Michael Casale, HealthBridge

For decades, the biopharma industry has employed product sampling to help physicians titrate a regimen, as part of a trial usage of a new drug, or as a resource to gain access to physician’s offices. Biopharmaceutical companies spend over $14 billion in providing samples and managing the distribution process. [1] The activity is closely regulated by the Prescription Drug Marketing Act (PDMA), originally signed into law in 1988. 

Today’s industry, however, is being compelled to manage this process differently. Regulations have tightened the availability of samples. Some hospitals and physicians’ offices have restrictions on sample placement. More to the point, the biopharma industry is being driven by cost pressure to manage its overall sales and marketing processes more efficiently.

	Although there are plenty of permutations in pharmaceutical sampling methodologies, the traditional model for pharmaceutical companies who use sampling as a marketing tactic consists of three main components:

	An upfront targeting analysis (to determine who/how much)

	Delivery and accountability mechanisms (samples carried by salesperson, and reconciliation processes completed as per PDMA guidelines)

	ROI analysis (to determine rate of return for sampling related to New Prescriptions written (NRx)

	With an evolving sales promotional model combined with physician adoption of new media, pharmaceutical companies will have the opportunity to forge new promotional opportunities with their customers. Sales and marketing strategies can be tailored to suit the physician’s channel preference. Requests for samples will come from a multitude of channels, both personal and non-personal. The future promotional model will need to support various channels, blending personal and non-personal promotion. On the personal promotion side, the move towards key account management will open up promotional possibilities (and sample opportunities) through expanded channels such as regional clinical specialists, medical science liaisons, web detail representatives, and merchandisers (employees who deliver information to physician offices). On the non-personal side, physician adoption of technology has opened up new channels for pharmaceutical companies, while traditional forms of channel promotion still exist.

	In practice, there are many opportunities that arise from these changing dynamics. When an account territory manager, tasked with maintaining relationships visits a targeted healthcare professional, a sample opportunity may exist. When a medical science liaison communicates with key opinion leaders about a product, a sample opportunity exists. When a healthcare professional visits an online resource, sample opportunities exist.

	The traditional model where samples are carried by one stakeholder (the sales representative) would no longer support a multi-channel promotional model and would be logistically cumbersome. To eliminate coordination issues, pharmaceutical companies must create a platform that integrates all channels, allows for data mining, and is easy to manage.

	A modern sample-management system can accommodate all these pressures, while maximizing the business potential of the process. Such systems have six main features:

	Effective campaign management and execution

	Building a robust prescriber master database is vital to the success of any sampling platform. It is estimated that each year 15% of practitioners change their address, phone number or other attribute. [2] Likewise, practitioner eligibility to receive product samples may change on a daily basis and companies need to keep abreast of these changes. Key components to the prescriber master include source, update frequency and prescriber identification. 

PDMA dictates that all prescribers who will be sampled must be verified for eligibility on an annual basis, as well as each time a request for samples are made by a prescriber. A pharmaceutical manufacturer may decide to in or outsource the activity of building and maintaining a database suitable for prescriber verification. 

While the master database must utilize state boards for practitioner verification eligibility (and/or DEA verification for controlled substances), it is critical that the data source(s) used for prescriber verification have the latest information from each state board in the respective states. Most pharmaceutical companies rely on third-party vendors who specialize in the development and management of Prescriber Master databases which serve to be the hub of their sampling programs. 

Whether you are evaluating these vendors or looking to procure data internally, the following must be taken into consideration: 

Source: What data sources are/will be used to gather and harvest practitioner verification? Will the data be procured directly from state boards? 

Update Frequency: What frequency is the optimal period for refreshing data? What other criteria drives the update frequency? 

Unique Identification: How can we identify and match practitioner lists through data scrubbing techniques and unique identification? 

Integration with Sales Force Automation Systems (SFA): How can we ensure technological interoperability between the SFA system and the prescriber master?

When evaluating master databases providers, verify that the state licenses information is procured directly from the state boards for all types of professional designations (MD, DO, NP, PA, and others), including all up-to-date sanction information. Ensure updates are frequent (weekly to monthly in most cases) and that the provider either is one of the direct licensees of the American Medical Assn. data repository, or has access to it through one of these licensees. And of course, supplemental data should be part of the update pool, including data from the National Provider ID (NPI) system of CMS.

	The heart of a good sample management system is reliable, efficient software. In our estimation, this is best accomplished by a service-oriented architecture (SOA) approach. SOA is an architectural approach (or style) for constructing complex software-intensive systems from a set of universally interconnected and interdependent building blocks, called services. More specifically, configuration rather than code changes to accommodate for changes in business rules and various workflow processes. A robust technological platform will have the ability to make changes to business rules and model workflow processes to meet the changing needs of the pharmaceutical sampling business. 

3. Effective campaign management and execution 

	The ability to manage and execute campaigns in the context of pharmaceutical sampling can be simplified through a real life business scenario. Take for example, a pharmaceutical manufacturer with, say, 1,000 sales representatives. Representatives are split into three main sales forces: Retail-Primary Care, Specialty, and Institution Channel. All sales forces detail and sample products. In addition to these channels, five brand teams have programs that use non-personal promotion to solicit product samples to healthcare practitioners through electronic channels. 

Given the above scenario, this pharmaceutical manufacturer has eight campaigns. Each campaign has unique characteristics, business rules, and workflow processes. The Primary Care sales force may have restrictions around sampling practitioners in a certain specialty, such as Pediatrics. The Specialty sales force may have similar restrictions but that sales force currently utilizes a paper sampling method. 

Any sample-management service provider with sufficient resources can run multiple campaigns, but the key differentiator is the ability to consolidate the results and reporting of all the campaigns, so that a holistic view of the overall trend is obtained across the multiple channels. 

	A business rules engine is a software system that executes one or more business rules in a technology environment. The rules might come from PDMA legal regulation (“A practitioner must have a valid state license in order to receive product samples”), company or brand policy (“All low decile 2-4 practitioners may only receive 20 units of samples per month”), or other sources. An efficiently designed IT infrastructure allows rules like these to be created without IT code changes—it should be a normal part of the user experience. 

By utilizing configurations for business rules, our customers see strategic benefit in the following ways: 

 Having the ability to add, modify, and remove business rules associated with sampling programs quickly and efficiently, with limited technology involvement. Parameter-driven business rules related to sampling program may include sample allocations per HCP, restrictions on sampling various practitioner specialties, and excessive sampling by sales representatives. 

 Having the ability to consolidate all business rules in one central location. The consolidation of business rules allows for a holistic view of existing business rules to ensure there are no rule conflicts. Rules consolidation also allows for separation of business logic and technology systems, which provides support parameters for auditing purposes. 

5. Centralized sample delivery clearinghouse

	The deployment of key account management and utilization of other media channels by practitioners will provide many new promotional opportunities for pharmaceutical manufacturers. With multiple prescriber touch points available, requests for samples may come through various channels. In order to support multiple channels, Pharmaceutical manufacturers will need the ability to centralize the delivery of product samples to healthcare professionals through one medium. To accomplish this goal, pharmaceutical manufacturers can deploy a sample delivery clearing house. A sample delivery clearing house has the ability to consolidate sample requests from all promotional channels, including personal and non-personal promotion, verify business rules, deliver product therapy to practitioners, and reconcile all transactions according to the PDMA. 

In practice, having the ability to centrally manage the delivery of samples simplifies the workflow of pharmaceutical constituents. Some examples include: 

 When an account territory manager, tasked with maintaining relationships, visits a targeted HCP, a sample promotional opportunity may exist. In this case, required signatures needed for samples maintain the access to the practitioner, while removing the responsibility of accounting for samples by the territory account manager. 

 By consolidating all sample request transactions into one centralized sample delivery clearing house, the risk of sample product diversion is dramatically reduced. Sample inventory is centrally located, and all transactions are proactively monitored for practitioner verification and applicable business rules. The freight fees associated with sending thousands of shipments to prescribers (instead of hundreds of shipments to sales representative) are mitigated through order consolidation and rate shopping techniques. 

 Various electronic and interactive marketing programs to healthcare professionals have integrated e-sampling and other promotional components into their marketing mix. When a healthcare professional visits an online resource, promotional opportunities for product samples may exist. Instead of having a separate silo of business processes to fulfill these promotional sample requests, marketing teams now have the ability to link personal and non-personal promotion through the use of a central sample delivery clearing house. 

	Once foundational support has been created through a centralized sample delivery clearing house, pharmaceutical manufacturers have the ability to view activity across multiple channels for use in market intelligence, performance metrics, and ROI analysis. Among the metrics that could be mined for each constituent are: 

 Proactively monitor sales force sample activity and determine sample patterns (and patterns of abuse) along with distribution of samples by sales representatives over various sales forces and alignments. 

 Allows marketing stakeholders to create new campaign initiatives using trial samples over multiple channels. Provide the ability to link marketing-driven programs with personal sales efforts to view sample activity and resulting prescribing lift. 

 A centralized sample delivery clearing house ensures that all samples are delivered to valid healthcare practitioners. It also accounts for the delivery and receipt of all samples requested, validated, and delivered. Key compliance scorecard metrics include sample proof of delivery, (also known as Acknowledgement of Delivery), Practitioner Signature Audit outcomes, and the ability to track patterns of abuse. 

The volatility in today’s biopharmaceutical business environment is driven variables ranging from the overall economic downturn to patent expirations, causing unprecedented financial pressure. Sales and marketing groups need to be nimble. Many companies have used consolidation to ensure solid revenue growth by streamlining their commercial operations along with sales and marketing efforts. Pharmaceutical sampling has always been a key sales and marketing tactic, but with increasing financial pressures and dynamic physician preferences, companies need to be nimble enough to support a multitude of channels in order for sampling to remain the most cost-effective promotional tactic while remaining compliant with regulations. PC 

The opinions expressed in this article do not necessarily represent those of the affiliated companies. The information published herein is subject to change without notice. This publication is for informational purposes only, without representation or warranty of any kind, and the author shall not be liable for errors or omissions with respect to this publication.

	1 IMS Health data cited in Pharmaceutical Commerce, June, p. 31.

	2 SK&A Information Services, March 2009 

	Michael Casale is Senior Manager, Product Management, at HealthBridge (One Phoenix Drive, Lincoln Park, NJ 07035). Michael has spent close to 10 years in the biopharmaceutical industry working for companies such as Thomson Physicians’ Desk Reference and Cardinal Health, understanding the needs of pharmaceutical constituents including brand managers, field sales forces, and commercial operations. He currently leads the product management group within HealthBridge and is responsible for shaping the future of HealthBridge’s sample management offering by developing innovative ways to increase sales force efficiency and reduce compliance risk. He can be reached at mike.casale@healthbridgeinc.com or 973-709-4095. 

Articles

New technological capabilities will enable management of sample-distribution processes to keep up with a challenging environment