πŸ“› Medication Error: An Adverse Event

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This blog covers the following topics:

  1. An overview of medication errors.
  2. Considering medication errors special case scenarios.
  3. Specific conventions related to medication errors.
  4. An explanation of MedDRA coding conventions.

Introduction

In this blog, we explain the useful topic about the event medication errors. Examining why they represent a unique and significant concern in healthcare.

We will discuss how to handle this adverse event. The conventions surrounding them, and the MedDRA coding conventions that apply.

Join us as we explore the nuances of medication errors and their implications in clinical practice.

Medication Error: Definition

A medication error is an unintended and preventable event that can result in inappropriate medication use while the medication is under the control of healthcare professionals, patients, or consumers.

This can occur at various stages including:

  1. Prescribing
  2. Storing
  3. Dispensing
  4. Preparing, or administering medications in clinical practice.

In some cases, medication errors can lead to serious harm for the patient.

Sources of reports

Medication error reports can be recorded from:

  1. Unsolicited Reports: Submitted spontaneously by healthcare professionals, consumers, marketing authorization holders, or other organizations. Click here to learn more in deeper about spontaneous reports.
  2. Solicited Reports: These come from non-interventional studies or registries. Medication errors may also be identified through literature reviews or other non-medical sources.

Medication Errors: Special Case Scenarios

Medication errors differ from traditional adverse drug reactions because they are fundamentally errors in the medication process.

Timely sharing of information is crucial for preventing and analyzing medication errors.

While it is good practice to document cases of medication errors that do not lead to adverse reactions in the format of an Individual Case Safety Report (ICSR).

It’s important to note that these cases are not considered valid ICSRs under Good Pharmacovigilance Practices (GVP).

Conventions for Recording Medication Error Reports

Good practice guidelines dictate the recording, coding, reporting, and assessment of medication errors related to medicinal products that are associated with suspected adverse reactions.

By the ICH E2C (R2) guidelines and GVP Module VII.B.5.9 on PSURs:

Marketing authorization holders allowed to summarize information on medication errors.

Regardless of whether they linked to adverse reactions to support benefit-risk evaluations.

This approach aids in the interpretation of safety data and the benefit-risk assessment of medicinal products.

“Effective handling of medication error cases in pharmacovigilance is crucial for patient safety. By systematically analyzing these events, we can identify root causes, implement preventive measures, and ultimately enhance the quality of care within the healthcare system.”

Classification of Medication Error Reports

To ease the recording, coding, reporting, and assessment of medication errors, these errors classified based on factual information about each case.

It’s essential to distinguish between:

  1. Medication errors associated with adverse reactions
  2. Medication errors without harm
  3. Intercepted medication errors
  4. Potential medication errors

Intercepted Medication Error

In pharmacovigilance, an intercepted medication error refers to an intervention that breaks the chain of events leading to a medication error.

Thereby preventing actual harm to the patient.

For example, if a nurse notices a wrongly prepared medication and does not administer it, this constitutes an intercepted error.

In patient safety reporting systems, the term “near miss” is often used synonymously with intercepted errors in the context of pharmacovigilance.

Potential Medication Error

An identified potential medication error when circumstances arise that could lead to a medication error, whether or not a patient involved.

This term encompasses all possible mistakes that may occur during the prescribing, storing, dispensing, preparation, or administration of a medicinal product.

Potential medication errors can lead to:

a) A medication error resulting in harm, without knowing the actual cause

b) A medication error without harm, without knowing the actual cause

c) A medication error without harm, with an awareness of the actual cause

Challenges with Medication Error Pharmacovigilance

  • Diverse Terminology: Different stakeholders may use varying terminology for medication errors.
  • Incomplete Reporting: There is often a lack of tailored reporting forms to capture comprehensive medication error information.
  • Product Identification Issues: Inaccurate identification of products can complicate reports.
  • Inconsistent Coding: Ambiguous and inconsistent coding of medication errors can hinder data analysis.
  • Document Review: Identifying and reviewing product-specific documents can be challenging.

Facts About Medication Error Reports

  • The FDA receives over 100,000 reports annually in the U.S. related to suspected medication errors.
  • Estimates suggest that 18.7% to 56% of adverse events in hospitalized patients stem from preventable medication errors.

Medication Error: MedDRA Coding Conventions

The terminology used by stakeholders for coding medication error reports varies based on the intended purpose.

Currently, there is no universally accepted terminology for recording patient safety incident reports related to medication errors.

MedDRA terminology enables coding at various stages of the drug treatment process, including:

  1. where the error occurred,
  2. the circumstances surrounding it, and
  3. the potential clinical consequences, regardless of whether the medication error is associated with adverse reactions.

When coding medication errors with MedDRA, it is crucial to accurate and consistent term selection.

MedDRA coders should strictly code what is explicitly stated in the report, without inferring or altering any information.

A medication error should only be coded if the primary source clearly describes it.

Important considerations when coding medication errors with MedDRA include:

  1. Intercepted and potential errors
  2. Medication errors in the context of contraindications
  3. Patient treatment non-compliance
  4. Whether intentional re-challenge is classified as a medication error
  5. Ambiguous information
  6. Is reported a lack of efficacy? (To learn more…)

Key Takeaways

Intentional or deliberate uses (e.g., abuse, misuse, off-label use) are generally not classified as medication errors.

Medication errors represent a significant global public health burden.

There has been a noticeable increase in medication error reports in recent years.

Failures in the drug treatment process relate to human or process-related issues, rather than lack of efficacy of the drug itself.

Lack of efficacy of a medicinal product is not classified as a medication error, although some medication errors may result in a lack of efficacy for the patient.

Individual Case Safety Reports (ICSRs) should be followed up to obtain any incomplete information necessary for scientific evaluation and causality assessment of the reported case.

Conclusion

From the discussion above, you may have uncovered some critical nuances related to managing medication errors as adverse events. To enhance your understanding further, consider exploring the following links for more in-depth information.

Is there anything crucial that we might have missed in this discussion? Feel free to share your thoughts or questions!

Bibiliography:
  1. Dalmolin, G.R.D.S., Rotta, E.T., Goldim, J.R., 2013. Medication errors: classification of seriousness, type, and of medications involved in the reports from a university teaching hospital. Braz. J. Pharm. Sci. 49, 793–802. https://doi.org/10.1590/S1984-82502013000400019
  2. Ferner, R., n.d. Medication errors and pharmacovigilance.
  3. World Health Organization, 2014. Reporting and learning systems for medication errors: the role of pharmacovigilance centres. World Health Organization, Geneva.
References:
  1. FDA: Medication error & Pharmacovigilance: pdf
  2. EMA Guidance: Medication Error: pdf

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.



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Meet Bala, the founder of Drugvigil, a service provider specializing in pharmacovigilance. He’s not only an expert in this field, but also a passionate entrepreneur who enjoys creating new opportunities and helping others grow. Despite starting from scratch, he’s determined to develop his company from the ground up. If you’re interested in his work, be sure to show your support and share his message with others.




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5 responses to “πŸ“› Medication Error: An Adverse Event”

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