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Patient ID to be used:

Country A: Portugal

Country B: Czech Republic


All workflow tests must be executed in coordinated manner, with both Country A and Country B participating together. Tests must not be executed independently by Country B without ongoing communication with Country A.

Note that Step 0 (prerequisite) in all workflow tests is that the CTD documents referenced in the test have been prepared and made available by Country A.

Workflow test id: WF-eP1

Version: 1.1

CTD references: eP-C1, eP-C4

Test target: Verify that (1) partial dispensation of modified prescription works properly in Country B, (2) the partially dispensed prescription may be dispensed fully or overdispensed locally in Country A after a dispensation in Country B. In addition, dispensations with and without substitutions are tested.

Actors involved: Country A, Country B

Mandatory: yes, if partial dispensation is supported by Country A and Country B.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country A

Modify prescription

Prescriptions are not dispensed

Prescriptions are modified, not dispensed

Unable to modify in PT; unable to dispense partially.

2

Country B

Dispense partially: half of the amount (NB: number of units, strength change is not allowed in eHDSI) for eP-C1, 1/3 of the amount for eP-C4. Dispense one of the prescriptions without substitution and the other one with substitution, local availability of drugs permitting.

Prescriptions are available on the list, not dispensed

Prescriptions available on the list, partially dispensed

Dispensation confirmed for Teriparatide, 0.25 mg/ml, Solution for injection in a pre-filled pen, Pre-filled pen - 1 unit (s) - 2.4 ml.


Dispensation not confirmed for eP-C4. Didn't receive the dispensation. Prescription still visible on the list and available for dispense.


3

Country A

Using a local pharmacy system, dispense full remaining amount for eP-C1, dispense amount slightly exceeding the remaining amount for eP-C4 (if allowed according to Country A rules, otherwise dispense fully). Dispense one of the prescriptions without substitution and the other one with substitution, local availability of drugs permitting.

Prescriptions available on the list, partially dispensed

Prescriptions not available on the list, because of full dispensation.

Partial dispensation not allowed in PT, prescriptions was marked as fully dispensed.

Workflow test id: WF-eP2

Version: 1.1

CTD references: eP-C9

Test target: Verify that a prescription partially dispensed with a different package size in Country A may be dispensed in Country B. Also overdispensation is tested, and brand name change will most likely be tested for a prescription for which substitution is prohibited.

Actors involved: Country A, Country B.

Mandatory: yes, if partial dispensation is supported by both A and B.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country A

Dispense partially, changing the package size.

Prescription is not dispensed

Prescription is partially dispensed

Unable to modify in PT; unable to dispense partially.


2

Country B

Dispense amount slightly exceeding the remaining amount (if allowed according to the Country B rules, otherwise dispense fully). As substitution is prohibited, dispense the same drug, but a name change may happen.

Prescriptions is available on the list, partially dispensed

After successful dispensation the prescription is not any more visible on the list.



Workflow test id: WF-eP3

CTD references: eP-C7, eP-C8, eP-C11, eP-C13, eP-C16

Test target: Verify negative conditions: none of the prescriptions should be available for dispensation, although valid in Country A.

Actors involved: Country A (only for step 0, preparing CTD data), Country B.

Mandatory: yes, but not all steps may be supported by Country A.

Step id

Actor

Operation

Status before

Expected status after

Report by PT
Report by CZ

1

Country B

Get a list of prescriptions for the patient indicated in CTD definition. If the prescription is presented on the list, try opening the prescription and dispensing (even if not allowed in Country B).

Prescription: eP-C7 (drug affecting the central nervous system, but not necessarily classified as a narcotic).

Prescription valid in Country A, potentially visible on the prescription list returned to Country B

Prescription cannot be opened or dispensation data cannot be submitted

NB: for eP-C7 dispensation might be possible if supported both by Country A and Country B.

Dispensation confirmed for Diazepan 5 mg Blister - 25 unit(s).

2

Country B

Repeat the same for eP-C8 (narcotic)

Same as above

Same as above

Medicine not allowed for dispensation abroad.

3

Country B

Repeat the same for eP-C11 (ex tempore drug, prepared in pharmacy)

Same as above

Same as above

Medicine not allowed for dispensation abroad.

4

Country BRepeat the same for eP-C13 (medicine prescribed for a certain time period, no other indication of prescribed amount)Same as aboveSame as aboveThere is no time period for PT prescriptions.

5

Country B

Repeat the same for eP-C14 (iterated prescription not available for dispensation)

Same as above

Same as above

There is no interval range for PT prescriptions.

6

Country B

Repeat the same for eP-C16 (combination package)

Same as above

Same as above

Not available in PT.

Workflow test id: WF-eP4

CTD references: eP-C2, eP-C3, eP-C5, eP-C17

Test target: Verify dispensation of potentially challenging medicines: should result in successful dispensations despite possible differences in pharmaceutical databases of Country A and B or other pharmaceutically challenging conditions.

Actors involved: Country A (only for step 0, preparing CTD data), Country B.

Mandatory: yes.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country B

Try dispensing the prescription, using a minimum possible amount, so that prescription can be reused for other tests if allowed by Country A rules. Pay attention to Reason for inclusion in test in CTD definition.

Prescription: eP-C2.

Prescription not dispensed or partially dispensed

Dispensation can be performed, prescription is partially or fully dispensed

Dispensation confirmed for Insulin glargine, 100 U/ml, Solution for injection - 1 unit (s) - 10 ml.

2

Country B

Repeat the same for eP-C3

Same as above

Same as above

Dispensation not confirmed for eP-C3. Didn't receive the dispensation. Prescription still visible on the list and available for dispense.

3

Country B

Repeat the same for eP-C5

Same as above

Same as above

Dispensation not confirmed for eP-C5. Didn't receive the dispensation. Prescription still visible on the list and available for dispense.

4

Country BRepeat the same for eP-C17Same as aboveSame as aboveNot available in PT.

Workflow test id: WF-eP6

CTD references: eP-C8

Test target: Verify that dispensation of narcotics prescriptions is prevented even if prescription is modified.

Actors involved: Country A, Country B.

Mandatory: yes if prescription modification is supported by Country A rules.

Step id

Actor

Operation

Status before

Expected status after

Report by PT
Report by CZ

1

Country A

Modify prescription

Prescription is not dispensed

Prescription is modified, not dispensed

Unable to modify in PT.

2

Country B

Get a list of prescriptions for the patient indicated in CTD definition. If the prescription is presented on the list, try opening the prescription and dispensing (even if not allowed in Country B).

Prescription is modified, not dispensed

Prescription is modified, not dispensed



3

Country A

Verify status of prescription

Prescription is modified, not dispensed

No changes to status, only report results of the check.



Workflow test id: WF-eP7

CTD references: eP-C6

Test target: Verify that dispensation of prescription with negative amount is prevented in Country B.

Actors involved: Country A, Country B.

Mandatory: yes

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country B

Try dispensing negative amount, without substitution.

Prescription is available on the list, not dispensed or partially dispensed

No changes to status, dispensation cannot be submitted

Negative amount not allowed by PT system.

2

Country B

Try dispensing negative amount, with substitution.

Prescription is available on the list, not dispensed or partially dispensed

No changes to status, dispensation cannot be submitted



3

Country A

Verify status of prescription

Prescription is available on the list, not dispensed or partially dispensed

No changes to status, only report results of the check.



Workflow test id: WF-eP8

CTD references: eP-C10

Test target: Verify that dispensation of renewed prescription works properly in Country B, and prescription may be renewed after dispensation abroad.

Actors involved: Country A, Country B

Mandatory: yes, if prescription renewal is supported by Country A.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country A

Renew prescription

Prescription not renewed

Prescription renewed, not dispensed

Unable to renew in PT.

2

Country B

Dispense fully with substitution

Prescription available on the list, not dispensed

Prescription fully dispensed.



3

Country A

Verify status of prescription and renew.

Prescription fully dispensed

Prescription renewed, not dispensed.



4

Country B

Dispense fully with substitution

Prescription renewed, not dispensed.

Prescription fully dispensed



5

Country B

Fetch the list of prescriptions and check that the prescription has disappeared from it.

Prescription fully dispensed

No changes to status, only report results of the check.



Workflow test id: WF-eP9

CTD references: eP-C12

Test target: Verify that a name and id change may be performed while dispensing a prescription for which substitution is prohibited.

Actors involved: Country A, Country B.

Mandatory: yes.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country B

Dispense smallest possible amount, without substitution but with product name and product id modification

Prescription available on the list, not dispensed or partially dispensed

Prescription partially or fully dispensed



2

Country A

Verify that dispensation data includes the changed name and id.

Prescription partially or fully dispensed

No changes to status, only report results of the check.

Dispensation not confirmed for eP-C12. Didn't receive the dispensation. Prescription still visible on the list and available for dispense.

Workflow test id: WF-eP10

CTD references: eP-C6

Test target: Verify that package type may be changed during dispensation.

Actors involved: Country A, Country B.

Mandatory: yes.

Step id

Actor

Operation

Status before

Expected status after

Report by PT
Report by CZ

1

Country B

Dispense smallest possible amount, changing package type (for example, blisteràjar)

Prescription available on the list, not dispensed or partially dispensed

Prescription partially or fully dispensed

Dispensation confirmed for Paracetamol, 500 mg, Tablet, Blister - 20 unit(s).


2

Country A

Verify that dispensation data includes the changed package type.

Prescription partially or fully dispensed

No changes to status, only report results of the check.



Workflow test id: WF-eP11

CTD references: eP-C14

Test target: Verify that it is not possible to dispense an iterated prescription with interval range that has not passed yet for the next dispensation to be possible. Dispensation may become possible after the interval range, if allowed by Country A rules, and this is also tested.

Actors involved: Country A, Country B.

Mandatory: yes if iterated prescriptions are supported by Country A rules.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country A

Set an interval range for prescription. If dispensation of iterated prescriptions is supported by Country A after certain interval ranges, set the range to end on the next day, and indicate this in the test instance comments.

Prescription not dispensed or partly dispensed

Prescription not dispensed or partly dispensed

There is no interval range for PT prescriptions.

2

Country B

Try opening and dispensing the prescription, if the prescription is visible on the list returned from Country A.

Prescription not dispensed or partly dispensed. Not necessarily visible on the prescription list returned to Country B.

Prescription cannot be opened or dispensation data cannot be submitted



3

Country B

Wait for the next day if Country A has indicated that dispensation should be possible on the next day. Try dispensing. If Country A has not provided such indication, skip the step.

Prescription not dispensed or partly dispensed.

Prescription partly dispensed or fully dispensed.



4

Country A

Verify status of prescription

Prescription partly dispensed or fully dispensed.

No changes to status, only report results of the check.



Workflow test id: WF-eP12

CTD references: eP-C15

Test target: Verify that cancellation of prescription in Country A after the start of the dispensation process in Country B prevents the completion of the dispensation process.

Actors involved: Country A, Country B.

Mandatory: yes if cancellation of prescriptions is supported by Country A rules.

Step id

Actor

Operation

Status before

Expected status after

Report by PTReport by CZ

1

Country B

Fetch prescription list, select and open the prescription. Do not dispense yet. Leave the prescription open, do not close it. Signal to Country A that the prescription is open.

Prescription not dispensed or partly dispensed

Prescription visible on screen



2

Country A

Cancel the prescription.

Prescription not dispensed or partly dispensed

Prescription has been cancelled.

Prescription was cancelled.

3

Country B

Try submitting the dispensation of the prescription which is open in the portal or pharmacy system.

Prescription visible on screen

Dispensation submit results in an error.

<RegistryError codeContext="Search did not return any results"
errorCode="XDSRepositoryError"
location="urn:oid:2.16.17.710.820.1000.990.1"
severity="urn:oasis:names:tc:ebxml-regrep:ErrorSeverityType:Error"/>

4

Country B

Fetch prescription list again, ensure that the prescription has disappeared from it.

Prescription has been cancelled and should not be visible on the list.

No changes to status, only report results of the check.



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