Hospital pharmacies have to meet Joint Commission anticoagulant rules

Here's some advice on improving your P&Ps

Hospital pharmacists will need to continue their focus on anticoagulation therapy and improving safety, as indicated by a recent sentinel event alert by the Joint Commission on Accreditation of Healthcare Organizations of Oakbrook Terrace, IL.

The alert, issued Sept. 24, 2008, precedes the deadline for meeting the Joint Commission's National Patient Safety Goals (NPSG.03.05.01) of January 2009.

"The Joint Commission has outlined these goals to improve patient safety around the use of these drugs," says Ann K. Wittkowsky, PharmD, CACP, FASHP, FCCP, a clinical professor at the University of Washington School of Pharmacy and director of anticoagulation services at the University of Washington Medical Center in Seattle, WA. Wittkowsky also was among the experts on anticoagulation therapy scheduled to speak at the 43rd American Society of Health-System Pharmacists (ASHP) Mid-Year Clinical Meeting, held Dec. 7-11, 2008, in Orlando, FL.

According to the Joint Commission's alert, 7.2% of all medication-related sentinel events reported from January 1997 to December 2007 involved anticoagulants, and of those, two-thirds involved heparin.1

The Joint Commission's National Patient Safety Goals include nine elements that provide guidelines for organizations that desire to both improve anticoagulant safety and meet Joint Commission standards.

Wittkowsky offers these suggestions for interpreting and meeting the Joint Commission's safety goals for anticoagulant therapy:

1. Implement a defined anticoagulation management program to individualize the care provided to each patient receiving anticoagulant therapy.

"What hospitals typically are working on is coming up with what these programs, protocols, etc. will be," Wittkowsky says.

"We have a plan in place for the University of Washington, and every hospital is charged with meeting those guidelines," she adds. "What we have are guidelines, patient education materials, goals, and all kinds of things on our web site."

The hospital medical staff and others have access to the information, and they're required to use the materials, Wittkowsky notes.

"It's nothing new in our program," she says. "We've had these in place for many years, and it's a continuous effort to make sure everything is updated and expanded as necessary."

Some hospital officials might interpret this to mean they'll need to have a warfarin dosing adjustment nomogram in place for every patient, Wittkowsky says.

"A defined individual management program doesn't necessarily mean you have to have a warfarin-dosing nomogram," she adds. "That might be one way to do it, but there may be other ways to do it, as well."

The important thing is for hospitals to show the Joint Commission how they're improving patient safety, Wittkowsky says.

2. Reduce compounding and labeling errors, using only oral unit-dose products, pre-filled syringes, or pre-mixed infusion bags when these types of products are available.

Taking the measures the Joint Commission now requires will reduce compounding and labeling errors according to research that has shown these methods to be safer, Wittkowsky says.

"Our hospital uses only oral dose products, pre-dosed syringes, and pre-mixed infusion bags, and this was inherent in our drug distribution process," Wittkowsky says. "But there are hospitals where that's not true."

3. Use approved protocols for the initiation and maintenance of anticoagulant therapy appropriate to the medication used, to the condition being treated, and to the potential for medication interactions.

The Joint Commission and ASHP are working on having resources available for hospitals in improving and writing these protocols, Wittkowsky says.

Although some hospital officials might be concerned that they need to have an ambulatory anticoagulation clinic, this is not what is required, she notes.

"That's a nice way to improve safety, but it's not a requirement," Wittkowsky says.

4. Obtain a baseline International Normalized Ratio (INR) for patients starting on warfarin, and use a current INR for all patients receiving warfarin therapy to monitor and adjust therapy.

This makes a lot of sense, but hasn't always been employed, Wittkowsky says.

"It's shocking because it seems like such basic medical care, but it doesn't mean everyone does it, so the Joint Commission is mandating this, " she notes.

5. Notify dietary services of all patients receiving warfarin; dietary services should respond according to an established food/medication interaction program.

"There are lots of foods that interact with warfarin, and hospitals have to be aware of when patients have dietary changes in terms of the amount of vitamin K ingested," Wittkowsky says.

"There can be changes in the INR, which can lead to bleeding complications or clotting complications," she adds. "Hospitals have to come up with programs to make sure this goal is being met."

This might be difficult for larger hospital systems, but a program that manages dietary and drug interaction issues is necessary, she says.

6. Use programmable infusion pumps to provide consistent and accurate dosing when heparin is administered intravenously and continuously.

"I believe that there are other regulations that are pointing toward using programmable infusion pumps, so many hospitals are in the process of doing this," Wittkowsky says.

7. Develop a written policy that addresses baseline and ongoing laboratory tests that are required for heparin and low molecular weight heparin therapies.

"This is important because you can't dose or monitor these drugs without baseline labs," Wittkowsky says. "So the Joint Commission is saying, 'You'll do this and have a written policy about it.'"

8. Provide education regarding anticoagulant therapy to prescribers, staff, patients, and families.

Hospitals have to come up with their own education strategies, Wittkowsky says.

At the University of Washington Medical Center nurses are required to take certain educational courses each year, and the hospital has added anticoagulation topics for the past few years, she says.

"We include how to use the heparin protocol, and we've incorporated anticoagulation education into ongoing nurse education efforts," Wittkowsky says. "My guess is a lot of hospitals will do the same."

The problem is that hospital leaders might make these requirements more difficult than they are, Wittkowsky says.

For example, Wittkowsky has personally heard rumors that the Joint Commission would require every hospital physician to take anticoagulation training and document this training.

"That's taking it many steps beyond the intention," Wittkowsky says. "You can incorporate anticoagulation training into what the medical staff is teaching if you have a grand rounds program."

It's important for hospital leadership to look at the system in place and see what can be done to meet the goals.

"The overall structure is a good one because the intention is to improve patient safety, and that's critical," Wittkowsky notes.

9. Evaluate anticoagulation safety practices, take appropriate action to improve practices, and measure the effectiveness of those actions on a regular basis.

"In our system we have the safe medication committee and our center for clinical excellence, which is really a quality improvement program," Wittkowsky says. "A multidisciplinary team works on this, which is very important for all of these efforts — to make sure you have all relevant specialties involved."

Through measuring the programs' effectiveness, the hospital discovered that although the appropriate policies and procedures were in place, there wasn't a good way to find out whether the staff followed the P&P, she adds.

"So we started doing audits to ensure the systems we have in place are effective and being used," Wittkowsky says. "That's part of our ongoing QI effort, and I think that's worked very well, as a process."

Hospitals likely will find that having adequate pharmacist resources in place is the biggest problem, Wittkowsky notes.

"Hospitals want to do a good job, but they don't have enough staff," she explains. "The requirements essentially are rather basic, but the resources to do it and develop the systems to make it work can be very difficult."