Adverse Events and Errors in Healthcare

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Questions and Answers

What is an adverse event in medical care?

An intentional injury resulting from medical care

An unintended injury resulting from or contributed to by medical care (correct)

A side effect of a medication that is always preventable

A desired outcome of a medical treatment

What is the difference between an adverse drug event and an adverse drug reaction?

An adverse drug event is an unintended response to a medication, while an adverse drug reaction is a side effect

An adverse drug event is always preventable, while an adverse drug reaction is not

An adverse drug event is related to medication dispensing, while an adverse drug reaction is related to medication use (correct)

An adverse drug event is a type of adverse drug reaction

What is an example of an adverse drug event?

A patient experiencing a medication allergy

A patient receiving a medication in a manner that was inappropriate (correct)

A patient experiencing a side effect from a medication

A patient not experiencing a desired outcome from a medication

What is a characteristic of adverse drug reactions?

They are expected negative outcomes inherent to the pharmacologic action of the drug Signup and view all the answers

What is the outcome of an adverse event in medical care?

It requires additional monitoring, treatment, or hospitalization Signup and view all the answers

Are adverse drug reactions the same as side effects?

No, they are different Signup and view all the answers

What is the primary focus of the Institute for Safe Medication Practices (ISMP)?

Medication error reporting and prevention Signup and view all the answers

According to the National Coordinating Council for Medication Error Reporting and Prevention, what is a medication error?

A preventable event that may cause or lead to inappropriate medication use or patient harm Signup and view all the answers

What is the estimated number of Americans harmed by medication errors annually, according to the Institute of Medicine?

More than 1.5 million Signup and view all the answers

Which of the following is an example of a medication error?

A nurse administering Humalog U-100 insulin instead of the influenza vaccine Signup and view all the answers

What is the purpose of the Joint Commission's sentinel event definition?

To describe unexpected occurrences involving death or serious injury Signup and view all the answers

What is the role of the pharmacist in medication safety, according to the Institute of Medicine?

Ensuring safe and high-quality care Signup and view all the answers

What is a medication misadventure?

An iatrogenic incident inherent to medication therapy Signup and view all the answers

What is the primary goal of the National Coordinating Council for Medication Error Reporting and Prevention?

To reduce medication errors Signup and view all the answers

What is the Institute for Safe Medication Practices (ISMP) known for?

Running a national voluntary practitioner medication error reporting program Signup and view all the answers

What can a sentinel event include, according to the Joint Commission?

All forms of medication misadventure Signup and view all the answers

What is the primary goal of the Pharmacists' Patient Care Process?

To optimize patient health and medication outcomes Signup and view all the answers

What is the contraindication for metformin in terms of renal function?

CrCl < 30 mls/min Signup and view all the answers

What is the term for medications that are similar in appearance or sound?

LASA Signup and view all the answers

What is the highest level of medication warning assigned by the FDA?

Boxed warning Signup and view all the answers

What is the role of pharmacists in ensuring medication safety?

To have a key role in ensuring medication safety Signup and view all the answers

What is the purpose of a REMS program?

To monitor high-alert medications Signup and view all the answers

What is a common feature of look-alike medications?

Similar packaging Signup and view all the answers

What is the primary reason for the confusion between Timolol maleate ophthalmic 0.5% solution and its generic formulation?

Similar packaging and dropper bottles Signup and view all the answers

What is the potential risk of using the once-daily formulation of Timolol maleate ophthalmic 0.5% solution twice daily?

Increased systemic absorption, with the potential risk of adverse cardiovascular events Signup and view all the answers

What is the primary reason for the mistake in the heparin vial concentration?

Similar packaging and volume Signup and view all the answers

What is the consequence of the nurse's mistake in the labor and delivery unit?

The patient developed tachycardia and severe hypertension Signup and view all the answers

What is a characteristic of sound-alike medications?

Similar names or phonetics Signup and view all the answers

What is the consequence of confusing the once-daily formulation with the twice-daily formulation of Timolol maleate ophthalmic 0.5% solution?

The patient's condition was not effectively treated Signup and view all the answers

What is the reason for the mistake in the administration of ephedrine in the labor and delivery unit?

The resident's behavior was distracting Signup and view all the answers

What is the purpose of the organization that identified the problem with the look-alike packaging of Timolol maleate ophthalmic 0.5% solution?

To identify and prevent medication errors Signup and view all the answers

What is the potential consequence of using the wrong concentration of heparin?

Overdose Signup and view all the answers

What is the main reason for the medication error in the LASA example?

The pharmacy filled the prescription with the wrong medication Signup and view all the answers

What is the difference between SR, CR, ER, LA, and XL formulations?

The release mechanism of the medication Signup and view all the answers

What is polypharmacy defined as?

Taking five or more medications chronically Signup and view all the answers

What is the purpose of a boxed warning on a medication?

To indicate the highest safety-related warning assigned by the FDA Signup and view all the answers

What is the goal of the isotretinoin REMS?

To prevent fetal exposure to isotretinoin and inform prescribers, pharmacists, and patients about its serious risks Signup and view all the answers

What is the prescriber's responsibility in the isotretinoin REMS?

To assess the patient's reproductive status and counsel patients on the risks of the medication Signup and view all the answers

What is the pharmacist's responsibility in the isotretinoin REMS?

To enroll the patient in the iPLEDGE REMS Signup and view all the answers

What is the purpose of the package insert?

To provide information on the medication's use and safety Signup and view all the answers

What is the result of post-marketing surveillance reports?

A boxed warning is assigned to the medication Signup and view all the answers

What is the risk of isotretinoin in pregnant women?

High-risk of life-threatening birth defects Signup and view all the answers

Study Notes

Adverse Events and Medication Errors

Adverse event: unintended injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization, or that results in death.
Can be preventable or non-preventable.

Adverse Drug Events and Reactions

Adverse drug event: patient suffers a negative consequence from receiving a medication in the manner it was intended, not receiving a required medication, or receiving a medication in a manner that was inappropriate.
Can be preventable or non-preventable.
Adverse drug reaction: response to a medication that is unintended or undesired, and occurs at doses normally used in humans for prophylaxis, diagnosis, treatment of disease, or modification of physiological function.
Adverse drug reactions are expected negative outcomes inherent to the pharmacologic action of the drug and are not always preventable.

Medication Errors and Misadventures

Medication error: 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.
Medication misadventure: an iatrogenic incident that is inherent to medication therapy, including medication errors, adverse drug events, and adverse drug reactions.

Sentinel Events and Medication Safety

Sentinel event: unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof, which may include medication misadventures.
Role of the pharmacist in medication safety: ensuring safe and high-quality care, including identifying and preventing medication errors.
According to the Institute of Medicine, more than 1.5 million Americans are harmed every year by medication errors in hospitals, nursing homes, and doctor's offices.

Pharmacists' Patient Care Process

Used to optimize patient health and medication outcomes, especially for high-alert medications.
Applies patient-centered care, including collecting patient data, designing an education and monitoring plan, and monitoring for safety.

Look-Alike, Sound-Alike (LASA) Medications

Look-alike medications: visually similar packaging, shape, color, or size.
Sound-alike medications: similar names, doses, or strengths.
Confusion can occur between brand-brand, brand-generic, or generic-generic names.
Examples of LASA medications include Timolol maleate ophthalmic solution, Heparin, and Ephedrine-Epinephrine.

Other Safety Considerations

Unique dosing frequency: examples include Methotrexate, Bisphosphonates, and Warfarin.
Differing formulations: examples include SR, CR, ER, LA, and XL.
Polypharmacy: defined as taking five or more medications chronically, particularly prevalent in the elderly and individuals with diabetes and/or heart disease.
Package insert: provides important information to healthcare professionals, including boxed warnings, full prescribing information, and REMS.
Boxed warnings: the highest safety-related warning assigned by the FDA, often resulting from post-marketing surveillance reports.
REMS: risk evaluation and mitigation strategy, which helps ensure benefits of taking a medication outweigh the risks, especially for high-risk medications like isotretinoin.

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Description

Test your knowledge of adverse events, near misses, and errors in medical care. Learn about the definitions and types of adverse events, including preventable and non-preventable ones, and how they can be ameliorated or cause permanent harm. Reference: Agency for Healthcare Research and Quality.