CREATING A SAFETY MESSAGE STEP-BY-STEP GUIDE This step by step describes the process of creating an ADR initial report. The information in the fictitious European Veterinary Pharmacovigilance Reporting Form for MAHs shown below will be used to complete the ADR report.
Safety issues in animals in humans Lack of expected efficacy Withdrawal period issues Environmental problems ANIMAL CASE 1 SENDER REPORT IDENTIFICATION CASE REF. No: 1 Test Case F Reporting country: Belgium Purchase country: Belgium Report source: European Veterinary Pharmacovigilance Reporting Form for MAHs 1. ADDRESS OF COMPETENT AUTHORITY 2. NAME AND ADDRESS OF SENDER MAH Date complaint received by sender: 02/02/2004 (dd/mm/yy) Type of report: Initial Follow-up (date, case number) Person who reported the reaction: veterinarian owner physician pharmacist other: 3. VETERINARIAN / PHYSICIAN / PHARMACIST 4. ANIMAL OWNER / HUMAN PATIENT Name: Name (according to the confidentiality legislation in EU country): Koen Kumpen Address: Address: Hasselt Telephone No. 5. ANIMAL DATA No. of animals treated: 1 Animal characteristics (animal(s) showing signs): Species: Dog Breed/production type: Boston Terrier Telephone No. No. of animals showing signs: 1 Sex/physiological status: female male pregnant neutered lactating other: Weight (kilos): 8.79 Age: 5 ½ months State of health at time of treatment: good fair poor critical unknown Reason(s) for treatment (prevention against what disease(s) or initial diagnosis): surgical intervention No. of animals died: 1 6. PRODUCT DATA # 1 Trade name (include dosage form and strength): Inhalodorm M.A. number: Active substance(s) (INN): ATC vet code(s): Batch No.: 00052K206 Expiry date: 08/04 Storage details: Treatment details: Dose/frequency: Route/site of administration: Inhalation use Start date of treatment: Stop date or duration: Who administered the product: veterinarian owner other Use according to label: yes unknown no explain: Action taken after reaction: drug withdrawn dose reduced other Did reaction abate after stopping drug? yes no not applicable Did reaction reappear after reintroduction? yes no not applicable List all other relevant medications given to animal(s): Give the list of the other veterinary medicinal products used concurrently and go to special field for completion of details (page 3)
7. REACTION DATA (applicable for all types of adverse reaction(s) reported following administration of veterinary product(s) SENDER CASE REF. No: 2 Date of onset of signs: Duration of reaction: Describe the sequence or events including administration of product(s), all clinical signs, site of reaction, severity, pertinent lab tests, necropsy results, possible contributing factors (if necessary use extra sheet): Include details of treatment given to address this adverse reaction. Dr Peters operated the dog to repair an umbilical hernia. Premedication included atropine and butorphanol. The dog was masked down with Inhalodorm, intubated and maintained @ 4% for 20 minutes. The apnoea alarm went off. Mechanical ventilation was started. There was no pulse although pulse ox showed HR of 90-100, probably malfunctioning of the monitor as stated by the vet. IV injections with Epinephrine, Dopram and Dexamethasone followed by intra-cardiac epinephrine. Dog could not be revived. Post-mortem results are awaited Were the signs treated? No Yes Outcome of reaction to date: Killed/euthanised died under treatment alive with sequalae recovered unknown No. of animals: 1 Date when: 8. ATTENDING VETERINARIAN S LEVEL OF SUSPICION THAT PRODUCT #1 CAUSED REACTION possible unlikely no attending vet 9. PREVIOUS EXPOSURE AND REACTION(S) TO PRODUCT #1 Previous exposure to this product? no yes Date(s): Previous reaction to this product? no yes Describe: De-challenge information: 10 10. DETAILS OF SUSPECTED ADVERSE REACTION(S) IN HUMANS Patient details Sex: Age/date of birth: Occupation (with relevance to exposure): Date of exposure: Date of reaction: Nature and duration of exposure, reaction details (including symptoms) and outcome: 11. CAUSALITY ASSESSMENT RELATED TO PRODUCT #1 Classification: A (probable) B (possible) O (unclassified) N (unlikely) Reason for classification: 12. OVERALL CAUSALITY ASSESSMENT RELATED TO ALL SUSPECTED PRODUCTS FOR COMPETENT AUTHORITY USE ONLY Name and title of person responsible for the accuracy of the information Signature Date 3
The EudraVigilance Screen Dynamic button set Tree-view area Active area General tips: Remember to always press enter to open a field to allow data entry. Once you have typed the information, or chosen an entry from a lookup table, you must then press enter again in order to record that information in the field and move to the next one. The sections that need completing appear in red. Some of the sections are repeatable, for example Animal Suspect Drug and Animal signs, to allow the user to input multiple entries, like several VeDDRA terms, or concomitant drugs. To enter the first item, you should click on the relevant section on the Tree view area, and then you create your entry by clicking in the New tick box that appears in the Active area
Once you have filled your first entry, to enter the second item, you must click again on the original section on the tree view area (in this example it would be Animal signs ), and you would then be able to create a second entry by clicking on New again. If you wish to delete an entry on a repeatable section, select the relevant section on the tree view area, then untick the entry you wish to delete from the list that appears in the Active area, and press the Clear button on the toolbar; this will remove the entry. 5
Create and send ADRs: This is the opening page of EVWEB. Click on Send ADRs. The following screen appears. A Message in EudraVigilance is like an envelope used to send one or more Safety Reports. Start by selecting the field Message Number ; press enter. There are no conventions stated for the Message Number as it is used for administrative purposes only, and will not be used to retrieve information on the Safety Reports. Therefore the users can choose whatever number they wish. Type the number you wish to give to this message (in this case we called it Animal Case 1), press Enter. Then select Safety Reports, and Enter 6
The system gives you the choice of New Human Safety Report or New Animal Safety Report. In this example, since the adverse reaction reported occurs to an animal, select New Animal Safety report by ticking the box. The right hand side (active area) displays the fields that have to be filled in. It also indicates what Fields are Mandatory. Select the field Report identification Number. (This field will eventually be renamed Sender s report identification number in accordance with the Data elements guideline ). This is the number given to the case by the sender. This number should remain constant in subsequent transmissions of the case by the same sender (i.e. follow-up reports). Re-transmitters, (i.e. a Competent Authority adding their assessment to a report sent by a MAH), should replace this value with their own Sender s report identification number. Type the information following the convention (Country code - MAH name or Name of CA- Case number), and press Enter. 7
Go to Type of report, Enter. A pop-up window will appear. Choose the appropriate item in the look-up list (Spontaneous in this case) and Enter. Click on Information type, Enter. Select the relevant information as indicated on the Reporting Form, and Enter. On the field Case registration type, select whether the reporter is the MAH or a Competent Authority, and Enter Next, enter the Worldwide case number. (This field is going to be renamed Unique case registration number, in accordance with the Data elements guideline ). This is the number used by the system to uniquely identify this case; any subsequent follow-up reports would be linked to this case through this number, therefore it must never be changed. In this case, the Worldwide case number and the Report identification number are the same, as this is the first time this case has been reported to the EudraVigilance system. This particular case is being sent by a MAH. If, for example, the relevant Competent Authority (CA) were to add their assessment to this case, the new report created by the CA would have the same Worldwide case number but the Report Identification number would change to reflect the identity of the new sender, i.e. BE-Name of CA-Test case F 8
Select Received date. This is the date when the sender of the ADR report first received information on this case from the primary source. A calendar will appear. Choose the date by using the little arrows at the left and right side of the year and the month, click on the right day, and enter 9
The Received date field has been completed. Now use the same process to complete the Most recent info date field. As this example is an Initial report, this date is the same as the Received date. Select the field Primary Source Country and press enter; choose the appropriate entry from the look-up table, and enter. Repeat the same process for the next field, Occur country. 10
Now select the field Animal treated Species, and enter The following screen, containing two fields Species (Code) and Species (Text) is displayed. The Species (Code) field contains a look-up with the List of Species and Breeds for Electronic reporting of adverse reactions as adopted by the CVMP. This list includes the names of the species and breeds and their corresponding codes, which have been created to facilitate electronic reporting using XML (Extended Mark-up Language). You should first search this list to find the species you require for the case you are entering (how to search is explained below). In the unlikely case that the species you require is not on the list, you can enter the name of this Species in the Species (Text) field. Therefore, if you complete the Species (text) field the Species (Code) field will remain blank. You must fill only one of these entries. Select Species (code), and Enter. The screen shows a query area: Type the name of the species you need to find, and enter. On the look-up table, choose the relevant information, and press Enter. 11
As stated before, the field Species (Text) is only used if you cannot find the species you need on the look-up table. In such case, type the species name on the text field, and press enter. The Breed(s) section works on the same way as the Species section. Select Breed(s), and enter. Click on New breed, enter. 12
Click on Breed (code), type the relevant name on the look-up table query field, select the correct result and Enter. As explained before for the Species, if the breed required is not found on the look-up list, it can be entered using the Breed (Text) field. To continue entering the ADR report, select Animal data on the left side of the screen, press Enter. On the new area displayed, select Exposed number, and Enter. Type the number of animals as per the information shown on the reporting form The same applies to the next field, Affected number 13
Select Sex, Enter. Choose the correct term from the pop-up window, and Enter. Click on Animal role, Enter. Select the appropriate role from the pop-up window, and enter. To continue entering the data, go to Weight type, and Enter. Since the exact weight is stated on the Reporting form, select Exact, and Enter. 14
Now go to Weight, and enter the exact figure (8.79 on this example) The same principle applies for entering the age data. Fill in the appropriate fields, in this case Age type is Exact, Age is 5.5 and Age unit will be months. Continue by selecting Animal adverse reaction, and press Enter 15
You can now enter the reaction data on the relevant fields. Go to Reaction start date, and enter. As previously, choose the appropriate date on the calendar and Enter. Continue to fill in the fields with the information available on the Reporting Form. Go to Time to onset of reaction, press enter. Select the appropriate time period from the look-up table and enter Select Serious? Enter. 16
Select the correct information. Continue entering the details of the adverse reaction. As in this example the animal died as a result of the reaction, click on Results in death? and choose Yes. Then enter the outcome of the reaction. In this case, choose Outcome died and type the number of animals that died. Continue by selecting Case narrative, and Enter. 17
On the next field Narrative text including clinical, describe the full sequence of events. Press enter and an additional area will be displayed where the text should be written. Once you have completed the appropriate information, click the green tick sign so that the text is accepted. You shall now proceed with entering the relevant information about the signs shown by the animal. Select the Animal sign(s) section on the left-hand side of the screen, press Enter. You arrive to the following screen; 18
Click on New animal sign, and Enter. Select Reaction veddra term (Code), Enter. Type the term, and press the enter key to start the search. The results will be displayed in a look-up table. Select the appropriate entry by double clicking on the term. This section is repeatable, to allow you to enter as many terms as necessary. To enter the next term, click on Animal sign again, and repeat the above procedure. Repeat as many times as necessary. 19
Once you have entered all the key terms from the narrative, go to Animal suspect drug on the lefthand side of the screen, and Enter. Then click on New animal suspect drug to input the information for the suspect drug (s); this section is also repeatable, to allow data entry for any other concomitant and/or interacting drug. Select Treatment start date, press enter. A calendar pops-up. Choose the right date and Enter. Then go to Characterisation, press enter. Choose the appropriate term, and enter. 20
The next field we have information for is the Brand name. Select it and Enter. A look-up table will appear at the bottom of the screen. Type the name of the product and Enter. In this example, the product is not yet included in the Product dictionary, so the system informs you there are no results for your query. 21
Therefore, you have to enter the brand name in the system. Click OK, and press the ESC key to return to the Brand name field. Click on the button E on the toolbar to edit the field, then type the name of the product. Continue entering the available information. To input the Administration route you must choose the appropriate term from the look-up table containing the List of Standard terms. 22
The next mandatory field on this section is Who administered the VMP. Pick the correct person from the look-up table. The next section to be completed is Assessment. Select it on the left-hand side of the screen, press enter. Click on the tick box next to New assessment, and press enter. On Assessment source select who has performed the assessment. 23
Next, on Assessment classification, enter the information as stated on the Reporting form. On the next field, type any comments that have been supplied on the form. The Assessment section has now been completed. Move on to the next section, Animal suspect substance, and press enter. Tick New animal suspect substance to display the menu where to input the substance(s) information, and press Enter. 24
This is a repeatable section, to allow you to enter several substances if needed. First choose the Role of the substance you wish to enter. In this example, we only have information about the Active substance, so select it, and enter. Next select the Substance name field, and enter. A look-up query section will be displayed. Type the name of the substance on the Name field of the look-up table, and enter. In this case, the substance has not yet been entered on the Substance dictionary; therefore you are informed that the lookup returned no results. Click E on the button on the toolbar to edit the field. Type the name of the substance, and press enter. In this case, you have no further information on the active substance, so you can progress to the next steps of the data entry. 25
To input any other drug that has been administered concomitantly, return to the Animal suspect drug(s) section, then click on New. A new section appears, where you can input the information about the other drug (s). The Animal Treating drug(s) section works on the same way as the Animal suspect drug(s) section, and it should be used to enter information on drugs used to treat the adverse reaction. 26
Once you have entered all information available on any products administered to the animal(s), you can progress to the next section, the Primary source section. Select Primary source on the lefthand side of the screen, and Enter. You can now input the details you have available from the Reporting form about the primary source. Click on the relevant field, press enter, type the information, and enter. The only mandatory field on this section are Last name, and Categorisation. Once you have finished completing this section, the data entry for this case is finalised. You are now ready to send the message. Select the Message Receivers section on the left hand side of the screen. The active area will display all the possible receivers for the message grouped in alphabetical order. 27
Select the group required, then the specific receiver(s) by ticking the box next to them. Before sending the message, it is useful to validate the message, to discover if any mandatory fields have been left out by mistake during data entry. Click on the Validate button. In this example, the message has been completed correctly, so the validation is OK. If any of the mandatory fields have not been completed, you will get a Validation failed note on the pop-up window and the system will inform you where the errors are. You can then return to the relevant section and fill in the information. 28
You may now save the message on your system on XML or RTF format. You may now send the message by pressing the Send button 29
You can access your Outbox in the Webtrader Section to verify any outgoing safety messages and acknowledgement messages. You can access your Inbox in the Webtrader Section to verify any incoming safety messages and acknowledgement messages. 30