Handling Drug Recalls

When pharmaceutical giant Pfizer pulled its popular painkiller Bextra from the market in April 2005, it was all hands on deck at Fox Valley Orthopaedic Institute. A point person was designated to search the practice for all patients who had been prescribed the drug, which was found to increase the risk of heart attack and stroke. Letters were mailed immediately to each patient instructing them to stop taking the medication. “We asked our patients to bring their unused drugs back into the office,” says Mary O’Brien, chief executive officer of the Geneva, Ill.-based practice, noting her staff followed up with new appointments for patients, where necessary, to discuss alternative treatment options.

The Bextra recall, which came just seven months after competitor Merck voluntarily withdrew its blockbuster arthritis medication, Vioxx, from the shelves, made national headlines due to the vast number of patients (an estimated 7 million) who had been prescribed the drug. Yet, the majority of pharmaceutical and medical device recalls fly under the media radar: Over the last five years, the Food and Drug Administration has issued more than 4,000 recalls and safety-based withdrawals on everything from faulty syringes and spinal implants to prescription drugs and individual lots of H1N1 flu vaccines. Considering the frequency of recalls affecting patient safety, then, the obvious question becomes: Is your practice recall ready?

According to Cindy Dunn, a consultant for MGMA Health Care Consulting, Fox Valley Orthopaedic Institute did everything right. Practices of all sizes, she says, should draft a recall response plan - preferably before they need to use it - that enables them to contact patients as quickly as possible. “It doesn’t have to be a big formal thing, but you do need to have a process in place,” says Dunn. “Discuss it amongst yourselves and decide as a practice how you’re going to handle medication recalls. Answer the question: ‘How are we going to do that here?’”

Step one

Typically, public health officials who recall products and the drug companies that voluntarily pull their medications from the market issue guidance on how patients should proceed. Keep in mind a product recall doesn’t always mean the patient must stop using the product. A medical device recall, for example, may simply mean that the device needs to be checked, adjusted, or fixed. In the case of implanted devices, such as pacemakers or artificial hips, the physicians are usually instructed to discuss with the patient the risks of removing the device compared with the risk of leaving it in place.

Once notified of a recall, either by news media, pharmaceutical sales representatives, equipment vendors, or colleagues, it’s your job as administrator to put someone in charge of pulling charts to be sure all patients affected are notified posthaste.

Unfortunately, that’s easier said than done, says Craig Gillispie, administrator of Commonwealth Urology in Lexington, Ky. “Even if you have an EMR, people seem to think all those fields are searchable. And they may be, but it probably takes a computer programming engineer to extract it from the system,” he says. “You can’t just plug in a lot number and run a report to make it spit out a nice list with all the names of your patients who were prescribed a drug. It’s not as easy as it sounds.”

Practices with paper records have a harder time still. At his previous practice, Gillispie says, the recall of certain flu vaccine lots forced his office to track down patients the old fashioned way. “We had kept a paper log of the vaccine lot numbers, but we didn’t log that by patient name so when the recall happened we went back to find out what date we received the recalled vaccines,” says Gillispie. “I was then able to run through the billing system to identify people who came in for their flu vaccine during those dates, and I estimated how long it would have taken to use up those lots and used that as a starting point.” In some cases, per the pharmaceutical company’s guidance, patients did not need to be revaccinated. “We contacted only those we thought should be revaccinated,” says Gillispie.

Practices that don’t yet have a full EHR may also have elements of one, including a practice management system, which could prove useful. “If the recalled drug affects diabetes patients you can start by searching for patients with a diagnosis of diabetes,” says Gillispie. “Even without an EMR there are still some searchable databases you could use to get started.”

Some practices may also be able to ask their transcriptionist to search their records for written references to all patients who have been prescribed the medication, says Dunn. If it’s a major recall that makes national headlines, of course, the patients are likely to contact you. In that case, be sure your phone staff is prepped to answer basic questions and provide instructions to patients who call in.

Is your sample closet safe?

You must also designate someone to rid the sample closet of recalled products. In fact, says Dunn, practices should name someone on staff to manage the sample closet on a regular basis - keeping a running log of all medication dispensed and ensuring all expired medication is disposed of properly.

“Some practices are very lenient,” she says. “They let vendors come in to see their doctors and they have no process in place for how to deal with the samples they leave behind. I’ve been in offices where doctors are standing in the hall saying, ‘I thought we had more samples.’” Importantly, she notes, the sample closet should also be kept under lock and key, with restricted access to ensure patients and staff can’t help themselves.

For her part, O’Brien says her practice keeps drug samples in a locked cabinet. When physicians dispense samples, a note gets added to that patient’s electronic record. “We log every sample we give with lot number and the patient’s name,” she says, making it easy to identify patients who have been given the drug if needed.

How you handle product recalls speaks volumes about the importance your practice places on patient safety. You need not huddle with your physicians for hours to create a complex flowchart, but everyone in management should agree on basic protocols to follow in the event a medical device or drug is pulled from the shelves - preferably before the alarm bells ring. “You may want to talk to your malpractice carrier for their input, or your state medical society,” says Dunn. “I would look to those resources to help you craft the process you’ll follow at your practice.”

Shelly K. Schwartz, a freelance writer in Maplewood, N.J., has covered personal finance, technology, and healthcare for more than 12 years. Her work has appeared on CNNMoney.com, Bankrate.com, and Healthy Family magazine. She can be reached via physicianspractice@cmpmedica.com.

This article originally appeared in the May 2010 issue of Physicians Practice.