ARCHETYPE Medication safety event (openEHR-EHR-EVALUATION.medication_safety_event.v1)

ARCHETYPE ID	openEHR-EHR-EVALUATION.medication_safety_event.v1
Concept	Medication safety event
Description	Summary of a patient safety event associated with medication for reporting purposes.
Purpose	To record a summary of a patient safety event associated with medication for reporting purposes.
References
Copyright	© openEHR Foundation
Authors	Author name: Dr Ian McNicoll Organisation: Ocean Informatics, UK Email: ian.mcnicoll@oceaninformatics.com Date originally authored: 25/06/2012
Other Details Language	Author name: Dr Ian McNicoll Organisation: Ocean Informatics, UK Email: ian.mcnicoll@oceaninformatics.com Date originally authored: 25/06/2012
Other Details (Language Independent)	MD5-CAM-1.0.1: DE77C8A5A958AD6D3C30B89716CBF495
Keywords
Lifecycle	AuthorDraft
Language used	en
Citeable Identifier	1013.1.1866
data
Main event for case?	Main event for case?: Is this the principal or main event recorded during the case? Allowed values: {true}
Safety event type	Safety event type: The type of event reported. Constraint: New constraint [*] Constraint binding: [SafetyEventType]
MEDRA classification	MEDRA classification: The category of event reported using MedDRA classification. Constraint: New constraint(sl) [*(sl)]
DateTime of event onset	DateTime of event onset: The date and/or time that the adverse event took place.
Description of event	Description of event: A narrative description of the medication safety event.
Cause of event	Cause of event: Details of the estimated cause of the event.
Estimated cause of event	Estimated cause of event: The reason suspected for this event occurring. at0067::Verbal miscommunication [Verbal understanding] at0068::Written miscomunication-Illegible handwritting [Written understanding] at0069::Written miscomunication-Abbreviations [Illegible writing] at0071::Written miscomunication-Non metric units of measurement [] at0072::Written miscomunication-Decimal point [] at0073::Misread or didnt read [] at0074::Misinterpretation of the order [] at0075::Sound-alike drug name [] at0076::Look-alike drug name [] at0077::Packaging-Inappropriate Packaging or Design [] at0078::Packing-Dosage form [] at0079::Packaging-Error due to similarity to another drug (colour, form, size) [] at0080::Packaging-Error due different strength [] at0358::Characteristics of the medicine [] at0081::Human factors-Lack of information/knowledge [] at0082::Work not accomplished [] at0083::Incomplete documentation [] at0084::Work overload, burn out syndrome [] at0085::Fatigue/Lack of sleep [] at0086::Confrontational or intimidating behaviour [] at0365::Control not carried out [] at0087::Inappropriate lighting [] at0088::Inappropriate temperature/humidity [] at0089::Frequent interuptions and distractions [] at0090::Lack of staff [] at0091::Other [*]
Comment	Comment: An additional comment on the estimated cause of the event.
Related trigger	Related trigger: Triggers thought to be related to this safety event recorded using IHCI classification. Choice of: Coded Text at0270::Transfusion of Blood or Use of Blood Products [(en)] at0271::Acute Dialysis [(en)] at0272::Positive Blood Culture [(en)] at0273::X-Ray or Doppler Studies for Emboli or Deep Vein Thrombosis [(en)] at0274::Decrease in Hemoglobin or Hematocrit of 25% or Greater [(en)] at0275::Patient Fall [(en)] at0276::Pressure Ulcers [(en)] at0277::Readmission within 30 Days [(en)] at0278::Restraint Use [(en)] at0279::Healthcare-Associated Infections [(en)] at0280::In-Hospital Stroke [(en)] at0281::Clostridium difficile Positive Stool [(en)] at0282::Partial Thromboplastin Time (PTT) Greater than 100 Seconds [(en)] at0283::International Normalized Ratio (INR) Greater than 6 [(en)] at0284::Glucose Less than 50 mg/dl [(en)] at0285::Rising BUN or Serum Creatinine Two Times (2x) over Baseline [(en)] at0286::Vitamin K Administration [(en)] at0287::Diphenhydramine (Benadryl) Administration [(en)] at0288::Romazicon (Flumazenil) Administration [(en)] at0289::Naloxone (Narcan) Administration [(en)] at0290::Anti-Emetic Administration [(en)] at0291::Over-Sedation/Hypotension [(en)] at0292::Abrupt Medication Stop [(en)] at0293::Intra- or Post-Operative Death [(en)] at0294::Mechanical Ventilation Greater than 24 Hours Post-Operatively [(en)] at0295::Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon [(en)] at0296::Pneumonia Onset [(en)] at0297::Readmission to the Intensive Care Unit [(en)] at0298::Terbutaline Use [(en)] at0299::Platelet Count Less than 50,000 [(en)] at0300::Administration of Oxytocic Agents (such as oxytocin, methylergonovine, and 15-methyl-prostaglandin in the post-partum period) [(en)] at0301::Administration of General Anesthesia [(en)] at0302::Readmission to the ED within 48 Hours [(en)] at0303::Time in ED Greater than 6 Hours [(en)] at0361::Abnormal laboratory parameter [] at0362::Falsely abnormal laboratory parameter [] at0332::Unknown [*(en)] at0357::No trigger [] Text
Adverse effect	Adverse effect: Details of one or more side effects.
Reaction details	Reaction details: Details of reaction
Reaction	Reaction: Description of the side-effect reported or observed using MEDRA or ATC codes. Constraint: New constraint(sl) [*(sl)]
Comment	Comment: An additional comment on the Reaction details.
DateTime of reaction onset	DateTime of reaction onset: The datetime at which the side effects began.
Severity	Severity: The severity of the reaction. at0223::Low [] at0224::Medium [] at0225::High [*]
Liklihood of causation	Liklihood of causation: An estimate of how likely the side-effects noted are due to the safety event. at0223::Low [] at0224::Medium [] at0225::High [*]
Intervention details	Intervention details: Details of interventions.
Intervention additional details	Intervention additional details: *
Intervention	Intervention: The clinical intervention undertaken to resolve or ameliorate the adverse effect, uses PCNE terminology. at0304::Prescriber informed [(en)] at0305::Nurse informed/instructed [(en)] at0306::Dispensing rejected [(en)] at0307::Drug recalled from the ward [(en)] at0308::Dietary regime changed [(en)] at0309::Food supplement discontinued [(en)] at0310::Food supplement initiated [(en)] at0311::Reconstitution solvent changed [(en)] at0312::Diluent changed [*(en)] at0366::Medical device (or change) suggested [] at0314::Drug changed [(en)] at0315::Dose increased [(en)] at0316::Dose decreased [(en)] at0317::Dosage form changed [(en)] at0318::Administration interval changed [(en)] at0319::Drug discontinued [(en)] at0320::Drug initiated [(en)] at0321::Drug administration rate changed [(en)] at0322::Route of administration changed [(en)] at0323::Resuscitation required [(en)] at0324::Heamodialysis required [(en)] at0325::Transplantation required [(en)] at0326::Transfusion required [(en)] at0327::Operating procedure required [(en)] at0328::Additional laboratory test(s) required [(en)] at0329::Physiotherapy required [(en)] at0330::Psychotherapy required [*(en)] at0359::Error corrected [] at0360::Monitoring required [] at0363::Patient informed [] at0331::Other [**(en)]
Comment	Comment: *
Intervention result	Intervention result: The result(s) of any interventions undertaken, recorded using MEDRA classification subset. at0335::Intervencija preprečila, da bi zaplet dosegel pacienta(en) [(en)] at0336::Intervencija popolnoma odpravila posledice, ki jih je zaplet povzročil pacientu(en) [(en)] at0337::Intervencija delno odpravila posledice, ki jih je zaplet povzročil pacientu(en) [(en)] at0338::Intervencija ni odpravila posledic, ki jih je zaplet povzročil pacientu(en) [(en)] at0339::Intervencija ni bila možna(en) [(en)] at0340::Rezultat intervencije ni poznan(en) [(en)] at0341::Zmanjšanje stroškov zdravljenja(en) [(en)] at0342::Skrajšan čas hospitalizacije(en) [(en)] at0343::Pacient je bil odpuščen(en) [(en)] at0344::Izboljšana kvaliteta življenja(en) [(en)]
Side effect recurrence	Side effect recurrence: This information is aplicable when at least one Intervention is Dose decreased or Drug discontinued at0354::Yes [] at0355::No [] at0356::NA [*]
Actual patient outcome details	Actual patient outcome details: *
Actual patient outcome	Actual patient outcome: The overall impact actually experienced by the patient. at0053::[A] Circumstances or events that have the capacity to cause error [] at0054::[B] An error that did not reach the patient [] at0055::[C] An error that reached the patient but did not cause harm [] at0056::[D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [] at0057::[E] Temporary harm to the patient and required intervention [] at0058::[F] Temporary harm to the patient and required initial or prolonged hospitalization [] at0059::[G] Permanent patient harm [] at0060::[H] Intervention required to sustain life [] at0061::[I] Patient death [*]
Comment	Comment: An additional comment on the Actual patient outcome comment.
Potential patient outcome	Potential patient outcome: An assessment of potential impact on the patient if interventions had been unsuccesful. Uses the MERP index. other remediation had not occured. at0053::[A] Circumstances or events that have the capacity to cause error [] at0054::[B] An error that did not reach the patient [] at0055::[C] An error that reached the patient but did not cause harm [] at0056::[D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [] at0057::[E] Temporary harm to the patient and required intervention [] at0058::[F] Temporary harm to the patient and required initial or prolonged hospitalization [] at0059::[G] Permanent patient harm [] at0060::[H] Intervention required to sustain life [] at0061::[I] Patient death [*]
Patient outcome category	Patient outcome category: The caetgory of impact on the patient's life. at0063::Clinical [] at0064::Personal [] at0065::Economic [*]
Additional comment	Additional comment: Any additional comment or narrative.
Summary details	Summary details: Details included only in Case Summary.
Admission diagnosis classification	Admission diagnosis classification: Admission diagnosis using ICD classification. Constraint: New constraint(sl) [*(sl)]
Discharge diagnosis classification	Discharge diagnosis classification: Discharge diagnosis using ICD classification. Constraint: New constraint(sl) [*(sl)]
Link to main event	Link to main event: A link to the main case event.
Oncological case details	Oncological case details: Details required for oncological cases.
TNM classification	TNM classification: Malignant disease classification using TNM. Constraint: New constraint(sl) [*(sl)]
Effectiveness of therapy	Effectiveness of therapy: * at0245::Completely effective [The therapy has been fully effective.] at0246::Partially effective [The therpay has been partially effective.] at0247::Disease status unchanged [*] at0248::Ineffective - disease progressing unchecked. [The therapy has been ineffective and the disease is progressing unchecked.]
Order of treatment	Order of treatment: ???????
Reason for case closure	Reason for case closure: Reason for the case being closed. at0266::Treatment complete [] at0267::Treatment aborted []
Reason treatment aborted	Reason treatment aborted: The reason why the treatment was aborted.
Medications involved	Medications involved: The medicine, vaccine or other therapetic good being ordered, administered to or used by the subject
Medications administered	Medications administered: Medications administered is used to enter wrongly administered drug for Safety event type at0254 Pacient dobil drugo zdravilo od predpisanega Wrong drug administered to a patient
Other contributors	Anže Droljc, Marand s.i.i, Slovenia
Translators	Slovenian: ?