OpenRIMS-PVM - User Manual Chapter 8
1 Spontaneous Reporting
| PViMS provides the mechanism to register spontaneous reports by the public. While these reports form part of the overall PViMS adverse event repository where Pharmacovigilance activities can be performed against the report, they do not form part of the analysis.
Note: spontaneous reporting is available to the public and no login to PViMS is required. |
1.1 Accessing Spontaneous Reporting
When you enter the correct URL to access PViMS, the system navigates you the login page. This page contains the primary link to register a spontaneous report.
To register a spontaneous report, click on the Public button. The system will navigate you to a page where you can enter the spontaneous report.
1.1.1 Add a New Report
Spontaneous reports are composed of the following sections:
| Patient Information | Information related to the patient who suffered the adverse event |
| Product Information | Information related to the medication that potentially caused the adverse event |
| Test Result | Any test results that are relevant to the adverse event |
| Reaction and Treatment | Details of the adverse event |
| Reporter Information | Details of the person who has logged the adverse event |
1.1.1.1 Patient Information
The Patient Information section captures basic patient demographic information about the person who suffered the adverse event.
To enter patient information, enter text in the corresponding fields (e.g., Initials of Patient). Or click the arrow in a selected field to display a list of values and select one value from the list. All elements with a red asterisk are mandatory.
Fields in the Patient Information section are described below:
| Initials of Patient | Identification of the patient is facilitated through the capturing of their initials in a text field |
| Identification Number | Identification of the patient is facilitated through the capturing of their ID Number in a text field |
| Identification Type | Dropdown list to select the patient’s type of identity number specified |
| Patient Date of Birth | Either specify the patient’s date of birth |
| Age | Or specify the patient’s age |
| Age Unit of Measure | If age is specified, specify the unit type for the age (e.g. days, months etc.) |
| Patient Weight (kg) | The weight of the page at the time of the adverse event, in kilograms |
| Sex | Dropdown list to specify the gender of the patient |
| Ethnic Group of Patient | Dropdown list to specify the ethnic group of the patient |
Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.
1.1.1.2 Product Information
The Product Information section captures a list of medications that the patient was taking at the time of the adverse event.
To enter medication information, click the Add Product Information item button. Once a product has been added, you are able to remove or edit the medication using the appropriate button next to the medication.
Fields in the Product Information Section are described below:
| Product | The name of the medication that the patient was taking (generic or brand name) |
| Drug Strength | Free format description of the drug strength, e.g. 250 |
| Drug Strength Unit | Dropdown list specifying the unit of the drug strength, e.g., mg |
| Product Suspected | Is this product suspected of causing the adverse event |
| Dose Number | Drug dosage |
| Dose Unit | Dropdown list specifying the unit of the drug dosage |
| Route of Administration | Dropdown list specifying how the drug has been administered |
| Start and End Date | When did the patient start the drug and if they have completed taking the drug, when was the last date of administration |
| Treatment Duration | How long has the patient been on the drug |
| Treatment Duration Unit | Dropdown list specifying the unit for the duration |
| Indication | Indication for why the patient is taking this drug |
| Frequency | How frequently is the patient taking the drug |
| Batch Number | The batch number the drug forms part of |
| Action Taken | What action was taken when the adverse event occurred |
| Product Challenge | Was a challenge performed on the product when suspected of the adverse event |
| Product Rechallenge | Was a rechallenge performed |
Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.
1.1.1.3 Test Results
The Test Results section captures a list of test results that are applicable to the adverse event.
To enter test results, click the Add Test Results item button. Once a test has been added, you are able to remove the result or edit the test using the appropriate button.
Fields in the Test Results Section are described below:
| Test Date | The date the test was conducted |
| Test Name | The name of the test conducted |
| Test Result | The result of the test conducted |
| Test Unit | Any unit associated to the test result |
| Low- and High-Test Range | Test result range that is considered normal |
| More Information | More information associated to the test result? |
Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.
1.1.1.4 Reaction and Treatment
The Reaction and Treatment section captures details of the adverse event.
To enter reaction and treatment information, enter text in the corresponding fields (e.g., Description of Reaction). Or click the arrow in a selected field (e.g.) to display a list of values and select one value from the list. All elements with a red asterisk are mandatory.
Fields in the Reaction and Treatment Section are described below:
| Description of Reaction | A description of the adverse event |
| Start Date of Reaction | The date the reaction first appeared in the patient |
| Estimated Start Date of Reaction | Only specify this date if the exact start date is not known |
| Reactions | Did the patient experience a reaction |
| Treatment for Reaction | Was a treatment given for the reaction itself |
| What Treatment Given for Reaction | If a treatment was given for the reaction, what treatment was it |
| Reaction Outcome | What was the outcome of the reaction |
| Recovery Date | If the patient has recovered, what is the date of the recovery |
| Deceased Date | If the patient has died from the adverse event, what was the date of death |
| Other Relevant Info | Is there other information relevant to the adverse event |
Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.
1.1.1.5 Reporter Information
The Reporter Information section captures details of the person who has reported the event.
To enter reporter information, enter text in the corresponding fields (e.g. Name or Initials of person reporting the event). Or click the arrow in a selected field (e.g.) to display a list of values and select one value from the list. All elements with a red asterisk are mandatory.
Fields in the Reporter Information Section are described below:
| Name or Initials | The name or initials of the person reporting the event |
| Telephone Number | Contact number of the person reporting the event |
| Email Address | Email address of the person reporting the event |
| Profession | The profession of the person who has reported the event |
| Reference Number | Reference number for the event that has been reported |
| Place of Practice | At which facility does the reporter work |
| Confidentiality | Should the report remain confidential |
Click the Next button to navigate to the next screen or the Cancel button to cancel the registration of the spontaneous report and return to the login screen.
Click the Save Report button to submit the report or the Cancel button to cancel the registration of the spontaneous report and return to the login screen. Please note that the Save button will only be activated once all mandatory fields and field validations are completed successfully.