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Call Planning Features Specific to the Japanese Pharmaceutical Market

The Japanese pharmaceutical market has some unique characteristics concerning patient safety as stipulated by government regulations. These market characteristics dictate how sales representatives engage with physicians and hospitals in their territories and how they plan future calls. For example, pharmaceutical companies must provide safety information about a product to a physician. Additionally, after a new product is released, sales representatives are required to meet with physicians at pre-determined intervals to gather information about any anomalous effects the product may be having on the patients.

NOTE:  Features specific to the Accounts Contacts in the Japanese pharmaceutical market are not covered in this section. For information about Accounts Contacts features specific to the Japanese market, see About Japanese Pharmaceutical Market Features.

The following Siebel Life Sciences features address the distinctive traits of the Japanese pharmaceutical market:

• Post Market Surveillance (PMS). The purpose of the PMS process is to encourage feedback relating to adverse effects that may have been noted in patients taking new drugs to be reported back to the drug company. When a drug is approved, sales representatives must visit each institution that purchases the drug. As stipulated by government regulation, these visits must occur every 2 weeks for the first 2 months after a hospital purchases the drug, and monthly thereafter for a period of 6 months after the launch date of the drug. For a specific example of how calls are scheduled for PMS after a product is released, see Visit Timeline During the PMS Period.

  The purpose of these visits is to remind the health care professionals of their obligations to report any adverse effects that they have observed, or that have been reported to them. This process is initiated only when a hospital (account) purchases a drug (product) for the first time. This an activity associated at the account level. For information about managing PMS, see Managing the PMS and Pre-Explain PMS Features.

• Pre-Explain PMS. A process that is a precursor to the PMS process. This process is triggered when a new hospital (account) is targeted for a drug (product). Using the Pre-Explain PMS feature will automatically set up a call for each hospital. The goal of the ensuing call is for the sales representative to explain to the hospital (account) contact how the PMS process will work. The Pre-Explain PMS typically occurs before any hospital (account) purchases a new drug (product). For information about managing Pre-Explain PMS, see Managing the PMS and Pre-Explain PMS Features.
• Package Insert Delivery (PID). Pharmaceutical companies are required to offer safety information about a drug (product). This safety information is called a package insert. Its purpose is to improve the doctor's recognition of the product, and protect patient safety in accordance with Japanese government regulations. Pharmaceutical companies are required to monitor whether their representatives are carrying out these calls whenever a package insert is updated for a product. After a modified package insert is delivered and the call has been made to the hospital contact, the sales representative is responsible for recording the call as having been completed. For information about managing PID, see Managing the PID Feature.

Visit Timeline During the PMS Period

As stipulated by Japanese government regulation, sales representatives from pharmaceutical companies must visit hospitals at preset intervals for six months after a drug is launched. These visits must occur every two weeks for the first two months after a hospital purchases the drug, and monthly thereafter for a total period of six months after the launch date of the drug.

For example, Drug XYZ is launched on February 1, 2009. The PMS period will also begin on February 1, 2009. The PMS period will end for Drug XYZ six months after its release: on August 1, 2009.

Hospital 1 buys Drug XYZ on February 1, 2009. This means that they will have the maximum amount of PMS visits from the pharmaceutical company. There will be a total of eight visits that will occur approximately on the following dates:

• Biweekly dates: February 15th, March 1st, March 15th, April 1st
• Monthly dates: May 1st, June 1st, July 1st, August 1st

Hospital 2 buys Drug XYZ on April 1, 2009. As a result, there will be a total of six PMS visits that will occur approximately on the following dates:

• Biweekly dates: April 15th, May 1st, May 15th, June 1st
• Monthly dates: July 1st, August 1st

Hospital 4 buys Drug XYZ on July 15, 2009. As a result, there will be a total of one PMS visit that will occur approximately on the following date:

• Biweekly date: August 1st

NOTE:  Once six months have elapsed after the launch date, there are no more PMS calls.