Among other, see as example:

  • IMSN Position Statement on Safer Design of Vaccines Packaging and Labelling
    Read on...
  • IMSN Position Paper on Making Medicines Naming, Labelling and Packaging Safer
    Read on...

IMSN updated resources on medication errors

IMSN member publications are a unique source of information on medication error risk, occurrence and prevention, with in-depth, specialized and high-level analysis providing unparalleled insight and action. Like an intelligence hub, all the latest information in this field is gathered on a single page and constantly updated. Of course, you can also find the latest information on the risks of errors threatening mothers and newborns.
Enjoy IMSN members publications...

The International Medication Error Reporting Portal

The International Medication Safety Network provides an international medication error reporting portal for the international healthcare community, to learn from these experiences and be in position to prevent future errors and possible patient harm. Any healthcare provider worldwide, including physicians, pharmacists, nurses, and other healthcare workers including those in the regulatory and the medical products industry can share their report for international review. Reports are investigated by the International Medication Safety Management Fellows at the Institute for Safe Medication Practices (ISMP) in the United States under the supervision of medication safety expert members of the IMSN.

  • Here you can report to IMSN
  • Here you can see how to learn from your reports, with the great example of the ivm VMI Praktijkprikkels (Practice Stings), whose last issue is about a mix-up between a newborn and her mother in administering hepatitis B vaccine and hepatitis B immunoglobulin

Medication during pregnancy: 10 principles to prevent adverse effects in the unborn child

For a woman who is pregnant, or who might be or become pregnant, taking certain medications can expose the unborn child to harmful effects, often poorly known, and sometimes extremely serious and irreversible. Prescrire, an IMSN member also an independent drug bulletin, promotes several principles useful in preventing them:

  • use caution when it comes to any woman who is pregnant, who might be pregnant, or who might soon become pregnant;
  • know the patently toxic drugs in order to avoid these drugs, or else to provide for effective contraception;
  • be aware that there is great uncertainty and lack of knowledge when it comes to most drugs;
  • avoid any treatments whose efficacy is uncertain;
  • take both the mother and the child into account when evaluating a treatment’s harm-benefit balance;
  • take maximum precautions during the first trimester of pregnancy: it is best to use a tried and tested drug, at minimal doses, and for the shortest time possible;
  • late in the pregnancy, be aware of the drug’s known effects outside of pregnancy, and take them into account;
  • keep in mind that the long-term effects on the development of the unborn child are unknown;
  • inform patients about the dangers of medications taken during pregnancy; 
  • organise monitoring and management of any adverse effects that can be anticipated in children.

Systematically think about the possibility of pregnancy. Thinking about drug risk is one thing. Thinking about drug risk during pregnancy is another. It is another to think systematically about the eventuality of a pregnancy...