Drug Allergies and ADR

Which of the following is a tool used by the FDA to reduce adverse drug reactions?

What term encompasses all unintended pharmacologic effects of a drug when administered correctly and at recommended doses?

Which of the following is a drug commonly associated with severe skin reactions?

What term is used to refer to a rash or reaction that causes itching?

What is the estimated percentage of ADRs that are accounted for by Type A reactions?

Which type of reaction is generally unrelated to the pharmacologic actions of the drug and not dose-dependent?

What do boxed warnings indicate?

Which patient group is mentioned as more susceptible to ADRs due to experiencing nephrotoxicity from aminoglycoside use?

What is the approximate number of deaths reported with the FDA in 2018 due to ADRs?

What are drug allergies classified into?

What do contraindications indicate?

What is the total number of ADR reports logged with the FDA in 2018?

Which type of reaction is dose-dependent and related to the known pharmacologic actions of the drug?

What is the primary purpose of FDA boxed warnings?

What is the classification of immediate reactions in drug allergies?

What is the relationship between ADR severity and drug dosage/reduced clearance?

Which system serves as a central collection point for drug-related problems?

What is the FDA-approved patient handout for over 300 medications called?

Which scale is used for assessing the causality of adverse drug reactions?

What program is used for reporting vaccine-related adverse events?

Which phase focuses on post-marketing safety surveillance programs for approved drugs and biologics?

What is used for the exclusion of high-risk patients in clinical trials and the importance of real-world post-marketing reports?

What is required by the FDA for certain drugs to mitigate risks?

What is the system for reporting side effects, adverse events, and allergies to the FDA?

What differentiates drug intolerance and drug allergy?

What does the FDA collect and analyze to better understand drug safety profiles in real-world settings?

What focuses on contraindications for using Evista due to the risk of venous thromboembolism?

What is the differentiation between drug intolerance and drug allergy based on?

Which of the following is a correct statement about adverse event reporting?

What is the consequence of the FDA receiving enough reports linking a drug to a particular problem?

What is the purpose of the MedWatch form used for reporting adverse events?

What led to the FDA requiring the manufacturer to update the prescribing information for Oseltamivir (Tamiflu)?

How are intolerances different from allergies?

What should be done if a patient reports an intolerance to a drug?

What is the potential consequence of reporting an intolerance incorrectly as a drug allergy?

What is the purpose of phase IV monitoring of drug usage?

What is the FDA evaluating in the case of Dulaglutide (Trulicity)?

What is the most appropriate way to categorize stomach upset or nausea caused by a drug?

Adverse drug reactions (ADRs) are always dose-dependent and related to the known pharmacologic actions of the drug.

The FDA's Boxed Warnings are used to indicate contraindications, warnings, and precautions for a drug.

Medication Guides are used to assess the causality of an adverse drug reaction.

Type B Reactions are generally unrelated to the pharmacologic actions of the drug and not dose-dependent.

Community-based adverse event reporting is not important for safe medication use.

The FDA does not require drug manufacturers to send adverse event reports to them.

Intolerances are immune system responses that can range from mild to severe.

Allergies can only affect one area of the body.

Stomach upset or nausea caused by a drug should always be categorized as an allergy.

The FDA may issue a drug safety alert before requiring a labeling update in especially risky cases.

The FDA required the manufacturer to update the prescribing information for Oseltamivir (Tamiflu) due to reports of unusual behavior in children.

Stomach upset or nausea caused by a drug is more accurately categorized as an intolerance.

A patient who reported getting a stomach ache from Chantix is an example of an allergy, not an intolerance.

Stomach upset or nausea caused by a drug is an allergy and should prevent drugs in the same class from being used.

Patients can report adverse events to the drug manufacturer, who is not required to send the report to the FDA.

Drug intolerances should be avoided if possible, as they are less serious complaints.

ADRs are always related to medication errors

Type B reactions are generally dose-dependent and related to the known pharmacologic actions of the drug

Drug allergies are not classified into different types

Boxed warnings indicate a risk of death or permanent disability from a drug

Contraindications indicate that the drug should be used under specific circumstances

Understanding ADRs is not crucial in ensuring patient safety and effective medication management

The majority of ADRs are accounted for by Type B reactions

Immediate (Type I) reactions are examples of Type B reactions

FDA tools to reduce ADRs include only contraindications

Boxed warnings can be due to prescribing or dispensing errors

Type A reactions are generally dose-dependent and related to the known pharmacologic actions of the drug

Some patients are more susceptible to ADRs, such as those with underlying renal impairment

Risk Evaluation and Mitigation Strategies (REMS) are only required for new drugs and not for existing ones.

Naranjo Scale is used for assessing the severity of adverse drug reactions.

Medication Guides (MedGuides) are only available for prescription medications and not for over-the-counter drugs.

The FDA Adverse Event Reporting System (FAERS) is primarily used for collecting reports related to vaccine-related adverse events.

Phase IV post-marketing safety surveillance programs are typically designed to exclude high-risk patients in order to focus on the general population.

The VAERS program is used for reporting side effects, adverse events, and allergies to the FDA MedWatch program.

The FDA's collection and analysis of reports are mainly focused on understanding drug safety profiles in controlled clinical trial settings.

The Naranjo Scale is used to assess the causality of adverse drug reactions based on a patient's medical history.

Reporting of side effects, adverse events, and allergies to the FDA MedWatch program is mandatory for healthcare providers but optional for patients.

Pharmacovigilance primarily focuses on the pre-marketing assessment of drug safety and efficacy.

The Exclusion of high-risk patients in clinical trials is not considered important for real-world post-marketing reports.

The FDA's collection and analysis of reports is primarily focused on understanding drug safety profiles in controlled clinical trial settings.

Match the following terms with their definitions:

Match the following drugs with their associated adverse reactions:

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Match the FDA tool with its purpose in reducing adverse drug reactions:

Match the following patient characteristics with their susceptibility to adverse drug reactions:

Match the following terms with their definitions:

Which type of reaction can occur with sun exposure and some medications, appearing as a red, itchy rash that can spread to areas not exposed to sun and occurs within days of sun exposure?

What is the recommended action when dispensing medications that can cause photosensitivity?

What is the primary cause of itching and hives in some patients when opioids are administered to opioid-naive patients or when non-naive patients receive higher-than-normal doses?

Which medication is recommended as a pre-medication to reduce or avoid pruritus caused by opioids or other sources?

What is the purpose of penicillin skin testing?

What does a localized reaction around the Pre-Pen or penicillin G test site indicate?

What type of reaction does penicillin skin testing predict?

When is induction of drug tolerance (desensitization) recommended?

What is the purpose of induction of drug tolerance (desensitization)?

What should be the immediate action following the desensitization procedure?

What could occur if doses are missed following desensitization?

What term is more accurate than desensitization to describe the process of induction of drug tolerance?

When should desensitization be avoided?

Where must the desensitization procedure take place?

What is the recommendation for a pregnant patient with syphilis and a penicillin allergy?

What is the recommended injection site for epinephrine auto-injectors?

Which of the following drugs is considered safe in patients with penicillin allergies?

What can occur after injection of an epinephrine auto-injector?

What is the purpose of a medical identification bracelet for patients with serious allergies or medical conditions?

Which of the following is true about the storage of epinephrine auto-injectors?

What is the first-line treatment for anaphylactic reactions?

Which of the following is a possible symptom of anaphylactic reactions?

What is the recommended angle for injecting epinephrine auto-injectors?

What should patients with serious allergies or medical conditions do in case of an emergency?

Which of the following is true about the administration of epinephrine auto-injectors?

What is recommended for patient counseling regarding epinephrine auto-injectors?

What is the most reliable way to determine drug allergies for certain types of rashes like SJS or TEN?

Which of the following drugs is NOT commonly associated with severe skin reactions?

What is the approximate time frame for the occurrence of SJS and TEN after drug administration?

Which of the following is NOT a symptom of anaphylaxis?

What is the primary treatment for anaphylaxis?

Which type of drug reaction involves excessive histamine release upon subsequent exposure?

What is the recommended immediate treatment for pseudoallergic reactions?

Which of the following drugs is associated with pseudoallergic reactions?

What is the primary purpose of epinephrine in the treatment of anaphylaxis?

What is the consequence of DRESS?

What is the primary purpose of plasma exchange in treating TTP?

What distinguishes pseudoallergic reactions from anaphylaxis?

Which of the following is a symptom of SJS and TEN?

What is the recommended action when a negative skin test result for penicillin allergy is obtained?

What is the consequence of using broad-spectrum antibiotics when penicillin allergy is reported?

In which situation is testing and desensitization necessary for penicillin allergy?

What is the possibility for tolerance of cephalosporins in patients with penicillin allergy?

Which type of reactions can NSAIDs lead to?

What is the warning regarding the use of sulfa drugs in patients with sulfa allergy?

What is the commonality between opioid intolerance and true opioid allergy?

What type of reactions can contrast media used in CT scans cause?

What is the potential cross-reactivity for patients with peanut allergies?

What can biologies such as rituximab cause?

What is the potential consequence of using sulfites in certain medications for patients with sulfite allergies?

What can be tolerated for some agents that cause hypersensitivity reactions?

Opioids can cause a non-allergic release of histamine from mast cells in the skin, leading to itching and hives in some patients.

Photosensitivity can cause tissue damage that looks like a severe sunburn on sun-exposed areas, and it occurs within hours of sun exposure.

Patients should limit sun exposure and use broad-spectrum sunscreens when taking medications that can cause photosensitivity.

Patients pre-medicated with an antihistamine, such as diphenhydramine, may not experience pruritus due to the non-allergic release of histamine caused by opioids.

Thrombotic Thrombocytopenic Purpura (TTP) is a blood disorder that causes clot formation, platelet consumption, and bleeding under the skin.

Severe skin reactions caused by drugs include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

SJS and TEN involve epidermal detachment and skin loss, leading to severe mucosal erosions, high body temperature, and organ damage.

DRESS includes skin eruptions accompanied by fever, hepatic and renal dysfunction, requiring stopping the offending agent and sometimes worsening after discontinuation.

Anaphylaxis, a severe, life-threatening allergic reaction, can occur within seconds to minutes of drug exposure, even with the first exposure, and requires immediate treatment with epinephrine.

Drugs commonly associated with severe skin reactions include clopidogrel, carbamazepine, and ibuprofen.

In cases of anaphylaxis, epinephrine is used to reverse bronchoconstriction, while antihistamines and systemic steroids can counteract histamine release and decrease swelling.

In pseudoallergic reactions, treatment involves stopping the offending drug, using antihistamines, systemic steroids, and sometimes NSAIDs to decrease swelling.

Some medications, like phytonadione and contrast media, are associated with pseudoallergic reactions, treated similarly to anaphylaxis, despite not being IgE-mediated.

Drug allergies can be treated similarly to non-drug allergies, with epinephrine auto-injectors and instructions provided by pharmacists.

Common drugs causing TTP include NSAIDs, quinine, and tetracyclines.

Drug allergies, such as those caused by penicillins and sulfonamides, result from prior exposure, causing Type I hypersensitivity reactions and excessive histamine release upon subsequent exposure.

Penicillin skin testing uses the components of penicillin that most often cause an immune (allergic) response.

A patient with a negative skin test can be considered to be at the same risk as a patient in the general population who does not report a penicillin allergy.

Desensitization is a process that cures the patient of an allergy and removes the reaction from the patient's medical record.

Desensitization should never be attempted if an agent has previously caused SJS or TEN.

Desensitization protocols exist for a number of antimicrobial agents, some biologies, and a few other medications such as aspirin.

Induction of drug tolerance is a more accurate term than desensitization to describe the process.

The desensitization procedure must take place in a medical setting where emergency care can be provided if a serious reaction occurs.

A patient should never be re-challenged with an agent that caused SJS or TEN, regardless of the skin test results.

Penicillin skin testing only predicts an IgE-mediated reaction.

The desensitization process allows the immune system to re-sensitize to the drug if doses are missed.

Desensitization is recommended when no acceptable alternative medication is available.

The CDC recommends desensitization and penicillin treatment for a pregnant patient with syphilis and a penicillin allergy, rather than using second-line agents.

The true incidence of IgG-mediated penicillin allergy is approximately 1%.

Reporting penicillin allergy leads to use of narrow-spectrum antibiotics, reducing resistance and cost.

Negative penicillin skin test result should be followed by an oral drug challenge dose.

Positive penicillin skin test result or past severe skin reaction indicates the drug should not be given.

Many cephalosporins can be safely tolerated despite penicillin allergy in acute otitis media infection.

Biologies like rituximab can cause hypersensitivity reactions, and desensitization is possible for some patients.

NSAID reactions can cause rhinitis, mild asthmatic-type reactions, or skin reactions.

COX-2 selective NSAIDs may be used in practice, but it is prudent to avoid all NSAIDs on the NAPLEX exam.

Reactions to sulfamethoxazole are commonly reported, and some drugs contain warnings for use in patients with sulfa allergy.

Sulfite or sulfate allergies do not cross-react with sulfonamides.

True opioid allergy is uncommon, opioid intolerance due to histamine release is common.

Contrast media used in CT scans can cause anaphylactoid reactions and delayed skin reactions.

Patients with serious allergies or medical conditions should wear a medical identification bracelet linked to a 24-hour information center

Refrigeration is required for epinephrine auto-injectors, and they cannot be injected through clothing

Anaphylactic reactions can present with generalized urticaria, swelling of the mouth and throat, difficulty breathing, abdominal cramping, and hypotension, requiring immediate treatment

Symjepi and Auvi-Q have specific dosages for different weight ranges

Epinephrine auto-injectors should be injected into the middle of the outer thigh at a 90-degree angle and emergency help should be sought

Patch testing by an allergist is the most reliable way to determine drug allergies, but it may not provide information for certain types of rashes like SJS or TEN

Aztreonam is considered safe in patients with penicillin allergies

Some drugs, such as penicillin and cephalosporins, can cause allergic reactions, and cross-reactivity may occur

Anaphylaxis treatment includes epinephrine injection, diphenhydramine, steroids, and IV fluids, with instructions to call 911

Patients should be instructed to inject into the middle of the outer thigh at a 90-degree angle and seek emergency help

Skin infections can occur after injection, and prolonged redness, swelling, or tenderness at the injection site should be reported

Epinephrine auto-injectors such as EpiPen, EpiPen Jr, Auvi-Q, Adrenaclick, Symjepi are available in different dosages and administration techniques

Match the following drug reactions with their descriptions:

Match the following drugs with their association with photosensitivity:

Match the following preventive measures with their corresponding recommendations:

Match the following types of reactions with their time frame of occurrence:

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Match the following types of adverse drug reactions with their descriptions:

Match the severe skin reaction with the corresponding drug:

Match the drug allergy with the corresponding reaction type:

Match the symptom with the corresponding severe allergic reaction:

Match the following symptoms with their correct description:

Match the following epinephrine auto-injectors with their correct dosages and administration techniques:

Match the following statements about epinephrine auto-injectors with their correct information:

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Match the following statements about drug allergies and adverse drug reactions with their correct descriptions:

Match the following adverse reactions with their associated drugs or substances:

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What is the approximate incidence of IgG-mediated penicillin allergy according to CDC reports?

What is the recommended action if a negative skin test result is obtained for penicillin allergy?

What is necessary if a patient has penicillin allergy and syphilis in pregnancy or HIV?

Which type of reactions can NSAIDs cause, leading to urticaria, angioedema, and anaphylaxis?

What is the consequence of sulfa drug use in patients with sulfa allergy?

What is the common manifestation of opioid intolerance due to histamine release?

What can contrast media used in CT scans cause?

What can have cross-reactivity with peanuts in some patients?

What is a possible consequence of biologies such as rituximab?

What is the primary purpose of an epinephrine autoinjector for patients with peanut allergies?

What can cause anaphylactoid reactions and delayed skin reactions in CT scans?

What should be done if a patient reports penicillin allergy and requires antibiotics for acute otitis media infection?

Explain the difference between Type A and Type B adverse drug reactions and provide an example of each type.

Describe the purpose and significance of boxed warnings for medications. Provide an example of a medication with a boxed warning.

Explain the process of skin testing and desensitization in the context of drug allergies. Provide an example of a drug for which skin testing and desensitization may be used.

What are the common manifestations of opioid intolerance due to histamine release? Provide an example of an opioid medication that may cause these manifestations.

1. What is the purpose of community-based adverse event reporting?

2. Provide an example of how ADR incidence in real life may differ from clinical trial findings.

3. What are the implications of voluntary adverse event reporting by healthcare professionals and patients?

4. How did ADR reports lead to FDA requirement for safety labeling changes for Oseltamivir (Tamiflu)?

5. What is an example of an adverse event reported as an intolerance rather than an allergy?

6. Describe an example of an intolerance being reported incorrectly as a drug allergy.

7. What is the difference between an intolerance and an allergy in the context of adverse drug reactions?

8. How can electronic medical records facilitate the documentation of intolerances and allergies?

9. What is the FDA evaluating in the case of Dulaglutide (Trulicity) based on adverse event reports?

10. What are the implications of adverse event reporting for drug manufacturers and prescribers?

11. What is the significance of the FDA's evaluation of adverse event reports for drugs like Dulaglutide (Trulicity)?

12. How can adverse event reporting contribute to the post-marketing surveillance of medications?

Explain the difference between adverse drug reactions (ADRs) and medication errors. Provide an example of each from the text above.

What are Type A and Type B reactions in the context of ADRs? Provide examples of each from the text.

What are some FDA tools to reduce ADRs? Provide examples of these tools and their purposes.

Why is understanding ADRs and medication errors crucial for patient safety and effective healthcare management?

Explain the difference between predictable (Type A) and unpredictable (Type B) ADRs. Provide examples of each from the text.

What are some patient-specific factors that can influence Type B reactions? Provide examples from the text.

Provide an example of a medication error mentioned in the text and explain its impact on patient safety.

What are some examples of Type B reactions mentioned in the text? Explain the characteristics of Type B reactions.

How are drug allergies classified, and what are the characteristics of Type I reactions?

What are boxed warnings, and what is their purpose in reducing ADRs?

Explain the difference between drug allergies and pseudoallergic reactions. Provide examples from the text.

What are some patient-specific factors that can influence Type B ADRs? Provide examples from the text.

Explain the purpose of Risk Evaluation and Mitigation Strategies (REMS) and its components, as mentioned in the text.

What is the Naranjo Scale used for, and what specific criteria and scoring does it involve?

Why is it important to differentiate between intolerance and drug allergy, and what specific questions can help in this differentiation?

Describe the process of reporting side effects, adverse events, and allergies to the FDA's MedWatch program and the specific reporting system for vaccines (VAERS).

What is the significance of the FDA's collection and analysis of reports from Phase IV post-marketing safety surveillance programs for approved drugs and biologics?

Discuss the potential impact of adverse drug reactions in real-world settings, and why comprehensive pharmacovigilance is necessary.

Explain the requirement of Medication Guides for over 300 medications, and provide examples of the types of medications for which Medication Guides are required.

Why is the exclusion of high-risk patients in clinical trials important, and what role do post-marketing reports play in identifying less frequent side effects?

What is the potential impact of understanding the drug safety profile in a real-world setting through post-marketing surveillance?

Discuss the potential consequences of contraindications for using certain drugs, such as Evista in a patient with a history of venous thromboembolism.

Explain the importance of comprehensive pharmacovigilance in ensuring patient safety and monitoring the real-world impact of medications.

Why is it important to assess the likelihood of a drug causing an adverse reaction using the Naranjo Scale, and what are the implications of the scoring?

What are some adverse reactions to opioids related to skin and how can they be managed?

What is photosensitivity and how can it manifest as a reaction to certain medications?

What drugs are commonly associated with photosensitivity, and what precautions should be taken when dispensing these medications?

How do opioids contribute to pruritus in patients, and what measures can be taken to reduce or avoid pruritus?

1. What are the symptoms of anaphylaxis that require immediate treatment?

2. What should patients at risk of anaphylaxis carry for future emergencies?

3. Where should epinephrine auto-injectors be administered?

4. Is refrigeration required for epinephrine auto-injectors?

5. What should patients inform family and caregivers of regarding the auto-injector?

6. What should patients be cautious of during injection of epinephrine auto-injectors?

7. What can occur after injection of an epinephrine auto-injector?

8. What are some drugs that can lead to allergic reactions?

9. What is considered safe for patients with penicillin allergies?

10. What can help determine true drug allergies?

11. What is the risk of cross-reactivity for cephalosporins in penicillin-allergic patients?

12. What should patients with severe allergies or medical conditions wear for emergency responders' awareness?

Which skin lesions are associated with Thrombotic Thrombocytopenic Purpura (TTP)?

What are the severe skin reactions caused by drugs mentioned in the text?

Which medications, generally considered safe, have been associated with severe skin reactions?

What are the potential consequences of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)?

What systemic symptoms can accompany skin eruptions in Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)?

What are the common culprits of drug allergies causing Type I hypersensitivity reactions?

What is the timeline for the occurrence of anaphylaxis after drug exposure?

Name some drugs commonly associated with severe skin reactions.

What are some other drugs associated with severe skin reactions mentioned in the text?

What similarities exist between the clinical appearance and treatment of pseudoallergic reactions and anaphylaxis?

What is the potential consequence of using broad-spectrum antibiotics when penicillin allergy is reported?

What are the potential symptoms of anaphylactic reactions?

Explain the discrepancy between reported penicillin allergy incidence and true IgG-mediated reaction incidence.

What is the recommended course of action after a negative penicillin skin test?

When is desensitization recommended for biologies like rituximab?

Explain the cross-reactivity risks between peanuts and soy, and their implications for medication use.

What is the risk associated with opioid intolerance and true allergy?

What is the recommended approach if a patient has a positive penicillin skin test or severe skin reaction?

Explain the relationship between penicillin allergy reporting and antibiotic resistance.

When can cephalosporins be tolerated despite a penicillin allergy?

What is the recommended action for patients with NSAID sensitivity or true allergic reactions?

What is the potential consequence of reporting a false penicillin allergy?

Explain the common reactions to contrast media and the implications for patient care.

What is the recommended approach for patients with sulfamethoxazole allergy and potential cross-reactivity risks?

What is the goal of penicillin skin testing?

What does a localized reaction around the Pre - Pen or penicillin G test site indicate?

What does skin testing predict?

When is induction of drug tolerance (desensitization) recommended?

What is the step-wise process of desensitization?

What is the more accurate term than desensitization for the process of modifying the patient's response to a medication?

Where must the desensitization procedure take place?

What should happen immediately following the desensitization procedure?

What could occur if doses are missed after desensitization?

Should desensitization be attempted if an agent has previously caused SJS or TEN?

What does the CDC recommend for a pregnant patient with syphilis and a penicillin allergy?

Where can the guidelines and references for drug allergy be found?