Medication Error Follow Verify

Other definitions

According to EU Good Practice Guide (GPG) from 2015, a medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to harm to the patient. The GPG further clarifies that a failure in the drug treatment process does not refer to lack of efficacy of the drug but rather to human or process-mediated failures.

The United States National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) defined medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

Different classifications

In correlation with harm and preventability

According to a Good practice guide on the recording, coding, reporting and assessment of medication errors form 2014, medication errors are classified according to correlation with harm and preventability, ie, depending on where the break occurs in the chain of events leading to the error and its consequences for the patient as medication errors associated with adverse reaction(s), medication errors without harm, intercepted medication errors and potential medication errors.

• Medication errors associated with adverse reaction(s)

• Intercepted medication errors

In the context of pharmacovigilance, an intercepted error indicates that an intervention caused a break in the chain of events in the treatment process before reaching the patient which would have resulted in a ‘potential’ ADR. The intervention has prevented actual harm being caused to the patient, e.g. a wrongly prepared medicine was actually not administered to the patient because the error was noticed by the nurse.

In the context of patient safety reporting systems the term ‘near miss’ is used as a synonym for describing what is classified ‘intercepted error’ for pharmacovigilance purposes. A near miss from a patient safety perspective is a random break in the chain of events leading up to a potential adverse event which has prevented injury, damage, illness or harm, but the potential for harm was nonetheless very near.

• Potential medication errors

According to GVP Module VII.B.5.9, a potential medication error is the recognition of circumstances that could lead to a medication error, and may or may not involve a patient. The term potential medication error refers to all possible mistakes in the prescribing, storing, dispensing, preparation for administration or administration of a medicinal product by all persons who are involved in the medication process and may lead to:

1. a medication error with harm, but without knowing the actual cause,
2. a medication error without harm and without knowing the actual cause, or
3. a medication error without harm, but with the awareness of the actual cause.

In correlation with the planning and execution

Psychologists consider an error to be a disorder of an intentional act, and they distinguish between errors in planning an act and errors in its execution. If a prior intention to reach a specified goal leads to action, and the action leads to the goal, all is well. If the plan of action contains some flaw, that is a ‘mistake’. If a plan is a good one but is badly executed, that is a failure of skill. Medication errors can then be divided into:

• knowledge-based errors and
• rule-based errors.

Failures of skill can be divided into:

• action-based errors ('slips', including technical errors) and
• memory-based errors (‘lapses’).

In correlation to drug prescribing, dosing and preparation

Medication errors can occur anywhere along the route, from the clinician who prescribes the medication to the healthcare professional who administers the medication. The different types of medication errors include (but are not necessarily limited to):

• • Prescribing errors, wherein the selection of a drug is incorrect based on the patient's allergies or other indications. Additionally, the wrong dose, form, quantity, route (oral vs intravenous), concentration, or rate of admission could be used.
  • Omission errors, in which there is a failure to give a medication dose before the next one is scheduled.
  • Wrong time errors, wherein a medication is given outside the predetermined interval from its scheduled time.
  • Improper dosing errors, wherein a greater or lesser amount of a medication is delivered than is required to manage the patient's condition.
  • Wrong dose errors, wherein the correct dosage was prescribed, but the wrong dose was administered.
  • Improper administration technique errors, such as administering a medication intravenously instead of orally.
  • Wrong drug preparation errors, wherein a medication is incorrectly formulated (i.e., too much or too little diluting solution added when a medication is reconstituted).
  • Fragmented care errors, wherein a lack of communication exists between the prescribing physician and other healthcare professionals.

CAUSES OF MEDICATION ERRORS

Every medication error can be associated with one, and usually more than one, error-producing condition.

• Distraction: A nurse who is distracted may read "diazepam" as "diltiazem." The outcome is not insignificant-if diazepam is accidentally administered, it could sedate the patient, or worse (e.g., if the patient has an allergy to the drug).

• Environment: A nurse who is chronically overworked can make medication errors out of exhaustion. Additionally, lack of proper lighting, heat/cold, and other environmental factors can cause distractions that lead to errors.

• Lack of knowledge/understanding: Nurses who lack complete knowledge about how a drug works, its various names (generic and brand), its side effects, its contraindications, etc. can make errors.

• Incomplete patient information: Lacking information about which medications a patient is allergic to, other medications the patient is taking, previous diagnoses, or current lab results can all lead to errors. Nurses who aren't sure should always ask the physician or cross-check with another nurse.

• Memory lapses: A nurse may know that a patient is allergic, but forget. This is often caused by distractions. Forgetting to specify a maximum daily dose for an "as required" drug is another example of a memory-based error.

• Systemic problems: Medications that aren't properly labelled, medications with similar names placed in close proximity to one another, lack of a barcode scanning system, and other issues can lead to medical errors.

Legal requirements

EU

The EU pharmacovigilance legislation regarding structures, processes and risk minimization measures relevant to medication errors include:

• GVP Module V (rev. 1) on risk management
• GVP Module VI (rev. 1) on the management and reporting of adverse reactions to medicinal products
• GVP Module VII (rev. 1) on periodic safety update report
• GVP Module XVI (Rev. 1) on risk minimization measures: selection of tools and effectiveness indicators
• Position paper on potential medication errors in the context of benefit-risk balance and risk-minimization measures, published in June 2013 by the Agency’s Committee for Medicinal Products for Human Use (CHMP). This paper focuses on medication errors caused by confusion of a newly introduced medicinal product with an existing one.
• The European Medicines Agency (EMA) published Medication-errors workshop report regarding a regulatory workshop on medication errors, where medication errors were an important topic.

Reporting requirements for medication errors

EU

Since July 2012, the new European Union (EU) pharmacovigilance legislation has required all adverse drug reactions resulting from medication errors at the EU level to be reported to EudraVigilance, the EU database of adverse drug reactions.

Medication errors without adverse reaction(s)

When there is no adverse event associated with medication/prescription errors, it is recommended that the MAHs keep a record of such events in their own database but these should not be reported as adverse events. However, where potential risks are identified as a result of medication errors without adverse events e.g. intercepted errors, the information should be summarised in the PSUR together with recommendations for addressing the issue. This is valuable information which may lead to improvements in the product information and the overall safety associated with the use of the product. Where such events have safety implications, impacting on the benefit-risk balance of the medicinal product, they should also be notified to the competent authorities.

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