TEMPLATE Intraocular injection (Intraocular injection)

TEMPLATE ID	Intraocular injection
Concept	Intraocular injection
Description	To schedule and register the outcomes of the procedure of intraocular injection therapy.
Purpose	To schedule and register the outcomes of the procedure of intraocular injection therapy.
References
Authors	name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-28
Other Details Language	name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-28
Other Details (Language Independent)	MetaDataSet:Sample Set : Template metadata sample set Copyright: © openEHR Foundation Owner: Aitor Eguzkitza, aitor.eguzkiza@unavarra.es Speciality: Ophthalmology
Language used	en
Citeable Identifier	1013.26.112
Root archetype id	openEHR-EHR-SECTION.intraocular_injection.v0
Intraocular injection	Intraocular injection: Manages the process of planning and then carrying out an ophthalmic treatment by means of intraocular injection.
Medication order	Medication order: Instructions for use of a medication, vaccine or other therapeutic item.
Order	Order: Order.
Description
Medication item	Medication item: Identification of the medication, vaccine or other therapeutic item being ordered. It is strongly recommended that the 'Medication item' be coded with a terminology capable of triggering decision support, where possible. The extent of coding may vary from the simple name of the medication item through to structured details about the actual medication pack to be used. Free text entry should only be used if there is no appropriate terminology available. Value set: terminology:Snomed?subset=Compounds%20for%20intravitreal%20injection&language=en-GB
Route	Route: The route of administration. For example: 'oral', 'intravenous', or 'topical'. Coding of the route with a terminology is preferred, where possible. Multiple potential routes may be specified. Default value: Intravitreal injection
Dose directions description	Dose directions description: Complete narrative description about how the medication is to be used. Including the amount, when to take it and additional instructions for use. Where the medication dose directions are fully carried by the structured, computable dose directions, this element should carry the narrative equivalent, generally auto-generated. If it is not possible to represent the intended dosage directions fully in computable form, partial representation is not recommended, and the directions should be only recorded in narrative form using this data element.
Parsable dose directions	Parsable dose directions: The structured, parsable and computable representation of the dose directions. Generally this is only used when passing information between legacy systems. For example: '10mg bd; 20mg n' as used by the NHS Dose syntax (in development). Formalism text/html text/plain text/xml text/rtf
Dose amount description	Dose amount description: The narrative description of the dose amount of the medication, vaccine or other therapeutic item. Will generally only be used for legacy formats where dose directions are simply split between textual representations of dose and amount.
Dose timing description	Dose timing description: The narrative description of the dose frequency and other timing of the medication, vaccine or other therapeutic item. Will generally only be used for legacy formats where dose directions are simply split between textual representations of dose and amount.
Clinical indication	Clinical indication: The clinical reason for ordering the medication, vaccine or other therapeutic good. For example: 'Angina'. Coding of the clinical indication with a terminology is preferred, where possible. This data element allows multiple occurrences.
Therapeutic intent	Therapeutic intent: The overall therapeutic intent of the medication. For example: 'palliative care', 'low-dose propylaxis'. Treatment for wet AMD Treatment for DR and DME
Order details	Order details: Details about the intended course of the medication.
Order start date/time	Order start date/time: The date and optional time to commence use of the medication, vaccine or other therapeutic good.
Order stop date/time	Order stop date/time: The date and optional time to cease use of the medication, vaccine or other therapeutic good.
Order start criterion	Order start criterion: A condition which, when met, requires the commencement of administration or use. For example: 'Start if symptoms recur'.
Order stop criterion	Order stop criterion: A condition which, when met, requires the cessation of administration or use. For example: 'Stop after symptoms disappear''.
Administrations already complete	Administrations already complete: The number of administrations of the medication, vaccine or other therapeutic good that have been completed, as part of the proposed overall course but prior to the issue of this order. For example: To record that the patient had been taking antibiotics three days prior to hospital admission, in the context of a 7-day course.
Duration of course already complete	Duration of course already complete: The time period during which the patient has already been using the medication, vaccine or other therapeutic good, as a part of the proposed overall course but prior to the issue of this order. For example: To record that the patient had been taking antibiotics 3 days prior to hospital admission, in the context of a 7 day course. >=PT0H Units: Week Day Hour
Administration directions	Administration directions: Details about the administration of the medication, vaccine or other therapeutic good.
Body site	Body site: Identification of the site of administration of the medication, vaccine or therapeutic good. For example: 'left upper arm', 'intravenous catheter right hand'. Coding of the body site with a terminology is preferred, where possible. Default value: Eye vitreous
Delivery method	Delivery method: The method by which the medication is to be delivered. For example: 'via nebuliser'. Default value: Intravitreal injection
Intravitreal injection details	Intravitreal injection details: Details about intravitreal injection procedure.
Laterality	Laterality: Eyes treated in the same sitting. Left Right Bilateral
Clinical Setting	Clinical Setting: Allocation where the intravitreal injection takes place. Office setting Treatment room Operating room
Contraindications	Contraindications: Identifies possible contraindications (if any) to be considered before conducting ITV injections. Ocular hipertension/glaucoma Previous conditions/surgeries Recent surgery Complex conditions Anticoagulation Allergy Infection Abnormalities
Anaesthetic	Anaesthetic: Details concerning the anaesthetic prior to the procedure.
Anaesthetic Type	Anaesthetic Type: Type of anesthesia chosen. Topical Drops Gel Injection
Anaesthetic Route	Anaesthetic Route: Route chosen to apply the anesthesia. Retrobulbar Peribulbar Subtenons Subconjunctival Topical Topical and intracameral Other
Anaesthetic Agent	Anaesthetic Agent: Anesthetic agent. Value set: ac0002
Preparation	Preparation: Details about preparation of the intervention.
Sterile Drape	Sterile Drape: Use or not of a sterile drape before injection.
Speculum	Speculum: Use of speculum or on the contrary manual eye lid retraction, to prevent contact of the eyelashes and eyelid margins with both the injection site and the injection needle.
Sterile Gloves	Sterile Gloves: Use of sterile or nonsterile gloves during the intervention.
Surgical Masks	Surgical Masks: Use of surgical masks by clinicians and patients, or on the contrary, do not use mask but minimize speaking to reduce infection risk during procedure.
Monitor IOP	Monitor IOP: *
Anti-infective on Eyelids	Anti-infective on Eyelids: Application or not of anti-infective agent to the eyelids, including the eyelid margins and eyelashes.
Dilation Required	Dilation Required: Need or not of pupillary dilation prior to the surgical intervention.
Pre Injection Skin Cleanser	Pre Injection Skin Cleanser: Anti-infective agent used for skin cleanse. Value set: ac0003
Pre Injection Conjunctival Cleanser	Pre Injection Conjunctival Cleanser: Anti-infective agent used as antiseptic. Value set: ac0004
Pre Injection IOP Lowering Therapy Required	Pre Injection IOP Lowering Therapy Required: Select if pre Injection IOP lowering therapy is required. Assumed value: false
Pre Injection IOP Lowering Therapy	Pre Injection IOP Lowering Therapy: Therapy chosen to lower patient's IOP prior to injections. Apraclonidine 0.5% Apraclonidine 1% Acetazolamide 250mg Acetazolamide 500mg
Intravitreal Injections	Intravitreal Injections: Details about application of injections.
Compound Injected	Compound Injected: Compound contained within the intravitreal injection. Value set: ac0005
Injection Site	Injection Site: Distance in mm of the needle posterior to the limbus between the vertical and horizontal rectus muscles. 2.5..4.5 mm
Number of injections	Number of injections: Number of injections involved in the current intervention. >=1 Assumed value: 1
Batch Number	Batch Number: Batch number of the injections used.
Batch Expiry Date	Batch Expiry Date: Expiry date for the batch of injections used.
Post Injection	Post Injection: Details about procedures after intravitreal injections to guarantee patient's safety.
Post Injection IOP Lowering Therapy Required	Post Injection IOP Lowering Therapy Required: Select if IOP lowering is required after injection. Assumed value: false
Post Injection IOP Lowering Therapy	Post Injection IOP Lowering Therapy: Therapy chosen to lower patient's IOP after injections. Apraclonidine 0.5% Apraclonidine 1% Acetazolamide 250mg Acetazolamide 500mg
Post Injection examination	Post Injection examination: Routine examination to check the patient's status after the therapy.
Counting Fingers	Counting Fingers: Evaluation about if the patient is able to count fingers or not.
IOP Checked	IOP Checked: Intraocular pressure measurement is recommended or not.
Complications	Complications: Possible complications due to intravitreal injections. Infectious endophthalmitis Subconjunctival haemorrage Conjunctival damage Corneal abrasion Lens damage Retinal damage Other
Comment	Comment: Additional narrative about the medication order not captured in other fields.
Medication	Medication: Details of use, administration, dispensing or other care step relating to a medicine, vaccine or other therapeutic good which may arise from an instruction from a clinician.
Description
Medication	Medication: The medicine, vaccine or other therapeutic good which was the focus of the action. This element will normally be coded with a medicines terminology but free text may be required in some cases. For example: 'Atenolol 100mg' or 'Atenolol tablets 100mg'. Value set: terminology:Snomed?subset=Compounds%20for%20intravitreal%20injection&language=en-GB
Product	Product: Details of the product dispensed, authorised or administered.
Manufacturer	Manufacturer: The manufacturer of the medication.
Batch ID	Batch ID: Assigned by the manufacturer to identify the manufacturing batch of the item.
Expiry date	Expiry date: The expiry date of the medicine administered as documented by the manufacturer.
Dispensing substitution	Dispensing substitution: Subsitution action taken by the dispenser. Substitute product dispensed Substitute product not dispensed
Dispensing substitution reason	Dispensing substitution reason: The reason or justification for the substitution action taken.
Order scheduled datetime	Order scheduled datetime: The datetime at which the medication order was scheduled to occur. Used to compare variance from actual action time where this is not readily calculable from the original instruction.
Reason	Reason: The reason(s) the specific action or step was carried out. Note: This is not the reason for the medication instruction, rather the specific reason e.g. for administration.
Delivery details	Delivery details: Details of body site and delivery of the medication.
Body site	Body site: Identification of the site of administration of the medication, vaccine or therapeutic good. For example: 'left upper arm', 'intravenous catheter right hand'. Coding of the body site with a terminology is preferred, where possible. Default value: Eye vitreous
Delivery method	Delivery method: The method by which the medication is to be delivered. For example: 'via nebuliser'. Default value: Intravitreal injection
Intravitreal injection details	Intravitreal injection details: Details about intravitreal injection procedure.
Laterality	Laterality: Eyes treated in the same sitting. Left Right Bilateral
Clinical Setting	Clinical Setting: Allocation where the intravitreal injection takes place. Office setting Treatment room Operating room
Contraindications	Contraindications: Identifies possible contraindications (if any) to be considered before conducting ITV injections. Ocular hipertension/glaucoma Previous conditions/surgeries Recent surgery Complex conditions Anticoagulation Allergy Infection Abnormalities
Anaesthetic	Anaesthetic: Details concerning the anaesthetic prior to the procedure.
Anaesthetic Type	Anaesthetic Type: Type of anesthesia chosen. Topical Drops Gel Injection
Anaesthetic Route	Anaesthetic Route: Route chosen to apply the anesthesia. Retrobulbar Peribulbar Subtenons Subconjunctival Topical Topical and intracameral Other
Anaesthetic Agent	Anaesthetic Agent: Anesthetic agent. Value set: ac0002
Preparation	Preparation: Details about preparation of the intervention.
Sterile Drape	Sterile Drape: Use or not of a sterile drape before injection.
Speculum	Speculum: Use of speculum or on the contrary manual eye lid retraction, to prevent contact of the eyelashes and eyelid margins with both the injection site and the injection needle.
Sterile Gloves	Sterile Gloves: Use of sterile or nonsterile gloves during the intervention.
Surgical Masks	Surgical Masks: Use of surgical masks by clinicians and patients, or on the contrary, do not use mask but minimize speaking to reduce infection risk during procedure.
Monitor IOP	Monitor IOP: *
Anti-infective on Eyelids	Anti-infective on Eyelids: Application or not of anti-infective agent to the eyelids, including the eyelid margins and eyelashes.
Dilation Required	Dilation Required: Need or not of pupillary dilation prior to the surgical intervention.
Pre Injection Skin Cleanser	Pre Injection Skin Cleanser: Anti-infective agent used for skin cleanse. Value set: ac0003
Pre Injection Conjunctival Cleanser	Pre Injection Conjunctival Cleanser: Anti-infective agent used as antiseptic. Value set: ac0004
Pre Injection IOP Lowering Therapy Required	Pre Injection IOP Lowering Therapy Required: Select if pre Injection IOP lowering therapy is required. Assumed value: false
Pre Injection IOP Lowering Therapy	Pre Injection IOP Lowering Therapy: Therapy chosen to lower patient's IOP prior to injections. Apraclonidine 0.5% Apraclonidine 1% Acetazolamide 250mg Acetazolamide 500mg
Intravitreal Injections	Intravitreal Injections: Details about application of injections.
Compound Injected	Compound Injected: Compound contained within the intravitreal injection. Value set: ac0005
Injection Site	Injection Site: Distance in mm of the needle posterior to the limbus between the vertical and horizontal rectus muscles. 2.5..4.5 mm
Number of injections	Number of injections: Number of injections involved in the current intervention. >=1 Assumed value: 1
Batch Number	Batch Number: Batch number of the injections used.
Batch Expiry Date	Batch Expiry Date: Expiry date for the batch of injections used.
Post Injection	Post Injection: Details about procedures after intravitreal injections to guarantee patient's safety.
Post Injection IOP Lowering Therapy Required	Post Injection IOP Lowering Therapy Required: Select if IOP lowering is required after injection. Assumed value: false
Post Injection IOP Lowering Therapy	Post Injection IOP Lowering Therapy: Therapy chosen to lower patient's IOP after injections. Apraclonidine 0.5% Apraclonidine 1% Acetazolamide 250mg Acetazolamide 500mg
Post Injection examination	Post Injection examination: Routine examination to check the patient's status after the therapy.
Counting Fingers	Counting Fingers: Evaluation about if the patient is able to count fingers or not.
IOP Checked	IOP Checked: Intraocular pressure measurement is recommended or not.
Complications	Complications: Possible complications due to intravitreal injections. Infectious endophthalmitis Subconjunctival haemorrage Conjunctival damage Corneal abrasion Lens damage Retinal damage Other
Sequence number	Sequence number: The sequence number specific to the action being recorded.
Comment	Comment: A comment on the action taken including details of any variance between the intended action and the action actually performed.
Adverse reaction risk	Adverse reaction risk: Risk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance. Substances include, but are not limited to: a therapeutic substance administered correctly at an appropriate dosage for the individual; food; material derived from plants or animals; or venom from insect stings. Optional[{source=openEHR,FHIR}]
Data
Substance	Substance: Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event. Both an individual substance and a substance class are valid entries in 'Substance'. If the value in 'Substance' is an individual substance, it may be duplicated in 'Specific substance'. It is strongly recommended that both 'Substance' and 'Specific substance' be coded with a terminology capable of triggering decision support, where possible. For example: Snomed CT, DM+D, RxNorm, NDFRT, ATC, New Zealand Universal List of Medicines and Australian Medicines Terminology. Free text entry should only be used if there is no appropriate terminology available. Optional[{source=openEHR,FHIR,DAM}] Value set: terminology:Snomed?subset=Compounds%20for%20intravitreal%20injection&language=en-GB
Criticality	Criticality: An indication of the potential for critical system organ damage or life threatening consequence. This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value. Optional[{source=DAM, openEHR}] Low High Indeterminate
Onset of last reaction	Onset of last reaction: The date and/or time of the onset of the last known occurrence of a reaction event. This date may be be a duplicate of the most recent 'Onset of reaction' date. Where a textual representation of the date of last occurrence is required e.g 'In Childhood, '10 years ago' the Comment element should be used. Optional[{source=IMH}]
Comment	Comment: Additional narrative about the propensity for the adverse reaction, not captured in other fields. For example: including reason for flagging a 'Criticality' of 'High risk'; and instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover. Optional[{source=openEHR}]
Protocol
Last updated	Last updated: Date when the propensity or the reaction event was updated. Note: maps to recordedDate in FHIR. Optional[{source=openEHR, FHIR, DAM}]
Supporting clinical record information	Supporting clinical record information: Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports. For example, presenting symptoms, examination findings, diagnosis etc. [Note: FHIR,DAM: Maps to Sensitivity Test.] Optional[{source=FHIR, openEHR, DAM}]
Reaction reported?	Reaction reported?: Has the adverse reaction ever been reported to a regulatory body? Optional[{source=openEHR}]
Report summary	Report summary: Structured details about reports that have been forwarded to regulatory bodies.
Date of report	Date of report: Date that the report was sent to the regulatory authority.
Report comment	Report comment: Narrative about the adverse reaction report or reporting process. For example, the reason for non-reporting. Optional[{source=openEHR}]
Adverse reaction report	Adverse reaction report: Link to an adverse reaction Report sent to a regulatory body. Optional[{source=openEHR}]
Other contributors	Jose Andonegui, Complejo hospitalario de Navarra (CHN), jose.andonegui.navarro@cfnavarra.es; Luis Serrano, Universidad Pública de Navarra (UPNA), lserrano@unavarra.es; Jesús D. Trigo, Universidad Pública de Navarra (UPNA), jesusdaniel.trigo@unavarra.es