Deviation in the Standard of Medical Care When Prescribing Medications for Failure to Advise of Side Effects & Warnings

Evaluate breaches in the standard of care to determine whether or not there has been a Deviation in the Standard of Medical Care When Prescribing Medications for Failure to Advise of Side Effects & Warnings

Answer the following questions to find out if the standard of care was followed for your case.

  • Was a history of medication allergies elicited and documented?
    Yes
    No
    Answer unknown
    Why is this important?
    Medication histories are important in the prevention of prescription errors. The medication history must encompass all currently and recently prescribed drugs, previous adverse drug reactions including hypersensitivity reactions, any over-the counter medications, including herbal or alternative medicines and adherence to therapy.
    (2004) 24 EIACNA 3 357-371

  • Did the clinician obtain a family history of medication allergies? Why is this important?
    Answer this question
    
Patients whose parents suffer from known drug allergies are more likely to develop drug sensitivities.

    (1998) 18 EIACNA 4 817-827 



  • Was a history of tobacco and alcohol use discussed and documented prior to prescribing information? Why is this important?
    Answer this question
    
Because both alcohol and tobacco interfere with and intensify the desired drug actions, it is essential for the clinician to verify the use of same.

    (1998) 18 EIACNA 4 817-827 



  • Were the potential adverse effects of the medication discussed with the patient? Why is this important?
    Answer this question
    
All medicines have the potential to produce effects other than those desired.

    (1998) 18 EIACNA 4 817-827 



  • Was the expectant mother educated regarding the potentially adverse fetal effects of the medication? Why is this important?
    Answer this question
    
Most drugs can cross the placenta, and some of these have adverse effects on the unborn child. In some cases, alternative medications with less potential for adverse pregnancy outcome can be prescribed, or doses can be lowered or eliminated during critical developmental periods.

    (2001) 15 ERETOX 6 619-629 



  • Was the patient provided education regarding drug interactions with specific food, and/or other medications? Why is this important?
    Answer this question
    
Drug interactions involve the interaction of two or more drugs causing toxicity that otherwise would not be present. It is imperative to provide the patient with that information prior to beginning drug therapy.

    (1998) 18 EIACNA 4 731-744 



  • Was the patient provided education regarding the early symptoms of an adverse reaction? Why is this important?
    Answer this question
    
Advice to patients on the correct use of their medication, and early warning signs of severe reactions can help mitigate the worst outcomes of drug therapy. Some mild adverse drug events may be indicative of a more severe reaction to come.

    (1998) 18 EIACNA 4 731-744 



  • Was the prescription correctly written? Why is this important?
    Answer this question
    
Prescription errors are common and are a major cause of adverse drug events.

    (1998) 18 EIACNA 4 817-827 



  • Which of the following did the patient develop after ingesting the medications?(Choose all that apply) Why is this important?
    Answer this question
    
All medication has the potential to produce effects other than those for which it was prescribed.

    (2004) 24 EIACNA 3 357-371 



  • Did the patient develop a serious drug reaction? Why is this important?
    Answer this question
    
A life-threatening adverse event is defined as an abnormal medical occurrence that may lead to death. Most life-threatening adverse events are considered to be idiosyncratic and caused directly or indirectly by an immunologic response.

    (2001) 47 EEPILR 1-2 155-174 



  • Was the medication discontinued? Why is this important?
    Answer this question
    
Discontinuation of the drug is the primary treatment for all reactions.

    (2004) 24 EIACNA 3 357-371 



  • Was a complete physical examination performed following the reaction? Why is this important?
    Answer this question
    
A complete physical examination is helpful in categorizing the drug reaction, because multiple organ systems may have been involved. Critical components of the physical examination include an assessment of the lymph nodes, lungs, liver, spleen, and joints. These areas must be examined in every patient when evaluated during a reaction.

    (2004) 24 EIACNA 3 357-371 



  • Did the clinician conduct further testing to evaluate and characterize the drug reaction? Why is this important?
    Answer this question
    
Adverse drug reactions are a major health problem encountered frequently in the inpatient and outpatient setting. The clinical evaluation of a drug hypersensitivity reaction is a formidable task for several reasons.

    (2004) 24 EIACNA 3 357-371 



  • Did the clinician perform a causality assessment for the adverse drug event? Why is this important?
    Answer this question
    
Causality assessment aims at determining the probability that a specific drug is responsible for the adverse drug event. Adverse events with high causal association (probable and certain) with the drug are likely to recur. Thus, providing information on this causal link may be useful in preventing future recurrences.

    (2009) 20 EJIMED 1 3-8 



  • Did the clinician initiate specific treatment once the drug reaction was characterized? Why is this important?
    Answer this question
    
Once a drug reaction has been characterized, specific treatment must be instituted.

    (2004) 24 EIACNA 3 357-371 



  • Did the clinician document the adverse drug reaction and report it to the Food and Drug Administration (FDA)? Why is this important?
    Answer this question
    
Once the diagnosis has been established, appropriate documentation must be included in the medical record specifying the causative drug and the nature of the adverse effect.

    (2009) 20 EJIMED 1 3-8 



  • Was the patient provided with health education regarding epinephrine administration? Why is this important?
    Answer this question
    
Once the diagnosis has been established, appropriate documentation must be included in the medical record specifying the causative drug and the nature of the adverse effect.

    (2009) 20 EJIMED 1 3-8 



  • Was the patient instructed to avoid the medication in the future and to alert all medical personnel of the allergy? Why is this important?
    Answer this question
    
Future use of the allergy causing medication is strictly forbidden. It is essential that the patient be made aware of the necessity to alert all medical personnel of the established drug allergy.

    (2004) 24 EIACNA 3 357-371 



  • Was the patient hospitalized? Why is this important?
    Answer this question
    
Patients who develop serious drug reactions require hospitalization and treatment must be initiated immediately.

    (2004) 24 EIACNA 3 357-371