Adverse Events and Errors in Healthcare

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.