HPID Records

When a pharmaceutical company receives ICSRs through ESTRI gateway, the reported products/active ingredients are expected to map either with the products/ingredients maintained in the CPD, (maintained within ARISg) or with products/substances in the WHO Drug Dictionary.

MAHs (Market Authorization Holder) and clinical trial sponsors usually submit ICSRs with valid health product names for their own products. These ICSRs are validated for proper drug names against the CPD and the cases in ARISg are coded with the details from the CPD dictionary.

The regulatory authority such as Health Canada (HC) does not populate the CPD with all the entries from WHO DDE, but at the same time does not want to reject the ICSRs due to non-availability of the health product information in HC’s CPD. So there is a need for an intermediate index which is called as Health Product Index Database (HPID).

The HPID maintains all possible health product combinations (reporting possibilities) from WHO and CPD, and maintains an index to the entries in the CPD. On receiving an ICSR, the reported health product information is matched (validated) with a record in the HPID. The index is used to map the CPD record, and the AER case drug coding is made using the CPD.

In agXchange ESM, after reviewing the received ICSR file, you can use the reported drug information to search it with available drug records in CPD/WHO/HPID.

Note: The HPID functionally is available in the Import Section only if the Product Indexing check box is selected on the ARISg Admin > ESM > Setup > General page.

You can perform simple search or product search to find the matching HPID records for the reported drug.

If the matching drug records exist in the CPD/WHO/HPID then while importing the case to ARISg, the reported health drug information is matched (validated) with a record in the HPID. The index is used to map the CPD record, and the AER case drug coding is made using the CPD.

If the matching drug record is not found in the CPD/WHO/HPID then you can notify the administrator to add the particular drug record in HPID and assign CPD internal code to the newly added HPID record.

Once the administrator adds a drug record in HPID and assign CPD internal code to it, you can import the case to ARISg so that AER case drug coding is made using the CPD.

Note: If the received case (reported drug which does not exist in CPD/WHO/HPID) is imported without adding reported drug details in HPID then the case is imported, and the acknowledgment is generated with error or warning message based on the predefined validation.

Searching HPID Records

On the Search tab, you can perform simple search to search for the HPID records.

To search for the HPID records using simple search option:

On the ARISg menu, click ESM > E2B Import section > Import Section to open the Import Section page > E2B (R2) tab.
On the Import Section page > E2B (R2) tab, click to open the HPID page > Search tab.
Refer the following field description table to enter or select the various search criteria fields.

Field Name	Description
Trade Name	Enter the name of the medicinal product.
Approval Number	Enter the approval number of the product to perform search based on the approval number.
Approval Country	Select the approval country of the product from the drop-down to perform a search based on the approval country.
Drug Dosage Form	Enter the dosage form of the product to perform a search based on the drug dosage form.
MAH/Sponsor Name	Enter the sponsor or MAH name to perform search based on the MAH/Sponsor Name.
Internal Code	Enter the internal product code to perform search based on the internal code.
Record Source	Select the source from where the HPID record is loaded, to perform search based on the record source. The available options are: Permutated: If you select this option, the application searches for the manually added HPID records. Drug Record Loaded from WHO: If you select this option, the application searches for the HPID records that are loaded from WHO Drug dictionary. Drug Record Loaded from CPD: If you select this option, the application searches for the HPID records that are loaded from CPD.
Generic Name (s)	Enter the active substance name of the product. You can also specify multiple generic names for a drug separated with “?”. When user searches only for active ingredients without specifying the medicinal product name in the Trade name field, the active ingredients whose internal code starts with WHO are displayed in alphabetical order in the search result. When you search only for active ingredients, the name of medicinal product associated with the active ingredient is not displayed unless the search result contains records with same internal code.
HPID	Enter the HPID product ID in which you want to search the record.

Click Search to view the search result.

Based on the specified search criteria, the HPID records are displayed under the HPID Search Result section on the Search tab.

In the search result, you can view both primary and synonym of the active ingredients. During the search operation, the primary and synonym is considered only up to 3 levels of active ingredients.
Click to print the current search result page.
Click Back to return to the HPID page > HPID Search section.

Searching HPID Records using Product Search

On the Product Search tab, you can perform advanced search based on the predefined logic to search for the HPID records.

If multiple Internal codes are returned even after doing Proximity Search and the percentage of match is not as per HC defined expectations then the Product Search (misspellings) is carried on the resulting set of IC records to get the best search result.

Product (Misspellings) Search tries to search for spelling mistakes.

For example, if “appple” is searched then it will try to match with “apple”.

To search for the HPID records using product search option:

On the Import Section page > E2B (R2) tab, click to open the HPID page > Search tab.
Click the Product Search tab.
Refer the following field description table to enter or select the various search criteria fields.

Field Name	Description
Trade Name	Enter the name of the medicinal product.
Approval Number	Select the approval number of the product from the drop-down to perform a search based on the approval number.
Approval Country	Enter the approval country of the product to perform search based on the approval country.
Primary Source Country	Select the primary source country for the case to perform a search based on the primary source country.
Drug Dosage Form	Select the dosage form of the drug from the drop-down to perform a search based on the drug dosage form.
Reaction/Event Occur Country	Select the country where the reaction or event occurred for the case to perform search based on the Reaction/Event Occur Country.
Generic Name (s)	The active substance name of the drug. Multiple generic names for a drug must be specified separated with “?”. When user searches only for active ingredients without specifying the medicinal product name in the Trade name field, the active ingredients whose internal code starts with only WHO are displayed in alphabetical order in the search result. When you search only for active ingredients, the name of medicinal product associated with the active ingredient is not displayed unless the search result contains records with same internal code.
Owner Unit	Select the company unit to search for the HPID records associated with the selected company unit. The available options are: BGTD and BGTDVAL, MHPD and MHPDVAL, NHPD and NHPDVAL, and TPD and TPDVAL. When you search for the records specific to an owner unit, the records are sorted in the following order and displayed in the search result: The records are first grouped based on the CPD Internal Code. HPID % rank sorting is applied on the above grouping of CPD Internal Code. Sorting based on Dosageform with null followed by NOT SPECIFIED records on top is performed on the above result set. Finally, sorting based on CPD Product Approval Type is performed as specified in the approval type rank order placing null records on top. While performing search based on owner unit: You must select the company unit in this field as the first level of sorting is performed on CPD Internal Code. You must select the country in the Occur Country and Primary Source Country field to identify whether the cases are Domestic (Canada) or Foreign (other than Canada).
Drug Obtain Country	Select the country from where the drug is obtained to perform a search based on the drug obtain country.
Product Flag	Select the product flag on which the search has to be performed. The available options are: Suspect/Interacting Concomitant

Click Search to view the search result.

Based on the specified search criteria, the HPID records are displayed under the HPID Product Search Result section on the Product Search tab.

In the search result, you can view both primary and synonym of the active ingredients. During the search operation, the primary and synonym is considered only up to 3 levels of active ingredients.
Click to print the current search result page.
Click Back to return to the HPID Product Search Algorithm section.