Pharma-Specific Checks for Business Partners and Products 

Use

As a field sales employee in the pharmaceuticals industry, you use this function to create activity journals for issuing samples, thereby complying with legal requirements. The legal requirements for issuing drug samples are country-specific. In the U.S., the distribution of drug samples must comply with the rules of the Prescription Drug Marketing Act (PDMA). Classified substances are also subject to the rules of the Controlled Substances Act (CSA). In the U.S., there is no regulation on the quantity of samples that can be issued. However, almost all European countries have defined restrictions (for example, there is an annual maximum of two samples per product and doctor in Germany). The pharmaceuticals-specific checks help you to comply with these laws.

Prerequisites

Europe

You have set country-specific checks for the number of drug samples that can be issued in Customizing for Customer Relationship Management, by choosing Industry-Specific Solutions ® Pharmaceuticals ® Sample Management ® Determine Number of Medical Samples.

United States

You have made the relevant settings in Customizing for Drug Enforcement Administration (DEA) classes, by choosing Customer Relationship Management ® Industry-Specific Solutions ® Pharmaceuticals ® Sample Management ® Enter DEA Classes.

You have imported DEA-relevant data into SAP CRM Enterprise using third-party tools or you have entered the data yourself in the Business Partners transaction:

·        DEA Number

You create the identification numbers for the DEA on the Identification tab page. You must enter the state license number (PHA001) and the DEA Number (PHA002), otherwise the check fails.

·        Validity of License

·        Registered DEA Address

·        DEA Class

·        Type of Business (Doctor, Hospital)

If you use SAP CRM Mobile, you have downloaded the following data from SAP CRM Enterprise to the consolidated database (CDB):

·        DEA numbers (CDB table CDBC_BUT0ID)

·        DEA classes that you assign to people (business partners) (CDB table CDBC_PH_FRG050)

·        DEA classes for products

·        DEA addresses of business partners (with Address Type: DEA Address indicator)

If you also want to download the DEA classes for products that you have created in the product master, you must have entered the value CDBC_ATTRVAL in the CDB Table field. For more information about the exchange of data between SAP CRM Enterprise and SAP CRM Mobile, see SAP Solution Manager, by choosing mySAP CRM 4.0 ® Basic Settings for Field Applications ® Special Settings for CRM Mobile ® Data Replication.

Features

Checks for the United States

The system checks whether your distribution of samples complies with the American legal regulations (Prescription Drug Marketing Act, PDMA). The PDMA legally ensures that doctors and hospitals receive only those samples for which they hold the relevant license. Every doctor is registered with the DEA and receives a unique DEA number. When you enter a drug sample and a doctor in the activity journal, the system checks whether the doctor has the required DEA class to receive the sample.

For more information about the DEA and the PDMA, see www.dea.org.

Checks for Europe

The system verifies that you have not exceeded the annual maximum number of samples that can be issued to the doctor.

Activities

Check for Products with DEA Class (United States)

...

       1.      Create a product in the product master with the set type DEA_INFO and the attribute DEA_SCHEDULE (Pharmaceuticals: DEA Information).

       2.      Display the data for a doctor with the DEA number, DEA class, and DEA address in the Business Partner transaction and check it manually.

       3.      Create an activity and an activity journal to log the issue of a pharmaceutical product (sample) to a doctor.

       4.      The system performs the following checks and issues a message if the legal requirements are infringed.

¡        Does the doctor have a valid license and DEA number for the specified date?

¡        Does the specified product have a DEA class?

¡        Does the doctor have a valid license for this DEA class?

       5.      Display the DEA address and check whether it matches the delivery address.

Check for Products without DEA Class (United States or Europe)

...

       1.      Proceed in the same way as in the check with DEA class.

       2.      The system only checks whether the doctor has a valid state license number (U.S.), or whether you have exceeded the maximum number of samples (Europe).