Adverse Event Analysis Jay Lyle, JP Systems for VHA Knowledge-Based Systems 11/30/18

Contents Definitions Use cases Characteristics Use case realizations

Definitions

Adverse Event Definition Categories harm associated with a drug (FDA, CTSI, ICH) harm resulting from care (IHID) care act that causes harm due to error (WHO) both act and harm (NHSN, AHRQ) Supports near-misses See Confluence page and slides appended to this presentation

Proposed Adverse event records are expressions of concern about actual or potential negative consequences of giving care. The domain covers different business objects; calling one of them “adverse event” will cause confusion in some communities. We propose five objects: care act, intermediate event, symptom, incident, and report. This definition covers both pharmacovigilance and patient safety cases. Exceptions: Allergy, because of its prevalence; & Unreported side effects, because of prevalence and lack of significance.

Use Cases Case Care Act Intermediate Symptom Pattern A Administer Pen V (1st time) Anaphylaxis Allergy B1 Administer Pen V (2nd time) Adverse Event B2 Fail to set rail Fall Bruise B3 Remove spleen from wrong patient Asplenia C Fail to mop spill None D Procedure Needle stick E1 Administer Amoxicillin Nausea Observation E2 Administer chemotherapy F1 Administer new medication, FAERS report F2 Administer vaccine, VAERS report Soreness G Unknown Staph infection Whether to model a symptom as Condition, Observation, or Questionnaire is a different question.

Characteristics Characteristic B. Fall from Bed C. Failure to Mop Allergy 1 B. Allergy 2 B. Fall from Bed C. Failure to Mop D. Needle Stick E. Med Nausea F. Med Nausea G. Staph Infection Problem Yes No Preceded by Known act Unknown act Care act caused problem n/a Variable Unknown Problem was avoidable Judged reportable

Use case realizations

Case A: Administer Pen V (1st time) Care Act Intermediate Event Symptom Judgment Record 2. Anaphylaxis (condition/obs) 1. Substance Administration (Med admin) 3. New Allergy (Allergy)

Case B1: Administer Pen V (2nd time) Care Act Intermediate Event Symptom Judgment Record 2. Anaphylaxis (condition/obs) 1. Substance Administration (Med admin) 6. Adverse Event Report ?. Incident ?. Adverse Reaction 5. Update Existing Allergy (Allergy)

(may not have record other than Report) Case B2: Fail to set rail Care Act Intermediate Event Symptom Judgment Record 2/3. Bruise (condition/obs) 1. Failure to set rail (may not have record other than Report) 5. Adverse Event Report 4. Incident 2/3. Fall (Condition?)

Case B3: Remove spleen from wrong patient Care Act Intermediate Event Symptom Judgment Record 2?. Asplenia (condition/obs) 1. Surgery (Procedure) 4. Adverse Event Report 3. Incident

Case C: Fail to mop spill Care Act Intermediate Event Symptom Judgment Record 1. Failure to mop (may not have record other than Report) 3. Adverse Event Report 2. Incident

1. Substance Administration Case D: Needle Stick Care Act Intermediate Event Symptom Judgment Record None (perhaps later) 1. Substance Administration (Med admin) 4. Adverse Event Report 3. Incident 2. Stick

Case E1: Administer Amoxicillin Care Act Intermediate Event Symptom Judgment Record 2. Nausea (condition/obs) 1. Substance Administration (Med admin) 3. Decline to call this an Incident

Case E2: Administer chemotherapy Care Act Intermediate Event Symptom Judgment Record 2. Nausea (condition/obs) 1. Substance Administration (Med admin) 3. Decline to call this an Incident

Case F1: Administer new medication, FAERS report Care Act Intermediate Event Symptom Judgment Record 2. Nausea (condition/obs) 1. Substance Administration (Med admin) 5. Adverse Event Report ?. Incident ?. Adverse Reaction

Case F2: Administer vaccine, VAERS report Care Act Intermediate Event Symptom Judgment Record 2. Soreness (condition/obs) 1. Substance Administration (Imm) 5. Adverse Event Report ?. Incident ?. Adverse Reaction

Case G: Staph infection Care Act Intermediate Event Symptom Judgment Record 2. Fever (condition/obs) 1. Possible unknown lapse 5. Adverse Event Report 4. Incident 3. Staph Infection (condition)

Definition References

FDA, common definitions An adverse event is any undesirable experience associated with the use of a medical product in a patient. FDA An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Wikipedia

HL7 Pre-marketing: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Post-marketing/US: Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose; an adverse event occurring from drug withdrawal; and any failure of expected pharmacologic action. Post-marketing/European Union: Any undesirable experience occurring to a patient treated with a pharmaceutical product whether or not considered related to the medicinal product.

AHRQ an injury that was caused by medical management (rather than the underlying disease) and that prolonged the hospitalization, produced a disability at the time of discharge, or both. (Harvard) Errors are defined as "an act of commission (doing something wrong) or omission (failing to do the right thing) leading to an undesirable outcome or significant potential for such an outcome."   A near miss is defined as "any event that could have had adverse consequences but did not and was indistinguishable from fully fledged adverse events in all but outcome."

NHSN biovigilance Adverse event: An unintended and undesirable occurrence before, during or after transfusion of blood or blood components. Adverse events include both incidents and adverse reactions. Adverse reaction: An undesirable response or effect in a patient temporally associated with the administration of blood or blood components. It may or may not be the result of an incident. Incident: Any error or accident that could affect the quality or efficacy of blood, blood components, or patient transfusions. It may or may not result in an adverse reaction in a transfusion recipient. Near miss: A subset of incidents that are discovered before the start of a transfusion that could have led to a wrongful transfusion or an adverse reaction in a transfusion recipient.

Other sources CDC medication safety:  harm resulting from medication use  VAERS: a health problem that happens after vaccination that may or may not be caused by a vaccine.

HHS The HHS regulations at 45 CFR part 46 do not define or use the term adverse event, nor is there a common definition of this term across government and non-government entities.  In this guidance document, the term adverse event in general is used very broadly and includes any event meeting the following definition:  Any untoward or unfavorable medical occurrence in a human subject, . . .