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Questions and Answers
What is a primary focus of the article by Nanji (2023) regarding medication administration?
What is a primary focus of the article by Nanji (2023) regarding medication administration?
Which of the following is NOT mentioned in the Kremer et al. (2019) study as a contributing factor to closed malpractice claims?
Which of the following is NOT mentioned in the Kremer et al. (2019) study as a contributing factor to closed malpractice claims?
According to the recommendations made by Wahr et al. (2017), what area requires significant improvement in the operating room?
According to the recommendations made by Wahr et al. (2017), what area requires significant improvement in the operating room?
What type of errors does the article by Welte et al. (2017) specifically focus on within pediatric anaesthesia?
What type of errors does the article by Welte et al. (2017) specifically focus on within pediatric anaesthesia?
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What is the primary regulatory focus of the article by Nahian & Wadhwa (2023)?
What is the primary regulatory focus of the article by Nahian & Wadhwa (2023)?
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Which act established the FDA and required new drug applications?
Which act established the FDA and required new drug applications?
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What key requirement was introduced by the Kefauver-Harris Amendment in 1962?
What key requirement was introduced by the Kefauver-Harris Amendment in 1962?
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What are manufacturers required to adhere to regarding drug safety?
What are manufacturers required to adhere to regarding drug safety?
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Under what condition can dietary supplements be classified as drugs?
Under what condition can dietary supplements be classified as drugs?
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What does the U.S. Pharmacopeia (USP) provide for drug regulation?
What does the U.S. Pharmacopeia (USP) provide for drug regulation?
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What responsibility does a clinician have regarding drug administration?
What responsibility does a clinician have regarding drug administration?
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Which of the following is NOT a focus of the Drug Administration Safety in Anesthesia?
Which of the following is NOT a focus of the Drug Administration Safety in Anesthesia?
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What is a potential outcome for biologics according to U.S. regulations?
What is a potential outcome for biologics according to U.S. regulations?
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What is one of the main risk factors contributing to medication errors in anesthesia care?
What is one of the main risk factors contributing to medication errors in anesthesia care?
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What percentage of medication errors during surgeries are reported to be preventable?
What percentage of medication errors during surgeries are reported to be preventable?
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Which medication errors are commonly associated with intravenous medications?
Which medication errors are commonly associated with intravenous medications?
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Which strategy has been shown to notably reduce adverse drug events in anesthesia care?
Which strategy has been shown to notably reduce adverse drug events in anesthesia care?
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In the prospective observational study regarding drug dilution samples, what percentage of samples deviated more than 10% from the target?
In the prospective observational study regarding drug dilution samples, what percentage of samples deviated more than 10% from the target?
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What common medication types are highly associated with medication errors?
What common medication types are highly associated with medication errors?
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What is a potential error during intravenous medication administration?
What is a potential error during intravenous medication administration?
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In which scenario could a surgical fire potentially occur?
In which scenario could a surgical fire potentially occur?
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Which technology can assist in preventing medication administration errors?
Which technology can assist in preventing medication administration errors?
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What does the strategy of medication reconciliation involve?
What does the strategy of medication reconciliation involve?
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What approach can be taken to reduce distraction during care?
What approach can be taken to reduce distraction during care?
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Which closed claim example highlights the inappropriate administration of medications?
Which closed claim example highlights the inappropriate administration of medications?
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What role does pharmacy strategy play in preventing medication errors?
What role does pharmacy strategy play in preventing medication errors?
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Study Notes
Medication Administration Safety in Anesthesia
- U.S. Federal Drug Regulation: The Food, Drug, and Cosmetic Act (FDCA) of 1938 established the FDA and the New Drug Application (NDA) process.
- The Kefauver-Harris Amendment of 1962 expanded FDA power, requiring "substantial evidence" of safety and effectiveness for new drugs.
- 1984 Dietary Supplement Health and Education Act (DSHEA) established regulations similar to foods for dietary supplements, allowing "qualified" health claims.
- Biologics, derived from living organisms to treat conditions, must demonstrate similar outcomes with no added risk.
- A "drug" is defined as anything meant to treat illness or alter body structure/function (FDCA).
- A device can be categorized as a drug based on intended use.
- Supplements are drugs if they contain medications.
- U.S. Pharmacopeia (USP) sets drug regulations.
Clinician Responsibilities
- Report significant abnormalities, product use faults, and quality issues (pharmaceuticals, biologics, devices, dietary items, and cosmetics) via MedWatch, the FDA's safety reporting program.
- Reporting is not a legal claim.
Medication Errors
- Common medications at risk include opioids, sedatives, antibiotics, vasoactive meds, and muscle relaxants.
- Risk factors are a lack of preventative measures, prolonged procedures, and poor implementation of prevention strategies.
- Error incidence is estimated at 4-11% of surgeries, with 79% preventable.
- Voluntary self-reporting hinders incidence estimates.
- Intravenous medication errors include: calculation errors, repetition of doses, omissions, substitutions, syringe/ampule swaps, wrong routes, labeling mistakes, and administering despite known allergies.
- Medication errors in pediatric anesthesia remain underreported and may result in serious, undiagnosed events.
Strategies for Prevention
- Technology: smart infusion pumps, barcode-assisted tracking, software tracking, unique device connections.
- Standardization: consistent labels, tall man lettering, color-coding, standardized concentrations, storage, and medication tray organization.
- Pharmacy: prefilled syringes, premixed solutions, avoiding multi-use vials, avoiding look-alike medications, and pharmacist consultation.
- Error detection, medication reconciliation, medication verification and appropriate documentation are important preventative measures.
- Minimize distractions, and promote good handoffs between providers.
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Description
This quiz covers key regulations and responsibilities related to medication administration safety in anesthesia. Topics include the FDA's role, the Food, Drug, and Cosmetic Act, and the clinician's responsibilities in reporting issues. Test your knowledge on how these regulations impact patient safety.
