Capturing Product Information

As per the regulations, once a medical product like drug, vaccine or device is marketed in various countries, a manufacturer is required to collect and monitor the complaints about the product and report the adverse reactions.

A strong pharmacovigilance system is required to ensure the periodic evaluation of the new safety data generated under the real-world conditions.

For example: Some of pain killers are effective remedy for fever, cold and cough, and body aches. If it is not used at the correct dosage and frequency, it may cause liver damage leading to liver failure.

ARISg provides the option of tracking and gathering information related to adverse reactions of the Product, each Product’s Labeling, Disease Indication details, Medication information, and Japanese clinical trials information with help of Product tab.

  1. On the Full Data Entry page, click the Product tab.
    The data entry page opens to enter the Product information. 

Adding Multiple Products

Click the right arrow of the slider bar and observe a row appearing in the list.

Important: The application does not allow you to enter any blank records.

Field Description of Product Information page

Field

Description

Product Information

Product Type

To indicate the classification of the product, select one of the following options:

  • Drug

  • Vaccine

  • Device

  • Cosmetics

  • Combination

The application considers Combination product in all the regulatory reports irrespective of Drug report, Device report, Vaccine or Cosmetic report.

Note: The information entered in Admin-->Product Type Country field gets reflected when a record is selected from local tradename tab of CPD lookup in Arisg.

  • Enter the product description manually and press tab key. All the applicable product type fields  like

Manufacturer unit,Model no.,Catalog no.,CE no.,Competent authority, Common device name,Nomenclature system,Nomenclature code,Nomenclature text,Procode,UDI No,ARTG number,Type of Device fields gets autopopulated in Medical devices screen successfully.

  •  Manually enter the Device or combination Product at Ingredient level and tab out

UDI No field gets autopopulated in Medical device screen

Not reportable in Japan

Considers the records that are not reported in Japan.

Product Flag (B.4.k.1/G.k.1)

The type of product used.

 

This parameter Product based available in Admin>>Parameters>>Installation Parameters>>General>>Security determine whether the product level security entered within an AER (for which users have access) are applicable for the 'Most suspect product, 'Any suspect product or, 'Any product’.

Coding Class

The standard codes used by the application.

For more information on Coding Class, refer to the section "Specifying the Standard Codes” in this guide.

Product Description

(B.4.k.2.1/D.8.r.1/D.10.8.r.1 /G.k.2.2)

B.4.k.20.FDA.1

 

The brand name of the product that caused the adverse reaction Or

  1. Click the Lookup icon. The Lookup window appears.

  2. Enter the search criteria and click OK. The search results appear in the list.

  3. Choose the required information from the list and click Select. The selected information appears in the Full Data Entry page.

When you enter the product description manually available in the Company Product Dictionary, the associated information with the entered product are displayed in the various fields such as Ingredient tab, App. No./Lot.No tab etc. Autocoding the product behaves as same as CPD Look up.

By default, the Primary Active field is selected for the first ingredient record when the product is selected from WHODD Lookup manually.

Note: By default, the Product status and License status are in Active status.

If a selection criterion is not entered, the application displays only those products which ’Product Status’ and ’License Status’ are in ’Active’ status.

  1. Open the Lookup window.

  2. Click the "Preferred Product Description" (PPD) tab.

  3. The values displayed in the "Form of ADMIN", "Strength", and "Strength Unit" columns are the values defined for the respective Drug/Vaccine in the Library > Company Product Dictionary (CPD) Maintenance screen in ADMIN.

  4. Click the "Local Trade Name" tab.

  5. The values displayed in the "Strength", and "Strength Unit" columns in the "Local Trade Name" tab are the values defined for the respective Drug/Vaccine in the Library > Company Product Dictionary (CPD) Maintenance screen in ADMIN.

The Generic Name (Chinese) field data gets populated, from CPD lookup and autocodes from LTN level, only when the Approval Country is China.

Displaying applicable indications

1. Enter the product description and press tab key

2. Applicable indications appear with all the indication record

3. All the selected record gets copied into local approval tab of FDE.

4. Set the parameter Copy approval countries with yes in admin and save.

Auto-coding with CPD

The following functionality is not applicable when you send the terms to agEncoder through Tools>submit to agEncoder or through workflow.

When you enter the Product name or use the Auto-code icon on the tool bar, the Auto-coding of drugs take place through CPD even when the coding system is set to agEncoder. If the entered product name finds a match in CPD library then the corresponding information such as Indications, Approval records, Ingredients etc gets displayed in the case.

If the there is no matching record found in CPD then the request is forwarded to agEncoder for further coding.

The coding type is ‘Dictionary’ for the drug names which are coded with CPD library.

Auto-coding IRT Cases

The agEncoder application, auto codes the MedDRA terms (Reaction, Disease, Lab, Indication) in ARISg for cases which are sent from IRT application. The terms are coded against the dictionary / VTA list of agEncoder, and updated back to the case in ARISg.

The coding information is not over written, if it is already present.

The terms are coded based on the parameters set in Admin>Installation Parameters>Coding

Following, is the order in which the terms are matched for Product terms

CPD Library>followed by direct match in WHO DD dictionary or agEncoder WHO DD VTA list.

Populates DRL and JPN DD codes from the CPD into the case.

The order of matching the dictionary or VTA is determined on the parameter set in agEncoder.

Preferred Product Description

The application displays the selected value in the Preferred Product Description field available in the Product Information section.

Or

You can enter the value manually or select the value by clicking the Lookup icon. The entered or selected value is displayed in the Product Description field available in the Product Information section.

Associated To

Indicates, if the product is a constituent product of any combination product.

1. Click the Copy Constituent Products button.

The constituent products are displayed

2. Select the Constituent Products and Click Copy

The constituent  products are displayed in the Products grid.

3. Select a record in the grid and the associated product Is displayed in the product information section.

4. When you delete the associated parent product, the system refuses to delete the auto populated constituent product. It displays the message

“'There are constituent products associated to the product(product Name). Do you want to continue?'

WHO DD(B.4.K.2.1/G.K.2.2)

Use the WHO DD lookup for capturing the decode values.

1. Click the Lookup icon.
   The Lookup window appears.

2. Enter the search criteria and click OK.

    The search results appear in the list.

3. Choose the required information from the list and click   
   Select. The selected information appears in the WHO DD  
   code and decode fields of data entry Pages.

4. To view the decode value in the popup, you  press CTRL and Select a row in the lookup screen or Click    icon adjacent to WHO DD decode in the data entry page.

The decode appears in the popup for better reading. The popup does not open if the decode is blank.

This is applicable to all the data entry screens displaying WHO DD code.

WHO DD MPID (G.K.2.1.KR.1b)

The MPID assigned from WHO Dictionary to a product.

Use the WHO DD MPID Lookup to capture the MPID of a product. The MPID value displays on selection of Who DD MPID from lookup.

Product name as reported

The name of the product (drug or device) provided by the reporter that caused the adverse reaction.

This name is not considered for printing in the regulatory reports sent to authorities. Whereas it is considered for printing in the AER Data and Audit Trail Reports.

ATC

The field gets displayed only when your administrator sets the installation parameter Coding system to agEncoder.

When you send a coding request for product term to agEncoder, ATC coding  information gets displayed  in the new ATC Code/decode field.

To derive ATC coding using agEncoder, set the parameter Derive ATC coding using agEncoder in the Admin > Parameters > Installation Parameters > Automatic Coding/Labeling.

 

Note: The Anatomical Therapeutic Chemical (ATC) Classification System is used for the classification of drugs. The classification system divides drugs into different groups according to the organ or system on which they act.

Japan Drug Code

The code for the drug in Japanese.

When you enter Product Description, the auto coding feature retrieves the Japanese drug decode and English decode from Japanese Drug Dictionary and display those values in the respective decode fields.

Korean Drug Code (D.8. r.1. KR.1b / D.10. r.1. KR. 1b)

The code for the drug in Korea.

When you enter Product Description, the auto coding feature retrieves the Korean drug decode and the English decode from the Korean Drug Dictionary and display the values in the appropriate decode fields.

Use the Korean Drug Code lookup for capturing the decode values.

1. Click the Lookup icon.

The Lookup window appears.

2. Enter the search criteria and click OK.

The search results appear in the list.

3. Choose the required information from the list and click Select.

The selected information appears in the Korean Drug code and decode fields of Data Entry Pages.

English Decode

Displays the english decode.

Vigilance type  

Indicates drug monitoring on a medicinal product or psychoactive substances such as alcohol or tobacco.

Select the type of drug.

The available options are:

  • Addicto-drug: Psychoactive substances with potentially dangerous effects. Addictovigilance, is a practice of evaluating cases of abuse and dependent cases due to psychoactive substances

  • Pharmaco-drug: Medicinal product. Pharmacovigilance is a practice of monitoring the effects of medical drugs after they have been licensed for use.

Manufacturer Name

The name of the company that manufactured the product.

Generic Name (Chinese) (G.K.CN.1)

Enter the Chinese chemical name of the drug rather than the advertised brand name of the product.

Related device (Chinese) (G.k.CN.2)

Enter the device information that is associated with the adverse reaction.

Product Description (Chinese) (G.k.2.2)

Enter the medicinal product name as reported by the primary source in Chinese.

OR

The Product Description (Chinese) field can also be auto populated from Preferred product description (PPD), Local Trade name (LTN) and Active Ingredients level, when the user selects and save a product containing approval country as China, from the CPD lookup or auto-code.

Note: Approval country is mandatory only when the product is selected from LTN level.

For non-CPD products, the information is based on the WHO DD Chinese dictionary.

Note: Product Description (Chinese) field data is auto populated on save only if the field data is blank or empty.

Not Relevant?

To print the reaction on the reports, select the Not relevant check box.
 Indication Information

Indication Term (G.k.7.r.1)

Symptom or disease for which the medicine is intended to act.

Example: Fever is the indication for Paracetamol.

Symptom or disease for which the medicine is intended to act.

 Example: Fever is the indication for Paracetamol.

1. Enter the term in the Disease Information section in the Patient tab.

2. The term entered in the Disease Information is copied to the Indication Information section in the Product tab.

3. The LLT code and PT code gets auto populated for the copied indication term in Product tab

4. Select Copy in the Indication information page. The copied indication terms along with LLT, code and PT code appear in the list of disease section.

5. When you select any product from the CPD lookup and the indication term is associated to the selected product, which has the LLT code value. Then the LLT code is auto populated.

6. If the LLT code is not auto populated then the PT code gets auto populated

7. This is not applicable in the manual entry of an Indication term.

ICD Code

The ICD (International Code for Diseases) code for the disease along with the decode.

Or

1. Click the Lookup icon.

The Lookup window appears.

2. Enter the search criteria and click OK.

The search results appear in the list.

3. Choose the required information from the list and click Select.

The selected information appears in the Full Data Entry page.

The ICD code and decode appear in the corresponding fields.

MedDRA Codes

Displays the MedDRA terms.

1. Click the Lookup icon.

The MedDRA Browser opens.

2. Enter the verbatim term and click Find.

The matching MedDRA terms are listed.

Choose the required term from the list and click Select.

The code and the corresponding decode indicating the diagnosis according to the sender of the case displays.

Indication Information

Cause Of Death

Indicates whether the disease had resulted in the death.

The possible values are:

• Yes

• No

Lack Of Effect

Provides the information related to the disease to have caused due to the lack of effect.

The possible values are:

• Yes

• No

Labeled Indication?

Indicates whether the disease is a valid indication for the drug or not.  Increased frequency report will not consider cases where lack of effect is reported but the indication is not labeled for the drug.

The possible values are:

• Yes

• No

Description As Per Reporter

A brief description of the disease as reported by the reporter.

Description As Per Company

A brief description of the disease as reported by the company.

Product Details

Pharmaceutical Product ID (D.10.8.r.3b/D.10.8.r.3b/G.k.2.1.2b )

The pharmaceutical product identifier to support E2B R3.

PhPID Operation Date (D.8.r.3a/ D.10.8.r.3a/ G.k.2.1.2a)  

The operation date of the pharmaceutical product identifier to support E2B R3.

Medicinal Product ID (D.8.r.2b /D.10.8.r.2b/G.k.2.1.1b/G.k.2.1.KR.1b)

An identifier assigned to a medicinal product by the authorized regulatory authority of the country.

MedID Operation Date (D.8.r.2a/D.10.8.r.2a/G.k.2.1.1a)

Operation date of the medicinal product identifier (MedID).
    Review Details

Reviewed By

Displays the name of the person by whom the case has been reviewed.

Review Level

Displays the reviewer level.

Reviewed Date

Displays the reviewed date.

Review Comments

Displays the comments entered by the reviewer.

Note: The data in the Review details section displays only if the case has been reviewed, else it remains blank.

 

Viewing Product-Reaction Summary

The Product-Reaction Summary link on the Product, Event, Causality, Labeling, and Assessment tabs of the Full Data Entry screen enables you to view the product-reaction summary.

NOTE: The Product-Reaction Summary IView link appears on the Product, Event, Causality, Labeling, and Assessment tabs only if the Product Reaction Summary check box is selected in the Admin > Roles & Privileges > IView Access tab.

The Product Reaction Summary IView is available only for saved cases.

To view the Product-Reaction Summary:

  1. On the Product, Event, Causality, Labeling, or Assessment tab, click the More links ( ) icon and then click Product-Reaction Summary from the short-cut menu.

The Product Reaction Summary screen appears.

The Product-Reaction Summary contains information of: Suspect Product, Reported Term, Company Causality, Dechallenge (G.k.9.i.CN.2),  Rechallenge, Assess Relationship, Labeled, and Labeling Country.

For multiple labeling records, the product-reaction records are repeated in the table with their different labeling.

  1. To view the complete list of product-reaction summary records, click .

  1. To refresh the list of product-reaction summary records, in the lower-right corner of the product-reaction summary, click Refresh icon on lower right corner of the screen.

  2. To print the product-reaction summary sheet, click the Print icon on lower right corner of the screen.

Displaying Combination products and associating constituent products

The LSSMV application enables you to associate, the constituent product to a combination product for easy identification of constituent parts, which may have been associated with the event.

1      Click the Lookup icon available in the Product Description field.

2      Select Combination product type and the required criteria in the Company Product Lookup, which appears.

3      Click OK.

The Lookup window appears displaying the combination products from all the levels of the CPD Library.

4      Select the required combination product.

5      Select the associated applicable indications and click OK.

6.  Select the applicable Product Formulations.

  1. The selected product appears in the Product Information section.

  2. Click Copy Constituent Products button.
    The application displays all the constituent products associated with the product. By, default all the products are selected.
    The following PPD fields are populated when the product is selected from LTN level:
    • ARTG Number
    • Device Commercial Date
    • Year
    • Month
    • Relevant Accessories Used with The Device
    • Manufacturing unit
    • Same or similar to product
    • Is Product a Combination Product

  3. To select a single product, click Deselect All button, which clears the selections, and then select the required product.
  4. Click Copy button.
    A message appears stating that the products are copied sucessfully.

The application creates the associated products as new products in the case with the respective product data.

If the selected constituent product is from PPD or LTN level, then the related information is displayed in the respective fields.

The constituent  products are displayed in the Products grid.

  1. Select a record in the grid and the associated product Is displayed in the product information section.
  2. The selected constituent products gets displayed in the associated product field.

 

 

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