Risk management programs need help of R.Ph.s

September 16, 2002

The industry needs to address the growing number of drugs requiring special risk managment programs that place undue burdens on pharmacies, according to APhA official Susan Winckler.

 

COMMUNITY PRACTICE

Risk management programs need help of R.Ph.s

The Food & Drug Administration and drug manufacturers need to wake up and smell the pharmacist care coffee when it comes to risk management programs for problem drugs, according to Susan Winckler of the American Pharmaceutical Association.

As the healthcare professionals most accessible to patients, pharmacists can do a lot more to reduce the risks of certain medications than slap stickers on prescription vials, said Winckler, R.Ph., APhA staff counsel and v.p.-policy and communications. Speaking at the recent Pharmacy & Technology Conference of the National Association of Chain Drug Stores in San Diego, she said that instead of just doing menial tasks, pharmacists can educate patients about a drug's risks and how to manage them, as well as monitor compliance with risk programs.

Rather than using the professional skills of pharmacists, current programs to manage the risks associated with nine drugs place undue burden on the pharmacists, contended Winckler. Accutane and Lotronex, for example, require stickers, and a new drug program coming on stream will require a rubber stamp to mark the back of the script.

"We've got all these different programs that are supposed to focus the pharmacist on working with the patient, but they all look different," Winckler said. "I expect that, in the not too distant future, we'll have pharmacists complaining not only about third-party payment programs but complaining about which number do I call, which color sticker do I look for, or which stamp do I have to have in the pharmacy to take care of these programs. The lack of standardization is going to really challenge us in pharmacy practice. We have to provide some consistency and come up with better programs."

Perhaps the biggest barrier to more pharmacist participation in risk management programs is the lack of an economic incentive, Winckler said. "If we want pharmacists to play a role, we have to pay for that," she said. "The good news is that we're now hearing from regulators and pharmaceutical companies that it would be cheaper to pay pharmacists to make sure these drugs are used correctly than to lose the drug completely from the market."

Risk management programs that restrict distribution to only one national pharmacy (as in the case of the recently approved Xyrem) pose another kind of risk for patients. The local pharmacy may be unaware that a patient is taking such a drug and thus not be able to warn about interactions with other medications dispensed locally.

"I don't understand how putting that product in one pharmacy and intentionally splitting the therapy of the patient between two different pharmacies helps us track drug interactions," said Winckler. "I think we have to take a broader look at the risks we are trying to manage and what tools should be used to do that."

The FDA is aware of questions being raised about the effectiveness of current risk management programs and of the burdens placed on R.Ph.s, said Jerry Phillips, R.Ph. He is associate office director of the Center for Medication Error Prevention and acting director of the Division of Medication Errors & Technical Support in the Office of Drug Safety—part of the FDA's Center for Drug Evaluation & Research. As part of its response, he said, the agency hopes to issue a white paper and action plan for improving risk management programs this year.

"Our vision for the future is that risk management decisions will be supported by postmarketing data and quantitative analysis," Phillips said. "We'll have a toolbox to rationalize how to approach risk management programs and make how it will work more transparent to you. As pharmacists, our role is having oral and written communication with patients at the time of dispensing. It's a great way to reduce risk."

APhA is working on a concept paper on what pharmacists can contribute to risk management programs. Three core principles are that any restricted distribution program must be done well, that there must be incentives for R.Ph.s to provide care, and that there must be minimal workflow disruption.

"We know pharmacists aren't the answer, but we absolutely are part of the answer," Winckler said. "We hope that with this [concept paper], we can help folks who know pharmacy articulate things that pharmacy can do."

Carol Ukens

Drug risk management programs

Alosetron (Lotronex)*

Bosentan (Tracleer)

Clozapine (Clozaril)

Fentanyl (Actiq and Oralet)

Sodium oxybate (Xyrem)

Isotretinoin (Accutane)

Mifepristone (Mifeprex)

Thalidomide (Thalobid)

Trovafloxacin (Trovan)

*Planned

Source: Food & Drug Administration

 

Carol Ukens. Risk management programs need help of R.Ph.s. Drug Topics 2002;18:30.