Medication Errors & FL Reporting Rules Materials

MEDICATION ERRORS AND FLORIDA REPORTING RULES

Faculty:

Steven Malen, PharmD, MBA

Steven Malen graduated with a dual degree in Doctor of Pharmacy (PharmD) and Master of Business Administration (MBA) from the University of Rhode Island. Steven Malen has worked as a clinical pharmacist in the retail, specialty, and compounding sectors.

Pamela Sardo, PharmD, BS

Pamela Sardo, PharmD, BS, is a freelance medical writer and licensed pharmacist. She is the founder and principal at Sardo Solutions in Texas. Pam received her BS from the University of Connecticut and her PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, and managed health care responsibilities across a broad range of therapeutic classes and disease states.

Abstract

Medication errors can occur at any stage of a drug's prescription, administration, or monitoring. These preventable events can harm a patient. The identification and prevention of medication errors require an understanding of their root causes. Once root causes are identified, a pharmacist can implement procedures and protocols to reduce and prevent medication errors, thereby promoting patient safety. If a medication error occurs, clinicians must know whether it must be reported and when. This course does not provide legal advice. Pharmacy staff should consult with their employer, a legal advisor, supervisor, online resources, or licensing boards to determine the laws regarding medication errors, incident report requirements, and reporting to governmental entities or patients. Pharmacists and pharmacy technicians can work collaboratively with healthcare teams to reduce and prevent future medication errors.

Accreditation Statements

In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation Council^TM for Continuing Medical Education (ACCME^®), the Accreditation Council for Pharmacy Education (ACPE^®), and the American Nurses Credentialing Center (ANCC^®), to provide continuing education for the healthcare team.

Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:

Pharmacists: JA4008424-0000-26-084-H05-P

Pharmacy Technicians: JA4008424-0000-26-084-H05-T

Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit.

Credit Types:

Pharmacy - 2 Credits

Type of Activity: Knowledge

Media: Computer-Based Training (i.e., online courses)

Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Activity Pre-Test, Post-Test, and Activity Evaluation.

Release Date: July 1, 2026 Expiration Date: July 1, 2027

Target Audience: This educational activity is for Pharmacists and Pharmacy Technicians

How to Earn Credit: From July 1, 2026, through July 1, 2027, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Take the “Educational Activity Pre-Test;”

Study the section entitled “Educational Activity;” and

Complete the Educational Activity Post-Test and Activity Evaluation. The Educational Activity Post-Test will be graded automatically. Following successful completion of the Educational Activity Post-Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

CE and CME Credits: Credits for this course will be uploaded to CPE Monitor^® for pharmacists and pharmacy technicians.

Statement of Need

Medical errors are a significant problem in the healthcare system. One of the most pervasive medical errors responsible for considerable patient harm is medication errors. Understanding the root causes of medication errors and prevention strategies can help reduce medication errors and improve patient safety in clinical settings.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Define medication errors

Discuss the root causes of medication errors

Describe how to reduce and prevent medication errors

Explain how to respond to a medication error

Discuss the importance of implementing policies, procedures, or systemic changes that create a safer healthcare system for patients

Disclosures

The following individuals were involved in planning, developing, and/or authoring this activity: L. Austin Fredrickson, MD, FACP; Steven Malen, PharmD, MBA; and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity. 

© RxCe.com LLC 2026: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Educational Activity Pre-Test

A medication error that results in harm to a patient is called

a contraindication.

an adverse drug event.

a near miss.

a monitoring error.

One of the root causes of medication errors is the fragmentation of medication information that arises when a patient’s medication information

is mixed with another patient’s medication information in the ICU.

is not given to the patient when purchasing a medication refill.

fails to follow the patient across providers, services, or levels of care.

is computerized with a printout of the instructions and potential adverse events.

Florida Statute, section 395.0197, requires licensed facilities to have an incident reporting system, and it requires healthcare facilities to

send a report to the Agency for Health Care Administration (AHCA) of all medication errors, even if no harm resulted.

report a medication error only after the affected patient has signed a waiver.

admit wrongdoing when an “adverse event” occurs.

inform patients of an “adverse incident” as soon as practicable.

Educational Activity

Medication Errors and Florida Reporting Rules

Introduction

Medical errors are a significant problem in the healthcare system. One of the most pervasive medical errors responsible for considerable patient harm is medication errors. A medication error can occur at any point, from the prescription to the administration or monitoring of a drug. Medication errors can be reduced or prevented by understanding their root causes and implementing policies, procedures, or systemic changes that address them, ultimately creating a safer healthcare system for patients.

Medication Errors: Definition and Scope

Medication errors fall within the broader concept of medical errors. Over twenty years ago, the Institute of Medicine (IOM) highlighted medical errors in its seminal monograph, "To Err is Human: Building a Safer Health System."¹ The Institute of Medicine (IOM) reported that 7% of all hospital admissions experience a serious medication error.¹ But what is a medication error? How should it be defined?

Definitions and detection methods for medication errors have varied and been subject to an individual researcher’s preferred description.² This has led to inconsistent and unreliable data on this topic. A clear, standardized definition was needed to define the scope and content of medication errors.²

To address this definitional quandary, the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) has defined the term "medication error" and asked that researchers, software developers, and institutions use this standard definition to identify errors.³ The NCC 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 health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use."³

This means a medication error does not necessarily result in patient harm.³ When harm does occur, this is referred to as an adverse drug event (ADE).⁴ According to the U.S. Agency for Healthcare Research and Quality (AHRQ), the occurrence of an ADE does not necessarily indicate an error or poor-quality care.⁴

The AHRQ provides the following categories to help healthcare professionals understand how to describe medication errors:⁴

An ADE is defined as harm experienced by a patient resulting from exposure to a medication.

Preventable ADEs result from a medication error that reaches the patient and causes any degree of harm. It is generally estimated that about half of ADEs are preventable.

Potential ADEs are medication errors that do not cause any harm—either because they are intercepted before reaching the patient or because of luck.

Ameliorable ADEs are events in which the patient experienced harm from a medication that, while not completely preventable, could have been mitigated.

Adverse drug reactions or nonpreventable ADEs are adverse drug reactions from a medication, even though it was prescribed and administered appropriately.

Adverse drug events are one of the most common preventable adverse events in all settings of care. This is mostly due to the widespread use of prescription and nonprescription medications.⁴ Nearly one-third of adults in the U.S., take 5 or more medications. Each year, approximately 700,000 patients visit emergency departments, and ~100,000 hospitalizations occur. Ambulatory patients may experience ADEs at even higher rates, as illustrated by the dramatic increase in deaths due to opioid medications, which has largely taken place outside the hospital. Transitions in care are also a well-documented source of preventable harm related to medications.⁴

In addition to the potential physical harm to patients, ADEs result in a globally significant economic burden.^5-7 In the U.S., ADEs result in annual direct medical costs estimated to be $21 billion.^5,6 Indirect medical costs related to increased mortality and lost productivity are less visible, but they increase the economic burden.^5,6

An example of a medication error leading to an ADE or ADR is the case where a patient receives medication even though the patient has a known allergy to the medication. This error could occur because the allergy was not documented, or a pharmacist and/or physician bypassed warnings about the allergy.⁸

Medication errors can be inconsequential or have mild outcomes for a patient; however, medication errors may also have serious consequences that can include life-threatening medical conditions, hospitalization, and possibly disability or death.³ When a medication error occurs with a pregnant patient, it may result in birth defects or other harm to the developing fetus.⁹

Given the potentially serious and negative outcomes that may result from medication errors, the healthcare industry has worked to reduce medication errors and create a safer healthcare system for patients and the public.^10,11 This effort involves identifying common types of medication errors, their root causes, and systemic changes to address them. Identifying the cause of medication errors is not always straightforward because causation is a complex process.^10,11

Types of Medication Errors

The Academy of Managed Care Pharmacy (AMCP) identifies several sources of medication errors, including the following:¹²

Professional Practice: Errors in prescribing, transcribing, or monitoring.

Healthcare Products: Issues with product labeling, packaging, or nomenclature.

Procedures and Systems: Mistakes during compounding, distribution, or administration.

Workflow and Staffing: Short staffing or workflow disruptions that increase error risk.

Prescribing Errors

A prescribing error pertains to the choice of a drug, including its indications, contraindications, and the patient’s known allergies.¹³ A patient’s personal characteristics must always be considered. Additional factors involve “dose, concentration, drug regimen, pharmaceutical form, route of administration, duration of treatment, and instructions of use.”¹³ A medication prescription error may also include the failure to prescribe a drug for a patient needing the treatment for a medical condition or a patient needing the drug in the treatment of another drug’s adverse effects.¹³ Patient-specific factors, such as age, weight, and renal function, must be considered, alongside social determinants of health, including language barriers, health literacy, and access to care, which disproportionately affect marginalized populations.¹⁴ Addressing these equity issues through culturally competent prescribing practices can reduce errors and improve outcomes for diverse patient groups.¹⁴

Prescribing Potentially Inappropriate Medications in the Elderly

A prescribing error may include prescribing a medication that is potentially inappropriate for a specific patient population, such as the elderly.¹⁵ In these situations, a medication may have adverse risks that exceed the health benefits to an elderly patient. There may also be safer or equally effective alternative medications that could be prescribed instead.¹⁵

In 1991, Dr. Mark H. Beers developed the Beers Criteria.¹⁶ The Beers Criteria guided the appropriate or inappropriate use of medications in geriatric patients.¹⁶ The American Geriatrics Society (AGS) is currently responsible for the regular updates of the Beers Criteria.¹⁶

The AGS criteria deal with prescribing drugs within the context of “consideration of diagnosis, use of caution, simultaneous prescription of drugs that could interact, and avoidance or reduction of dosage according to individual kidney function.”¹⁵ The updated Beers criteria, supported with a discussion of the quality of evidence and strength of each recommendation, are available directly from the AGS.¹⁷

The most current guidance is the 2023 American Geriatrics Society (AGS) Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, which provides evidence-based recommendations on medications to avoid, use with caution, or adjust based on diagnosis, kidney function, and drug interactions.¹⁷ In 2025, AGS released a companion document, Alternative Treatments to Selected Medications in the 2023 AGS Beers Criteria, to support safer, person-centered prescribing, including the AGS Beers Criteria mobile app.¹⁸

Drug Not Indicated

A prescribing error occurs when a patient is prescribed a medication that is not indicated for their medical condition.¹³ One study found that an average of 2.7 medications per patient were not indicated for the patient, given the patient’s diagnosis.¹³

Drug–disease Contraindications 

A medication error may result when a drug is contraindicated for a patient with a particular disease.¹³

Drug-drug Interactions

A medication error may result when a patient is prescribed multiple drugs that may interact negatively.¹³

Medication Consideration for Children

The age of a patient should always be verified and taken into account when prescribing medications for children, as they require extra caution. Doses for children are often smaller than for adults, and some require weight-based dosing for safe administration. Pediatric dosing should always be confirmed before processing prescriptions.

Transcription Errors

Transcription errors occur because of poor communication.^19,20 They typically do not occur because of a lack of knowledge.¹⁹ With these errors, an order from a prescriber fails to be properly communicated to the individual dispensing or administering the medication.¹⁹

A transcription error may arise with handwritten and verbal orders.¹⁹ Handwritten prescriptions can cause issues if they are illegible.¹³ “The process of transcribing a drug order manually from one sheet to another appears to be a significant source of error.” Over half of handwritten prescriptions have been reported to be “poorly readable or unreadable.”¹³ Orders are more likely to be unclear or misinterpreted when the prescription is given verbally.¹⁹ Verbal readback on telephone orders can significantly reduce misinterpreted orders. If a message is left on an answering machine and any part is unclear, the pharmacist should call the provider back to verify the information.

While electronic prescriptions have reduced some types of errors, they have introduced new challenges, such as selection errors from drop-down menus and auto-populated fields.^21,22 To combat these issues, pharmacists should implement a verification process that includes double-checking key fields, such as drug name, dosage, and patient identifiers. Continuous monitoring and feedback loops within electronic systems can further enhance accuracy and patient safety.^21,22 Prescription errors that persist even with electronic prescriptions are “wrong drug, wrong dose, wrong route, wrong duration, and wrong formulation.”²³ Drop-down lists can create issues, as it is easy for a provider to select the wrong drug, dose, or instructions. If any part of an electronic prescription seems odd to the pharmacist, they should verify with the provider that the correct information has been submitted electronically. Pharmacists should always verify the patient's date of birth on an electronic order and be aware of alternate name spellings and hyphenated names to ensure the prescription is entered under the correct patient. The notes field of an electronic prescription should also be considered, as some electronic prescriptions indicate dosing changes and request discontinuation of previous prescriptions. One solution is a verbal order read-back. When receiving a verbal medication order, read all verbal order information back and obtain confirmation that the order is correct.²⁴

Preparation and Administration Errors

Preparation errors typically occur when a drug is improperly constituted or incorrectly concentrated.²⁵ Administration errors involve mistakes when giving medication to a patient. Examples of administration errors include missed, untimely, or incorrect doses, unlicensed staff administering medication, wrong administration technique and rate, double dosing, and the administration of an expired medication, administering a medication longer than recommended or not long enough.^25-27

An administrative error can occur when clinicians fail to document medications, document them incorrectly, or fail to follow medication administration policies.²⁸ Patient education and informed consent should occur at the time of preparation and before administration for optimal awareness of medication risks and benefits.

Dispensing and Monitoring Errors

A dispensing error is multifactorial. This can include dispensing medication to the wrong patient, administering the wrong medication to a patient, or administering medication at the incorrect time. Pharmacists should never bypass allergy and interaction alerts without further investigating the patient’s profile. Many dispensing errors can be avoided through preventive measures, including avoiding abbreviations, being aware of look-alike/sound-alike drugs, and verbally confirming prescriptions and allergies when indicated. In a busy retail setting, errors can be minimized with the right staffing levels. When pharmacists are busy or rushing, errors are more likely to occur. Some examples of errors that occur when pharmacy staff members are rushed include administering the wrong medications in the wrong bottles (especially when multiple medications are being dispensed to the same patient), bypassing allergies and interactions, and technicians acting outside their scope of practice. If a prescription is received for an unfamiliar medication, pharmacists should always take the time to conduct thorough research on the medication, including its uses, indications, and contraindications.

Monitoring medications involves assessing treatment appropriateness and determining the need for dose adjustments.²⁸ Medication tolerance is an important consideration in monitoring treatment. Monitoring dosing, efficacy, and safety with high-risk medications like lithium, warfarin, and cardiac medications is important.²⁹ Some medications require routine laboratory monitoring of drug levels and the drug’s effect on bodily functions (such as renal function).²⁹

High-Alert Medications

The Institute for Safe Medication Practices (ISMP) is a nonprofit organization that leads the effort to prevent medication errors.³⁰ The ISMP identifies medications posing a high risk of patient harm or death should a medication error occur.³⁰ These medications are not always associated with an increased number of medication errors, but significant harm may be caused if an error occurs with these medications. High-risk medications require frequent monitoring before refills are approved or before large supplies are filled. These drugs are identified in a list titled “High-Alert Medications in Acute Care Settings” and may be accessed on the ISMP website.³⁰ Examples of these medications include opioids, oral and injectable antithrombotics, concentrated injectable potassium, magnesium, and hypertonic sodium chloride for injection, pediatric medications, chemotherapy agents, HIV medications, immunosuppressants, and medications contraindicated in pregnancy.^31,32

One of the highest-risk medications is intravenous anticoagulant heparin, which is used in the inpatient setting. Safe use of heparin requires weight-based dosing and frequent monitoring of blood clotting tests to avoid bleeding complications from an excessive dose or clotting risks from an inadequate dose. Prescribing an incorrect dose of heparin is a medication error; however, if the incorrect dose were dispensed and administered, it would be a potential ADE, which would be considered an ameliorable ADE if the patient were harmed.⁴

The 2024 ISMP List of High-Alert Medications in Acute Care Settings includes tranexamic acid injection. High-risk medications require special safeguards such as limiting access, independent double-checks, and auxiliary labeling. For community pharmacies, consult ISMP’s Targeted Best Practices for Community Pharmacy (2025-2026), which emphasizes weight-based dosing verification, return-to-stock protocols, and vaccine error prevention.³⁰

Useful Resource The ISMP provides alerts, articles, guidance, and tools to support safe medication use. Link to ISMP: https://home.ecri.org/pages/ismp

Root Causes of Medication Errors

Medication errors stem from both human and systematic issues, including:^33-35

Inadequate Training: Providers may lack sufficient education on medications.

Missing Guidelines: Unavailable or unclear medication administration protocols.

Fragmented Information: Incomplete transfer of medication data between providers.

Interruptions: Distractions during prescribing, dispensing, or administration.

Poor Communication: Misunderstandings between healthcare team members.

Non-Compliance with Procedures: Failure to follow established protocols. Time constraints often exacerbate these issues, increasing risks of patient harm, prolonged hospital stays, or other adverse outcomes.

Inadequate Training

Academic training and lifelong learning, combined with continuing education, are essential for optimal effectiveness in healthcare settings.³³ Lack of knowledge is a major cause of medication errors.^34,35 A lack of resources and/or time required for increasing knowledge has been identified as a significant barrier to safe and appropriate healthcare.^33,34 Pharmacists and pharmacy technicians may not receive the proper amount of on-site training due to time constraints and staffing shortages, which can lead to errors and create stressful environments for staff and patients.³⁵

Florida pharmacists renewing licensure must complete a 2-hour Board-approved continuing education course (like the one you are taking right now) on medication errors as part of the 30-hour requirement.³⁶ At least 10 hours of the 30 hours of continuing education must be completed through a live seminar, teleconference, or computer-based application. Effective May 22, 2025, the live requirement has been removed for pharmacists.³⁷ This change also applies to Florida registered pharmacy technicians who were required to complete 4 hours of their biennial CE hours via live continuing education.³⁷ Licensed pharmacy professionals should monitor the live continuing education requirements in case they are reinstated.

Gaps in Guidelines and Alerts for Medication Administration

Guidelines, whether clinical practice guidelines or computer systems with drug dosing guardrails, are not always available. Guidelines for administering medications are not always readily available.³³ For example, medications may lack formal FDA approval for a specific population or may lack dosing information for a specific patient population, such as pediatrics.³⁸ Off-label uses may result in drug administration that may result in administration errors.³⁸ For example, in one case, the computer system failed to alert a prescriber to an overdose of prednisolone (49.5mg instead of 15 mg).³⁸ In another case, the use of erythromycin was intended as an agent for gastrointestinal dysmotility (rather than as an antibiotic), which uses a lower dose.³⁸ Erythromycin was inappropriately prescribed at a higher dose, with an increased likelihood of gastrointestinal side effects.³⁸

Distractions and Staffing

Prescribing, transcribing, preparing, dispensing, or administering drugs requires a provider’s undivided attention. Distractions during these events can lead to medication errors.²⁸ Distractions are common and, unfortunately, unavoidable in the pharmacy setting. A lack of appropriate staffing can lead to further distractions as there are fewer people to perform necessary tasks.

In retail and hospital pharmacy settings, phone calls are received throughout the day and often are received before an important task is completed. Staff frequently interact with patients who visit the location to drop off or pick up prescriptions or to receive counseling. Staff may need to complete current tasks before responding to patient questions.

Fragmentation of Medication Information and Poor Communication

The use of multiple medical specialists or multiple medical systems to care for a patient has its benefits, but it can also increase the possibility of a medication error. A patient’s health information does not always follow them from one provider, service, or level of care to the next. Furthermore, fragmentation of medication information is implicated in the root causes of medication errors.³⁹ Fragmented medication information may also result in poor communication.

Effective communication is crucial for delivering safe and appropriate healthcare services. Communication occurs among the various providers involved in a patient’s treatment.³⁹ Poor communication may inhibit the flow of information during transfers to the next provider, service, and different level of care. This may cause harmful medication errors.³⁹ Medication reconciliation has become increasingly common and is discussed below as a strategy to mitigate the fragmentation of medical information.

Additional communication factors include the use of non-standard abbreviations or sound-alike medications, which may lead to transcription errors.¹⁹ Poor communication increases the risk of medication errors, which can lead to suboptimal patient outcomes.³⁹

Point to Ponder: A hospital ‘Code Blue’ is called regarding a patient. During the emergency, the attending physician made a verbal order to administer amiodarone; however, amrinone was administered in error. To determine how the error happened and what could be done to prevent a future event, what would you include in a post-event root cause analysis discussion?

Time Constraints

Healthcare processes can occur at a rapid pace. Each day, healthcare clinicians may see a high volume of patients, and pharmacists may be filling a large number of prescriptions.⁴⁰ When a pharmacist works under time constraints, the pharmacist is driven or compelled to work quickly, perhaps too quickly. This increases the risk of a medication error.⁴⁰

Failure to Follow the Rights of Medication Administration

The rights of medication administration are patient rights that are required for safe medication ordering and use.²⁸ The rights of medication administration are enumerated and discussed below. A healthcare provider who does not uphold these rights is more likely to make a medication error.²⁸

Medication Error Reduction Strategies

The pharmacy team may implement several strategies to reduce medication errors. These strategies include the use of technology and continuing education for lifelong learning.²⁵

Most healthcare facilities are computerized to help streamline the flow of information and the dispensing and administration of medications, making them timelier and more accurate.²⁵ Pharmacists should develop standardized protocols for medication use. This may include identifying risks of medication errors and developing strategies to reduce these errors. A pharmacist-led educational and reconciliation program is one strategy. Additional medication error reduction strategies include continuing education, implementing pharmacy workflow strategies such as the SBAR communication tool, utilizing the High-Alert Medications in Acute Care Settings provided by IMSP, and utilizing the Medication Error Reporting Program (MERP).^20,30,41

The communication tool SBAR stands for “Situation, Background, Assessment, and Recommendation or Request for Action.”⁴¹ It was developed to improve the quality of communication when a patient change or hand off occurs.^20,41 Improved communication skills improve patient safety.^20,41

The SBAR tool and its derivatives, ISBAR, SBAR-R, ISBARR, and ISOBAR, can improve communication.^20,41 The SBAR tool logically organizes the patient’s information. The sender and receiver of the shared information use “the same mental model,” thereby improving understanding and awareness during patient hand-off.^20,41 It also reduces barriers by encouraging the sender of the information to provide an assessment and suggestion, i.e., “Recommendation.” Because poor communication skills or communication breakdowns are major contributors to adverse events and medical errors, using a tool like SBAR could help address them.^20,41

Pharmacists' counseling regarding over-the-counter (OTC) medications is important. Pharmacy technicians also play a significant role in helping pharmacists reduce errors. Regular check-ins between pharmacists and technicians are crucial. Departments can structure this as formalized safety huddles or debriefings that include all team members.⁴⁰ Focus on identifying potential safety issues, discussing recent near-misses, and planning proactive strategies for error prevention are opportunities. Engaging the entire team leverages collective expertise, fosters a culture of safety, and encourages continuous improvement.⁴⁰

Standardized Medication Use Protocols

An institution may have a medication use protocol for specific medications, such as warfarin or DOACs, or protocols for specific conditions, such as myocardial infarction. One example is the American Society of Health-System Pharmacists (ASHP), which provides guidelines for preventing medication errors.⁴² These guidelines begin with the recommendation that healthcare facilities do a risk assessment and, from that assessment, prepare a plan to reduce medication errors.⁴² The focus is to identify facility-specific, high-alert medications and risk reduction strategies for medication errors.⁴² A list of high-alert medications may be reviewed from the ISMP list of high-alert drugs, and historical adverse events should also be considered.⁴³

The ISMP has published the Key Elements of Medication Use.⁴⁴ This document provides important information on the protocols to follow when medication is prescribed and administered. This information includes patient and drug details, as well as recommendations for communicating drug information, labeling, packaging, nomenclature, and storage.⁴⁴

Computerized Systems

Computerized systems have been incorporated into the modern healthcare industry. One goal of these systems is to help reduce medication errors at multiple points in the process.¹⁹ Pharmacists should remain vigilant when checking electronic prescriptions, as errors still occur.

Technology and automation have introduced new types of errors, including incorrect dosing directions, drug quantities, drug strengths, or patient information.⁴⁵ A 2019 study described the potential magnitude of electronic prescription errors.⁴⁵ Over 1.74 billion prescriptions were submitted electronically in the United States in 2017.⁴⁵ This study found patients' directions and drug quantity selection as the most frequent errors reported. Electronic prescribing incidents may increase the likelihood of patients receiving the incorrect drug therapy and have negative consequences for pharmacies and pharmacy personnel. Pharmacists and staff need to remain vigilant when processing electronic scripts.⁴⁵

In contrast, recent advancements, such as machine learning-based Clinical Decision Support Systems (CDSS) and real-time error detection algorithms, hold promise for further reducing errors by enhancing decision-making and alerting pharmacists to potential issues.⁴⁶ Pharmacists must remain vigilant, verify electronic prescriptions, and stay up to date on emerging technologies to maximize patient safety.

Computerized Provider Order Entry Systems

Transcription errors occur due to poor communication between the prescriber and the staff who dispense or administer the drug. Computerized provider order entry (CPOE) systems were developed to eliminate errors through direct entry of the prescribing information into the CPOE system.¹⁹ Utilizing these systems can reduce human error resulting from verbal or handwritten orders. Vulnerability persists because of sound-alike medications, abbreviations, and computer drop-down menus of drug lists that can lead to clicking and selecting the incorrect agent.¹⁹

Artificial Intelligence and Machine Learning

Emerging AI and machine learning clinical decision support systems (CDSS) represent a major advancement. Recent studies show AI-CDSS can reduce operating-room medication errors by up to 95% and IV administration errors by ~80% through real-time pattern recognition, improved alert relevance, and predictive analytics. Pharmacists play a key role in algorithm validation, data quality oversight, and workflow integration to minimize alert fatigue and bias.⁴⁷

Automated Dispensing Cabinets

Automated dispensing cabinets (ADCs) are devices that store and dispense medications through a computerized system. These devices provide pharmacists with the opportunity to profile patients and review medication orders before administering medication.¹⁹ As with other computer systems, medication errors may still occur without proper attention.¹⁹ Because these cabinets are sometimes located in areas available to patients when the pharmacy is closed, patient counseling processes are needed.

Barcode Medication Administration Systems

Barcode medication administration systems place a unique identification number on each medication and patient.¹⁹ Automatic scanning of patient, medication, and staff identification codes ensures that the correct patient, drug, dose, route, and time are administered before administration.¹⁹ The use of this technology has helped reduce administrative errors.¹⁹

Education to Fill Knowledge Gaps

Evidence-based medicine advances rapidly. Formal education is foundational in filling knowledge gaps.^34,38 National databases such as PubMed and clinicaltrials.gov, as well as journals, conferences, quick-reference guides, mobile apps, and brochures, can be useful for lifelong learning.¹⁹ It is important to become familiar with new medications, technologies, and advances in diagnoses before dispensing to ensure patient safety and quality of care.

Pharmacy Workflow Strategies

Pharmacy workflow strategies involve reducing office clutter and minimizing distractions when preparing prescriptions (e.g., answering questions, making or receiving phone calls, accessing the internet).⁴⁸ Incorporate systems such as bar code scanning, drug utilization review, two-step verification process, prescription post-fill auditing, and built-in technologies that provide alerts when medication may be incorrect.”⁴⁸ Workflow deficiencies can be identified by personnel at many levels of the facility. All members of the pharmacy team should feel valued and confident in suggesting constructive improvements to workflow strategies that optimize safety.

Pharmacist-led Educational Interventions

Pharmacist-led educational interventions may reduce medication errors. Educational programs may include brochures, in-services, journal clubs, or training activities presented by a pharmacist.²⁵ Koeck, et al. (2021) cited a study reporting that pharmacist-led educational programs helped reduce the risk of medication errors by about 15.8%.²⁶ In this study, the pharmacist observed staff members administering a drug to a patient and then followed the observation with feedback and education regarding observed risks or errors.^26,49

Pharmacist-led Medication Reconciliation Programs

Medication reconciliation is a process in which a healthcare provider reviews a patient's medication records to reconcile drug administration and identify discrepancies and medication errors.⁵⁰ Pharmacist-led medication reconciliation may reduce medication discrepancies during patient care transitions between providers. Pharmacist-led medication reconciliation reduced health system use (burden), improved medication safety, and decreased the severity of medication errors.⁵¹

Pharmacist-led medication reconciliation steps include reviewing the patient's file from the prior provider and reconciling any medication discrepancies.^50,52 Upon arrival at a facility, a pharmacist may discuss symptoms, medications, and diagnoses with the patient or family in a private setting. The pharmacist or technician, in accordance with applicable laws and protocols, makes phone calls to the patient’s pharmacy and to previous and current providers to verify the information discussed and confirm the patient's current medications and dosages.

One drawback of pharmacist-led medication reconciliation is that it is time-consuming and costly.⁵² Computerized medication reconciliation is an alternative to reduce prescribing errors, but some studies show that computerized medication reconciliation is not as effective as pharmacist-led reconciliation.⁵² Barriers to medication reconciliation include staff time constraints, transcription errors, and reduced access to records when associated pharmacies or prescriber offices are closed, or databases are incomplete.

Technologies such as telehealth and video conferencing, providing virtual healthcare with face-to-face interaction, may overcome some constraints.⁵¹ Telehealth consultation facilitates collaboration and communication among health professionals working together to develop a care plan for the patient and gathers medication information for reconciliation during the interaction.⁵¹

“Rights” of Medication Administration

The rights of medication administration can reduce medication errors.^28,53 The rights of medication administration vary in the number of rights listed.^28,53 The core list provides “five rights” that are required for safe medication ordering and use.

A provider should double-check that the rights of medication administration have been adhered to. The five rights are as follows:⁵³

The drug is being administered to the right patient

The right drug is being administered

The right dose is being administered

The drug is being administered at the right time

The drug is being administered via the right route

In some organizations, additional “rights of medication administration” have been added.”⁵³ One expanded right is the right indication.⁵¹ An indications-based computer prescribing system allows pharmacists to identify drug–indication mismatches,⁵⁴ perform root cause analysis, and make subsequent improvements.⁵³

High-Alert Medications in Acute Care Settings

To avoid medication errors, clinicians should be aware of high-alert medications, including look-alike and sound-alike drugs, as well as common drug abbreviations. A significant number of medication errors in the United States involve name confusion, which can cause serious harm.

Awareness of Error-Prone Abbreviations

Each healthcare facility should have a list of acceptable abbreviations, which should be integrated into electronic prescribing systems and incorporated into staff training. The ISMP provides a List of Error-Prone Abbreviations on its website and has recently been updated as of 2024.⁵⁵ Commonly used abbreviations that can be used mistakenly or misidentified units, such as U (or u), which are easily mistaken for a 0 or 4. The abbreviation SC, intended to mean subcutaneous, is easily mistaken for SL (sublingual). The abbreviation QOD, intended to mean every other day, is easily mistaken for QD (every day).⁵⁴ Although some prescribers still use abbreviations for drug names (e.g., MTX for methotrexate), they are not safe, and abbreviated prescription orders should be verified with the prescriber prior to dispensing.

Medication Errors Reporting Program (MERP)

The Medication Errors Reporting Program (MERP) is a program provided by the United States Pharmacopeia (USP) and the ISMP. The MERP is a nationwide reporting system for actual or potential medication errors.⁵⁶ The MERP includes reports of drug misinterpretations, miscalculations, misadministration, illegible handwritten orders, or misunderstood verbal orders.⁵⁶ The USP reviews these reports, and the information is sent to the FDA and the drug or product manufacturer.⁵⁶ Utilization of resources such as MERP can help reduce or prevent medication errors.

Patient Education

Open-ended questions can help educate patients and encourage dialogue. Patient education about medications is typically provided by pharmacists when patients pick up a prescription or before discharge from a facility.^42,44,52 This education should include “brand and generic names of medications they are receiving, their indications, usual and actual doses, expected and possible adverse effects, drug or food interactions, and how to protect themselves from errors.”⁴⁴

Medication errors can be identified during patient education and counseling. Sometimes, when reviewing a medication with a patient, the indication, dosage, or even the name of the medication may alert the patient to a potential medication error if the information does not match what the provider initially told them. Use the “talk back” approach to communicate effectively with patients, encouraging them to repeat what you just taught them and gauge what they remember.

The CDC recommends that clinicians provide the following safety tips to patients:⁵⁷

Tips for Adults:

Maintain a Medication List: Keep a list of your medicines, vitamins, and other supplements. Make sure your doctor knows about all the medicines, vitamins, and other supplements you take.

Follow Instructions: Take medicines as directed on the label or as instructed by a doctor or pharmacist.

Adhere to Timing: Some medicines should be taken with meals or during a certain time of day (e.g., bedtime). Set timers or reminders to help you remember to take your medicines. You might try a reminder app.

Ensure Visibility: Turn on a light when taking medicines so you do not misread the label and make a mistake. If you wear eyeglasses, put them on as well.

Ask Questions: If you do not understand label instructions, talk to your pharmacist or doctor before taking the medicine.

Monitor Health: Keep up with any blood tests your doctor recommends.

Tips for Caregivers of Children:

Know the Correct Dose: Always read the label and follow dosing instructions carefully. Never exceed the recommended dose on the package.

Check Active Ingredients: Review the active ingredients in both prescription and over-the-counter medications. Avoid giving children multiple medications with the same active ingredient to prevent overdose. Consult a doctor or pharmacist if unsure.

Use Proper Dosing Tools: If you do not have a measuring or dosing device, ask your pharmacist for one. Do not use household spoons to give medicines to children.

Clarify Instructions: If you do not understand the instructions, talk to your pharmacist or doctor before giving the medicine.

Educate youth: Teach children what medicine is and why you or a trusted adult must give it to them.

Secure Medication Caps: Always check that the cap on a medicine bottle is locked.

Store Safely: After locking the safety cap, always return medicines to their safe storage location. Keep medicines in a place that young children cannot reach or see.

Pharmacist Involvement with Over-the-counter (OTC) Medications

Over-the-counter medications pose a significant risk of drug interactions and medication errors that may lead to harm, especially in pediatric and elderly patients.⁵⁸ An estimated one-third of older adults reportedly use OTC drugs, and this percentage increases to one-half with people 75 to 85 years of age.⁵⁸ A 2021 study reported that the use of two or more OTC medications can place one million older adults in physical jeopardy from harms related to these products.⁵⁸

Of the ten drugs most frequently used by the public, four are available OTC.⁵⁹ These are ibuprofen, aspirin, acetaminophen, and diphenhydramine, also available in multi-ingredient preparations, which increases the risk of overdose.⁵⁹

To reduce these risks, pharmacy aisles may be redesigned to facilitate interaction with older adults or parents of young children regarding OTC purchases, thereby decreasing the potential for misuse, interactions, or exposure to information about possible OTC dangers.^58,59 For example, a “Senior Section” may be set up with signage designed for older adults.⁵⁸ The signage should be positioned where it is easier for older adults to read (e.g., at eye level), written in clear language with larger font sizes determined to be appropriate for older adults.⁵⁸ Another solution to reduce OTC confusion is to make it easier for patients or caregivers to read the ingredients in OTC medications.⁵⁸

Risk Management and Reporting Medication Errors

Under federal law, there are voluntary reporting systems for medication errors. For example, the FDA receives voluntary reports at the FDA Adverse Event Reporting System (FAERS).⁶⁰ Some states mandate reporting of medication errors by healthcare facilities, and hospitals and other institutions may have policies requiring medication error reporting.^61,62

In Florida, licensed facilities must have a risk management and incident reporting system:^63-65

Florida Statute, section 395.0197, requires licensed facilities to have a risk management and incident reporting system.⁶³

The risk management plan must require that adverse incidents be reported to the facility risk manager within 3 business days after their occurrence.⁶³

An “adverse event” under Florida Statute, section 395.0197, is an event that results in one of the following injuries:⁶³

Death

Brain or spinal damage

Permanent disfigurement

Fracture or dislocation of bones or joints

A resulting limitation of neurological, physical, or sensory function that continues after discharge from the facility

Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent

Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident

Immediate Actions: If a medication error involves the wrong medication, dosage, or patient, practitioners must notify a supervisor and the prescribing healthcare provider immediately.⁶⁴

The statute specifies that facilities must inform patients of an adverse incident as soon as "practicable."^63,65 Such notification does not constitute an acknowledgment of liability and cannot be introduced as evidence in legal proceedings.

Patient Monitoring: Observe the patient for at least 60 minutes and report any changes in condition to the prescriber.⁶⁴

Emergency Response: They must call 911 to request emergency services if the patient exhibits respiratory difficulty or other potentially life-threatening symptoms.⁶⁴

Facility Reporting: Healthcare facilities must submit an internal report of the incident to the facility administrator and provide the report to the state Regional Office within 24 hours .⁶⁴

Provide an incident report within 15 calendar days to the Florida Agency for Health Care Administration (AHCA).⁶⁴

For medication error reports, the APD Form 65G-7.006 A, effective as of April 2019, is available. A facility may use an alternate medication error report form generated by an electronic system, provided that the alternate electronic form collects all the information required and collected on the Agency form.⁶⁴

Qualified hospital patient safety organizations shall establish a nonpunitive, confidential reporting system to collect data on serious adverse events in hospitals.⁶⁶ Facilities and pharmacies are encouraged to foster a non-punitive, just culture for error reporting to drive system improvements.

This course does not provide legal advice. Pharmacy staff should consult with their employer, a legal advisor, supervisor, online resources, or licensing boards to determine the laws regarding medication errors, incident report requirements, and reporting to governmental entities or patients.

Even if a medication error report is not required, such reports are useful because they enable practitioners to evaluate errors and make improvements. The medication error reduction strategies, discussed above, such as education, training, and changes in pharmacy policies, may then be implemented to prevent future occurrences. Pharmacy personnel should feel confident in identifying and reporting errors without fear of punishment.^62,66

Disclosing Medication Errors to the Patient

When a medication error occurs, must the pharmacist disclose it to the patient? Florida does not require that patients be notified when a medication error occurs in a pharmacy in all circumstances. Most hospital settings have mandatory error reporting requirements, but fewer than half have a policy on error disclosure to patients.⁵¹ Most hospital pharmacists believe they are not responsible for disclosing a medication error.⁶¹

Medication errors should be disclosed to the patient and family when appropriate. While this may be challenging, it is essential for the patient’s well-being and the healthcare system.⁶¹ A pharmacist should consult with their employer, supervisor, or legal advisor to determine their obligation to report a medication error to the patient.

As stated above, this course does not provide legal advice. Pharmacy staff should consult with their employer, a legal advisor, supervisor, or licensing boards to determine the laws regarding medication errors and the requirements for reporting them to patients.

Quality Assurance vs Quality Control Roles

In the pharmacy setting, the separation of Quality Assurance (QA) and Quality Control (QC) roles is essential to minimize errors and enhance patient safety.⁶⁷ Quality Assurance encompasses the overarching management principles that ensure continuous improvement and adherence to standards. At the same time, QC focuses on the specific operational procedures, such as the accuracy and reliability of test results.⁶⁷ Integrating External Quality Assurance (EQA) with QC is crucial, as EQA serves as a monitoring mechanism to assess the effectiveness of QC processes and identify potential errors before they affect patient outcomes. By clearly delineating these roles, pharmacies can better manage the complexities of laboratory testing, thereby reducing the risk of misinterpreting results and ensuring that patient care is consistently based on accurate and reliable data.⁶⁷

Summary

The NCC identifies a medication error as a preventable event involving inappropriate medication use, which potentially may result in patient harm and an adverse drug event. Drug-ordering communication failures and illegible handwriting are among the more common causes of medication errors. Name confusion and dosing-unit errors are also common causes of medication errors. Medication errors can be due to human error; however, more typically, they result from system failures, such as fragmented medication information.

Medication error reduction strategies can include collaborating with healthcare facilities to identify medication error risks and developing pharmacist-led educational interventions and medication reconciliation programs. Pharmacists are an integral part of the healthcare team, and by working together with open communication, medication errors can be greatly reduced or avoided.

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DISCLAIMER

The information provided in this course is general in nature, and it is designed solely to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals must consult their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures to follow. The information provided in this course does not replace those guidelines, protocols, and procedures, but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses is constantly changing. Any person taking this course understands that such a person must make an independent review of medication information before any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

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