Safekeeping for Samples

Do you think you know which "perks" your staff members appreciate the most? Is it flex time? Weekly lunches from the pharmaceutical reps? A great benefit plan?

What about free prescription samples for the taking?

That last one may sound a bit unreal, but if your practice isn't monitoring its supply of prescription drug samples, you're leaving the door to the sample closet wide open to drug theft and abuse, not to mention unaccounted for, and possibly expired or recalled, inventory.

You may assume that your staff knows better, but some employees think of the drug sample closet as free and accessible as the office supply closet. "There were major issues with employees helping themselves to samples," says family practitioner Kristin Elliott of the practice where she worked from 1994 to 2000. "Several mentioned that they felt it was a 'perk' for working in a doctor's office."

Despite a policy that required staff to get a physician's permission to enter the sample closet, one employee was fired when it was discovered that "she had a supply of different medication samples in her desk drawers if she or her family needed them -- without a physician's OK, of course," Elliott recalls.

But office policies are likely to be ignored if there are no consistently applied procedures to back them up. That's why every physician's office should have a plan for monitoring both drug inventory and access to the prescription sample storage area, have at least one person responsible for overseeing the area, and make sure everyone follows the rules.

"I've seen a lot more [practices] that have sloppy systems than have good systems. This is an area that's ripe for abuse and misuse, and is not very well policed by practices or by a lot of the regulatory agencies," says William Jessee, MD, president and CEO of the Medical Group Management Association (MGMA). "The Joint Commission, as it started surveying physician offices that are owned by hospitals, [has] started requiring some of the same kinds of control over pharmaceuticals that they require in hospitals. But it's been a huge issue for them -- it's pretty sloppy in most physicians' offices."

Secure the space

So what can your practice do to keep sample prescriptions secure and up-to-date?

According to Jessee, "Step one is to take a look at your physical environment. Think about how easy it is for someone to get access to your samples -- and that could be a patient, a patient's child, or a staff member. You may want to centralize your samples into a single location, put it under lock and key, and establish a policy about who has access to it and for what purposes."

Then again, trying to keep samples locked up may not work for many busy practices. Jessee emphasizes that whatever steps you take should fit your practice's workflow. "As a practical issue, you don't want to create a barrier to the physicians' dispensing samples -- and if you have to unlock the cabinet every time, most people are going to leave it open."

One solution is to make sure samples are stored in an area that is not isolated from the hubbub of daily activity. At Snellville Pediatrics near Atlanta, for example, practice manager Linda Swadener says the sample closets "are not locked, but they are in a heavily trafficked area where there is constant staff [presence] so it's not anyplace a patient could go and have time alone." Access is limited to physicians or nurse practitioners.

Elizabeth Wertz, who is executive director of Pediatric Alliance in Carlisle, Pa., a practice with 27 physicians and 11 offices, agrees that "much depends on the setup of the office. The physician may say, 'Give Mrs. Jones two doses of amoxicillin to tide little Courtney over.' So the nurse will go in and get it. If it's a closed, segregated area we try to limit access to the nurses and medical assistants, so a front-desk or check-in person shouldn't be snooping around in there."

What to track

Monitoring what's in the sample closet is as important as knowing who's going in. Assign a staff member to keep track of inventory. "Each office has a person who is responsible for ordering supplies, ordering vaccines -- it usually falls to that person," says Wertz. "But you really have to dedicate a staff person."

The person in charge of the sample closet should keep a log of all inventory and check it "at least once a month," suggests Jessee. "If you are tracking your inventory as stuff comes in, that makes it very easy. When you add new inventory, you can record the expiration dates and pull any of the remaining lot if that expiration date comes around."

He points out that practices that have controlled substances among their samples are required to keep track of those, so it makes sense to pay as much attention to all other drug samples. "There are pretty stringent federal laws about how [controlled substances] have to be accounted for. You have to have an inventory, you have to be able to account for where each dose has gone. When you acquire those samples, you need to have a log showing when the stock was replenished, how many doses [were used], and how they were dispensed. That involves a fair amount of record keeping."

Elliott says that at Lakewood Medical Associates in Marquette, Mich., where she practices today, samples are "stocked by a staff member who double-checks the lot numbers and expiration dates." Recording lot numbers can be helpful in case of a drug recall or if a patient has an unexpected reaction to a medication.

"When samples are given to patients," Elliott says, "the drug name, lot number, expiration date, directions, and number of samples are printed on a triplicate form. One copy goes to the patient, one copy goes in the patient's chart, and one copy goes into a permanent file, filed under the drug name. This system keeps track of the medications well, but is very time-consuming," she admits.

Wertz also acknowledges that doing a thorough job of tracking samples is tough in a time-strapped environment. One solution may be to automate the process. "There is a drug company that has a scan system; they put little stickers on the samples and you scan them all in, which is wonderful. Right now a lot of practices do not inventory lot numbers. I feel strongly that you should, but when you look at the staff time involved ... We are looking for some type of automated system, so if there is a recall, we know exactly what patient received that sample." 

Technology may also be useful in reducing the risk of confusing look-alike or sound-alike medications. "There's a lot of discussion about going to bar coding to control that," says Jessee. For the time being, he says, "I think all you can do is organize your samples logically -- alphabetically or by drug class ... [and] double-check before dispensing. Telling a physician to double-check is an exercise in futility. So it becomes incumbent upon the staff to be well trained in what the potential pitfalls are and to double-check."

Who's helping?

Many practices also look to outside help -- in the form of pharmaceutical company representatives -- to help them maintain the sample inventory and take some of the burden off of the staff. Most practices are grateful for the help, but oversight of the reps' activities is often lacking.

"We have eight to 10 reps per month rotating through the practice," says Swadener. "[Our clinical supervisor] does an audit [of the samples] after the drug rep leaves. Our doctors are appreciative of what they give us."

"What's supposed to happen is one of our staff goes back with the pharma person while they're [stocking samples]," adds Wertz. The reality is, "there are times when the office is crazy" and staff supervision of the rep just doesn't happen.

Jessee says giving pharmaceutical reps that kind of access is "an invitation to disaster. If something is misdispensed or stolen, whose responsibility is it? Not the drug rep's."

He agrees that providing samples is a good idea, but insists that practices, not drug reps, must maintain control and be accountable for the sample closet.

"You want to encourage them to give you the sample. The whole point is to dispense enough for starter doses to make sure patients start [on the regimen]. The other purpose is, if you are concerned about a patient's ability to afford a medication, [to] give that patient a full course of samples. If those are your primary objectives, you need to maintain control over that sample cabinet. If you've got a system for how things are organized and are keeping track of the inventory, letting more than the one accountable person ... get into it is just an invitation to create nightmares for yourself."

Elliott agrees: "Allowing the drug reps to maintain samples is not a good idea, in my opinion. I have had experiences where reps threw out samples from other companies to highlight their own."

The bottom line: prescription samples are an effective way to get patients started quickly on a drug regimen. But having them in the office carries risks and inventory maintenance can be time-consuming. With that said, consider whether your office even needs a sample cabinet at all.

"Personally, I think drug samples are more of a hassle than a help to patients and physicians," says Elliott. "The voucher system [in which a special prescription for a sample is given to the patient to redeem at the pharmacy] is the best way I've seen to deal with the issue. Having samples around causes problems with both staff and physicians using medications for themselves, often without appropriate supervision." 
 
Joanne Tetrault, director of editorial services for Physicians Practice, can be reached at jtetrault@physicianspractice.com.

This article originally appeared in the January/February 2003 issue of Physicians Practice.