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Drug Allergies and ADR
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Drug Allergies and ADR

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Questions and Answers

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

  • Contraindications
  • Medication Guides
  • Boxed Warnings
  • Risk Evaluation and Mitigation Strategies (correct)

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

  • Contraindications
  • Boxed Warnings
  • Adverse Drug Reactions (correct)
  • Medication Guides

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

  • NSAIDs
  • Peanuts and Soy
  • Contrast Media
  • Heparin (correct)

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

    <p>Pruritus</p> Signup and view all the answers

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

    <p>80%</p> Signup and view all the answers

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

    <p>Type B reaction</p> Signup and view all the answers

    What do boxed warnings indicate?

    <p>Risk of death or permanent disability from a drug</p> Signup and view all the answers

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

    <p>Patients with underlying renal impairment</p> Signup and view all the answers

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

    <p>200,000</p> Signup and view all the answers

    What are drug allergies classified into?

    <p>Four types</p> Signup and view all the answers

    What do contraindications indicate?

    <p>Drug should not be used under specific circumstances</p> Signup and view all the answers

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

    <p>1,000,000</p> Signup and view all the answers

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

    <p>Type A reaction</p> Signup and view all the answers

    What is the primary purpose of FDA boxed warnings?

    <p>To warn about potential risks of death or permanent disability</p> Signup and view all the answers

    What is the classification of immediate reactions in drug allergies?

    <p>Type I</p> Signup and view all the answers

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

    <p>Severity increases at higher doses/reduced clearance</p> Signup and view all the answers

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

    <p>FDA Adverse Event Reporting System (FAERS)</p> Signup and view all the answers

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

    <p>Medication Guides (MedGuides)</p> Signup and view all the answers

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

    <p>Naranjo Scale</p> Signup and view all the answers

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

    <p>VAERS</p> Signup and view all the answers

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

    <p>Phase IV</p> Signup and view all the answers

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

    <p>Real-world post-marketing reports</p> Signup and view all the answers

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

    <p>Risk Evaluation and Mitigation Strategies (REMS)</p> Signup and view all the answers

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

    <p>FDA MedWatch program</p> Signup and view all the answers

    What differentiates drug intolerance and drug allergy?

    <p>Clinical symptoms</p> Signup and view all the answers

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

    <p>Reports</p> Signup and view all the answers

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

    <p>Evista's medication guide</p> Signup and view all the answers

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

    <p>Immune system response</p> Signup and view all the answers

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

    <p>Reporting adverse events to the drug manufacturer is voluntary.</p> Signup and view all the answers

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

    <p>The manufacturer can be required to update the labeling.</p> Signup and view all the answers

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

    <p>Reporting problems with biologies, medical devices, some dietary supplements and cosmetics.</p> Signup and view all the answers

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

    <p>Receiving enough reports of unusual behavior in children.</p> Signup and view all the answers

    How are intolerances different from allergies?

    <p>Allergies should be listed on the patient profile.</p> Signup and view all the answers

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

    <p>The drug should be avoided in the future.</p> Signup and view all the answers

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

    <p>The patient may receive an incorrect treatment.</p> Signup and view all the answers

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

    <p>To evaluate the need for regulatory action.</p> Signup and view all the answers

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

    <p>The need for regulatory action due to serious hypersensitivity reactions.</p> Signup and view all the answers

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

    <p>As an intolerance.</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

    Allergies can only affect one area of the body.

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    ADRs are always related to medication errors

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

    Drug allergies are not classified into different types

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    Contraindications indicate that the drug should be used under specific circumstances

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

    The majority of ADRs are accounted for by Type B reactions

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

    FDA tools to reduce ADRs include only contraindications

    <p>False</p> Signup and view all the answers

    Boxed warnings can be due to prescribing or dispensing errors

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Urticaria = A rash with red/pinkish raised patches. The patches have varied shapes and sizes. Pruritis = Any rash or reaction that causes itching can be referred to as with pruritus. Contraindications = Indications that a drug should not be used in certain patients or conditions due to the potential for harm. Boxed Warnings = FDA warnings indicating that the drug carries a significant risk of serious or life-threatening adverse effects.</p> Signup and view all the answers

    Match the following drugs with their associated adverse reactions:

    <p>NSAIDs = Commonly associated with severe skin reactions Heparin = Commonly associated with allergic reactions Peanuts and Soy = Commonly associated with allergic reactions Contrast Media = Commonly associated with severe skin reactions</p> Signup and view all the answers

    Match the following terms with their descriptions:

    <p>Type A Reactions = Dose-dependent and related to the known pharmacologic actions of the drug Type B Reactions = Not dose-dependent and not related to the known pharmacologic actions of the drug Medication Guides = Provide specific information about the drug and its use, including the risks and benefits Risk Evaluation and Mitigation Strategies (REMS) = Required for certain drugs to ensure the benefits of the drug outweigh its risks</p> Signup and view all the answers

    Match the following terms with their explanations:

    <p>Anaphylaxis = A severe, potentially life-threatening allergic reaction Naranjo Scale = Used for assessing the causality of adverse drug reactions based on a patient's medical history FDA Tools to Reduce Adverse Drug Reactions = Include Boxed Warnings, Contraindications, and Risk Evaluation and Mitigation Strategies Desensitization = The process of inducing drug tolerance in individuals with drug allergies</p> Signup and view all the answers

    Match the following with their respective descriptions:

    <p>Risk Evaluation and Mitigation Strategies (REMS) = Required by the FDA for certain drugs to mitigate risks Naranjo Scale = Used for assessing causality of adverse drug reactions FAERS = Central collection point for drug-related problems Medication Guides (MedGuides) = FDA-approved patient handouts for over 300 medications</p> Signup and view all the answers

    Match the following with their respective descriptions:

    <p>VAERS = Program for reporting vaccine-related adverse events Phase IV post-marketing safety surveillance programs = Surveillance programs for approved drugs and biologics Exclusion of high-risk patients in clinical trials = Importance of real-world post-marketing reports FDA's collection and analysis of reports = Better understanding of drug safety profiles in real-world settings</p> Signup and view all the answers

    Match the following with their respective descriptions:

    <p>Contraindications for using Evista = Due to risk of venous thromboembolism Adverse reactions and potential side effects of Evista = Information about Evista's negative effects Reporting to the FDA MedWatch program = Reporting of side effects, adverse events, and allergies Differentiation between drug intolerance and drug allergy = Distinguishing two types of drug reactions</p> Signup and view all the answers

    Match the following adverse event reporting terms with their definitions:

    <p>Adverse event reporting = Voluntary submission of reports by healthcare professionals and patients to the drug manufacturer, who is required by law to send the report to the FDA MedWatch = FDA program used for reporting adverse events, problems with biologies, medical devices, some dietary supplements, and cosmetics Intolerance = Less serious complaints such as stomach upset or nausea, not an immune system response, and should be listed on the patient profile to be avoided if possible Allergy = Immune system response, can range from mild to severe, and may affect multiple areas of the body</p> Signup and view all the answers

    Match the following drug-related terms with their correct descriptions:

    <p>Type A reaction = Predictable, related to the pharmacologic actions of the drug, and dose-dependent Type B reaction = Unpredictable, generally unrelated to the pharmacologic actions of the drug, and not dose-dependent Medication Guides (MedGuides) = FDA-approved patient handouts for over 300 medications, providing important information about the drug and its safe use Risk Evaluation and Mitigation Strategies (REMS) = Required by the FDA for certain drugs with serious safety concerns to mitigate risks</p> Signup and view all the answers

    Match the following drug safety measures with their descriptions:

    <p>Boxed warnings = Indicate a risk of death or permanent disability from the drug Drug safety alert = Issued by the FDA to prescribers in especially risky cases, usually before the labeling is changed Phase IV monitoring = Focuses on post-marketing safety surveillance programs for approved drugs and biologics VAERS program = System for reporting side effects, adverse events, and allergies to the FDA</p> Signup and view all the answers

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

    <p>Type A reactions = Dose-dependent, related to the known pharmacologic actions of the drug Type B reactions = Generally not dose-dependent, unrelated to the pharmacologic actions of the drug Drug allergy = Immune-mediated response to a medication or excipient Pseudoallergic reactions = Reactions similar to true allergies but not immune-mediated</p> Signup and view all the answers

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

    <p>Boxed warnings = Indicate a risk of death or permanent disability from a drug Contraindications = Indicate specific circumstances under which the drug should not be used Warnings and precautions = Provide information about potential adverse effects or risks Medication Guides (MedGuides) = Provide information about using the medication safely</p> Signup and view all the answers

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

    <p>Underlying renal impairment = Experiencing nephrotoxicity from aminoglycoside use High drug dosage/reduced clearance = Increased severity of adverse drug reactions Type B reactions = Influenced by patient-specific factors Type A reactions = Account for an estimated 80% of ADRs</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Medication errors = Distinct from adverse drug reactions Immediate (Type I) reactions = Classified under drug allergy and involve an immune-mediated response Community-based adverse event reporting = Important for safe medication use Nephrotoxicity = Experiencing kidney damage from aminoglycoside use</p> Signup and view all the answers

    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?

    <p>Type IV reaction</p> Signup and view all the answers

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

    <p>Advise the patient to limit sun exposure and use broad-spectrum sunscreens</p> Signup and view all the answers

    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?

    <p>Histamine release from mast cells in the skin</p> Signup and view all the answers

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

    <p>Diphenhydramine</p> Signup and view all the answers

    What is the purpose of penicillin skin testing?

    <p>To identify patients at the highest risk of Type I hypersensitivity reaction to systemic penicillin</p> Signup and view all the answers

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

    <p>High risk of a reaction to systemic penicillin</p> Signup and view all the answers

    What type of reaction does penicillin skin testing predict?

    <p>IgE-mediated reaction</p> Signup and view all the answers

    When is induction of drug tolerance (desensitization) recommended?

    <p>When no acceptable alternative medication is available</p> Signup and view all the answers

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

    <p>To temporarily allow safe treatment with the allergen</p> Signup and view all the answers

    What should be the immediate action following the desensitization procedure?

    <p>Start treatment with the desensitized agent</p> Signup and view all the answers

    What could occur if doses are missed following desensitization?

    <p>Serious hypersensitivity reactions, including anaphylaxis</p> Signup and view all the answers

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

    <p>Induction of drug tolerance</p> Signup and view all the answers

    When should desensitization be avoided?

    <p>If an agent has previously caused SJS or TEN</p> Signup and view all the answers

    Where must the desensitization procedure take place?

    <p>In a medical setting with emergency care available</p> Signup and view all the answers

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

    <p>Desensitization and penicillin treatment</p> Signup and view all the answers

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

    <p>Outer thigh</p> Signup and view all the answers

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

    <p>Aztreonam</p> Signup and view all the answers

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

    <p>Skin infections</p> Signup and view all the answers

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

    <p>To link to a 24-hour information center</p> Signup and view all the answers

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

    <p>Refrigeration is not required</p> Signup and view all the answers

    What is the first-line treatment for anaphylactic reactions?

    <p>Epinephrine injection</p> Signup and view all the answers

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

    <p>Abdominal cramping</p> Signup and view all the answers

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

    <p>90 degrees</p> Signup and view all the answers

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

    <p>Seek emergency help immediately</p> Signup and view all the answers

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

    <p>They can be injected through clothing</p> Signup and view all the answers

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

    <p>Inform family and caregivers about the device's location and usage</p> Signup and view all the answers

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

    <p>Patch testing by an allergist</p> Signup and view all the answers

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

    <p>Ibuprofen</p> Signup and view all the answers

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

    <p>1-3 weeks</p> Signup and view all the answers

    Which of the following is NOT a symptom of anaphylaxis?

    <p>Severe mucosal erosions</p> Signup and view all the answers

    What is the primary treatment for anaphylaxis?

    <p>Epinephrine</p> Signup and view all the answers

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

    <p>Type I hypersensitivity reaction</p> Signup and view all the answers

    What is the recommended immediate treatment for pseudoallergic reactions?

    <p>Antihistamines</p> Signup and view all the answers

    Which of the following drugs is associated with pseudoallergic reactions?

    <p>Contrast media</p> Signup and view all the answers

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

    <p>Reverse bronchoconstriction</p> Signup and view all the answers

    What is the consequence of DRESS?

    <p>Hepatic and renal dysfunction</p> Signup and view all the answers

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

    <p>Restore normal platelet count</p> Signup and view all the answers

    What distinguishes pseudoallergic reactions from anaphylaxis?

    <p>IgE-mediation</p> Signup and view all the answers

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

    <p>Epidermal detachment</p> Signup and view all the answers

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

    <p>Follow with an oral drug challenge dose before full treatment dose</p> Signup and view all the answers

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

    <p>Increased resistance and cost</p> Signup and view all the answers

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

    <p>In case of penicillin allergy and syphilis in pregnancy or HIV</p> Signup and view all the answers

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

    <p>Tolerance is possible in most cases</p> Signup and view all the answers

    Which type of reactions can NSAIDs lead to?

    <p>Urticaria, angioedema, and anaphylaxis</p> Signup and view all the answers

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

    <p>They should be avoided</p> Signup and view all the answers

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

    <p>Opioid intolerance is common, but true opioid allergy is uncommon</p> Signup and view all the answers

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

    <p>Anaphylactoid reactions and delayed skin reactions</p> Signup and view all the answers

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

    <p>Soy and tree nuts</p> Signup and view all the answers

    What can biologies such as rituximab cause?

    <p>Hypersensitivity reactions</p> Signup and view all the answers

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

    <p>Anaphylactic reactions</p> Signup and view all the answers

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

    <p>Tolerance is possible for some agents</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    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.

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    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.

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    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.

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    Penicillin skin testing only predicts an IgE-mediated reaction.

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

    Desensitization is recommended when no acceptable alternative medication is available.

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>False</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    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

    <p>True</p> Signup and view all the answers

    Aztreonam is considered safe in patients with penicillin allergies

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

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

    <p>True</p> Signup and view all the answers

    Match the following drug reactions with their descriptions:

    <p>MILD RASH SPOTS AND RASHES = Opioids cause a non-allergic release of histamine from mast cells in the skin, causing itching and hives in some patients. PHOTOSENSITIVITY = Photosensitivity can occur when sunlight reacts with a drug in the skin and causes tissue damage that looks like a severe sunburn on sun-exposed areas; this occurs within hours of sun exposure.</p> Signup and view all the answers

    Match the following drugs with their association with photosensitivity:

    <p>Amiodarone = Diuretics (thiazide and loop) Methotrexate = Oral and topical retinoids</p> Signup and view all the answers

    Match the following preventive measures with their corresponding recommendations:

    <p>Pre-medication with antihistamine = Reduction or avoidance of pruritus caused by opioids or other sources Limiting sun exposure and use of broad spectrum sunscreens = When dispensing medications that can cause photosensitivity</p> Signup and view all the answers

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

    <p>Immediate reaction = Occurs within hours of drug administration Delayed hypersensitivity reaction = Occurs within days of sun exposure</p> Signup and view all the answers

    Match the following terms with their descriptions:

    <p>Penicillin skin test = Predicts an IgE-mediated reaction Desensitization = Step-wise process that temporarily allows safe treatment with the agent SJS and TEN = Involve epidermal detachment and severe mucosal erosions DRESS = Includes skin eruptions accompanied by fever, hepatic and renal dysfunction</p> Signup and view all the answers

    Match the following drug safety measures with their descriptions:

    <p>Penicillin skin testing = Identifies patients at risk of Type I hypersensitivity reaction to systemic penicillin Desensitization = Induction of drug tolerance when no acceptable alternative medication is available Induction of drug tolerance = Begins with a small dose of the medication and incrementally increases to the target dose Plasma exchange in treating TTP = Used in treating thrombotic thrombocytopenic purpura</p> Signup and view all the answers

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

    <p>Immediate (Type I) reactions = Examples of Type B reactions Pseudoallergic reactions = Associated with biologies such as rituximab Photosensitivity reactions = Require patients to limit sun exposure and use broad-spectrum sunscreens Sulfite allergies = Consequence of using sulfites in certain medications</p> Signup and view all the answers

    Match the severe skin reaction with the corresponding drug:

    <p>Stevens-Johnson syndrome (SJS) = NSAIDs Toxic epidermal necrolysis (TEN) = Quinine Drug reaction with eosinophilia and systemic symptoms (DRESS) = Tetracyclines Thrombotic Thrombocytopenic Purpura (TTP) = Not caused by specific drugs</p> Signup and view all the answers

    Match the drug allergy with the corresponding reaction type:

    <p>Penicillins and sulfonamides = Type I hypersensitivity reactions Clopidogrel, carbamazepine, and ibuprofen = Severe skin reactions Phytonadione and contrast media = Pseudoallergic reactions NSAIDs, quinine, and tetracyclines = Causing TTP</p> Signup and view all the answers

    Match the symptom with the corresponding severe allergic reaction:

    <p>Severe mucosal erosions, high body temperature, and organ damage = SJS and TEN Fever, hepatic and renal dysfunction = DRESS Clot formation, platelet consumption, and bleeding under the skin = TTP Life-threatening allergic reaction, occurring within seconds to minutes = Anaphylaxis</p> Signup and view all the answers

    Match the following symptoms with their correct description:

    <p>Generalized urticaria = Widespread hives or welts on the skin Swelling of the mouth and throat = Edema of oral and pharyngeal tissues Abdominal cramping = Pain or discomfort in the abdomen Hypotension = Low blood pressure</p> Signup and view all the answers

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

    <p>EpiPen = Available in different dosages and administration techniques EpiPen Jr = Available in different dosages and administration techniques Auvi-Q = Specific dosages for different weight ranges Symjepi = Specific dosages for different weight ranges</p> Signup and view all the answers

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

    <p>Refrigeration requirement = Refrigeration not required Injection site = Inject into the middle of the outer thigh at a 90-degree angle Administration through clothing = Can be injected through clothing Emergency help = Seek emergency help after injection</p> Signup and view all the answers

    Match the following drug-related terms with their correct descriptions:

    <p>Desensitization = Process of inducing drug tolerance Patch testing = Reliable way to determine drug allergies Cross-reactivity = Allergic reaction to similar drugs Anaphylaxis = Severe allergic reaction requiring immediate treatment</p> Signup and view all the answers

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

    <p>Reporting penicillin allergy leads to use of broad-spectrum antibiotics, increasing resistance and cost = Negative penicillin skin test result should be followed by an oral drug challenge dose Many cephalosporins can be safely tolerated despite penicillin allergy in acute otitis media infection = Biologies like rituximab can cause hypersensitivity reactions, desensitization is possible for some patients NSAID reactions can cause rhinitis, mild asthmatic-type reactions, or skin reactions = 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</p> Signup and view all the answers

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

    <p>COX-2 selective NSAIDs = Contrast media used in CT scans Sulfamethoxazole = Rituximab Cephalosporins = Sulfites or sulfates Opioids = NSAIDs</p> Signup and view all the answers

    Match the following adverse reactions with their symptoms or outcomes:

    <p>Anaphylactoid reactions and delayed skin reactions = Rhinitis, mild asthmatic-type reactions, or skin reactions Hypersensitivity reactions = Clot formation, platelet consumption, and bleeding under the skin Histamine release intolerance = Life-threatening allergic reaction, can occur within seconds to minutes of drug exposure</p> Signup and view all the answers

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

    <p>1%</p> Signup and view all the answers

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

    <p>Followed by an oral drug challenge dose before full treatment dose</p> Signup and view all the answers

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

    <p>Testing and desensitization</p> Signup and view all the answers

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

    <p>Drug sensitivity or true allergic reaction</p> Signup and view all the answers

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

    <p>Warnings or contraindications</p> Signup and view all the answers

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

    <p>Urticaria</p> Signup and view all the answers

    What can contrast media used in CT scans cause?

    <p>Anaphylactoid reactions and delayed skin reactions</p> Signup and view all the answers

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

    <p>Soy</p> Signup and view all the answers

    What is a possible consequence of biologies such as rituximab?

    <p>Hypersensitivity reactions</p> Signup and view all the answers

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

    <p>To provide immediate treatment for anaphylaxis</p> Signup and view all the answers

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

    <p>Contrast media</p> Signup and view all the answers

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

    <p>Many cephalosporins can be tolerated despite penicillin allergy</p> Signup and view all the answers

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

    <p>Type A adverse drug reactions are predictable, dose-dependent reactions that are related to the pharmacologic actions of the drug, such as gastrointestinal bleeding from NSAID use. Type B adverse drug reactions are unpredictable, not dose-dependent, and not related to the pharmacologic actions of the drug, such as anaphylaxis from penicillin.</p> Signup and view all the answers

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

    <p>Boxed warnings are the strongest safety warnings issued by the FDA to alert healthcare providers about serious risks associated with a medication. They are intended to draw attention to potential serious or life-threatening risks of the medication. An example of a medication with a boxed warning is clopidogrel, warning about reduced effectiveness in patients who are poor metabolizers of the drug.</p> Signup and view all the answers

    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.

    <p>Skin testing involves applying a small amount of the drug to the skin to observe for a reaction, and desensitization is the gradual, controlled reintroduction of the drug to increase tolerance. An example of a drug for which skin testing and desensitization may be used is penicillin.</p> Signup and view all the answers

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

    <p>Common manifestations of opioid intolerance due to histamine release include itching, hives, and contraction of respiratory airways. An example of an opioid medication that may cause these manifestations is morphine.</p> Signup and view all the answers

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

    <p>Community-based adverse event reporting is critical for identifying adverse drug reactions (ADRs) that may not have been observed during clinical trials, and for providing real-world data on the safety and efficacy of medications used in diverse patient populations.</p> Signup and view all the answers

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

    <p>An example of ADR incidence in real life differing from clinical trial findings is the use of spironolactone in heart failure patients. In the RALES trial, patients with renal insufficiency or elevated potassium levels were excluded. However, in real life settings, these excluded patients were occasionally prescribed spironolactone, leading to adverse events such as arrhythmias and sudden death due to hyperkalemia.</p> Signup and view all the answers

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

    <p>Voluntary adverse event reporting by healthcare professionals and patients can lead to important implications for safe medication use. Reports are sent to the FDA, and if enough reports link a drug to a particular problem, the manufacturer may be required to update the labeling or a drug safety alert may be issued to prescribers.</p> Signup and view all the answers

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

    <p>ADRs reported to the FDA led to a warning to prescribers in 2006, and eventually, in 2008, the FDA required the manufacturer to update the prescribing information of Oseltamivir to include a precaution about hallucinations, confusion, and other strange behavior in children.</p> Signup and view all the answers

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

    <p>An example of an adverse event reported as an intolerance rather than an allergy is stomach upset or nausea, which is often incorrectly reported as an allergy. Stomach upset or nausea should be listed on the patient profile as an intolerance, as it bothers the patient but is not an immune system response.</p> Signup and view all the answers

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

    <p>An example of an intolerance being reported incorrectly as a drug allergy is a patient who got very nauseated from acetaminophen/codeine (Tylenol #3) and reported being 'allergic' to codeine when admitted to the hospital for a different procedure. The reported allergy led to the use of a less desirable pain control option.</p> Signup and view all the answers

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

    <p>An intolerance refers to less serious complaints such as nausea or constipation, where the drug bothers the patient and should be avoided if possible. An allergy, on the other hand, is an immune system response that can range from mild to severe reactions, such as pruritus or Stevens-Johnson syndrome.</p> Signup and view all the answers

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

    <p>Electronic medical records allow for the separate documentation of intolerances and allergies. This allows healthcare providers to accurately record and differentiate between adverse drug reactions that are intolerances and those that are allergies, leading to more appropriate medication management.</p> Signup and view all the answers

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

    <p>The FDA is evaluating serious hypersensitivity reactions reported with the use of Dulaglutide (Trulicity) to determine the need for regulatory action based on the safety profile of the drug.</p> Signup and view all the answers

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

    <p>Adverse event reporting can have implications for drug manufacturers and prescribers, as the FDA may require manufacturers to update drug labeling or issue safety alerts to prescribers based on the reported adverse events. This can impact the safe use of medications in clinical practice.</p> Signup and view all the answers

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

    <p>The FDA's evaluation of adverse event reports for drugs like Dulaglutide (Trulicity) is significant as it can lead to regulatory actions such as safety labeling changes or warnings, impacting the prescribing and use of the medication to enhance patient safety.</p> Signup and view all the answers

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

    <p>Adverse event reporting contributes to post-marketing surveillance of medications by providing real-world data on the safety and efficacy of drugs used in diverse patient populations. This data can lead to regulatory actions and updates to drug labeling, ensuring the continued safe use of medications beyond clinical trials.</p> Signup and view all the answers

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

    <p>ADRs are unintended and harmful reactions to medications, while medication errors involve administering drugs incorrectly. An example of an ADR from the text is nephrotoxicity with aminoglycoside use, and an example of a medication error is giving the wrong dose to a patient.</p> Signup and view all the answers

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

    <p>Type A reactions are dose-dependent and related to the drug's known pharmacologic actions, accounting for 80% of ADRs. An example from the text is erythema, angioedema, and morbilliform reactions. Type B reactions are generally not dose-dependent, unrelated to the drug's pharmacologic actions, and can be influenced by patient-specific factors. An example from the text is drug allergies, pseudoallergic reactions, intolerances, and idiosyncratic reactions.</p> Signup and view all the answers

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

    <p>Some FDA tools to reduce ADRs include boxed warnings, indicating a risk of death or permanent disability from a drug, and contraindications, warnings, and precautions. Boxed warnings highlight risks of death or permanent disability from a drug, while contraindications specify situations where the drug should not be used.</p> Signup and view all the answers

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

    <p>Understanding ADRs and medication errors is crucial for patient safety and effective healthcare management because it helps in preventing harmful reactions to medications and ensuring the correct administration of drugs, ultimately leading to improved patient outcomes and reduced healthcare costs.</p> Signup and view all the answers

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

    <p>Predictable (Type A) ADRs are dose-dependent and related to the drug's known pharmacologic actions, accounting for 80% of ADRs. An example from the text is erythema, angioedema, and morbilliform reactions. Unpredictable (Type B) reactions are generally not dose-dependent, unrelated to the drug's pharmacologic actions, and can be influenced by patient-specific factors. An example from the text is drug allergies, pseudoallergic reactions, intolerances, and idiosyncratic reactions.</p> Signup and view all the answers

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

    <p>Patient-specific factors that can influence Type B reactions include factors such as genetics, immune status, and previous exposure to the drug. Examples from the text include drug allergies, pseudoallergic reactions, intolerances, and idiosyncratic reactions.</p> Signup and view all the answers

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

    <p>An example of a medication error from the text is administering drugs incorrectly, such as giving the wrong dose to a patient. This type of error can have a significant impact on patient safety, potentially leading to adverse effects or lack of therapeutic benefit.</p> Signup and view all the answers

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

    <p>Examples of Type B reactions mentioned in the text include drug allergies, pseudoallergic reactions, intolerances, and idiosyncratic reactions. Type B reactions are generally not dose-dependent, unrelated to the drug's pharmacologic actions, and can be influenced by patient-specific factors.</p> Signup and view all the answers

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

    <p>Drug allergies are classified into four types, including Type I reactions that are immediate and IgE-mediated. Type I reactions involve excessive histamine release upon subsequent exposure and are associated with an immediate immune response.</p> Signup and view all the answers

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

    <p>Boxed warnings are used to indicate a risk of death or permanent disability from a drug. Their purpose in reducing ADRs is to provide healthcare providers and patients with essential information about the potential severe risks associated with the use of specific medications.</p> Signup and view all the answers

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

    <p>Drug allergies result from prior exposure, causing Type I hypersensitivity reactions and excessive histamine release upon subsequent exposure. Pseudoallergic reactions, on the other hand, are not mediated by the immune system and can mimic true allergic reactions. An example from the text is drug allergies caused by penicillins and sulfonamides and pseudoallergic reactions mentioned as Type B reactions.</p> Signup and view all the answers

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

    <p>Patient-specific factors that can influence Type B ADRs include genetics, immune status, and previous exposure to the drug. An example from the text is the influence of patient-specific factors on drug allergies, pseudoallergic reactions, intolerances, and idiosyncratic reactions.</p> Signup and view all the answers

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

    <p>REMS is used to manage known or potential serious risks associated with a drug product. Its components include Medication Guides and Elements to Assure Safe Use (ETASU) to ensure safe use and implementation of risk minimization strategies.</p> Signup and view all the answers

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

    <p>The Naranjo Scale is used to assess the likelihood of a drug causing an adverse reaction. It involves specific criteria related to the temporal relationship between drug administration and the adverse event, the presence of alternative causes, previous documentation of the reaction with the suspected drug, and the drug's response on re-administration. Each criterion is assigned a score, and the total score determines the likelihood of the drug causing the adverse reaction.</p> Signup and view all the answers

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

    <p>It is important to differentiate between intolerance and drug allergy to ensure appropriate management and avoid unnecessary avoidance of medications. Specific questions about the reaction, timing of the reaction in relation to drug administration, patient's age, and use of similar drugs can help in this differentiation.</p> Signup and view all the answers

    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).

    <p>Healthcare professionals and consumers can report side effects, adverse events, and allergies to the FDA's MedWatch program either online, by mail, or by fax. VAERS is a specific reporting system for vaccines, where healthcare professionals and vaccine manufacturers are required to report adverse events following vaccination.</p> Signup and view all the answers

    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?

    <p>The FDA's collection and analysis of reports from Phase IV post-marketing safety surveillance programs is significant in identifying less frequent side effects that may not have been evident during clinical trials. It helps in understanding the real-world impact of medications and ensuring patient safety.</p> Signup and view all the answers

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

    <p>Adverse drug reactions in real-world settings can have a significant impact, especially when high-risk patients receive the medication. Comprehensive pharmacovigilance is necessary to ensure patient safety and monitor the real-world impact of medications, including the identification of less frequent side effects.</p> Signup and view all the answers

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

    <p>Medication Guides are required for over 300 medications to provide information about the safe and effective use of the medication. Examples of the types of medications for which Medication Guides are required include anticonvulsants, antidepressants, and long-acting opioids.</p> Signup and view all the answers

    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?

    <p>The exclusion of high-risk patients in clinical trials is important to minimize potential risks and ensure the safety of participants. Post-marketing reports play a crucial role in identifying less frequent side effects that may not have been observed during clinical trials, thus contributing to a comprehensive understanding of a drug's safety profile.</p> Signup and view all the answers

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

    <p>Understanding the drug safety profile in a real-world setting through post-marketing surveillance can help in identifying and mitigating potential risks, ensuring patient safety, and providing valuable information for healthcare professionals and patients regarding the safe and effective use of medications.</p> Signup and view all the answers

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

    <p>Contraindications for using certain drugs, such as Evista in a patient with a history of venous thromboembolism, can lead to serious adverse reactions and risks. It is important to consider contraindications to ensure patient safety and avoid potential harm.</p> Signup and view all the answers

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

    <p>Comprehensive pharmacovigilance is crucial in identifying, assessing, and managing the risks associated with medications. It helps in ensuring patient safety, monitoring the real-world impact of medications, and improving the overall quality of healthcare.</p> Signup and view all the answers

    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?

    <p>Assessing the likelihood of a drug causing an adverse reaction using the Naranjo Scale is important to determine the causality and potential risks associated with the drug. The scoring on the Naranjo Scale helps in categorizing the likelihood of the drug's involvement in the adverse reaction, thus guiding the appropriate management and decision-making process.</p> Signup and view all the answers

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

    <p>Opioids can cause non-allergic release of histamine from mast cells in the skin, leading to itching and hives, which can be managed by pre-medicating the patient with an antihistamine such as diphenhydramine.</p> Signup and view all the answers

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

    <p>Photosensitivity occurs when sunlight reacts with a drug in the skin, causing tissue damage resembling severe sunburn on sun-exposed areas. It can manifest as a red, itchy rash that can spread to non-sun-exposed areas, typically occurring within hours or days of sun exposure.</p> Signup and view all the answers

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

    <p>Common drugs associated with photosensitivity include amiodarone, diuretics, methotrexate, oral and topical retinoids, and quinolones. Patients should be advised to limit sun exposure and to use broad-spectrum sunscreens that block both UVA and UVB radiation.</p> Signup and view all the answers

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

    <p>Opioids can cause pruritus due to non-allergic release of histamine from mast cells in the skin, which can be reduced or avoided by pre-medicating the patient with an antihistamine, such as diphenhydramine.</p> Signup and view all the answers

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

    <p>Hives, throat swelling, difficulty breathing, abdominal cramping, and hypotension</p> Signup and view all the answers

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

    <p>Single-use epinephrine auto-injectors (e.g., EpiPen, Auvi-Q)</p> Signup and view all the answers

    1. Where should epinephrine auto-injectors be administered?

    <p>Into the middle of the outer thigh at a 90-degree angle</p> Signup and view all the answers

    1. Is refrigeration required for epinephrine auto-injectors?

    <p>No, refrigeration is not required</p> Signup and view all the answers

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

    <p>Location and usage of the auto-injector</p> Signup and view all the answers

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

    <p>Vasoconstriction and necrosis</p> Signup and view all the answers

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

    <p>Skin infections, prolonged redness, swelling, or tenderness</p> Signup and view all the answers

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

    <p>Penicillin and cephalosporins</p> Signup and view all the answers

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

    <p>Aztreonam</p> Signup and view all the answers

    1. What can help determine true drug allergies?

    <p>Patch testing</p> Signup and view all the answers

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

    <p>Low</p> Signup and view all the answers

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

    <p>Medical identification bracelets linked to their health profile</p> Signup and view all the answers

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

    <p>Skin lesions associated with TTP include purpura, petechiae, ecchymoses, and hematoma.</p> Signup and view all the answers

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

    <p>The severe skin reactions caused by drugs include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).</p> Signup and view all the answers

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

    <p>Acetaminophen and ibuprofen, generally considered safe, have also been associated with severe skin reactions.</p> Signup and view all the answers

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

    <p>SJS and TEN involve epidermal detachment and skin loss, occurring 1-3 weeks after drug administration and can result in severe mucosal erosions and organ damage.</p> Signup and view all the answers

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

    <p>DRESS can cause skin eruptions accompanied by systemic symptoms such as fever, hepatic and renal dysfunction, and lymphadenopathy.</p> Signup and view all the answers

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

    <p>Common culprits of drug allergies causing Type I hypersensitivity reactions include penicillins and sulfonamides.</p> Signup and view all the answers

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

    <p>Anaphylaxis, a severe allergic reaction, can occur within seconds to minutes of drug exposure.</p> Signup and view all the answers

    Name some drugs commonly associated with severe skin reactions.

    <p>Drugs commonly associated with severe skin reactions include clopidogrel, carbamazepine, ibuprofen, and allopurinol.</p> Signup and view all the answers

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

    <p>Other drugs associated with severe skin reactions include quinine, phenytoin, and sulfamethoxazole.</p> Signup and view all the answers

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

    <p>The clinical appearance and treatment of pseudoallergic reactions are similar to those of anaphylaxis, though they are not IgE-mediated.</p> Signup and view all the answers

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

    <p>Using broad-spectrum antibiotics when penicillin allergy is reported can lead to unnecessary antibiotic exposure, increased risk of adverse reactions, and antibiotic resistance.</p> Signup and view all the answers

    What are the potential symptoms of anaphylactic reactions?

    <p>Potential symptoms of anaphylactic reactions include hives, swelling of the face or throat, difficulty breathing, rapid heartbeat, and low blood pressure.</p> Signup and view all the answers

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

    <p>The reported penicillin allergy incidence is 10%, but the true IgG-mediated reaction incidence is 1%, indicating that a large number of reported allergies are not true allergic reactions.</p> Signup and view all the answers

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

    <p>After a negative penicillin skin test, an oral drug challenge is recommended to confirm tolerance to penicillin.</p> Signup and view all the answers

    When is desensitization recommended for biologies like rituximab?

    <p>Desensitization is recommended for biologies like rituximab when hypersensitivity reactions occur, as a way to gradually increase tolerance to the medication.</p> Signup and view all the answers

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

    <p>Peanuts and soy have cross-reactivity, and some medications contain soy, so patients with peanut allergy may need to avoid medications containing soy to prevent an allergic reaction.</p> Signup and view all the answers

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

    <p>Opioid intolerance due to histamine release is common, but true allergy is rare, indicating that most reported symptoms are not due to a true allergic reaction.</p> Signup and view all the answers

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

    <p>A positive penicillin skin test or severe skin reaction indicates that the patient should avoid penicillin due to the risk of a true allergic reaction.</p> Signup and view all the answers

    Explain the relationship between penicillin allergy reporting and antibiotic resistance.

    <p>Reporting penicillin allergy leads to increased resistance and cost due to the use of broad-spectrum antibiotics, which are often prescribed as an alternative to penicillin.</p> Signup and view all the answers

    When can cephalosporins be tolerated despite a penicillin allergy?

    <p>Cephalosporins can be tolerated despite penicillin allergy in acute otitis media infection.</p> Signup and view all the answers

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

    <p>For patients with NSAID sensitivity or true allergic reactions, COX-2 selective NSAIDs may be an option to consider.</p> Signup and view all the answers

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

    <p>Reporting a false penicillin allergy can lead to unnecessary avoidance of penicillin and the use of alternative, less effective antibiotics, contributing to antibiotic resistance.</p> Signup and view all the answers

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

    <p>Contrast media can cause anaphylactoid reactions and delayed skin reactions, necessitating careful monitoring and immediate treatment if an allergic reaction occurs.</p> Signup and view all the answers

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

    <p>Sulfamethoxazole in Bactrim is a common sulfonamide causing reactions, but the cross-reactivity risks are low, so alternative medications may be considered if necessary.</p> Signup and view all the answers

    What is the goal of penicillin skin testing?

    <p>The goal of penicillin skin testing is to identify patients who are at the greatest risk of a Type I hypersensitivity reaction if exposed to a systemic penicillin.</p> Signup and view all the answers

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

    <p>A localized reaction around the Pre - Pen or penicillin G test site indicates a high risk of a reaction to systemic penicillin and the patient should not receive it.</p> Signup and view all the answers

    What does skin testing predict?

    <p>Skin testing only predicts an IgE-mediated reaction.</p> Signup and view all the answers

    When is induction of drug tolerance (desensitization) recommended?

    <p>When no acceptable alternative is available, induction of drug tolerance (desensitization) may be recommended.</p> Signup and view all the answers

    What is the step-wise process of desensitization?

    <p>Desensitization is a step-wise process that begins by administering a very small dose of the medication and then incrementally increasing the dose at regular time intervals up to the target dose.</p> Signup and view all the answers

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

    <p>Induction of drug tolerance is a more accurate term than desensitization, because the process does not 'cure' the patient of an allergy.</p> Signup and view all the answers

    Where must the desensitization procedure take place?

    <p>The desensitization procedure must take place in a medical setting where emergency care can be provided if a serious reaction occurs.</p> Signup and view all the answers

    What should happen immediately following the desensitization procedure?

    <p>Treatment with the agent must start immediately following the desensitization procedure and must not be interrupted.</p> Signup and view all the answers

    What could occur if doses are missed after desensitization?

    <p>If doses are missed, the drug-free period allows the immune system to re-sensitize to the drug and serious hypersensitivity reactions (including anaphylaxis) could occur with subsequent doses.</p> Signup and view all the answers

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

    <p>Desensitization should never be attempted if an agent has previously caused SJS or TEN.</p> Signup and view all the answers

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

    <p>The CDC recommends desensitization and penicillin treatment, rather than using second-line agents.</p> Signup and view all the answers

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

    <p>The guidelines and references for drug allergy can be found in the Food and Drug Administration MedWatch program.</p> Signup and view all the answers

    Study Notes

    Pharmacovigilance and Drug Safety

    • Contraindications for using Evista due to risk of venous thromboembolism
    • Adverse reactions and potential side effects of Evista
    • Risk Evaluation and Mitigation Strategies (REMS) for certain drugs required by the FDA
    • Medication Guides (MedGuides) as FDA-approved patient handouts for over 300 medications
    • Naranjo Scale for assessing causality of adverse drug reactions
    • Differentiation between drug intolerance and drug allergy
    • Reporting of side effects, adverse events, and allergies to the FDA MedWatch program
    • FDA Adverse Event Reporting System (FAERS) as a central collection point for drug-related problems
    • Phase IV post-marketing safety surveillance programs for approved drugs and biologics
    • Exclusion of high-risk patients in clinical trials and the importance of real-world post-marketing reports
    • Different program (VAERS) for reporting vaccine-related adverse events
    • FDA's collection and analysis of reports to better understand drug safety profiles in real-world settings

    Pharmacovigilance and Drug Safety

    • Contraindications for using Evista due to risk of venous thromboembolism
    • Adverse reactions and potential side effects of Evista
    • Risk Evaluation and Mitigation Strategies (REMS) for certain drugs required by the FDA
    • Medication Guides (MedGuides) as FDA-approved patient handouts for over 300 medications
    • Naranjo Scale for assessing causality of adverse drug reactions
    • Differentiation between drug intolerance and drug allergy
    • Reporting of side effects, adverse events, and allergies to the FDA MedWatch program
    • FDA Adverse Event Reporting System (FAERS) as a central collection point for drug-related problems
    • Phase IV post-marketing safety surveillance programs for approved drugs and biologics
    • Exclusion of high-risk patients in clinical trials and the importance of real-world post-marketing reports
    • Different program (VAERS) for reporting vaccine-related adverse events
    • FDA's collection and analysis of reports to better understand drug safety profiles in real-world settings

    Understanding Adverse Drug Reactions (ADRs)

    • ADRs are distinct from medication errors, with over one million reports logged with the FDA in 2018, including 197,060 deaths.
    • ADRs can result in substantial morbidity and mortality and are dose-related, with severity increasing at higher doses/reduced clearance.
    • Some patients are more susceptible to ADRs, such as those with underlying renal impairment experiencing nephrotoxicity from aminoglycoside use.
    • ADRs are categorized into two types: predictable (Type A) and unpredictable (Type B) reactions.
    • Type A reactions are dose-dependent, related to the known pharmacologic actions of the drug, and are the most common, accounting for an estimated 80% of ADRs.
    • Type B reactions are generally not dose-dependent, unrelated to the pharmacologic actions of the drug, and can be influenced by patient-specific factors.
    • Drug allergies, pseudoallergic reactions, drug intolerances, and idiosyncratic reactions are examples of Type B reactions.
    • Drug allergy refers to an immune-mediated response to a medication or excipient and is classified into four types, including immediate (Type I) reactions.
    • FDA tools to reduce ADRs include boxed warnings, which indicate a risk of death or permanent disability from a drug, and contraindications, warnings, and precautions.
    • Boxed warnings can be due to prescribing or dispensing errors, as seen with conventional amphotericin b deoxycholate's dosing.
    • Contraindications indicate that the drug should not be used under specific circumstances.
    • Understanding ADRs is crucial in ensuring patient safety and effective medication management.

    Anaphylaxis and Epinephrine Auto-Injector Administration

    • Anaphylactic reactions can present with generalized urticaria, swelling of the mouth and throat, difficulty breathing, abdominal cramping, and hypotension, requiring immediate treatment
    • Patients with serious allergies or medical conditions should wear a medical identification bracelet linked to a 24-hour information center
    • Anaphylaxis treatment includes epinephrine injection, diphenhydramine, steroids, and IV fluids, with instructions to call 911
    • Epinephrine auto-injectors such as EpiPen, EpiPen Jr, Auvi-Q, Adrenaclick, Symjepi are available in different dosages and administration techniques
    • Patients should be instructed to inject into the middle of the outer thigh at a 90-degree angle and seek emergency help
    • Refrigeration is not required for epinephrine auto-injectors, and they can be injected through clothing
    • Symjepi and Auvi-Q have specific dosages for different weight ranges
    • Patient counseling for epinephrine auto-injectors includes informing family and caregivers about the device's location and usage
    • Skin infections can occur after injection, and prolonged redness, swelling, or tenderness at the injection site should be reported
    • Some drugs, such as penicillin and cephalosporins, can cause allergic reactions, and cross-reactivity may occur
    • Aztreonam is considered safe in patients with penicillin allergies
    • 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

    Severe Skin Reactions and Drug Allergies

    • Thrombotic Thrombocytopenic Purpura (TTP) is a blood disorder causing clot formation, platelet consumption, and bleeding under the skin, fatal if not treated immediately with plasma exchange.
    • Common drugs causing TTP include NSAIDs, quinine, and tetracyclines.
    • Severe skin reactions caused by drugs include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), all requiring prompt treatment.
    • SJS and TEN involve epidermal detachment and skin loss, leading to severe mucosal erosions, high body temperature, and organ damage, generally occurring 1-3 weeks after drug administration.
    • DRESS includes skin eruptions accompanied by fever, hepatic and renal dysfunction, requiring stopping the offending agent and sometimes worsening after discontinuation.
    • 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.
    • 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, similar to anaphylaxis but not IgE-mediated, 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.

    Drug Allergies and Adverse Drug Reactions Overview

    • CDC reports the true incidence of IgG-mediated penicillin allergy is ~1%
    • Broad-spectrum antibiotics are often used when penicillin allergy is reported, increasing resistance and cost.
    • Negative skin test result should be followed by an oral drug challenge dose before full treatment dose.
    • If penicillin allergy and syphilis in pregnancy or HIV, testing and desensitization are necessary.
    • Many cephalosporins can be tolerated despite penicillin allergy in acute otitis media infection.
    • Biologies such as rituximab can cause hypersensitivity reactions; desensitization is possible for some agents.
    • NSAID reactions can be drug sensitivity or true allergic reaction, leading to urticaria, angioedema, and anaphylaxis.
    • Sulfa drugs, including sulfamethoxazole, carry warnings or contraindications for use in patients with sulfa allergy.
    • Sulfite or sulfate allergies do not cross-react with sulfonamides, and sulfites are present in certain medications.
    • Opioid intolerance due to histamine release is common, but true opioid allergy is uncommon.
    • Contrast media used in CT scans can cause anaphylactoid reactions and delayed skin reactions.
    • Peanuts and soy can have cross-reactivity; patients with peanut allergies should have ready access to an epinephrine autoinjector.

    Pharmacovigilance and Adverse Drug Reactions

    • Contraindications for using certain drugs, such as Evista in a patient with a history of venous thromboembolism
    • Adverse reactions and potential risks associated with starting Evista in a patient, including hot flashes and achy joints
    • Risk Evaluation and Mitigation Strategies (REMS) and its components, such as Medication Guides and Elements to Assure Safe Use (ETASU)
    • The requirement of Medication Guides for over 300 medications, including anticonvulsants, antidepressants, and long-acting opioids
    • The use of Naranjo Scale to assess the likelihood of a drug causing an adverse reaction, with specific criteria and scoring
    • Differentiating between intolerance and drug allergy by asking specific questions about the reaction, timing, age, and use of similar drugs
    • Reporting side effects, adverse events, and allergies to the FDA's MedWatch program and the specific reporting system for vaccines (VAERS)
    • The FDA's collection and analysis of reports from Phase IV post-marketing safety surveillance programs for approved drugs and biologics
    • The exclusion of high-risk patients in clinical trials and the importance of post-marketing reports in identifying less frequent side effects
    • The potential impact of adverse drug reactions in real-world settings, where some high-risk patients may receive the medication
    • The significance of understanding the drug safety profile in a real-world setting through post-marketing surveillance
    • The need for comprehensive pharmacovigilance to ensure patient safety and monitor the real-world impact of medications

    Drug Allergies and Adverse Drug Reactions

    • Reported penicillin allergy incidence is 10%, but true IgG-mediated reaction incidence is 1%
    • Reporting penicillin allergy leads to increased resistance and cost due to broad-spectrum antibiotic use
    • Negative penicillin skin test followed by oral drug challenge is recommended
    • Positive test or severe skin reaction indicates avoiding penicillin
    • Cephalosporins can be tolerated despite penicillin allergy in acute otitis media infection
    • Biologies like rituximab can cause hypersensitivity reactions, necessitating desensitization
    • NSAIDs can cause drug sensitivity or true allergic reactions, with COX-2 selective NSAIDs being an option
    • Sulfamethoxazole in Bactrim is a common sulfonamide causing reactions; cross-reactivity risks are low
    • Sulfite or sulfate allergies do not cross-react with sulfonamides
    • Opioid intolerance due to histamine release is common, but true allergy is rare
    • Contrast media can cause anaphylactoid reactions and delayed skin reactions
    • Peanuts and soy have cross-reactivity; some medications contain soy and should be avoided with peanut allergy

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    Related Documents

    Drug Allergies and ADR_RX Prep 2020_1-4.pdf
    Drug Allergies and ADR_RX Prep 2020_5-9.pdf

    Description

    Test your knowledge of pharmacovigilance and drug safety with this quiz. Explore topics such as adverse reactions, contraindications, FDA risk evaluation strategies, medication guides, causality assessment, reporting systems, post-marketing surveillance, and more. Brush up on your understanding of drug safety in clinical and real-world settings.

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