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Patrick O?Hara is head of marketing and sales for CSSC, Inc., a global validation and regulatory services provider.
Parma sales reps have long been using customer relationship management (CRM) systems to detail doctors and provide them with samples. But it was not until late 2000, when FDA initiated the final rule of 21 CFR Part 203 and 205, enforcing the Prescription Drug Marketing Act (PDMA) of 1987, that the industry grew attentive to the regulations governing CRM systems, also known as sales force automation (SFA) or sales force effectiveness (SFE) systems.
Pharma sales reps have long been using customer relationship management (CRM) systems to detail doctors and provide them with samples. But it was not until late 2000, when FDA initiated the final rule of 21 CFR Part 203 and 205, enforcing the Prescription Drug Marketing Act (PDMA) of 1987, that the industry grew attentive to the regulations governing CRM systems, also known as sales force automation (SFA) or sales force effectiveness (SFE) systems.
On December 4, 2000, FDA announced plans to hire more than 100 investigators to focus on PDMA violations and the diversion of prescription products. According to FDAWeb.com, in January 2002, President Bush asked for an 8 percent increase in FDA's 2003 budget for inspection-related activities. In February 2000, FDA stated that it would increase its investigative staff by 50 percent between 2002 and 2003. That translates into an additional 520 inspections next year and 600 new investigators. Those investigators will reach into all pharma company divisions, including sales and marketing, where sample accountability is mandated by federal law. Companies (manufacturers and distributors) or individuals that violate the law can incur substantial felony penalties and civil liabilities, ranging from $50,000 to $1 million in civil fines levied against sales reps or companies to a felony conviction of ten years in prison. (See "Risks and Penalties.")
Risks and Penalties
This article addresses the importance of embracing PDMA and other federal regulations and outlines how companies must implement and validate computer CRM systems as well as conduct sales training and awareness programs that reinforce sample accountability procedures.
CRM systems are designed primarily to optimize return on investment (ROI). They collect, organize, and analyze all pertinent data related to the market for a particular therapy. They are also used to distribute samples-the most effective way to detail a prescription product-but there are risks. Sample accountability is mandated by federal law, and pharma companies must have a program in place to track their distribution.
The PDMA was enacted to regulate channels of distribution and to protect the public health by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and samples. Companies must ensure that samples are not diverted to the black market. The PDMA exists to ensure that counterfeit, adulterated, misbranded, subpotent, or expired drugs do not reach US consumers. CRM software programs must include an audit and security process that governs sample delivery, distribution, and tracking and must be validated to comply with the impending regulations. Pharmaceutical companies must also train employees in, and practice, a sample accountability policy.
According to IMS Health, the industry distributed nearly $8 billion worth of pharma samples in 2000. Reps distribute most of those through a service visit (54 percent) or in-person (36 percent). Furthermore, a study in the first quarter of 2002 showed a 14 percent increase in physician detailing since 2001. If detailing and sampling continue to increase, then the potential for violations grows proportionally.
Regulations-savvy, disciplined sales professionals are a must. According to Scott-Levin, there are roughly 80,000 pharma reps in the United States. Responsible for 90 percent of the total sample drops across the country, they represent the biggest regulatory risk to companies in terms of violations. Some sales reps may be tempted to sell pharma samples on the street. Others may accidentally leave samples of a blockbuster drug in an office building or be robbed on their way in. Reps may want to swap samples with a colleague in a pinch or neglect to get a practitioner signature after leaving a sample. Those are all plausible scenarios, and they occur every day.
Therefore, companies need to insulate themselves from liability by documenting that all sales professionals handling pharma products understand PDMA regulations. To ensure that they do, companies must test reps and keep on file a signed acknowledgement of a compliance waiver in the event of sample diversion or an FDA audit of the sales force.
Regulatory training and testing is an implied requirement. Although the regulations do not specify that a field force must be trained on every first Friday of each quarter, that would not be a bad business practice. It is implicit in the regulations that a field force must be responsible for sampling inside the requirements of the law. An untrained sales force substantially increases a company's regulatory risk or vulnerability to noncompliance.
Staying on Track
Quarterly, documented awareness programs are one way to head off a possible threat of non-compliance in the field. Quarterly training also would reinforce the sales force's knowledge through repetition, so the "dos and don'ts" of sampling become second nature. For more detail, see "Staying on Track."
Neither the CRM technology-which is upgraded every 6-12 months-nor the training of end-users has caught up with regulatory requirements, which remain steadfast. Regardless of how innovative technology is, people must implement, test, maintain, and control it.
Staff are needed to manage and test its processes, to document that it is functioning as specified, and to record changes as they occur. Even if the technology is entirely compliant and validated and the sales force is exemplary in detailing within legal requirements, an IT staff in concert with a Sample Accountability staff will still need to ensure that compliance is maintained and that all drug samples are accounted for and reconciled.
Jack Rubin, president and CEO of Integrated Pharmaceutical Technologies and a leading authority on sample accountability, offers an interesting analogy: "Accounting for samples should utilize the same attention as accounting for every dollar in a checkbook. In the beginning of the month there is $500 in the account. At the end of the month there is $250. All transactions between those two amounts are accounted for-bills, mortgage payment, and schooling. The same attention to detail must be taken when reconciling drug samples."
Companies also need to ensure that those who train the sales force are properly trained. It is important that they develop business rules and establish standard operating procedures (SOPs) for every process involved in product sampling. There is nothing more damaging to a company than demonstrating to an FDA auditor a business practice that fails to adhere to an established SOP. To ensure that doesn't happen, companies can follow a 12-step sample compliance program:
1. Establish business rules. Pharma companies must define all business rule requirements to identify specific performance responsibilities as well as to establish various thresholds. Following are some examples of business rules. Management must
2. Follow standard operating procedures. PDMA requires written SOPs for all activities related to sample accountability. The importance of following such procedures cannot be overstated. A company's PDMA SOPs can include, but are not limited to:
3. Complete PDMA sales training. Training for sales reps and operating staff on regulatory requirements for PDMA and 21 CFR Part 11 is a must-as is a commitment to the company's SOPs. Documented training is an important aspect of limiting exposure to liability.
4. Establish a baseline inventory. Identifying a baseline inventory, also called the starting balance, is the first critical step in the reconciliation process. From that inventory, the sample manager can add or subtract all sample receipts and disbursements (transfers, returns, thefts, and losses), ultimately ensuring that all samples are accounted for in the ending balance. All the transactions in between the starting and ending balances can be tracked and the difference can be pinpointed.
5. Monitor shipments. Companies often send samples to their sales forces. Reps must acknowledge receipt of the samples and identify the quantity of each received.
6. Regulate disbursements. Sales reps distribute samples to licensed practitioners via CRM or paper forms and must document the practitioner's signature at the time of the drop.
7. Get physician validation. Pharma companies can assure regulatory compliance by validating practitioner licenses-through state license numbers or Drug Enforcement Agency numbers for controlled substances-against data provided by appropriate state or federal authorities. They should maintain and regularly update a database that incorporates information from all appropriate licensing authorities, including practitioner name, address, license number, date and expiration, active/inactive status, and other information. The database should include mid-level practitioners-nurse practitioners, interns, and physician assistants-as well as physicians.
8. Perform random signature audits. Companies should also conduct confidential auditing of compliance procedures, sales representatives, co-promotion partners, and selected authorized distributors such as contract sales organizations. They should conduct such audits with particular attention to PDMA and relevant state and federal laws, rules, and regulations. To verify practitioner signatures, companies can conduct random letter audits, and, if need be, interview practitioners to verify their signatures.
9. Report lost or stolen samples. When a pharma sales rep reports that samples have been lost and the quantity meets or exceeds significant loss criteria, the company must immediately report the loss to FDA. When samples are stolen, reps must obtain a police report and send a copy to FDA.
10. Document sample transfers. When one sales rep transfers samples to another, both parties must follow strict protocols that document the quantity of samples transferred.
11. Document sample returns. Sales reps must also follow strict protocols when they return samples to the company. Both the rep and the company's sample inventory clerk must document the quantity being returned.
12. Take inventory. The law requires that field reps take a physical inventory of samples on hand at least once a year. Periodic, random, and "for cause" physical inventories are a good business practice.
According to an industry leader in CRM validation, Raymond A. Roggero, COO of CSSC, "21 CFR Part 203 states that electronic systems may be used to collect sample disbursement information as long as those systems meet the requirements identified in 21 CFR Part 11. Given that one of the requirements of Part 11 is validation, there is no longer a decision to make-SFA and sample accountability systems must be validated."
Once a company chooses CRM software for disbursing or tracking samples, it must validate the computer-related process, or as FDA's "Guidance for Industry 21 CFR Part 11; Electronic Records, Electronic Signatures, Glossary of Terms" says, companies must "confirm by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled."
Before one sales rep can use a CRM tool in the field, companies must develop a library of documentation, signed and dated by responsible parties, proving that the tool is operating as specified. Companies are at an elevated regulatory risk when a system is "live" and being used in the field before validation occurs. A validated system includes the following deliverables, signed and dated by business owners:
All testing documentation must be written, executed, and summarized, including
It is imperative to remember that a company is particularly vulnerable to liability and regulatory risk when
FDA does not care that the company's CRM solution has "flexible application architectures with operational technology convergence in a robust analytical environment."
The agency's primary objective is to protect public health from prescription product diversion, adulterated drugs, and ineffective products. By embracing the regulations for sample accountability and operating in a validated environment, pharma companies can insulate themselves from liability and optimize their return on investment.