Introduction

The purpose of this whitepaper is to demonstrate adherence to government regulations through a collaborative IT and Business process solution. Key inputs for this whitepaper are derived from the experience of working with the IT team of a multinational pharmaceutical company in Japan.

Background

Methylphenidate Hydrochloride is a psychotropic drug that is effective in treating narcolepsy and sleep disorders. Given the industry concerns that the drug is addictive and abused due to its amphetamine-like effects, the health ministry has instructed the manufacturing company (henceforth referred to as the manufacturer) to take measures that can promote proper prescription of the drug and tighten its supervision of the distribution process.

Collaborative IT and Business Process Solution

The fundamental goal is to monitor the sale of the drug. To address this situation the manufacturer has a committee of experts (henceforth referred to as the business team) to designate Doctors, Medical Institutions and Pharmacies that can diagnose narcolepsy and dispense the prescription appropriately.

To begin with, the committee identifies and selects Doctors based on their qualifications and experience. These Doctors are then requested to complete an e-learning followed by certification. This course certifies that they know the necessary details of the drug and all related parameters such as dosage and the symptoms for which it can be prescribed. The complete list of certified Doctors is maintained by the manufacturer.

Along similar lines, a list of pharmacies is prepared which are authorized to dispense the drug. A pharmacy will not be able to dispense a prescription from a doctor who is not on the registration list (the list of Doctors certified by the manufacturer) and will be obliged to call the manufacturer and confirm before dispensing.

Along similar lines, when the pharmacies procure the drug from wholesalers, the wholesalers will be obliged to call the manufacturer and confirm whether the requesting pharmacy is on the authorized list of pharmacies. The manufacturer records the call information. This call information is later compared with the actual sales data of the drug to measure compliance with the process. A compliance report thus created is shared with the regulating government body periodically.

Key IT systems involved

For the successful execution of this business process, and to ensure compliance to government regulations, several IT systems are key. The key IT systems involved are described below.

E-learning and Certification registration system

The E-learning and certification registration system is the system that keeps up-to-date records on the list of certified doctors and authorized pharmacies. This system is the source of truth for this information and it provides the most up-to-date list of authorized doctors and pharmacies to the call center staff for ready reference. This system is owned by the Sales Force Automation business team.

Call Center Information System

The Call Center information system is responsible for effectively recording the call details in the predetermined format. This data is timely fed to the Manufacturer’s Sales Data Warehouse.

Manufacturer’s Sales Data Warehouse

The sales data warehouse records the drug sales data. This data contains the sales information at a granular level for each bulk drug dispensed from pharmacies. In the data warehouse, this sales data is further aggregated at the pharmacy level. The pharmacy-level drug dispensing data is tallied with the call center data to confirm whether or not a call was registered by the pharmacy before dispensing the drug.

Similarly, checks are made for each pharmacy whether a call from the wholesaler was registered before delivering the bulk drugs to the pharmacy. Any discrepancies observed are enquired and the corresponding explanation is recorded and investigated.

Compliance Reports and Dashboards

The routine compliance reports cover the pharmacy and wholesaler level compliance, such as -

• stack the pharmacy-level drug dispensing data with the call center data to confirm compliance with the requirement that call was made and checks were done before dispensing the drug.

• stack the wholesaler-to-pharmacy sales data with the call center data to confirm compliance with the requirement that a call from the wholesaler was registered before delivering the bulk drugs to the pharmacy.

Certain other types of reports are also generated based on historical data analysis, such as –

• a sudden increase in the quantity of the drug being dispensed

• a sudden increase in the dosage of the drug being dispensed, etc.

Such random incidents are then investigated for genuineness.

Periodically, a compliance report is generated to show adherence to this process and is shared with the regulating government body. While the responsibility of generating accurate reports is that of the IT team, the business team is largely responsible for defining the requirements for various reports and setting clear expectations from key stakeholders that include all the parties involved in this business process.

Key Challenges

There are several challenges in the implementation and adherence of the underlying business processes which are managed by effective collaboration of all the concerned parties.

One of the major challenges was mapping the call center information data with the data warehouse codes for corresponding pharmacies and other entities. This was achieved by the active involvement of the call center staff by correctly recording the call information against the corresponding codes. Random cases of mismatch in the name or data unavailability of an entity such as a pharmacy or Doctor are dealt with by sharing such call data with the business team and with their active involvement in such conflict resolution.

Yet another challenge was to deliver the compliance reports to government authorities timely to avoid penalties. This was achieved by designing the IT processes in the data warehouse and reporting solution to prioritize the report generation and delivery within the SLA.

Conclusion

Compliance in the pharmaceutical industry is a very important factor in establishing the safety and efficacy of medicine and medicinal practices, complying with regulatory scrutiny and avoiding legal and financial consequences associated with noncompliance. A well-thought-out coordination of efforts between business and IT stakeholders is the key to a reliable and compliant operation and avoiding any future challenges.