EE-FI 2017 September Workflow tests

Transcription

1 EE-FI 2017 September Workflow tests 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. Estonia is acting as country B, and Finland is acting as country A. During this trial period, if the test specification refers to countries B.1 and B.2, Estonia is playing these roles. Workflow test id: WF-eP1 CTD references: ep-c1, ep-c4, ep-c6 Test target: Verify that (1) partial dispensation of modified prescription works properly in Country B, (2) the partially prescription may be fully or over in another Country B, (3) dispensation with and without substitution is performed. 1, Country B.2. Mandatory: yes, if partial dispensation is supported by Country A and Country B.1. 1 Country A Modify prescription s are not s are Modified 3 prescriptions with small changes (ep- C1, ep-c4, ep-c6). 2 Country B.1 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. s are list, not s list, partially ep-c1 - successfully half of the amount (in Estonia we were able to dispense 5 x 2,4ml 3 piece package of the 28 package). However, since the prescription did not include information about what is the amount of 1 dose, this was wrongly. ep-c1 - this was fully. Requires some thinking on how to handle cases like this when the amount might not be clear in other countries. Was also wondering if the strenght was showing correctly on our end (20.0 µg /80.0 µl), was expecting it to be translated. ep-c4 - according to pharmacist since the strength is in different order than for the available medications in Estonia, she would not be able to dispense this. However, during testing and knowing that it is in the wrong a dispensation was made for 4 x 30 tablet package (120 tablets total of 400). Substitution for ep- C4 - substitution options are not available. ep-c4 - Is the unit showing as it should on our end ({piece})? Strength comes in different order than on the prescription: prescription: <originaltext>20/10 /5 mg< /originaltext> dispensation: <originaltext>10.0 mg mg mg</originaltext>

2 3 Country B.2 Dispense full remaining amount for ep-c1, dispense amount slightly exceeding the remaining amount for ep-c4 (if allowed according to Country B.2 rules, otherwise dispense fully). Dispense one of the prescriptions without substitution and the other one with substitution, local availability of drugs permitting. s list, partially s not list, because of full dispensation. For ep-c4, an error returned by Country A is permitted, if overdispensation is not supported in Country A. ep-c1 - ep-c4 - the same prescription was still on the prescriptions list and included now 280 tablets. A successful dispensation of 300 tablets was made. After that the prescription was no longer visible in the prescriptions list. ep-c1 - ep-c4 - This shows as fully. 4 Country A Verify status of prescription Both prescriptions fully, or ep-c4 is still partly, if overdispensation is not allowed according to Country B.2 or Country A rules. Both show as fully (ep-c1 with just one dispensation though). Workflow test id: WF-eP2 CTD references: ep-c15 Test target: Verify that a prescription partially with a different package size in Country A may be in Country B. Also overdispensation is tested, and brand name change will most likely be tested for a prescription for which substitution is prohibited. Mandatory: yes, if partial dispensation is supported by both A and B. 1 Country A Dispense partially, changing the package size. is not is partially Amount left on prescription 0,35 ml x 220 packages. Dispensed 20 x 0.35 ml. Remaining 220 x 0.35 ml. 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. s is list, partially After successful dispensation the prescription is not any more visible on the list. The prescription states that substitution is allowed. Since there is no LOMUDAL available in Estonia, there was a need to substitute. Also, no single conteiner packages are available, only 5 ml solution. Has been slightly over the remaining amount. Bit unsure if all the changes are okay (no single dose containers)? 16 packages of 5 ml solution was. Workflow test id: WF-eP3 CTD references: ep-c7, ep-c8, ep-c11, 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.

3 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). valid in Country A, potentially visible on the prescription list returned to Country B cannot be opened or dispensation data cannot be submitted could be opened and successfully. This seems like a bug. Would have expected that the prescription could not be opened (error FINNCP- 0001). : ep-c7 (drug affecting the central nervous system, but not necessarily classified as a narcotic). 2 Country B Repeat the same for ep-c8 (narcotic) 3 Country B Repeat the same for ep-c11 (ex tempore drug, prepared in pharmacy) 4 Country B Repeat the same for ep-c14 (iterated prescription not available for dispensation) 5 Country B Repeat the same for ep-c16 (combination package) Same as above Same as above could not be opened (error FINNCP- 0002) Same as above Same as above could not be opened (error FINNCP- 0003). Additionally it was already noted in the prescriptions list that it's "not dispensable" Same as above Same as above could not be opened (error FINNCP- 0008) Additionally it was already noted in the prescriptions list that it's "not dispensable" Same as above Same as above could not be opened (error FINNCP- 0010) Should have returned error FINN CP-0006? Workflow test id: WF-eP4 CTD references: ep-c2, ep-c3, ep-c5, ep-c10 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. 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. not or partially Dispensation can be performed, prescription is partially or fully Successfully 5ml package of 10 ml. still available the first dispensation and for half the amount (5ml). Is strength coming as it should? original prescription: 100 U /ml dispensation: {unit}/1.0 ml : ep-c2.

4 2 Country B Repeat the same for ep-c3 3 Country B Repeat the same for ep-c5 Same as above Same as above Successfully 1 package with 21 tablets. still available the first dispensation. However the amount of available tablets is now shown 42 instead of 21 and number of available packages is 1. Usually for Yasminelle it is 21 tablets in 1 package and before the first dispensation the prescription had 21 tablets 3 package. Is this correct? Same as above Same as above Successfully 1 package of 60 tablets (prescription included 100 tablets). was still available the first dispensation and the amount of tablets was now 40. However, the strength of the medicine is described differently in Estonia (500.0mg /400IU not 500mg /10 mg as in the prescription). So first, it should be checked how this information can be used in the Finnish prescription centre. And second, it should be separately discussed in the CEF Pharmaceutical WG about whether the pharmacist is allowed to convert units. Strength in different order also on this: prescription: 0,02/3 mg dispensation: 3.0 mg mg I think the value remaining is showing as it was on the dispensation: <value unit="fol" value="42" xsi: type="pq"/> However, it would be possible to use different structure in this? <value unit="fol" xsi: type="pq"> <translation> <originaltext> 2X21</originalText> </translation> </value> Strength is indeed different than on the original prescription. prescription: 500 mg/10 mikrog dispensation: mg [iu]

5 4 Country B Repeat the same for ep-c10 Same as above Same as above Successfully 1 package of 100 ml (same as the full prescription amount since there is no smaller package available in Estonia). Since there is no Amorion available, substitution was made. Has been fully. Wondering about strength on this one too: prescription: 50 mg /ml dispensation: 50.0 mg/1.0 ml Workflow test id: WF-eP5 CTD references: ep-c6, ep-c10 Test target: Verify that dispensation of modified prescription works properly in Country B regardless of whether substitution is performed. Mandatory: yes, if prescription modification is supported by Country A rules. 1 Country A Modify prescriptions, for example restricting their validity time. s not s Modified ep-c6 slightly (couldn't change the times though). Added new ep-c10 as the previous one had been fully. 2 Country B Dispense partially: half of the amount and change the package size (NB: number of units, strength change is not allowed in ehdsi). Dispense one of the prescriptions without substitution and the other one with substitution, local availability of drugs permitting. s are list, not s list, partially Since the neither of the medicines on the prescriptions are available in Estonia, there was a need to substitute on both cass. ep-c6 - prescribed 100 tableks x 1 package; 40 tablets (20tableks x 2 package) ep-c10 - Since there is only 1 available package to dispense to this prescription and the size of the package is the same as prescribed, it is not possible to dispense only half of the amount. This step was thus skipped during this test. ep-c6 - Dispensed "40 kpl", remaining "60 kpl"

6 3 Country A Verify status of prescriptions s list, partially Given names change order in our metadata on the dispensation: "Katriina Kastehelmi" changes to "Kastehelmi Katriina". Possibly this happen when we form friendly/pivot formats as on those the name is: <given>kastehelmi </given> <given qualifier=" CL">Katriina< /given> <family>kukko< /family> On our original cda the name is: <given>katriina< /given> <given>kastehelmi </given> <given qualifier=" CL">Katriina< /given> <family>kukko< /family> Workflow test id: WF-eP6 CTD references: ep-c8 Test target: Verify that dispensation of narcotics prescriptions is prevented even if prescription is modified. Mandatory: yes if prescription modification is supported by Country A rules. 1 Country A Modify prescription is not is Modified ep-c8 slightly. 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). is is The prescription was presented in the list but it was not possible to open the prescription (error code FINNCP- 0002) 3 Country A Verify status of prescription is There's been no changes to status, looks okay.

7 Workflow test id: WF-eP7 CTD references: ep-c6 Test target: Verify that dispensation of prescription with negative amount is prevented in Country B. Mandatory: yes 1 Country B Try dispensing negative amount, without substitution. 2 Country B Try dispensing negative amount, with substitution. 3 Country A Verify status of prescription is list, not or partially is list, not or partially is list, not or partially status, dispensation cannot be submitted status, dispensation cannot be submitted The epsos web portal does not allow to dispense negative numbers. So this test cannot be performed. 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 dispensation abroad. Actors involved: Country A, Country B Mandatory: yes, if prescription renewal is supported by Country A. 1 Country A Renew prescription not renewed renewed, not 2 Country B Dispense fully with substitution 3 Country A Verify status of prescription and renew. 4 Country B Dispense fully with substitution 5 Country B Fetch the list of prescriptions and check that the prescription has disappeared from it. list, not fully renewed, not. fully fully. renewed, not. fully 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. Mandatory: yes.

8 1 Country B Dispense smallest possible amount, without substitution but with product name and product id modification list, not or partially partially or fully Dispensation was made for CO- RENITEC (product name change), 28 tablets of total 98 prescribed. However, there are some difficulties here in regards to how pharmacist is able to find the correct medicinal product when substitution is not allowed and the medicinal product does not exist in Country B with the exact same name. At the moment when dealing with paper Finnish prescriptions, pharmacists sometimes even use Google and find the company name for the medicinal product supplyer in Finland and if these match with one of the Estonian options and the pharmacist is sure that this is the same medication, he/she dispenses it. Not all pharmacists would do this and it is really hard to have rules or guidance for this. Strength has changed order. prescription: 20/12, 5 mg dispensation: 12.5 mg mg We think that there should be a wider and more sufficient definition about what is/is not substitution. 2 Country A Verify that dispensation data includes the changed name and id. partially or fully Changed name is shown (RENITEC COMP CO- RENITEC). Not sure if the final dispensation cda shows the changed id? Workflow test id: WF-eP10 CTD references: ep-c6 Test target: Verify that package type may be changed during dispensation. Mandatory: yes.

9 1 Country B Dispense smallest possible amount, changing package type (for example, blisteràjar) list, not or partially partially or fully Since the Estonian medicinal registry does not include information about package type, this information is not sent with the dispensation. Thus this test cannot be performed. 2 Country A Verify that dispensation data includes the changed package type. partially or fully 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 the interval range, if allowed by Country A rules, and this is also tested. Mandatory: yes if iterated prescriptions are supported by Country A rules. 1 Country A Set an interval range for prescription. If dispensation of iterated prescriptions is supported by Country A certain interval ranges, set the range to end on the next day, and indicate this in the test instance comments. not or partly not or partly - 2 Country B Try opening and dispensing the prescription, if the prescription is visible on the list returned from Country A. not or partly. Not necessarily visible on the prescription list returned to Country B. cannot be opened or dispensation data cannot be submitted This prescription is displayed in the list of prescriptions with the "not dispensable" mark. When trying to open the prescription, a FINNCP-0008 error is received. It shouldn't be possible to dispense any iterated prescriptions from Finland, interval range has no effect. 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. not or partly. partly or fully. - 4 Country A Verify status of prescription partly or fully. is showing as not as no dispensation can be made.

10 Workflow test id: WF-eP12 CTD references: ep-c15 Test target: Verify that cancellation of prescription in Country A the start of the dispensation process in Country B prevents the completion of the dispensation process. Mandatory: yes if cancellation of prescriptions is supported by Country A rules. 1 Country B Fetch prescription list, select and open the prescription. Do not dispense yet. not or partly visible on screen Opened the prescription but did not make a dispensation yet. 2 Country A Cancel the prescription. not or partly has been cancelled. Cancelled the prescription. 3 Country B Try submitting the dispensation. visible on screen Dispensation submit results in an error. When trying to dispense the prescription and error is received: Failed to submit document. Is this error okay or should it be more descriptive? 4 Country B Fetch prescription list, ensure that the prescription has disappeared from it. has been cancelled and should not be visible on the list. This prescription is no longer in the list of prescriptions.