FHIR IG analytics| Package | hl7.fhir.uv.adverseeventclinicalcare |
| Resource Type | AdverseEvent |
| Id | AdverseEvent-clinicalcareexample1stage1.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: AdverseEvent
Resource AdverseEvent "clinicalcareexample1stage1" Version "1" Updated "2021-12-10 21:05:01+0000"
Profile: Adverse Event Clinical Care
identifier: id: 001
status: in-progress
actuality: actual
category: Medication mishap (AdverseEventCategory#medication-mishap)
code: Adverse reaction caused by drug (disorder) (SNOMED CT#62014003)
subject: : 39 year-old male
encounter: : encounter where nurse noticed the problem
detected: 2021-12-10 13:28:17-0500
location: : Palliative Care Agency
outcome: Transient abnormality with full recovery (finding) (SNOMED CT#398056004)
recorder: : Palliative Care nurse
suspectEntity
instance: : A pancreatic enzyme capsule (Creon / Nutrizym / Pancrease / Pancrex) is the only other drug that this patient is prescribed and taking.
Causalities
- EntityRelatedness * unlikely (AdverseEventCausalityAssessment#unlikely)
suspectEntity
instance: : The nurse made an assessment that there was a temporal relationship between the adverse reactions and administration of this new batch of premixed morphine + hyoscine medication supply, recorded the S/S, the assessment.
Causalities
- EntityRelatedness * Probably/Likely (AdverseEventCausalityAssessment#probably-likely)
mitigatingAction
item: : The nurse immediately stopped the syringe driver, initiated review all previous medication administration record to the moment adverse event was identified. There was no evidence of adverse reaction to the medications administration since the start of the morphine + hyoscine therapy.
mitigatingAction
item: : The nurse reported the adverse event to the pharmacy for investigation.
supportingInfo
item: : The pharmacy contacted the supplier to initiate an investigation, which revealed that a software error had occurred resulting in a wrong label (morphine 40 + hyoscine 80) being printed and attached to this batch of pre-mixed morphine + hyoscine with dose strength of 60 + 120.
supportingInfo
supportingInfo
item: : temperature = 38.7C
supportingInfo
item: : Signs and Symptoms observation, 123640000 | Mucous membrane dryness (finding)
supportingInfo
item: : Signs and Symptoms observation, 16386004 | Dry skin (finding)
supportingInfo
item: : Signs and Symptoms observation, 37125009 | Dilated pupil (finding)
supportingInfo
item: : Signs and Symptoms observation, 102835006 | Difficulty passing urine (finding)
supportingInfo
item: : Signs and Symptoms observation, 71782001 | Drowsy (finding)
note: Use Case 8 - Adverse Event resulted from a separate prior breach A 39 yo male patient with terminal pancreatic cancer in a palliative care agency is prescribed morphine hydrochloride 40 mg/24 hours + hyoscine butylbromide 80 mg/24 hours by continuous subcutaneous infusion via syringe driver for symptomatic control of pain, respiratory secretion/rattles, and anxiety. Breakthrough doses of 5 mg q1h prn SC is also prescribed for incidental pain (related to care or ADL activities). Pre-mixed morphine hydrochloride 40 mg + hyoscine butylbromide solution 80 mg in 20 ml syringes are ordered by the pharmacy from a pharmaceutical supplier and delivered to the palliative care ward in 3-day supply batches. The medications are administered as continuous SC infusion using a syringe driver device. Each syringe containing the pre-mixed medications are double checked by two nurses, attached to the syringe driver, administration rate setting on the device checked, and start button pressed. The patient on average also receives 3-4 breakthrough doses per day 30 mins before certain care/ADL activities. In week 5, a new 3-day batch of supply was delivered by the pharmacy. In the morning of the third day, the nurse found that the patient appeared to be a bit drowsy. On observation, the heart rate was 62/min (patient’s baseline heart rate = 76-82/min), temperature = 38.7C (with no indicative signs of infection); dry skin and mucosa; bilateral increased pupil size; patient also complained of slight difficulty in urination. A pancreatic enzyme capsule (Creon / Nutrizym / Pancrease / Pancrex) is the only other drug that this patient is prescribed and taking. The nurse immediately stopped the syringe driver, initiated review all previous medication administration record to the moment adverse event was identified. There was no evidence of adverse reaction to the medications administration since the start of the morphine + hyoscine therapy. The nurse made an assessment that there was a temporal relationship between the adverse reactions and administration of this new batch of premixed morphine + hyoscine medication supply, recorded the S/S, the assessment. The nurse reported the adverse event to the pharmacy for investigation. The pharmacy contacted the supplier to initiate an investigation, which revealed that a software error had occurred resulting in a wrong label (morphine 40 + hyoscine 80) being printed and attached to this batch of pre-mixed morphine + hyoscine with dose strength of 60 + 120. NOTE - a use case in which the initial reporting of adverse event will not have a condition or diagnosis The nurses at palliative care agency are unlikely to have the clinical knowledge to determine that the S/S exhibited by the patient are those of morphine toxicity and anticholinergic syndrome resulted from drug overdose. It is more likely that the nurse will record the adverse reaction S/S The case will be reviewed by a physician and the diagnosis of morphine toxicity and anticholinergic syndrome caused by drug overdose will be determined and recorded (See also the Adverse Event and Consequences confluence page for another similar use case Drug overdose scenario) (By Nurse)
FHIR
FHIRsmith{
"resourceType": "AdverseEvent",
"id": "clinicalcareexample1stage1",
"meta": {
"versionId": "1",
"lastUpdated": "2021-12-10T21:05:01.812+00:00",
"profile": [
"http://hl7.org/fhir/uv/adverseeventclinicalcare/StructureDefinition/AdverseEvent-clinical-care"
]
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"identifier": [
{
"system": "http://acme.com/ids/patients/risks",
"value": "001"
}
],
"status": "in-progress",
"actuality": "actual",
"category": [
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-category",
"code": "medication-mishap",
"display": "Medication mishap"
}
]
}
],
"code": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "62014003",
"display": "Adverse reaction caused by drug (disorder)"
}
]
},
"subject": {
"display": "39 year-old male"
},
"encounter": {
"display": "encounter where nurse noticed the problem"
},
"detected": "2021-12-10T13:28:17-05:00",
"location": {
"display": "Palliative Care Agency"
},
"outcome": [
{
"coding": [
{
"system": "http://snomed.info/sct",
"code": "398056004",
"display": "Transient abnormality with full recovery (finding)"
}
]
}
],
"recorder": {
"display": "Palliative Care nurse"
},
"suspectEntity": [
{
"instanceReference": {
"type": "MedicationRequest",
"display": "A pancreatic enzyme capsule (Creon / Nutrizym / Pancrease / Pancrex) is the only other drug that this patient is prescribed and taking."
},
"causality": {
"entityRelatedness": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
"code": "unlikely",
"display": "unlikely"
}
]
}
}
},
{
"instanceReference": {
"type": "MedicationAdministration",
"display": "The nurse made an assessment that there was a temporal relationship between the adverse reactions and administration of this new batch of premixed morphine + hyoscine medication supply, recorded the S/S, the assessment."
},
"causality": {
"entityRelatedness": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
"code": "probably-likely",
"display": "Probably/Likely"
}
]
}
}
}
],
"mitigatingAction": [
{
"itemReference": {
"type": "MedicationAdministration",
"display": "The nurse immediately stopped the syringe driver, initiated review all previous medication administration record to the moment adverse event was identified. There was no evidence of adverse reaction to the medications administration since the start of the morphine + hyoscine therapy."
}
},
{
"itemReference": {
"type": "DocumentReference",
"display": "The nurse reported the adverse event to the pharmacy for investigation."
}
}
],
"supportingInfo": [
{
"itemReference": {
"type": "DocumentReference",
"display": "The pharmacy contacted the supplier to initiate an investigation, which revealed that a software error had occurred resulting in a wrong label (morphine 40 + hyoscine 80) being printed and attached to this batch of pre-mixed morphine + hyoscine with dose strength of 60 + 120."
}
},
{
"itemReference": {
"reference": "Observation/heartrateobservation",
"display": "heart rate was 62/min. Patient Base line is 76-82/min. Observation has a referenceRange with type=Patient base-line, this is an additional code, to indicate the base-line range for the patient"
}
},
{
"itemReference": {
"type": "Observation",
"display": "temperature = 38.7C"
}
},
{
"itemReference": {
"type": "Observation",
"display": "Signs and Symptoms observation, 123640000 | Mucous membrane dryness (finding)"
}
},
{
"itemReference": {
"type": "Observation",
"display": "Signs and Symptoms observation, 16386004 | Dry skin (finding)"
}
},
{
"itemReference": {
"type": "Observation",
"display": "Signs and Symptoms observation, 37125009 | Dilated pupil (finding)"
}
},
{
"itemReference": {
"type": "Observation",
"display": "Signs and Symptoms observation, 102835006 | Difficulty passing urine (finding)"
}
},
{
"itemReference": {
"type": "Observation",
"display": "Signs and Symptoms observation, 71782001 | Drowsy (finding)"
}
}
],
"note": [
{
"authorString": "Nurse",
"text": "Use Case 8 - Adverse Event resulted from a separate prior breach A 39 yo male patient with terminal pancreatic cancer in a palliative care agency is prescribed morphine hydrochloride 40 mg/24 hours + hyoscine butylbromide 80 mg/24 hours by continuous subcutaneous infusion via syringe driver for symptomatic control of pain, respiratory secretion/rattles, and anxiety. Breakthrough doses of 5 mg q1h prn SC is also prescribed for incidental pain (related to care or ADL activities). Pre-mixed morphine hydrochloride 40 mg + hyoscine butylbromide solution 80 mg in 20 ml syringes are ordered by the pharmacy from a pharmaceutical supplier and delivered to the palliative care ward in 3-day supply batches. The medications are administered as continuous SC infusion using a syringe driver device. Each syringe containing the pre-mixed medications are double checked by two nurses, attached to the syringe driver, administration rate setting on the device checked, and start button pressed. The patient on average also receives 3-4 breakthrough doses per day 30 mins before certain care/ADL activities. In week 5, a new 3-day batch of supply was delivered by the pharmacy. In the morning of the third day, the nurse found that the patient appeared to be a bit drowsy. On observation, the heart rate was 62/min (patient’s baseline heart rate = 76-82/min), temperature = 38.7C (with no indicative signs of infection); dry skin and mucosa; bilateral increased pupil size; patient also complained of slight difficulty in urination. A pancreatic enzyme capsule (Creon / Nutrizym / Pancrease / Pancrex) is the only other drug that this patient is prescribed and taking. The nurse immediately stopped the syringe driver, initiated review all previous medication administration record to the moment adverse event was identified. There was no evidence of adverse reaction to the medications administration since the start of the morphine + hyoscine therapy. The nurse made an assessment that there was a temporal relationship between the adverse reactions and administration of this new batch of premixed morphine + hyoscine medication supply, recorded the S/S, the assessment. The nurse reported the adverse event to the pharmacy for investigation. The pharmacy contacted the supplier to initiate an investigation, which revealed that a software error had occurred resulting in a wrong label (morphine 40 + hyoscine 80) being printed and attached to this batch of pre-mixed morphine + hyoscine with dose strength of 60 + 120. NOTE - a use case in which the initial reporting of adverse event will not have a condition or diagnosis The nurses at palliative care agency are unlikely to have the clinical knowledge to determine that the S/S exhibited by the patient are those of morphine toxicity and anticholinergic syndrome resulted from drug overdose. It is more likely that the nurse will record the adverse reaction S/S The case will be reviewed by a physician and the diagnosis of morphine toxicity and anticholinergic syndrome caused by drug overdose will be determined and recorded (See also the Adverse Event and Consequences confluence page for another similar use case Drug overdose scenario)"
}
]
}