CDA+-+Medications+Section

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This report is generated from comments in the sample file. In each table, the first rows identify the topic and what the various specifications (CCD, C83, IHE) say about it. The proposed consolidated requirement is provided in bold prose and in semi-formal notation.
 * "Required if known" (R2) is represented as "SHOULD [0..1]".
 * The multiple templateIds required by the various specifications are not required. Each template will get a new templateId.
 * The CCD Source of Information is not required, per the 3/15 Consolidation Team conference call.
 * A decision about the HITSP required linking from originalText/reference to narrative block is pending. In a very few places, guidance on the content suggests something more that might be required even if the "routine" text/reference requirement is dropped. These places are noted.

= Meds-1: Medication Activity = (Back to the top)
 * **path** || **Medication Activity** ||
 * || SHOULD [0..*] entry CCD-298 ||
 * || SHALL [1..*] entry C83-[CT-112-2] ||
 * || SHALL [1..] entry [also specifies a templateId] and entry//templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.4.7" IHE PCC-6    .3.3.3.1// ||
 * issue || CCD allows Level 2 sections that have only a narrative block. C83 and IHE require at least one coded entry, and IHE specifically requires one or more entries that represent a Medication Activity. ||
 * **proposal** || **A Medications Section SHALL contain one or more entries representing a Medication Activity. Source constraint:// IHE PCC-6.3.3.3.1** ||
 * guidance || To record lack of information or negative information about medication activity, see code, below. ||
 * formal || SHALL [1..*] Medication Activity ||

= Meds-2: substanceAdministration = (Back to the top)
 * **path** || **substanceAdministration in Medication Activity** ||
 * || CCD 1.3.6.1.4.1.19376.1.5.3.1.4.7, 2.16.840.1.113883.10.20.1.24; C83 2.16.840.1.113883.3.88.11.83.8 ||
 * || SHALL [1..1] substanceAdministration CCD-304 ||
 * || SHALL [1..1] substanceAdministration/@moodCode="EVN" or @moodCode="INT" CCD-305 ||
 * || The general model is to record each prescribed medication in a  intent (moodCode='INT'). Medications that have been reported by the patient or administered (instead of prescribed), are recorded in the same element, except that this is now an event 4665 (moodCode='EVN'). IHE 16.3.4.16.3 ||
 * || SHALL [1..1] per CDA R2 @classCode="SBADM" ||
 * issue || IHE requires two templateIds - one specifies the general type of administration (see discussion of code, below), the second refines the category: simple (normal), split, tapered, conditional, and combination-component administrations. These refined categories are not described by HITSP and are not modeled here. ||
 * **guidance** || **A Medication Activity can record a medication prescribed (@moodCode INT), or a medication the patient reports taking (@moodCode EVN).** ||
 * **proposal** || **A Medication Activity SHALL be represented by a substanceAdministration element where the value of @classCode is SBADM and the value of @moodCode is INT (prescribed) or EVN (patient report of medication taken).** **//Source constraint:// CCD-305 and IHE 16.3.4.16.3** ||
 * **formal** || **The context node for the template is substanceAdministration** ||
 * **formal** || **with @moodCode='EVN' or 'INT' and @classCode='SBABM'** ||

= Meds-3: id (Medication Activity) = (Back to the top)
 * **path** || **Medication Activity: id** ||
 * || SHALL [1..*] id CCD-306 ||
 * || SHALL [1..*] id and id/@root IHE PCC-6 .3.4.16.6 ||
 * issue || CCD requires an id element, which can be nullFlavored. C83 is silent on this. IHE does not allow a nullFlavor. ||
 * **guidance** || **An id element has two important roles: to record an external identifier, such as a person's hospital id or an incident id; and to assert the identity of two objects in the CDA document. The second role allows information to be recorded in one place, and thereafter referenced.** ||
 * **proposal** || ** A Medication Activity SHALL contain at least one id element. It may be nullFlavored. //Source constraint:// CCD-306 ** ||
 * **formal** || **SHALL [1..*] id** ||

= Meds-4: code (Med Activity) = (Back to the top)
 * **path** || **Medication Activity: code** ||
 * || MAY [0..1] code C83-8.12 - Delivery Method ||
 * || MAY [0..1] Delivery method in code C83-[DE-8.12-CDA-1 ] ||
 * || MAY [0..1] code IHE PCC-6 .3.4.16.7 ||
 * || MAY [0..1] code IHE PCC-6 .3.4.16.7 ||
 * || MAY [0..1] code IHE PCC-6 .3.4.16.7 ||
 * resolved || The CCD extract from the RIM (Figure 11) specifies CD C/WE SubstanceAdministrationActCode, HL7 V16532 "The specific chemical or radiological substance administered or to be administered into the body for therapeutic effect." This is an error. The role of this code is to record -type- of administration, such as intravenous injection. ||
 * issue || C83 did not specify a vocabulary for Delivery Method because, at time of publication, harmonization work with the NCPDP Industry SIG Task Force and the e-Prescribing pilots had not yet published results. ||
 * issue || IHE specifies SNOMED codes to document lack of information or negative information: lack of knowledge about drug therapy (182904002: Drug treatment unknown); absence of any prescribed medications (182849000: No drug therapy prescribed); no treatment (408350003: Patient not on self-medications). IHE PCC-6.3.4.16. These are recommended for use in consumable//code, below. ||
 * **guidance** || **The role of this code is to record type of administration act, such as intravenous injection. It is optional, available to be used when a substance could be appropriately administered in more than one way. It might record a procedure code, or a method of administration such as intravenous injection. (The substance administered/prescribed is recorded in the consumable element, below.)** ||
 * **proposal** || **[No constraint to propose]** ||
 * **formal** || **[No constraint to record]** ||

= Meds-5: text = (Back to the top)
 * **path** || **Medication Activity: text** ||
 * || MAY [0..1] text C83-8.01 - Free Text Sig, C83-2.2.2.8.2 ||
 * || SHALL [1..1] text/reference pointing to the narrative block IHE PCC-6 .3.4.16.8 ||
 * issue || The use of text/reference to point to the narrative block was resolved by SDWG to SHOULD. ||
 * issue || In a Medication Activity, the C83 example, and IHE explicit direction, are that this data item describe the medication fully as text. The example implies that the text be the original form of the prescription. ||
 * **guidance** || **In a Medication Activity, the text element records a full description of the medication. Examples: "Acetaminophen 325 mg tablet tid po prn", "2 puffs QID PRN wheezing".** ||
 * old proposal || A Medication Activity SHALL contain a text/reference element. //Source constraint:// IHE PCC-6 .3.4.16.8 ||
 * **new proposal** || **A Medication Activity SHOULD contain a text/reference to a full description of the medication in the narrative block. //Source constraint:// IHE PCC-6 .3.4.16.8** ||
 * **formal** || **SHOULD [0..1] text/reference/@value** ||

= Meds-6: statusCode (Med Activity) = (Back to the top)
 * **path** || **Medication Activity: statusCode** ||
 * || SHOULD [0..1] statusCode CCD-307 ||
 * || SHALL [1..1] statusCode/@code="completed" IHE PCC-6 .3.4.16.9 ||
 * issue || CCD allows, and IHE requires, a statusCode element. IHE further requires the value be 'completed', however this may not be appropriate with @moodCode INT. ||
 * issue || Some developers rely on the Status template rather than the statusCode element. ||
 * **guidance** || **The statusCode records the status of the Medication Activity.** ||
 * doc || Document HL7 ActStatus: aborted / active / cancelled / completed / held / new / suspended. ||
 * **guidance** || **If the Medication Activity contains a Status template, the value of statusCode/@code must be consistent with what is recorded in the Status template.** ||
 * old proposal || A Medication Activity template SHALL contain a statusCode element with the value 'completed'. //Source constraint:// IHE PCC-6 .3.4.16.9 ||
 * **new proposal** || **A Medication Activity template SHOULD contain a statusCode element. //Source constraint:// CCD-307** ||
 * **formal** || **SHOULD [1..1] statusCode** ||

= Meds-7: effectiveTime-1 (Med Act) = (Back to the top)
 * **path** || **Medication Activity: effectiveTime, sense 1: period of administration (start and stop dates)** ||
 * || SHOULD [0..*] effectiveTime CCD-308 ||
 * || MAY [0..1] effectiveTime/high C83-8.02 - Indicate Medication Stopped ||
 * || SHALL [1..1] effectiveTime[1][@xsi:type="TS"] if single administration C83-[DE-8-CDA-3 ] or SHALL [1..1] effectiveTime[1][@xsi:type="IVL_TS"] if more than single administration C83-[DE-8-CDA-3 ] ||
 * || SHALL [1..1] effectiveTime[@xsi:type="IVL_TS"] IHE PCC-6 .3.4.16.10 ||
 * || SHALL [1..1] effectiveTime/low IHE PCC-6 .3.4.16.2.1 Start and Stop Date ||
 * || If start date not known, low/@nullFlavor="UNK" IHE PCC-6 .3.4.16.11 ||
 * || SHALL [1..1] effectiveTime/high ... IHE PCC-6 .3.4.16.2.1 Start and Stop Date ||
 * || If stop date not known, high/@nullFlavor="UNK" IHE PCC-6 .3.4.16.11 ||
 * issue || (naming) C83 names this Indicate Medication Stopped, but it records start date also. ||
 * issue || C83 allows a single effectiveTime with either datatype IVL_TS or (for a single administration) with datatype TS. IHE instead requires a first effectiveTime with datatype IVL_TS and with low and high values representing start/stop dates (both may be nullFlavored), and recommends ("should") a second effectiveTime to record timing, frequency including single administration, interval, and duration. The IHE approach avoids a need for coding interpretation, albeit at the cost, for a single administration, of adding an effectiveTime that C83 does not require. ||
 * **guidance** || **In a Medication Activity, effectiveTime is used in two senses. The first is required and records the period of administration, i.e., the start and stop dates. This sense of effectiveTime is described here. Additional effectiveTime elements recording the schedule of administration - timing, frequency, interval, and duration - are optional; that sense of effectiveTime is specified separately below.** ||
 * **proposal** || **A Medication Activity SHALL contain an effectiveTime[1] element where the value of @xsi:type is IVL_TS and both low and high elements are present. To record that the low or high date is not known, use @nullFlavor="UNK". //Source constraint:// IHE PCC-6 .3.4.16.10, 11** ||
 * **formal** || **effectiveTime[1] [@xsi:type = 'IVL_TS'** ||
 * **formal** || **with low, having @value or @nullFlavor='UNK'** ||
 * **formal** || **with high, having @value or @nullFlavor='UNK'** ||

= Meds-8: effectiveTime-2 (Med Act) = (Back to the top)
 * **path** || **Medication Activity: effectiveTime, sense 2: schedule of administration (timing, frequency, interval, duration)** ||
 * || SHOULD [0..*] effectiveTime CCD-308 ||
 * || MAY [0..*] effectiveTime[2] C83-8.03 - Administration Timing ||
 * || MAY [0..*] effectiveTime[2] C83-8.04 - Frequency ||
 * || MAY [0..*] effectiveTime[2] C83-8.05 - Interval ||
 * || MAY [0..*] effectiveTime[2] C83-8.06 - Duration ||
 * || SHOULD [0..1] (required if known) effectiveTime[2] IHE PCC-6 .3.4.16.12 ||
 * || SHOULD [0..1] (required if known) effectiveTime[2] IHE PCC-6 .3.4.16.2.1 Frequency ||
 * resolved || The IHE section heading includes "@operator="A", but (a) this is not mentioned in the text, and (b) in IHE Table 6.3.4.16.12.1-1 an important example (single administration) doesn't use it. Conclusion: The IHE heading is not prescriptive: the operator attribute is not always required in effectiveTime sense (2). ||
 * issue || C83 specifies each of Administration Timing, Frequency, Interval, and Duration as optional, repeatable (O/Y). It seems likely that the intent is not to record multiple frequencies, intervals, etc., but rather to allow more than one of each type of scheduling requirement, e.g., [1..1] interval with [1..1] duration. ||
 * issue || IHE records effectiveTime (2) as required-if-known. It is not clear whether the intent is to allow a nullFlavor as for effectiveTime (1) ||
 * doc || Provide the examples in a table, as in C83 and IHE. ||
 * **guidance** || **In a Medication Activity, effectiveTime is used in two senses. The first is required and records the period of administration, i.e., the start and stop dates. That sense of effectiveTime is described separately, above. Timing, frequency, interval, and duration of administration (e.g., 4 times per day, every 12 hours, in the morning, with breakfast) can be recorded in additional effectiveTime elements. This sense of effectiveTime is specified here.** ||
 * **guidance** || **To record a single administration, use @value. Otherwise, use the CDA features period, event, and phase, as shown in the examples, to record timing, frequency, interval, or duration.** ||
 * **guidance** || **The period element can represent either timing between doses or frequency. Use @institutionSpecified to distinguish these: To specify an interval between doses (e.g., every 8 hours), set the value of @institutionSpecified to false or omit the attribute. To specify frequency of administration (e.g., 3 times per day), set the value of @institutionSpecified to true.** ||
 * **proposal** || **A Medication Activity SHOULD contain one or more additional effectiveTime elements. They can be nullFlavored.** **//Source constraint://** **CCD-308 ; C83 8.03,4,5,6; IHE 6.3.4.16.12 and PCC-6 .3.4.16.2.1** ||
 * **proposal** || **A frequency SHOULD be recorded (this may be a single administration).** ||
 * **formal** || **SHOULD [0..*****]** **effectiveTime[preceding-sibling::effectiveTime]** ||
 * **formal** || **with @xsi:type from value set, or @value, or @nullFlavor** ||

= Meds-9: routeCode = (Back to the top)
 * **path** || **routeCode in Medication Activity** ||
 * || SHOULD [0..1] routeCode CCD-309 ||
 * || MAY [0..1] routeCode C83-8.07 - Route ||
 * || SHOULD [0..1] (required if known) routeCode IHE PCC-6 .3.4.16.2.1 Route ||
 * || if not known: omit routeCode element IHE PCC-6 .3.4.16.13 ||
 * issue || The CCD, C83, and IHE conformance verbs differ. ||
 * issue || IHE specifies to omit this element if a value is not known. The proposal interprets C83 as allowing nullFlavor. ||
 * || CCD: The value of @code SHOULD be selected from HL7 RouteOfAdministration (2.16.840.1.113883.5.112) CCD-310 ||
 * || C83: The value of @code SHALL be selected from Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 C83-[DE-8.07-CDA-1 ] and C80-[2.2.3.3.4.1] ||
 * || IHE: The value of @code SHALL be selected from HL7 RouteOfAdministration vocabulary IHE PCC-6 .3.4.16.13 ||
 * issue || C83 and IHE require different code systems. ||
 * issue || The C83 example code shows codeSystem "NCI Thesaurus" but its constraint text says "SHALL be coded as specified in HITSP/C80 Section 2.2.3.3.4.1 Medication Route FDA" which in turn requires Medication Route FDA Value Set, consistent with SPL, available as an NCI value set at [] ||
 * issue || Recent/proposed SNOMED work on route and method vocabulary hierarchy may be the best-structured concepts available. ||
 * **proposal** || **A Medication Activity MAY contain a routeCode element. The value of @code SHALL be selected from Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7. When a value is not known, a nullFlavor can be used or the element can be omitted. //Source constraint:// C83-[DE-8.07-CDA-1] and C80-[2.2.3.3.4.1]** ||
 * doc || Document the FDA Medication Route value set 2.16.840.1.113883.3.88.12.3221.8.7, incidentally available as NCI Route of Administration value set with OID 2.16.840.1.113883.3.26.1.1 ||
 * **formal** || **MAY [0..1] routeCode** ||
 * **formal** || **MAY @nullFlavor** ||
 * **formal** || **The value of @code, if present, SHALL be selected from Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7** ||

= Meds-10: approachSiteCode = (Back to the top)
 * **path** || **Medication Activity: approachSiteCode** ||
 * || MAY [0..*] approachSiteCode C83-8.09 - Site ||
 * || MAY [0..*] approachSiteCode IHE PCC-6 .3.4.16.2.1 Site ||
 * || The value of @code SHALL be [long specification, see formal constraint below] C154-[DE-8.09-1] / C80 Section 2.2.3.2.1 Body Site. ||
 * || may be coded to a controlled vocabulary that lists such sites (e.g., SNOMED-CT). IHE PCC-6 .3.4.16.14 ||
 * issue || C154 provides a specification for a value set for this code. IHE merely says the code may come from a controlled vocabulary. ||
 * **proposal** || **A Medication Activity MAY contain an approachSite Code. The value of approachSiteCode/@code SHALL be [long specification, see formal constraint below]. //Source constraint:// C154-[DE-8.09-1] / C80 Section 2.2.3.2.1 Body Site.** ||
 * **formal** || **MAY [0..1] approachSiteCode** ||
 * **formal** || **MAY @nullFlavor** ||
 * **formal** || **The value of @code, if present, SHALL be a value descending from SNOMED CT Anatomical Structure (91723000), or Acquired body structure (body structure) (280115004) or Anatomical site notations for tumor staging (body structure)(258331007), or Body structure, altered from its original anatomical structure (morphologic abnormality) (118956008), or Physical anatomical entity (body structure) (91722005)** ||

= Meds-11: doseQuantity units = (Back to the top)
 * **path** || **Medication Activity: doseQuantity units** ||
 * issue || IHE manages the relationship between doseQuantity and consumable differently than C83 does. Conformant to IHE, - consumable/code describes the product - consumable/code/originalText records the name -and- strength - consumable/name records the product generic or brand name, or failing those the type, purpose, or other description, but must not include packaging strength or dosing information. - a doseQuantity in countable units (e.g. tablets) must not specify the unit. The C83 model is followed here. ||
 * || Pre-coordinated: ||
 * || If the consumable code is a precoordinated unit dose (e.g. "metoprolol 25mg tablet") then doseQuantity is a unitless number that indicates the number of products given per administration (e.g. "2", meaning 2 x "metoprolol 25mg tablet") CCD-361 ||
 * || If the consumable code records strength or concentration, e.g. "Acetaminophen 325 mg tablet", the value of @unit SHOULD be the preferred name of the presentation unit, within braces {}, drawn from NCI Thesaurus. e.g.  C154-[DE-8.08-2] ||
 * || Not pre-coordinated: ||
 * || If the consumable code is not pre-coordinated, then doseQuantity must represent a physical quantity with @unit, e.g. "325" and "mg", specifying the amount of product given per administration. CCD-362 ||
 * || MAY [0..1] doseQuantity units C154-[DE-8.08-1] ||
 * || If dosage is specified, the value of @unit SHALL be selected from UCUM 2.16.840.1.113883.3.88.12.80.29 C154-[DE-8.08-1] ||
 * **guidance** || **The doseQuantity element records the amount of product given per administration and can be nullFlavored.** ||
 * **guidance** || **If strength/concentration is not recorded in the coded product or brand name, it is represented in doseQuantity (e.g., product: Acetaminophen - doseQuantity: 325 mg).** ||
 * **guidance** || **However, if strength/concentration is recorded in the coded product name or brand name, doseQuantity can represent units of administration (e.g., product: Acetaminophen 325mg tablet - doseQuantity: 1 tablet).** ||
 * **proposal** || **When doseQuantity represents strength/concentration, @unit SHALL be present and the value of @unit SHALL be selected from UCUM 2.16.840.1.113883.3.88.12.80.29.  Source constraint: C154-[DE-8.08-1]** ||
 * **proposal** || **When doseQuantity represents units of administration, @unit SHOULD be present and, if present, the value of @unit SHOULD be the preferred name of the unit, within braces {}, drawn from NCI Thesaurus.  Source constraint: C154-[DE-8.08-2]** ||
 * **toDo** || **"NCI Thesaurus" covers more than units of administration: get a precise specification.** ||

= Meds-12: doseQuantity: low & high = (Back to the top)
 * **path** || **Medication Activity: doseQuantity: low and high** ||
 * || SHALL [1..1] doseQuantity/low and doseQuantity/high IHE PCC-6 .3.4.16.15 ||
 * issue || IHE PCC seems to indicate high and low should always be present; (if not a range, low and high have the same value). The Joint Commission discourages such ranges: instead, specify the dosages/rates separately, e.g. "1 tablet every 3h for severe pain", "1/2 tablet every 6h for mild pain". ||
 * **guidance** || **If it is necessary to record a range, use the doseQuantity low and high elements** ||

= Meds-13: rateQuantity: low & high = (Back to the top)
 * **path** || **Medication Activity: rateQuantity: low and high** ||
 * || SHALL [1..1] rateQuantity/low and rateQuantity/high IHE PCC-6 .3.4.16.15 ||
 * issue || IHE PCC seems to indicate high and low should always be present; (if not a range, low and high have the same value). The Joint Commission discourages such ranges: instead, specify the dosages/rates separately, e.g. "1 tablet every 3h for severe pain", "1/2 tablet every 6h for mild pain". ||
 * **guidance** || **If it is necessary to record a range, use the doseQuantity low and high elements.** ||

= Meds-14: statusCode = (Back to the top)
 * **path** || **Medication Activity: maxDoseQuantity** ||
 * || MAY [0..1] maxDoseQuantity CCD-312 ||
 * || MAY [0..*] maxDoseQuantity C83-8.10 - Dose Restriction ||
 * issue || C83 allows maxDoseQuantity to repeat. It seems unlikely that was the intention. ||
 * **guidance** || **The maxDoseQuantity can be used to record the maximum dose of the medication that can be given over a stated time interval (e.g., maximum daily dose of morphine, maximum lifetime dose of doxorubicin).** ||
 * **proposal** || **A Medication Activity may contain a maxDoseQuantity. It may be nullFlavored.** ||
 * **formal** || **MAY [0..1] maxDoseQuantity** ||
 * **formal** || **MAY @nullFlavor** ||

= Meds-15: Generic Product Code = (Back to the top)
 * **path** || **Medication Information: manufacturedMaterial: Product (code)** ||
 * || code is coded product name C83-[DE-8.13-CDA-1  ] ||
 * || may contain a precoordinated product strength, product form, or product concentration CCD-360 ||
 * || code should represent generic medication name and strength, or generic medication name alone IHE PCC-6  .3.4.19.3 ||
 * || SHALL [1..1] code CCD-358 ||
 * || SHOULD [0..1] (required if known) code C83-8.13 - Coded Product Name ||
 * || SHOULD [0..1] (required if known) code IHE PCC-6  .3.4.16.2.1 Code ||
 * issue || The CCD and C83 conformance requirements for Coded Product Name are different. The proposal requires the code and allows it to be nullFlavored. ||
 * || The value of @code SHOULD be selected from RxNorm (2.16.840.1.113883.6.88) code system for medications, or from CDC Vaccine Code (2.16.840.1.113883.6.59) code system for immunizations, or MAY be selected from ValueSet 2.16.840.1.113883.1.11.20.8 MedicationTypeCode STATIC 20061017 CCD-359 ||
 * || if coded, code must come from a controlled vocabulary IHE PCC-6  .3.4.19.3 ||
 * || SHOULD [0..1] (required if coded name is known) @code from RxNorm C154-[DE-8.13-1] ||
 * || or SHALL [1..1] (if only drug class is known) @code from NDF-RT C154-[DE-8.13-2] ||
 * || or SHALL [1..1] (if only ingredient name is known) @code from UNII C154-[DE-8.13-3] ||
 * issue || C83/C154 are not explicit what to do when no code is known. ||
 * issue || The CCD and C83 requirements for allowed values are different. ||
 * || if @code, SHOULD [0..1] @displayName and @codeSystemName IHE PCC-6  .3.4.19.3 ||
 * issue || It is uncommon in CDA to require @displayName, and the combination of code/@code with code/originalText already provides a human-readable representation of the coded information. ||
 * **guidance** || **Within Medication Information, manufacturedMaterial records the code and name for the generic product (e.g., albuterol) in code/@code and code/originalText, and the code and name for the brand (e.g., Proventil) in code/translation/@code and name (This name element is a sibling of code, not a child of code.)** ||
 * **guidance** || **The code is meant to represent a product, which can include strength. When the product is not known, the code can represent a drug class, or if the drug class is not known, an ingredient; or it can be nullFlavored.** ||
 * **formal** || **SHALL [1..1] code** ||
 * **formal** || **MAY @nullFlavor** ||
 * **formal** || **The value of @code, if present, SHOULD be drawn from RxNorm (product), or from NDF-RT (drug class) or UNI (ingredient name), or MAY be SNOMED CT 182849000: No drug therapy prescribed, or 408350003: Patient not on self-medications.** ||

= Meds-16: Generic Product Name = (Back to the top)
 * **path** || **Medication Information: manufacturedMaterial: Product Name** ||
 * || SHALL [1..1] originalText which represents generic name CCD-363 ||
 * || SHALL [1..1] originalText C83-8.15 - Free Text Product Name ||
 * || SHALL [1..1] originalText which represents generic name C83-[DE-8.15-CDA-1 ] ||
 * || SHALL [1..1] originalText contains name and strength of medication IHE PCC-6 .3.4.16.2.1 Strength ||
 * || SHALL [1..1] originalText contains name and strength of medication with reference to narrative IHE PCC-6 .3.4.19.3 ||
 * issue || C83 specifically directs that the product code and name be recorded in code/@code and code/originalText, with brand code and name recorded in translation/@code and translation/name. ||
 * issue || C83 guidance allows, but IHE guidance appears to require, that the value of originalText represent both the product and its strength. ||
 * **guidance** || **See guidance for the generic and brand code and name, documented with Medication Activity code, above.** ||
 * old proposal || An originalText element SHALL be present representing the coded Product, either as text in situ or as a reference to content in the narrative block. ||
 * **new proposal** || **A text/reference element pointing to content in the narrative block representing the generic product name SHOULD be present.** ||
 * **formal** || **SHOULD [0..1] originalText/reference/@value** ||

= Meds-17: Product Brand Code = (Back to the top)
 * **path** || **Medication Information: manufacturedMaterial: Brand (translation)** ||
 * || SHOULD [0..1] translation C83-8.14 - Coded Brand Name ||
 * || SHOULD [0..1] (required if known) translation contains coded brand name C83-[DE-8.14-CDA-1  ] ||
 * || SHALL [1..1] translation/@code from RxNorm for Medication Brand Name or NDC for Medication Packaged Product C154-[DE-8.14-1] ||
 * issue || C83 allows the parent code to represent a brand, a drug class, or an ingredient. ||
 * **proposal** || **A Medication Information manufacturedMaterial code SHALL contain a translation element recording a Brand or a nullFlavor. The value of @code, if present, SHALL be selected from RxNorm for Medication Brand Name or NDC for Medication Packaged Product.** ||
 * **formal** || **SHALL [1..1] translation** ||
 * **formal** || **MAY [0..1] @nullFlavor** ||
 * **formal** || **The value of @code, if present, SHALL be selected from RxNorm for Medication Brand Name or NDC for Medication Packaged Product.** **//Source constraint://** **C154-[DE-8.14-1]** ||

= Meds-18: Product Brand Name = (Back to the top)
 * **path** || **Medication Information: manufacturedMaterial: Brand Name (translation/name)** ||
 * || MAY [0..1] name which represents brand name CCD-364 ||
 * || SHOULD [0..1] (required if known) name C83-8.16 - Free Text Brand Name ||
 * || SHALL [1..1] name which represents brand name C83-[DE-8.14-CDA-2 ] ||
 * || **SHALL [1..1] name contains brand or generic name, if not known then purpose or other descriptor (but not packaging, strength, or dose) IHE PCC-6 .3.4.16.2.1 Product** ||
 * || SHOULD [0..1] name contains brand name or active ingredient IHE PCC-6 .3.4.19.4 ||
 * issue || C83 allows name but IHE requires it. ||
 * issue || C83 specifies this must represent the brand name, but also allows the parent code to represent, instead, a drug class or an ingredient. ||
 * **proposal** || **A Medication Information manufacturedMaterial SHOULD contain a name element, which represents the Brand Code. //Source constraint:// C83-8.16,C83-[DE-8.14-CDA-2 ]** ||
 * **formal** || **SHOULD [0..1] name** ||

= Meds-19: manufacturerOrg. (Med Info) = (Back to the top)
 * **path** || **Medication Information: manufacturerOrganization** ||
 * || MAY [0..1] manufacturerOrganization which represents manufacturer of the material CCD-365 ||
 * || if Manufactured Product has an id, SHOULD [0..1] manufacturerOrganization CCD-367 ||
 * || MAY [0..1] manufacturerOrganization C83-8.17 - Drug Manufacturer ||
 * issue || C83 appears to relax the requirement of CCD-367 . ||
 * **proposal** || ** ﻿ If the Medication Information records an id for the medication, it SHOULD also record the manufacturer organization. //Source constraint:// CCD-367 ﻿ ** ||
 * **formal** || **If Medication Information has an id/@root, it SHOULD [0..1] manufacturerOrganization** ||

= Meds-20: manufacturerOrg. (CDA R2) = (Back to the top)
 * **path** || **manufacturerOrganization** ||
 * || CDA R2 ||
 * issue || All the content of manufacturerOrganization is optional, and there appear to be no additional constraints from other specifications. The constraint here departs from the specifications in requiring that at least one of (name, id, telecom) be present. ||
 * **proposal** || **The manufacturerOrganization element, if present, SHALL contain at least one of name, or id, or telecom.** ||
 * **formal** || **SHALL [1..*] (name|id|telecom)** ||

= Meds-21: procedure = (Back to the top)
 * **path** || **Medication Activity: performer** ||
 * || MAY [0..*] performer CCD-313 ||
 * issue || This is guidance (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Medication Activity with @moodCode EVN, i.e. recording a past medication activity, can record one or more performers, to indicate the person(s) who administered a substance.** **//Source constraint//****//:// CCD-313** ||
 * **proposal** || **[no constraint proposed]** ||
 * **formal** || **[no constraint to record]** ||

= Meds-22: Product Instance (part.) = (Back to the top)
 * **path** || **Medication Activity: Product Instance (participant)** ||
 * || MAY [0..*] participant which is a Product Instance CCD-368 ||
 * issue || This is guidance (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Medication Activity MAY contain Product Instances; however, the Product Instance template is intended for use in a Supply Activity rather than in a substanceAdministration; for example, to record the supply of a wheelchair or other object. In a substanceAdministration one cannot document the particular instance of a pill prescribed or administered. (To reference a lot number, use manufacturedMaterial/lotNumber.)** ||
 * **formal** || **[no constraint to record]** ||

= Meds-23: Drug Vehicle (part.) = (Back to the top)
 * **path** || **Medication Activity: Drug Vehicle (participant)** ||
 * || MAY [0..*] participant representing a drug vehicle C83-8.24 - Vehicle; C83-[DE-8.24-CDA-2 ]; C83-[DE-8.24-CDA-3 ]; C83-[DE-8.24-CDA-4 ] ||
 * || vehicle for administrating medication C83-[DE-8.24-CDA-1 ] ||
 * issue || This is guidance (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Medication Activity MAY contain participants representing the Drug Vehicle, i.e. the vehicle for administering the medication****; for example, an antibiotic mixed with salt water or with sugar water.** **//Source constraint://** **C83-8.24 and C83-[DE-8.24.CDA-2, -3, -4]** ||
 * **proposal** || **[no constraint proposed]** ||
 * **formal** || **[no constraint to record]** ||

= Meds-24: address in Drug Vehicle = (Back to the top)
 * **path** || **Medication Activity: address in Drug Vehicle/participantRole** ||
 * || SHOULD [0..*] addr CDA4CDT-HP-8 ||
 * issue || CDA4CDT-HP recommends an address for any participant. C83 does not mention an address for a Drug Vehicle, and it may be nullFlavored. ||
 * issue || It may be unusual for a Drug Vehicle to have an address, but on the other hand it seems undesirable to create variants of the standard participant requirements. ||
 * **proposal** || **A Drug Vehicle SHOULD have one or more addresses.** ||
 * **formal** || **SHOULD [0..*] addr** ||
 * **formal** || **MAY @nullFlavor** ||

= Meds-25: telecom in Drug Vehicle = (Back to the top)
 * **path** || **Medication Activity: telecom in Drug Vehicle/participantRole** ||
 * || SHOULD [0..*] telecom CDA4CDT-HP-8 ||
 * || SHALL [1..1] match the regular expression pattern tel:+?[-0-9.]+ CDA4CDT-HP-12 ||
 * || SHALL [1..1] at least one dialing digit present in the phone number after visual separators are removed CDA4CDT-HP-13 ||
 * || SHALL [1..1] unknown telephone numbers represented by appropriate nullFlavor CDA4CDT-HP-14 ||
 * issue || CDA4CDT-HP recommends one or more phone numbers for any participant. C83 does not mention a phone number for a Drug Vehicle, and it may be nullFlavored. ||
 * issue || It may be unusual for a Drug Vehicle to have a telephone number, but on the other hand it seems undesirable to create variants of the standard participant model. ||
 * **proposal** || **A Drug Vehicle SHOULD have one or more telephone numbers.** ||
 * **formal** || **SHOULD [0..*] telecom** ||
 * **formal** || **MAY @nullFlavor** ||

= Meds-26: playingEntity/code in Drug Vehicle = (Back to the top)
 * **path** || **Medication Activity: playingEntity/code in Drug Vehicle participantRole** ||
 * || MAY [0..1] code C83-[DE-8.24-CDA-6 ] ||
 * || The value of @code shall be a concept descending from SNOMED CT 412307009, representing a coded term for the Drug Vehicle. C154-[DE-8.24-1] ||
 * issue || The hierarchy below 412307009 may not be sufficient. In this example, albuterol inhalers use other vehicles including oleic acid (427281002). ||
 * **proposal** || **In a Drug Vehicle, the playingEntity element may contain a code representing a coded term for the Drug Vehicle. The value of @code SHALL be a concept descending from SNOMED CT 412307009. //Source constraint:// C83-[DE-8.24-CDA-6 ], C154-[DE-8.24-1]** ||
 * **formal** || **[context = Drug Vehicle's participant Role] MAY [0..1] code** ||
 * **formal** || **The value of @code SHALL be a concept descending from SNOMED CT 412307009** ||

= Meds-27: as child of Med Activity (IHE) = (Back to the top)
 * **path** || **Medication Activity as child of simple/normal Medication Activity** ||
 * || SHALL [0..0] templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.4.7.1 and */substanceAdministration" IHE PCC-6  .3.4.16.3.1 ||
 * issue || IHE refines Medication Activity to distinguish simple (normal), split, tapered, conditional, and compound dosing. Types other than simple require a child substanceAdministration.. ||
 * **guidance** || **The IHE subcategories of Medication Activity are optional, are not described by HITSP, and are not modeled here.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-28: Medication Type = (Back to the top)
 * **path** || **Medication Activity: Medication Type** ||
 * || SHOULD [0..1] (required if known) Type of Medication C83-8.19 ||
 * || MAY [0..1] Medication Type in entryRelationship/@typeCode="SUBJ" C83-[DE-8.19-CDA-2 ] ||
 * issue || The C83 conformance requirement appears to be specified differently in these two locations. ||
 * issue || The Medication Type template is not necessarily aligned with the Pharmacy Committee. ||
 * old proposal || A Medication Activity SHOULD (required if known) record the Medication Type. ||
 * **new proposal** || **[defer decision on how to record prescription/OTC]** ||
 * **formal** || **[no constraint to record]** ||

= Meds-29: Status: Value = (Back to the top)
 * **path** || **Status: value** ||
 * || (Medication Activity) SHALL [1..1] value/@xsi:type="CE" is from ValueSet medicationStatusCode 2.16.840.1.113883.1.11.20.7 CCD-516 ||
 * || (Medication Activity) SHALL [1..1] value/@code is from ValueSet medicationStatusCode 2.16.840.1.113883.1.11.20.7 CCD-353 ||
 * || SHALL [1..1] value from the value set defined in CCD C154-[DE-8.20-1] ||
 * issue || Not clear whether it is intended that this value can be nullFlavored. The template is SHOULD (required if known). ||
 * doc || Pick up the MedicationStatusCode value set from CCD ||
 * **guidance** || **When this template is used, the status reported by its value element must be consistent with the statusCode, if any, of the parent clinical statement.** ||
 * **proposal** || **In a Medication Activity Status, Prescription Order, or Prescription Fill, the value of value/@xsi:type SHALL be CE and the value of value/@code SHALL be selected from ValueSet medicationStatusCode 2.16.840.1.113883.1.11.20.7 STATIC [date].** ||
 * **formal** || **Within a Medication Activity, Prescription Order, or Prescription Fill - SHALL value/@code from ValueSet MedicationStatusCode 2.16.840.1.113883.1.11.20.7 STATIC [date]** ||

= Meds-30: Indication (rationale) = (Back to the top)
 * **path** || **Medication Activity: Indication (rationale for activity)** ||
 * || MAY [0..*] entryRelationship[@typeCode="RSON"]/Indication CCD-328; CCD-329 ||
 * || target SHALL [1..1] be a Problem Act (templateId 2.16.840.1.113883.10.20.1.27), Problem Observation (templateId 2.16.840.1.113883.10.20.1.28), or some other clinical statement CCD-329 ||
 * || MAY [0..*] entryRelationship[@typeCode="RSON"][Indication] C83-8.21 - Indication ||
 * || MAY [0..*] entryRelationship IHE PCC-6.3.4.16.2.1 Indication ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * issue || IHE appears to only allow an Internal Reference (use of the id element to assert identity with/point to another clinical statement in the CDA document). ||
 * **guidance** || **A Medication Activity MAY record indications or reasons for the activity, within entryRelationships that have @typeCode 'RSON' (Reason). It is likely the target will be a Problem Act or Problem Observation. An Indication Observation can be used to reference a problem or concern that is detailed elsewhere in the document.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-31: Template for Indication = (Back to the top)
 * **path** || **template for Indication** ||
 * || SHALL [1..1] observation that conforms to CCD section 3.9.2.2.1 C83-[DE-8.20-CDA-1] ||
 * || SHALL [1..1] observation/@moodCode="EVN" CCD-155 ||
 * issue || The specifications were hard to interpret. The **guidance** and proposal here represent a possible model, given direction from the discussion of Procedure to relax the requirement to provide a value for id in Indication there. ||
 * **guidance** || **The Indication Observation's role is document the rationale for an activity. It can do this using the id element to reference a problem recorded elsewhere in the document; or, a code and value can record the problem type and problem within the Indication. For example, the indication for a prescription of a painkiller might be a headache that is documented in the Problems Section.** ||
 * **proposal** || **An Indication SHALL be represented by an observation element where the value of @moodCode is EVN and the value of @classCode is COND, within an entryRelationship where the value of @typeCode is RSON (reason).** ||
 * **formal** || **self::observation[@moodCode='EVN'][@classCode='COND'][../entryRelationship/@typeCode='RSON']** ||

= Meds-32: statusCode (Indication) = (Back to the top)
 * **path** || **Indication: statusCode** ||
 * || SHALL [1..1] statusCode CCD-156 ||
 * || SHALL [1..1] statusCode/@code="completed" CCD-157 ||
 * issue || The referenced problem may be ongoing, indeed is likely to be if the Medication Activity is prescribing a substance to treat it. ||
 * **proposal** || **If the indication is represented in the value element, statusCode SHALL be present.** ||
 * **formal** || **If value, SHALL statusCode** ||

= Meds-33: effectiveTime (Indication) = (Back to the top)
 * **path** || **Indication: effectiveTime** ||
 * || SHOULD [0..1] effectiveTime CCD-158 ||
 * issue || The effectiveTime might be documented in a clinical statement elsewhere in the document; repeating the date invites confusion. ||
 * **proposal** || **If the indication is represented in the value element, effectiveTime SHALL be present.** ||
 * **formal** || **If value, SHALL effectiveTime.** ||

= Meds-34: Instructions = (Back to the top)
 * **path** || **Medication Activity: Instructions** ||
 * || CCD 2.16.840.1.113883.10.20.1.49, C83 1.3.6.1.4.1.19376.1.5.3.1.4.3 ||
 * || MAY [0..1] entryRelationship containing patient instructions CCD-330 ||
 * || SHALL [1..1] @typeCode="SUBJ" CCD-333 ||
 * || MAY [0..*] (Patient) Instructions ||
 * || SHOULD [0..1] (required if known) entryRelationship IHE PCC-6.3.4.16.2.1 Instructions ||
 * || MAY [0..1] entryRelationship/@typeCode=SUBJ" and inversionInd="true" containing patient instructions IHE PCC-6.3.4.16.21 ||
 * || MAY [0..1] entryRelationship/@typeCode=SUBJ" and inversionInd="true" containing patient instructions IHE PCC-6.3.4.7.3 ||
 * issue || In Medication Activity CCD allows, but IHE recommends (required if known) Instructions (patient instructions). ||
 * **guidance** || **In a Medication Activity, patient instructions are recorded in an Instruction template with code/@code='PINSTRUCT' (patient instructions).** ||
 * **proposal** || **A Medication Activity SHOULD (required if known) contain an Instructions template where the value of code/@code is PINSTRUCT 1.3.6.1.4.1.19376.1.5.3.2 IHEActCode. On the enclosing entryRelationship the value of @typeCode SHALL be SUBJ and the value of @inversionInd SHALL be 'true'.** ||
 * **formal** || **SHOULD [0..1] (required if known) entryRelationship[@typeCode='SUBJ'][@inversionInd='true'] [Instructions[code[@code='PINSTRUCT'][@codeSystem='1.3.6.1.4.1.19376.1.5.3.2']]]** ||

= Meds-35: Code (Instructions) = (Back to the top)
 * **path** || **Instructions: code** ||
 * || SHALL [1..1] code per base CDA ||
 * || SHALL [1..1] code/@code="PINSTRUCT" and codeSystem="1.3.6.1.4.1.19376.1.5.3.2" and codeSystemName="IHEActCode" IHE [|PCC-6].3.4.7.6 ||
 * issue || Only IHE specifies values for the code element. ||
 * **proposal** || **To record patient instructions, the value of code/@code SHALL be PINSTRUCT (Patient Instructions). To record Fulfillment Instructions, the value of code/@code SHALL be FINSTRUCT (Fulfillment Instructions). Both values are from codeSystem 1.3.6.1.4.1.19376.1.5.3.2 IHEActCode.** ||
 * **formal** || **As Patient Instructions, usually in Medication Activity (substanceAdministration @moodCode INT), code[@code='PINSTRUCT'][@codeSystem='1.3.6.1.4.1.19376.1.5.3.2']** ||
 * **formal** || **As Fulfillment Instructions, usually in Prescription Order (supply @moodCode INT), code[@code='FINSTRUCT'][@codeSystem='1.3.6.1.4.1.19376.1.5.3.2']** ||

= Meds-36: Patient Instructions: text/ref = (Back to the top)
 * **path** || **Patient Instructions: text/reference** ||
 * || MAY [0..1] text/reference/value contain url C83-2.2.2.8.19 Patient Instructions ||
 * || examples for C83-2.2.2.8.19:   ||
 * || SHALL [1..1] text/reference IHE PCC-6.3.4.7.7 ||
 * || SHALL [1..1] text/reference/@value with narrative section text reference C83-[DE-8.20-CDA-2] ||
 * issue || CCD-498-501 specify how to record references to external documents: as contained observations in which reference/externalDocument/text/reference/@value records a URL, with a corresponding linkHTML element (SHOULD) in the narrative block. However, (a) Instruction is represented by an act element, not an observation element, (b) the C83 example of an external reference in Fig. 2-37 does not show an externalDocument node. ||
 * issue || CCD and C83 allow Instruction to be represented as a link to text in the narrative block or as a link to an external document; IHE requires a link to the narrative block (to either content or a linkHTML). ||
 * issue || The instruction content or URL is the entire point of this template: the recommended treatment for originalText (a pointer into the narrative block) would yield in this case a clinical statement that does not contain its information in any form. ||
 * **guidance** || **Instructions can be represented either as a text string or as a reference to an external document. In either case, the template information must also be presented in the narrative block, as for any entry.** ||
 * **guidance** || **When referencing an external document, set the value of reference/@separatableInd to 'false' in order to indicate that the referenced document SHOULD be included in the exchange package, or to 'true' to indicate that it need not be included.** ||
 * doc || Include examples of each allowed form. ||
 * doc || Document the mediaTypes. ||
 * **proposal** || **An Instruction template SHALL contain either a text element where the content is the instructions, or a reference[@separatableInd]/externalDocument/text element in which @mediaType is present and in which reference/@value represents the URL for the instructions.** ||
 * **formal** || **SHALL [1..1] text OR reference[@separatableInd]/externalDocument/text[@mediaType]/reference/@value** ||

= Meds-37: statusCode (Instructions) = (Back to the top)
 * **path** || **Instructions: statusCode** ||
 * || SHALL [1..1] statusCode/@code="completed" IHE PCC-6.3.4.7.8 ||
 * issue || IHE constrains statusCode to 'completed'. Is there a use case for other values? ||
 * **proposal** || **The value of statusCode/@code SHALL be 'completed'.** ||
 * **formal** || **SHALL [1..1] statusCode/@code='completed'** ||

= Meds-38: Reaction Observation = (Back to the top)
 * **path** || **Medication Activity: Reaction observation** ||
 * || MAY [0..*] reaction observation (templateId 2.16.840.1.113883.10.20.1.54) CCD-348 ||
 * || each MAY [0..1] severity observation (templateId 2.16.840.1.113883.10.20.1.55) and MAY [0..1] reaction intervention CCD-348 ||
 * || SHALL [1..1] @typeCode="CAUS" CCD-349 ||
 * || **MAY [0..1] entryRelationship/@typeCode="CAUS" and entryRelationship/observation/templateId/@root="2.16.840.1.113883.10.20.1.54" 8.23 - Reaction** ||
 * issue || CCD-348 allows multiple reactions, C83-8.23 does not. It seems unlikely that C83 intended to preclude recording multiple reactions. ||
 * issue || This is guidance **(MAY), not a constraint, but useful to mention for the implementer.** ||
 * guidance || A Medication Activity with @moodCode EVN, i.e. recording a past medication activity, can record a Reaction Observation, within entryRelationships with @typeCode CAUS. ||
 * guidance || Each Reaction Observation can in turn record a Severity Observation and a Reaction Intervention, q.v. ||
 * proposal || [no constraint to propose] ||
 * formal || [no constraint to record]** ||

= Meds-39: Prescription Order (supply) = (Back to the top) = =
 * **path** || **Medication Activity: Prescription Order (supply)** ||
 * || Medication Section SHOULD [1..*] Medication Activities and/or Supply Activities CCD-298 ||
 * || SHALL [1..1] @typeCode="REFR" ||
 * || SHALL [1..1] entryRelationship/@typecode="REFR" and entryRelationship/supply/@moodCode="INT" C83-Order Information ||
 * || MAY [0..*] entryRelationship/@typeCode="REFR" and entryRelationship/templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.4.7.3" IHE PCC-6.3.4.16.19 ||
 * || MAY [0..*] entryRelationship/@typeCode="REFR" and entryReplationship/@nversionInd="false" IHE PCC-6.3.4.18.2 ||
 * issue || IHE requires that @inversionInd must be valued 'false'. This is the default value: the other specifications allow the attribute to be omitted. ||
 * **proposal** || **A Medication Activity MAY contain Prescription Orders, within entryRelationships where the value of @typeCode is REFR.** ||
 * **formal** || **MAY [0..*] entryRelationship[@typeCode='REFR'] / Prescription Order** ||

= Meds-40: id (Prescription Order) = (Back to the top)
 * **path** || **Prescription Order: id** ||
 * || SHALL [1..*] id CCD-318 ||
 * || SHOULD [0..1] (required if known) id C83-8.26 - Order Number and C83-[DE-8.26-CDA-1] ||
 * || SHALL [1..1] id IHE PCC-6.3.4.18.6 ||
 * issue || CCD requires one or more ids; C83 recommends one; IHE requires exactly one. An order would normally have only one id but there seems no need to preclude recording others if they exist. ||
 * **proposal** || **A Prescription Order SHALL contain at least one id representing the order number. It may be nullFlavored.** ||
 * **formal** || **SHALL [1..*] (required if known) id** ||
 * **formal** || **MAY @nullFlavor** ||

= Meds-41: effectiveTime (Prescription) = (Back to the top)
 * **path** || **Prescription Order: effectiveTime** ||
 * || SHOULD [0..1] effectiveTime CCD-320 ||
 * || SHALL [1..1] effectiveTime/high C83-8.29 - Order Expiration Date/Time ||
 * issue || C83 specifies the use of effectiveTime/high to record the order expiration date. CCD specifies the use of effectiveTime to record the intended time of dispensing, appearing to allow effectiveTime/@value. IHE does not address Prescription Order effectiveTime. ||
 * **guidance** || **In a Prescription Order, effectiveTime/low records the intended time of dispensing and effectiveTime/high records the order expiration date. The date of the order itself is recorded in author/time, below.** ||
 * **proposal** || **A Prescription Order SHALL contain an effectiveTime where the value of @xsi:type is IVL_TS and both low and high elements are present. Both low and high may be nullFlavored.** ||
 * **formal** || **SHALL [1..1] effectiveTime[@xsi:type='IVL_TS'][low][high]** ||
 * **formal** || **low and high MAY @nullFlavor** ||

= Meds-42: repeatNumber (Prescription) = (Back to the top)
 * **path** || **Prescription Order: repeatNumber** ||
 * || MAY [0..1] repeatNumber CCD-321 ||
 * || MAY [0..1] repeatNumber C83-8.27 - Fills ||
 * || SHOULD [0..1] repeatNumber IHE PCC-6.3.4.18.7 ||
 * issue || CCD and C83 allow a repeat number, IHE recommends it (SHOULD). ||
 * **guidance** || **The repeatNumber element records the number of fills (not refills) prescribed. To record an unbounded number of fills, use @nullFlavor PINF.** ||
 * **proposal** || **A Prescription Order SHALL contain a repeatNumber. It may be nullFlavored.** ||
 * **formal** || **SHOULD [0..1] repeatNumber** ||
 * **formal** || **MAY @nullFlavor** ||

= Meds-43: product (Prescription Order) = (Back to the top)
 * **path** || **Prescription Order: product** ||
 * || MAY [0..1] product is 2.16.840.1.113883.10.20.1.53 CCD-355 ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **The Medication Information in a Prescription Order (or Fill) can record all the detail of the medication, or can use its id element to reference details recorded elsewhere, e.g. to reference the Medication Information within Medication Activity above.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-44: author (Prescription Order) = (Back to the top)
 * **path** || **Prescription Order: author** ||
 * || MAY [0..*] author [|CCD-323] ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **In a Prescription Order, the author element can be used to document the prescriber, for example when the prescriber is different than the author of the document.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-45: Product Instance (device participant) = (Back to the top)
 * **path** || **Prescription Order: Product Instance (device participant)** ||
 * || MAY [0..*] Product Instance [|CCD-369] ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **An Order/Fill can record a medication (see product or Medication Information, above) or record a device, such as a wheellchair, as a product instance. When recording a device, the Order/Fill would not be contained within a Medication Activity (substanceAdministration) template, since there's no substance involved.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-46: instructions (Prescription) = (Back to the top)
 * **path** || **Prescription Order: Instructions** ||
 * || Fulfillment Instructions is contained within a supply activity with @moodCode="INT" ||
 * || MAY [0..1] entryRelationship containing fulfillment instructions CCD-334 ||
 * || SHALL [1..1] @typeCode="SUBJ" CCD-337 ||
 * || MAY [0..1] Fulfillment Instructions C83-8.32 - Fulfillment Instructions ||
 * issue || In C83-83.32, the table nesting seems to place Fulfillment Instructions as a child of Medication Activity rather than as a child of Prescription Order; is this a C83 formatting error? ||
 * || MAY [0..1] entryRelationship/@typeCode="SUBJ" IHE PCC-6.3.4.18.19 ||
 * || SHALL [1..1] entryRelationship/@inversionInd="true" IHE PCC-6.3.4.8.3 ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Prescription Order can record fulfillment instructions using an Instructions template where the value of code/@code is FINSTRUCT from codeSystem 1.3.6.1.4.1.19376.1.5.3.2 IHEActCode. If present, it appears within an entryRelationship where the value of @typeCode is SUBJ and the value of @inversionInd is 'true'. See the Instructions template, above.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-47: Status (Medication Supply) = (Back to the top)
 * **path** || **Prescription Order: Status (Medication Supply)** ||
 * || MAY [0..1] entryRelationship CCD-351 ||
 * || SHALL [1..1] if status observation, entryRelationship/@typeCode="REFR" CCD-509 ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Prescription Order can record status using a Status template. within an entryRelationship where the value of @typeCode is REFR. See the Status template, above.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-48: Prescription Order: Medication Type = (Back to the top)
 * **path** || **Prescription Order: Medication Type** ||
 * || MAY [0..1] type of medication in entryRelationship/@typeCode="SUBJ" C83-[DE-8.19-CDA-2] ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * issue || The decision on how to record prescription/ITC is deferred; see the Medication Type template, above. ||
 * **proposal** || **[no constraint to propose]** ||
 * **formal** || **[no constraint to record]** ||

= Meds-49: id (Prescription Fill) = (Back to the top)
 * **path** || **Prescription Fill: id** ||
 * || SHALL [1..*] id CCD-318 ||
 * || SHOULD [0..1] id C83-8.34 - Prescription Number ||
 * || SHALL [1..1] id/@extension C83-[DE-8.34-CDA-1] ||
 * || SHOULD [0..1] id/@root is OID of assigning authority C83-[DE-8.34-CDA-2] ||
 * || MAY [0..1] id/@root is a GUID C83-[DE-8.34-CDA-3] ||
 * || SHALL [1..1] id IHE PCC-6.3.4.18.6 ||
 * issue || CCD requires one or more ids; C83 recommends one; IHE requires exactly one. An order would normally have only one id but there seems no need to preclude recording others if they exist. ||
 * **guidance** || **The constraints for id in Prescription Fill are the same as those in Prescription Order.** ||
 * **proposal** || **A Prescription Order SHALL contain at least one id representing the order number. It may be nullFlavored.** ||
 * **formal** || **SHALL [1..*] (required if known) id** ||
 * **formal** || **MAY @nullFlavor** ||

= Meds-50: statusCode (Prescription Fill) = (Back to the top)
 * **path** || **Prescription Fill: statusCode** ||
 * || SHOULD [0..1] statusCode CCD-319 ||
 * || **MAY [0..1] statusCode C83-8.40 - Fill Status** ||
 * || Location in C83 does not seem to place this field here. CHECK THIS ||
 * || MAY [0..1] statusCode is fill status C83-[DE-8.40-CDA-1] ||
 * || SHALL [1..1] statusCode from Act Status "Completed" or "Aborted" C83-[DE-8.40-CDA-2] ||
 * issue || C83 constrains the values. ||
 * **guidance** || **See also the Status template, which some implementations rely on in preference to the statusCode element.** ||
 * **proposal** || **A Prescription Order SHOULD contain a statusCode.** ||
 * **formal** || **SHOULD [0..1] statusCode** ||

= Meds-51: performer (Prescription Fill) = (Back to the top)
 * **path** || **constraints for performer** ||
 * || SHALL [1..1] time if ../../supply/@moodCode="EVN" IHE PCC 6.3.4.18.15 ||
 * || SHOULD [0..1] time if ../../supply/@moodCode="INT" IHE PCC 6.3.4.18.15 ||
 * || If not known, set @nullFlavor="UNK" IHE PCC 6.3.4.18.15 ||
 * issue || See supply[@moodCode='EVN']/effectiveTime, also recording the dispense date. ||
 * **guidance** || **In a Prescription Fill, the performer/time records the dispense date.** ||
 * **proposal** || **In a Prescription Fill, a performer/time SHALL be present. It may be nullFlavored.** ||
 * **formal** || **SHALL [1..1] time** ||

= Meds-52: author (Prescription Fill) = (Back to the top)
 * **path** || **Prescription Fill: author** ||
 * || MAY [0..*] author CCD-323 ||
 * || MAY [0..*] author when ../../supply/@moodCode="INT" IHE PCC 6.3.4.18.9 ||
 * **guidance** || **In a Prescription Order/Fill, the author records the author of the prescription.** ||
 * issue || This is **guidance** (MAY) but useful to record for the implementer. ||
 * **proposal** || **[no constraint to propose]** ||
 * **formal** || **[no constraint to record]** ||

= Meds-53: status (Prescription Fill) = (Back to the top)
 * **path** || **Prescription Fill: Status** ||
 * || MAY [0..1] entryRelationship CCD-351 ||
 * || SHALL [1..1] if status observation, entryRelationship/@typeCode="REFR" CCD-509 ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Prescription Fill can record medication supply status in a Status template. If present, it appears within an entryRelationship where the value of @typeCode is REFR.** ||
 * **formal** || **[no constraint to record]** ||

= Meds-54: Prescription Fill: Sequence # = (Back to the top)
 * **path** || **Prescription Fill: Sequence Number** ||
 * issue || IHE has specialized requirements related to its models for recording split, tapered, conditional, and compound dosing. Those models are not included here. ||
 * || SHOULD [0..1] (required if known) entryRelationship/@typecode="COMP" and entryRelationship/sequenceNumber C83-8.39 - Fill number ||
 * || SHOULD [0..1] entryRelationship/@typecode="COMP" and entryRelationship/sequenceNumber is fill number C83-[DE-8.39-CDA-1] ||
 * || MAY [0..1] entryRelationship/@typecode="COMP" and entryRelationship/sequenceNumber IHE PCC-6.3.4.16.20 ||
 * issue || The act code shown is "Administration of Medication", which seems inappropriate for a dispense activity. ||
 * **guidance** || **The Sequence Number template records the fill number; it identifies this dispense as a distinct event of a prescription.** ||
 * **guidance** || **Emerging practice appears to be to use a Sequence Number template contained within the Prescription Fill, rather than a sequenceNumber element (see above) directly preceding the supply element.** ||
 * **proposal** || **A Prescription Fill SHOULD (required if known) contain a Sequence Number template, within an entryRelationship where the value of @typeCode is COMP.** ||
 * **formal** || **SHOULD [0..1] (required if known) entryRelationship[@typeCode='COMP']/Sequence Number.** ||

= Meds-55: template for Sequence # = (Back to the top)
 * **path** || **template for Sequence Number** ||
 * issue || The value shown for code is "Administration of medication", is there a more appropriate value or set of values for a dispense activity. ||
 * issue || Need a reference for these constraints. ||
 * **proposal** || **A Sequence Number SHALL be represented by an act element where the value of @classCode is ACT, the value of @moodCode is EVN, and the value of code/@code is 18629005 (SNOMED: Administration of medication), preceded by a sequenceNumber element.** ||
 * **formal** || **self::act[@classCode='ACT'][@moodCode='EVN'] [code[@code='18629005'][@codeSystem='2.16.840.1.113883.6.96']] [preceding-sibling::sequenceNumber]** ||

= Meds-56: Medication Series Number = (Back to the top)
 * **path** || **Medication Activity: Medication Series Number** ||
 * || MAY [0..1] entryRelationship containing medication series number CCD-338 ||
 * || SHALL [1..1] @typeCode="SUBJ" CCD-339 ||
 * issue || This is **guidance** (MAY), not a constraint, but useful to mention for the implementer. ||
 * **guidance** || **A Series Number is available to record which, in a medication series, a particular medication represents (e.g. "hepatitis B vaccine number 2 was administered on Feb 07, 2004"). If present, it appears within an entryRelationship where the value of @typeCode is SUBJ.** **//Source constraint://** **CCD-338, CCD-339** ||
 * **proposal** || **[no constraint to propose]** ||
 * **formal** || **[no constraint to record]** ||

= Meds-57: Precondition (Criterion) = (Back to the top)
 * **path** || **Pattern for Criterion for administration (precondition)** ||
 * **guidance** || **A Criterion for administration can be used to record that the medication is to be administered only when the associated (coded or free text) criteria are met.** ||
 * **proposal** || **A Criterion for administration SHALL be represented by a precondition element where the value of @typeCode is PRCN, containing a criterion element where the value of code/@code is ASSERTION and the criterion for administration is recorded as text and/or as a coded value. The coded value MAY be nullFlavored.** ||
 * **formal** || **self::precondition[@typeCode='PRCN'] [criterion [code[@code='ASSERTION'][@codeSystem='2.16.840.1.113883.5.4']] [text|value] ]** ||
 * **formal** || **precondition/criterion/value MAY @nullFlavor** ||
 * || SHALL [1..1] criterion per CDA R2 ||
 * issue || C83-8.25 labels this "Dose Indicator" ||
 * issue || C83-8.25 specifies substanceAdministration/criterion, i.e., without the intervening "precondition" node. ||
 * || **?SHALL [1..1] text/reference/@value pointer to narrative IHE PCC 6.3.16.23 ||
 * || **SHALL [1..1] text IHE PCC 6.3.16.24 ||
 * || SHALL [1..1] value (may be nullFlavor if unknown) IHE PCC 6.3.16.24 ||