Accreditation

Prep staff on drug recalls before your next JCAHO survey

Accreditation Connection, March 8, 2004

Drug recalls may be a topic of conversation during your next Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) survey. Make sure your staff are on the same page now to reduce survey day stress.

The JCAHO's medication management standard MM.4.70 requires pharmacies to retrieve recalled drugs.  Knowing your hospital's procedure will help you during your survey.

Under Shared VisionsNew Pathways T, the new JCAHO survey process, surveyors will select a patient and trace his or her stay in the hospital from admission to discharge. Surveyors may ask pharmacists what they would do if a manufacturer recalled any of the patient's medications, says Joseph Deffenbaugh, MPH, RPh, director of public health quality for the American Society of Health-System Pharmacists (ASHP).
"Hopefully the pharmacist would know the policies and say, This is what I would do,' " Deffenbaugh says.

Look for the lot number
Drug manufacturers assign lot numbers to groups of medications as they are manufactured and shipped. Therefore, pharmacists should look for a lot number when the recall notice arrives.

Check your pharmacy's stock record for the recalled lot number. Depending on your hospital's system, you may be able to record it in an electronic database or automated cabinets such as Omnicell or Pyxis. If not, keep it in a written log.

Your record should tell you where the medication is located in the hospital. Pharmacy technicians at St. Michael's Hospital in Stevens Point, WI, manually search their stock records for lot numbers, says pharmacy director Todd Faulks, RPh.

"It's fairly easy to track," Faulks says. "We start in the pharmacy and work our way out to look for the lot number."

Some vendors place the lot number on the invoice pharmacies receive with medication shipments, Deffenbaugh says. That provides pharmacies with a documented lot number record and makes it easier to enter the number in a database.

If there is no lot number on the invoice, check the packages for the number, Deffenbaugh says.

TIP: Maintain an up-to-date log with medication lot numbers and expiration dates. If you do not have a computerized database, record the lot numbers in a log.

The Food and Drug Administration (FDA) is developing standards for manufacturers to place the medication's lot number and expiration date in bar codes, Deffenbaugh says. That would help facilities electronically record where the medication is located in the hospital.

"That's the best part of it," Deffenbaugh says. "You have a bar code right down to the unit of use. Electronically, [the medication] is very easy to retrieve."

The FDA will publish the final bar-coding rule early this year, FDA spokesperson Crystal Rice says. The rule will apply to all prescription drugs, including biological products and vaccines, as well as over-the-counter drugs commonly used in hospitals.

Track down those meds
Pharmacy staff at St. Michael's Hospital search the floor stock for the medications when a recall notice arrives, Faulks says. Pharmacy technicians check the inventory and notify clinics that may use the medication.

Faulks checks with pharmacy technicians and other staff responsible for stocking the medications to see whether the recalled drug is in the hospital's inventory, he says. Staff check the pharmacy first and then move out to patient care areas, he says.

For example, drug manufacturer Pharmacia recalled Lunelle, a monthly birth-control injection, in October 2002 because it was subpotent, Faulks says. His staff immediately located it in several hospital clinics in central Wisconsin and retrieved it, he says.

"No one wants a subpotent birth control injection out there," Faulks says. "We jumped on that one right away."

Follow the manufacturer's instructions
Once you have collected the recalled medications, follow the manufacturer's instructions on what to do with them, Faulks says. These instructions will be included in the recall notice.

For more serious recalls, manufacturers may require you to ship medications back and will provide shipping instructions, Faulks says. Other times, he adds, manufacturers may simply send you new labels to place on the medication if the recall is due to a labeling error.

Read the fine print
A group purchasing organization (GPO) often notifies hospitals when a manufacturer issues a drug recall, Deffenbaugh says. Wholesalers such as McKesson or Cardinal will also pass along recall notices, he says.

Manufacturers often send recall notices through priority mail and e-mail alerts, Faulks says. Manufacturers and GPOs send the notices to any pharmacist with a license and sometimes to the entire pharmacy in general, he says.

Sometimes pharmacists don't receive notices because they are unaware of the notification process, Deffenbaugh says.

It is important to know how you receive recall notices, either from manufacturers, prime vendors, or industry associations such as ASHP.

"Sometimes a physician will call the pharmacy saying, We've received a notice that Product A has been recalled,' and the pharmacy doesn't know anything about it yet," Deffenbaugh says.

TIP: Make sure you know what your contract with your drug vendor says about recalls, Deffenbaugh says.

Network with your peers
Having a drug recall policy will be important when JCAHO surveyors arrive at your hospital. Surveyors may want to know what you would do if a manufacturer recalled a drug, and your staff must be able to explain the policy, Deffenbaugh says.

Talk with your colleagues if your hospital does not have a defined drug recall policy, Faulks says. Other pharmacy directors may be able to offer guidance and suggestions to help you design a recall policy, he says.

"Most JCAHO standards require you to have a policy and that's all they say," Faulks says. "It's a matter of networking."



Standard MM.4.70 at a glance
The pharmacy must retrieve medications recalled or discontinued by the Food and Drug Administration (FDA) or the manufacturer.

Requirements for MM.4.70
1.    Staff retrieve medications according to the organization's policy when the FDA or the manufacturer informs the hospital of a recall.
2.    The hospital must notify all staff ordering, dispensing, and giving out medications when the FDA or manufacturer issues a recall order.
3.    Staff identify and notify patients who may have received the recalled medication.



Sample drug recall policy

The Food and Drug Administration (FDA) defines a Class I recall as a situation where there is a reasonable possibility that use or exposure to a violative product will cause serious adverse effects or even death.

Pharmacy personnel are responsible for checking all floor stock, patient medication boxes, as well as the stock in the pharmacy. Pharmacy will notify clinics that have purchased the recalled products.

The FDA defines a Class II recall as situations where use or exposure to a violative product may cause temporary or medicinally reversible adverse health consequences.

Pharmacy personnel are responsible for checking all floor stock and patient medication boxes as well as the stock in the pharmacy. Pharmacy will notify clinics that may have purchased the recalled product.

The FDA defines a Class III recall as situations in which use of the product is not likely to cause adverse health consequences.

Pharmacy personnel are responsible for checking floor stock as well as stock in the pharmacy. Pharmacy will notify clinics that have purchased the recalled product. Class I and II recalls will be processed within 24 hours upon receipt of recall notice in the pharmacy. Recall records shall be kept on file in the pharmacy for two years.

Source: St. Michael's Hospital, Stevens Point, WI. Reprinted with permission.

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