The Association of the British Pharmaceutical Industry's (ABPI) Code of Conduct clearly spells out the ways in which pharmaceutical firms can interact with physicians, healthcare providers and patient organisations. ABPI comprises more than 90 companies in the UK who produce prescription medicines for human use research, and who, as a group collectively develop, manufacture and supply more than 80 per cent of the medicines prescribed through the National Health Service (NHS). The group's mission is to it ensure that the UK remains a world leader in creating, valuing and accessing innovation by combining the talents of researchers, companies, patients, professionals, and external experts to creatively tackle the barriers to innovation wherever they may be found.
A noble goal, but what is less clear is how pharmaceutical firms can best organise the vast amounts of information and data needed to stay in compliance with issues such as physician spend management and clearly document these compliance efforts.
The physician spend management challenge
The scope of the physician spend management challenge is so daunting largely because of two factors: the complex combination of caps placed on per-provider contacts and promotional spending and the documentation and audit provisions required to prove compliance. Consider just some of the ABPI provisions pharma firms must adhere to:
No promotional gifts worth more than £6 (plus VAT) can be given to medical professionals. The number of calls made on a doctor or prescriber by company representatives each year should not exceed three on average.
Companies must track and audit medicines held by representatives, including expiry dates. Copies of materials relating to the provision of medical and educational goods and services must be made available on request to the Prescription Medicines Code of Practice Authority – a group responsible for administering The Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry.
Companies are encouraged to make publicly available information about donations or grants.
Compliance challenges are complicated by the reality that most companies store and track physician information across numerous, disparate transactional systems. This kind of fractured IT infrastructure makes it extraordinarily difficult to gain the kind of real-time visibility into operations that can be crucial in preventing code violations. Passive tracking and reporting capabilities that provide after-the-fact insight into violations is of little use in a regulatory environment where non-compliance can be costly. Moreover, reinventing the wheel is out of the question. Most large firms already have in place expense tracking, business intelligence (BI) reporting and other IT infrastructure that supports critical compliance tasks. The most sensible approach is one that takes advantage of these investments and maximises previous technology investments.
As a result, the only sensible course of action is to build a reliable, integrated source of physician data that can easily cross-reference to various accounts payable, expense reporting, enterprise resource planning (ERP), and clinical trial management systems (CTMS). While reporting requirements will continue to morph, putting in place a reliable data foundation will allow pharmaceutical companies and device manufacturers to rapidly respond to these changes as they occur. Before beginning it is important to adhere to some proven ground rules.
First, one should begin by creating a strong data foundation that can easily integrate with existing BI environments, and area where the bulk of regulatory reporting is likely to occur, as well as into the operational systems that firms use to alert personnel to spend limits. Today, several health and life sciences companies have achieved success and optimised their regulatory compliance capabilities using a new class of software known as master data management (MDM).
Using master data management (MDM)
Physician-spend management efforts built using a master data management (MDM) approach have proven tremendously successful because effective compliance requires that accurate data be available in real time throughout the enterprise. Effective MDM platforms consolidate information across all applications and make the data available for tracking against regulatory initiatives, reporting periods, geographical locations and any number of other attributes. Moreover, by consolidating data across internal applications, MDM creates one single, reliable source of truth. A single version of master data prevents discrepancies and duplicates, and eliminates confusion and potential oversights that can lead to spending cap or reporting violations.
Implemented correctly, MDM enables pharmaceutical companies and device manufacturers to:
Authoritatively determine the exact total spend at any time on each healthcare provider across several payment systems such as reimbursement, grants, accounts payable, etc.
Ascertain all the organisations with which a specific healthcare professional is associated.
Confirm the number of contacts made with individual practitioners—or enable the issuance of alerts in cases where companies are approaching contact limits.
Maintain a dynamic view of the relationship between the sales reps and the healthcare provider.
Anticipate and prevent possible gift-cap violations.
The relationship between the medical community and the health and life sciences industry has been extraordinarily beneficial in the development of life-saving drugs, devices and procedures. The ABPI Code of Conduct clearly spells out the ways in which pharmaceutical firms can interact with physicians, healthcare providers and patient organisations to ensure these industry-provider ties continue to follow ethical guidelines that deliver true benefits to patients.
However, in order to comply, drug and device manufacturers need the ability to access current and reliable information related to their company’s interactions with physicians. After all, without having access to a central repository of reliable information, companies will find it very difficult, if not impossible, to comply. Worse, predicting how regulations will change in the coming years, or determining what unforeseen event that may trigger new regulations, is a near impossible endeavour. Master data management presents the most sensible and effective way to achieve physician spend management and regulatory compliance today and to be prepared for unseen events in the future.