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Dosage Instructions Start/Stop, Frequency, Dose
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History (21)
Date Author Status Type
2022-06-20 15:54:51 Quentin Ligier Draft version
2021-06-08 14:25:54 Quentin Ligier Draft version
2021-05-06 13:11:19 Quentin Ligier Draft version
2021-05-06 13:08:13 Quentin Ligier Draft version
2021-05-05 11:19:26 Quentin Ligier Draft version
2021-05-05 11:05:16 Quentin Ligier Draft version
2021-04-08 13:29:03 Annatina Foppa Draft version
2021-02-19 10:57:02 Annatina Foppa Draft version
2021-02-19 10:54:46 Annatina Foppa Under pre-publication review version
2021-02-19 10:36:50 Pero Grgic Draft version
2021-02-19 09:47:22 Pero Grgic Draft version
2021-02-18 23:46:02 Pero Grgic Draft version
2021-02-11 15:30:15 Pero Grgic Draft version
2021-02-11 15:30:03 Pero Grgic Draft version
2021-02-11 14:16:25 Pero Grgic Draft version
2021-02-11 14:16:11 Pero Grgic Draft version
2021-02-11 14:14:47 Pero Grgic Under pre-publication review version
2020-05-08 13:48:42 Oliver Egger Draft version
2020-02-03 19:46:23 Oliver Egger Draft version
2019-10-17 14:42:15 Oliver Egger Draft version
2019-09-11 17:04:22 Oliver Egger Draft version
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Issues (5)
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Change Request Status = Closed ( chdachpharm-issue-3 ): rateQuantity and doseQuantity should be constrained
Type Change Request Status Change Request Status = Closed Priority Normal
Events
Tracking / Status = Closed 2021-06-08 13:55:33 : Tracking by Annatina Foppa
Description
for decisions on how to model dosage in the first stage see http://build.fhir.org/ig/ehealthsuisse/ch-emed/dosage.html 
Tracking / Status = Open 2020-08-04 20:14:53 : Tracking by Quentin Ligier
Description
Finding:

In IHE PCC TF2 (revision 11.0), p.187, the dose (doseQuantity) and rate (rateQuantity) are defined by their low and high bounds that are different if a range is given, or equal otherwise (<doseQuantity><low value='' unit=''/><high value='' unit=''/></doseQuantity). 
In IHE PHARM PRE (revision 1.9), pp.47-48, they are only defined by their value and unit (<doseQuantity value='' unit=''/>).
In IHE PCC CDA (revision 2.6), p.141 and p.144, low+high is given in the definition and @value + @unit is shown in the example.

The two standards disagree on the correct structure, Stéphane is investigating why PHARM is not following PCC here.

In any case, the rateQuantity and doseQuantity IVL_PQ structure should be restrained to either @value + @unit or low + high. The examples that show a doseQuantity with a center are wrong for both PHARM and PCC.

I guess the same correction should be applied to the template Dosage Instructions Dosage Change.

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Suggestion:

Wait for IHE guidance on this, then constrain both rateQuantity and doseQuantity to the chosen structure.
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Further explanation:

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Change Request Status = Closed ( chdachpharm-issue-6 ): repeatNumber should be mandatory
Type Change Request Status Change Request Status = Closed Priority Normal
Events
Tracking / Status = Closed 2021-06-10 08:28:02 : Tracking by Annatina Foppa
Description
ok!
Assignment 2021-06-08 15:19:18 : Assigned To Annatina Foppa by Quentin Ligier
Tracking / Status = Feedback needed 2021-06-08 15:18:25 : Tracking by Quentin Ligier
Description
The repeatNumber element has been changed back to optional.
A Schematron assert has been added to the templates:
The Schematron has been tested against the 4 types of documents.
Tracking / Status = Feedback needed 2021-06-07 14:39:33 : Tracking by Quentin Ligier
Description
When this template is included in a dispense item (and related PADV part), the repeatNumber is forbidden (as per IHE Pharm DIS 6.3.4.5.3.17, see below); otherwise it's required.

The following elements part of the Dosage Instructions:
• Prescription Item Entry Additional Template ID
• Effective Time (Duration of Treatment)
• Medication Frequency
• Route of Administration
• Approach Site Code
• Dose Quantity
• Rate Quantity
• Related Components
So the current modification is invalid.
We can either duplicate the template to have the right cardinality, or set the repeatNumber as optional and add two schematron asserts to ensure it's present or absent, depending on the parent template IDs.
Tracking / Status = Feedback needed 2021-05-10 16:26:59 : Tracking by Annatina Foppa
Description
to discuss tomorrow 11.5. 
Tracking / Status = Feedback needed 2021-05-05 11:23:53 : Tracking by Quentin Ligier
Description
The content of repeatNumber has been described.
The attributes @value and @nullFlavord have been added, two schematron rules assert that the @value is not negative and that either @value or @nullFlavor is specified.
Tracking / Status = Open 2021-03-01 22:46:21 : Tracking by Annatina Foppa
Description
content of repeatNumber (as described in the ticket) missing; ticket reopened
Tracking / Status = Closed 2021-02-19 09:49:02 : Tracking by Pero Grgic
Description
the element hl7:repeatNumber is set to 1…1
Tracking / Status = Open 2021-02-15 16:41:28 : Tracking by Quentin Ligier
Description
After discussion with Stéphane, he confirms the IHE PRE profile applies here, making the hl7:repeatNumber required here (§6.3.4.2.3.9).

Proposed template modifications:
  • The hl7:repeatNumber is set to 1…1.
  • Its content is set to a mandatory choice (1…1) between the @value attribute (1…1) and the @nullFlavor="NI" attribute (1…1).
  • The @value attribute is constrained to value equal or greater than zero.
  • The description is updated to specify that a value of zero means that no repeat/refill is allowed, the NI null flavor means that unlimited repeats/refills are allowed, a positive value sets the number of repeats/refills (so the total number of dispenses could equal this value plus one).
Do you see any issue with that way of proceeding?
Tracking / Status = Open 2020-10-18 12:11:19 : Tracking by Quentin Ligier
Description
Finding:

In IHE Pharm PRE profile, it is said:
The <repeatNumber> element SHALL be present, and SHALL contain the number of allowed repeats/refills of the Prescription Item. [...] If the repeatNumber is not limited (e.g., in case a renewal duration is defined), this element SHALL be set to nullFlavor=’NI’.

IHE Pharm MTP and PADV profiles don't override this, so the element is also required there.
IHE Pharm DIS profile says it shall not be present in the 'supply', the template is correct for that one. But I'm not sure if it should be absent or mandatory in the 'Dosage instructions' (the profile doesn't explicitly mention it).

If that's right, 'repeatNumber' would also be missing from the Medication Treatment Plan Item Entry Content Module example. 

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Suggestion:

Set the 'repeatNumber' cardinality to 1...1 and add the following attributes: @value (0...1) and @nullFlavor="NI" (0...1), at least in Medication Treatment Plan Item Entry Content Module, Prescription Item Entry Content Module and Pharmaceutical Advice Item Entry Content Module.

Change Request Status = Closed ( chdachpharm-issue-12 ): Incomplete description of repeatNumber
Type Change Request Status Change Request Status = Closed Priority Normal
Events
Tracking / Status = Closed 2021-02-15 16:31:31 : Tracking by Quentin Ligier
Description
Tracking / Status = Open 2021-01-21 12:04:02 : Tracking by Quentin Ligier
Description
Finding:

As per IHE PCC TF-2 §6.3.4.18.7 and IHE PHARM PRE §6.3.4.2.3.9, the repeatNumber is constrained to have either the attribute value or the attribute nullFlavor='NI'.

Suggestion:

This template could be improved by including these constraints. I'm not sure if it's possible, but for the sake of completeness, the value could also be constrained to ≥ 0.
The schematron would be more precise while validating this part.
If that seems right, I'll also propose a patch for the XML Schema that is expecting an IVL_INT here.

Further explanation:

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For future consideration Status = Open ( chdachpharm-issue-18 ): Element order may be wrong
Type For future consideration Status For future consideration Status = Open Priority Lowest
Events
Tracking / Status = Open 2021-02-15 18:15:20 : Tracking by Quentin Ligier
Description
The IHE PCC specification (§6.3.4.16.2) specifies the following element order: routeCode , doseQuantity , approachSiteCode and rateQuantity .
The IHE PRE profile (§6.3.4.6.3) has a different (presumably wrong) element order: routeCode , approachSiteCode , doseQuantity and rateQuantity .
Stéphane will open the discussion at IHE PHARM and presumably propose a CP to change the approachSiteCode element position and match the PCC ordering.
I'll update the issue if/when it's voted.
Change Request Status = Closed ( chdachpharm-issue-28 ): Issues in 'Dosage Instructions Start/Stop, Frequency, Dose'
Type Change Request Status Change Request Status = Closed Priority Normal
Events
Tracking / Status = Closed 2021-06-09 08:38:10 : Tracking by Quentin Ligier
Description
Closing for now as no immediate action is required. The template can be improved, will do later.
Assignment 2021-06-08 14:01:32 : Assigned To Quentin Ligier by Annatina Foppa
Tracking / Status = Feedback needed 2021-06-08 14:00:51 : Tracking by Annatina Foppa
Description
as discussed today, most of these points won't be of relevance for the current "dosage policy" (see http://build.fhir.org/ig/ehealthsuisse/ch-emed/dosage.html). But please check and then close issue
Tracking / Status = In Progress 2021-05-06 13:13:15 : Tracking by Quentin Ligier
Description
1. Fixed description, changed cardinality of low and high to 1...1, added attributes @value and @nullFlavor and asserts to require only one at a time.

2. Not sure if it's already implied or if it has to be explicitly stated.

3. Depends on https://art-decor.org/art-decor/decor-issues--ch-pharm-?id=2.16.756.5.30.1.127.77.4.6.39&language=en-US .

4. More complex than I thought, the whole  hl7:effectiveTime  (  SXPR_TS  ) has to be reviewed I think.

5. The assert has to be added to including templates, it doesn't seem possible to add an assert at the template's root.  hl7:templateId[@root='1.3.6.1.4.1.19376.1.5.3.1.4.7.1'] and (not(hl7:doseQuantity) or hl7:doseQuantity[@nullFlavor])

6. The assert has to be added to including templates, it doesn't seem possible to add an assert at the template's root.  hl7:templateId[@root='1.3.6.1.4.1.19376.1.5.3.1.4.7.1'] and (not(hl7:rateQuantity) or hl7:rateQuantity[@nullFlavor])

7. Depends on  https://art-decor.org/art-decor/decor-issues--ch-pharm-?id=2.16.756.5.30.1.127.77.4.6.39&language=en-US .

8. Depends on  https://art-decor.org/art-decor/decor-issues--ch-pharm-?id=2.16.756.5.30.1.127.77.4.6.39&language=en-US .
Tracking / Status = Open 2021-03-15 15:57:26 : Tracking by Quentin Ligier
Description
1. In the first  hl7:effectiveTime  ( IVL_TS ),  hl7:low  and  hl7:high  are described with " If Start of Treatment is unknown this element SHALL be set to null flavor "UNK" ". There is a typo, it should be "End of Treatment" for  hl7:high . To ensure it's the case, the two elements should be required (they are optional now) and their content should be described as
OR (1…1):
  - @value (1…1)
  - @nullFlavor="UNK" (1…1)

2. On the first  hl7:effectiveTime  ( IVL_TS ),  @value@operator  and  @nullFlavor  should be forbidden?

3. In the second  hl7:effectiveTime  ( EIVL_TS ), is the  hl7:offset  child allowed?

4. In the third  hl7:effectiveTime  ( SXPR_TS ), both  hl7:comp  (without and with  @operator="I" ) are annotated as 1…*. Shouldn't the first be annotated as 1…1? I.e. the first  hl7:comp  has no  @operator  attribute, and all following ones shall have it.

5. The  hl7:doseQuantity  is required when the template id  1.3.6.1.4.1.19376.1.5.3.1.4.7.1  is used.
IHE Pharm PRE 6.3.4.6.3.8: In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, this element SHALL be present and SHALL NOT be null flavor.
Proposition for a Schematron error: hl7:templateId[@root='1.3.6.1.4.1.19376.1.5.3.1.4.7.1'] and not(hl7:doseQuantity)
6. The  hl7:rateQuantity  is required when the template id  1.3.6.1.4.1.19376.1.5.3.1.4.7.1  is used.
IHE Pharm PRE 6.3.4.6.3.9: In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, this element SHALL be present and SHALL NOT be null flavor.
=> Not sure why, this is a bit weird.
7. The first  hl7:effectiveTime  ( IVL_TS ) is always required.
IHE Pharm PRE 6.3.4.6.3.4: In case the (structured) dosage instructions include a dose regime [For the scope of this Content Module, “dose regime” groups the data elements Medication Frequency, Dose Quantity and Rate Quantity, provided in a certain type of dosing (“Normal dosing”, “Split dosing”, etc.)] this element SHALL be present and specify the entire duration of the medication treatment.
8. In a normal dosing (template id  1.3.6.1.4.1.19376.1.5.3.1.4.7.1 ), at least one of the second or third  hl7:effectiveTime  is required.
IHE Pharm PRE 6.3.4.6.3.5: In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, this element SHALL be present and SHALL NOT be null flavor.
Proposition for a Schematron error: hl7:templateId[@root='1.3.6.1.4.1.19376.1.5.3.1.4.7.1'] and not(hl7:effectiveTime[@xsi:type='EIVL_TS']) and not(hl7:effectiveTime[@xsi:type='SXPR_TS'])
 
 
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