Direct-to-practitioner sampling may sound like a new concept, but it has existed in some form or another since 1990, when Phoenix, a sampling solutions company based in Lincoln Park, NJ, started it to help reps from Knoll Pharmaceuticals promote Vicodin® (hydrocodone bitartrate/acetaminophen tablets USP), a schedule-three painkiller with the potential for abuse. “It is extremely difficult for a pharmaceutical manufacturer to have peace of mind in cases where their sales reps are distributing controlled substance samples, primarily due to the high degree of risk for theft and potential for diversion,” says Jim Reidy, senior director of pharmaceutical business solutions for Phoenix. “Knoll understood that by removing the responsibility of delivering samples from the reps, it would save them the infrastructure and administrative costs of developing an internal sample accountability system and, most importantly, reduce the risk associated with sampling a controlled substance.”
This was the foundation in place when AstraMerck started forming in the United States in 1993. “When AstraMerck was evaluating their business model for setting up operations in the U.S., they evaluated the costs and resources that would be required for the traditional sampling process. It didn’t take them long to choose the direct-to-practitioner method as the best alternative,” says Reidy. “AstraMerck then decided to proceed with an extensive selection process, evaluated many possible outsourcing partners and, in the end, chose Phoenix. We had the right systems and processes in place to provide the best possible solution.”
In 1998, Astra USA and AstraMerck merged to form Astra Pharmaceuticals Inc., and in 1999, Astra Pharmaceuticals merged with Zeneca to form AstraZeneca. In both cases, the AstraMerck model for sampling won out, and all the reps who were folded into the new companies (approximately 1,000 at Astra USA and 1,500 at Zeneca) were transitioned to direct-to-practitioner sampling.
The final shift to direct-to-practitioner sampling at AstraZeneca was a gradual one. The sales teams were allowed to ease into the new process on their own, and by March of 2001, 100% of AstraZeneca’s sales force was sending samples directly to physicians’ offices.
Samples in the mail
At AstraZeneca, direct-to-practitioner sampling, or “sample send,” as it’s referred to internally, works like this: Two weeks before the end of each month, regional managers get a certain allotment of samples — a percentage of the nationwide total — which they distribute at their discretion to the different districts under their control. The district managers then allocate the samples, also at their discretion, down to the sales rep level.
On the first of each month, AstraZeneca reps synchronize their NEC Mobile Pro 780 handheld device on their home computer, which tells them their allocation of samples for that month. Each device is also configured by the rep to hold his or her list of targeted practitioners, including each practitioner’s sample eligibility status and address information, as well as the list of products the rep details to that doctor. Armed with these data, the rep goes into the doctor’s office and conducts his or her product presentation. If the doctor would like to order samples, the rep calls up a sample order screen on the NEC and enters the quantities of each product the doctor wants. The screen then changes to a signature screen, and the doctor uses the stylus to sign his or her name at the bottom. The sales rep saves the order, leaves that office and continues his or her day in the field — beginning the sample process again in the office of each new doctor. At quitting time, the rep goes home and synchronizes the handheld device, which transmits the day’s orders to Phoenix’s fulfillment center. In the morning, when the fulfillment center receives all the electronic orders, they go through a validation process to make sure the practitioner is eligible to receive samples (his or her state license is up to date, etc.). If the order clears, the samples are packed and shipped via FedEx third-day air to the doctor’s office.
As the rep continues to synchronize the handheld device every night, the status of the order is updated, as well as the order history for the practitioner — including samples the doctor may have received from other AstraZeneca reps.
Benefits of shipping to doctors
There are many reasons why a company might not want its reps to carry samples, and almost all of them have to do with compliance with the Prescription Drug Marketing Act, which regulates pharmaceutical samples and requires that they be audited by pharmaceutical companies. “If your sales reps do not have physical inventory in their possession, you are helping limit your exposure from being non-PDMA-compliant,” says Stan Braxton, director of promotional customer operations for AstraZeneca. “Because you remove exposure, you remove reconciliation, you remove independent audits, and you remove the need for product storage and maintenance in a rep’s home. All the administrative work associated with the reps having inventory is eliminated.”
The costs involved in shipping samples to doctors individually as opposed to bundling them in larger shipments to reps are tremendous — Braxton estimates that his company sent out 3.7 million FedEx shipments to doctors in 2002 — but the cost of violating the PDMA can potentially be much higher. On Oct. 16, 2001, Lake Forrest, IL-based TAP Pharmaceutical Products Inc. pled guilty to conspiracy to commit violations of the PDMA and paid $879 million in fines to the United States government. Included in that total was a $290 million criminal fine — the largest ever imposed on a healthcare company (TAP is currently piloting a version of direct-to-practitioner sampling through Phoenix).
The benefits of direct-to-practitioner sampling to the rep are substantial as well. Soon after the merger of Astra and Zeneca, Tripp Webb began to see firsthand that not only was his customer access not being impacted by the new process, but his productivity was beginning to increase as well. At the time, Webb sold his products in two-thirds of the state of Kansas, and the length of his forays into that sprawling territory were dictated by how many samples he could fit in the trunk of his car. With direct-to-practitioner sampling, he had to make fewer return trips home to pick up product, and his range was extended.
The end of each month, when he would normally reconcile his samples, started to look a bit brighter as well. “The end of the month was something you always dreaded, because you were going to spend three or four hours counting and checking your samples on top of whatever other end-of-the-month reports you did,” he says. “So [sample send] frees you up at home.”
“Based on the feedback I have received from clients and from what is discussed throughout the marketplace, a traditional sample carry model requires a sales rep to spend two days a month managing all the tasks associated with sample accountability,” says Phoenix’s Reidy. “This equates to one hour a day, and one hour a day is potentially one customer the rep is not visiting that day. Looking at this over multiple weeks or months, this one hour of time equates to significant time and potential revenue loss. This is exactly the thought process of our clients that have chosen the [direct-to-practitioner] model – the scale tips in favor of ‘We don’t want our reps carrying samples.’ There is a clear benefit in distributing samples directly to practitioners. Not only is it giving sales reps more face time with practitioners; it saves on the administration costs of having the systems and processes in place for sample accountability.”
Braxton has heard many reps sing the praises of direct-to-practitioner sampling. “The reps I’ve spoken to about direct-to-practitioner, they love it and would not want to go back again,” he says, adding that when reps were required to carry samples for the recent launch of Crestor® (rosuvastatin calcium) (AstraZeneca’s reps still carry samples for three months at the beginning of a launch so that doctors may evaluate the safety and efficacy of the newly approved drug more quickly), many newer reps who never had to carry samples before had difficulty adjusting. “They had to go through their first exposure to being home for sample deliveries, and it was a little bit of a learning curve for them,” Braxton says.
What doctors think
AstraZeneca reps’ access to doctors has not been negatively impacted since the adoption of direct-to-practitioner sampling, despite the fears of some sales reps and managers. Because doctors are still required to sign for the samples, the sales representatives are still able to get at least a few seconds of detail time during the process. “It’s really more of a misconception that the direct-to-practitioner sampling is taking away samples,” says Reidy. “It’s not doing that at all, it’s just changing the way the order is handled.”
There is one aspect of direct-to-practitioner sampling that doctors and nurses have had a problem with. “The negative feedback you will get is that now some administrative person in the doctor’s office will have to put away the samples when the shipment arrives,” says Braxton. “So they’re getting a FedEx delivery and now someone in the office has to open up the box and put the samples away, whereas that wasn’t something they had to do before.” Braxton says that most reps have neutralized this complaint by finding out when the shipment is due and coordinating their next visit to put the samples away when they arrive.
“There are enough reps working the territory that by the time the samples come in, there’s usually another rep coming through, and we tend to put up anything we see that’s not put up yet in the closet,” confirms Webb.
An emerging trend?
If reps, managers, doctors and executives are all happy with the program, why haven’t other companies switched their reps to direct-to-practitioner sampling? None of the major pharmaceutical companies contacted for this article were willing to speak about their sampling practices, but some industry consultants say the reason direct-to-practitioner sampling hasn’t caught on is the same reason Tripp Webb initially dreaded it: fear of lost access.
“Most people feel that it could affect rep access,” says Terry Herring, president of Somerset, NJ-based industry consultant Ventiv Health Inc. “AstraZeneca is a very reputable company, and if it’s not affecting them, that’s very good. The areas we happen to compete in, the companies we are competing against and the companies we are representing continue to believe that access and reps having the ability to have samples are valuable.”
Says Dilip Phadnis, president of the Rowan Group, a pharmaceutical industry consulting company based in Maywood, NJ, “Samples are the one thing that doctors always find as a useful service that reps provide, and if you take that away, then the incentive for the doctors to see the rep is going to be even less. There’s nothing like getting stuff right then and there.”
Herring says he anticipates more of an industry-wide shift toward increased independent auditing of samples and greater education of sales reps on PDMA issues, rather than a change in the way samples are distributed. The competitive nature of pharmaceutical sales and marketing also makes it likely that companies will continue to be reluctant about sending samples directly to doctors as long as their competition sends reps into physicians’ offices with product. “Until the majority of companies move to alternative means, it is unlikely that too many will take the first step,” says Herring. “Then no one is likely to get hurt competitively.”
Of course, the industry could one day end up in the position of Tripp Webb, an initially reluctant convert to the program. Today he is a true believer in direct-to-practitioner sampling. “It’s just much easier,” says Webb. “At the end of the month, you don’t have to physically reconcile samples; you’re not worried about whether your samples are going to match up and whether that’s going to be an administrative headache. I would hate to go back to the other way.”