Accreditation

Know how to handle drug shortages

Accreditation Connection, January 19, 2004

Don't get caught unprepared if a drug manufacturing plant should suddenly shut down. Check out how your colleagues at two New England hospital pharmacies handle drug shortages.

Make a plan to fit the shortage
Your initial response to a drug shortage should include the following two steps:

1. Contact the manufacturer when you receive a back order or shortage alert, says Ernie Anderson, MS, pharmacy director at the Lahey Clinic in Burlington, MA. Wholesalers sometimes alert pharmacies ahead of time, telling them that they will not have a full supply of the drug. If this happens, pharmacy directors or purchasing managers should call the manufacturer to determine how long the drug shortage will last.
2. Create a plan to successfully handle the drug shortage. The Lahey Clinic does not have a universal policy to handle all drug shortages because each shortage can vary in length or severity, says Anderson. The shortage could be because of a problem with the manufacturer's production line or a lack of basic ingredients, Anderson says.

"You make your decisions on the fly," Anderson says. "All of these variables change."

Most shortages occur between the scheduled pharmacy and therapeutics (P&T) committee meetings, so pharmacists and medical staff do not have enough time to present a plan to the full committee, says Anderson. He usually remains in contact with the P&T committee chair when creating a plan.

Your drug shortage response plan may require one or more of the following three actions:

 Buy in bulk
 Borrow from other hospitals
 Consider alternative drugs

Following is an assessment of these three options with tips on how to make better financial decisions and maximize productivity.

Buy drugs in bulk
Sometimes pharmacies purchase drugs in bulk instead of the unit-dose, ready-to-administer forms they usually receive, Anderson says.

Your pharmacy may choose to buy a 10-g dose instead of a 1-g dose, and pharmacy staff would have to repackage the medication into 1-g doses for use on the floor.

This alternative is labor-intensive and puts more pressure on staff already concerned with the daily pharmacy operations, says Anderson. Unfortunately, there is no way to save time when repackaging drugs, he says.

Make communication and education a priority when repackaging medications, says John Foley, PharmD, pharmacy director at Southern New Hampshire Medical Center in Nashua.

Train pharmacists to repackage the medication properly and ensure that staff understand the replacement medication labels, thereby preventing administration errors and making sure the patient receives the correct doses.

Borrow from your colleagues
Borrowing medications from another hospital is a short-term fix when a shortage begins. As pharmacy director, call your area colleagues to see how much of the drug is available, Anderson says.

Replenish the other facility's stock when the shortage ends, he says.

In the long run, the borrowing hospital will not be hurt financially because the pharmacy will send some of its medication supply to the lending hospital once more drugs come in, Anderson says.Borrowing from other facilities can be difficult if the shortage affects several hospitals, Anderson says.

Pharmacies will not be as willing to lend some of their stock if they are working with a limited drug supply as well, he says.

TIP: Be honest with pharmacists at other hospitals, Foley says. If your hospital and others face a shortage of antibiotics, you can't borrow another hospital's entire stock of antibiotics because that would place a strain on the lending facility, he says.

Design a plan so that the sickest patients would get the medication, he says.
At the very least, another hospital's pharmacy director or purchasing manager will be able to give you advice about your policy, offering suggestions about how to weather the shortage and find alternate drug sources, Foley says.

Ask colleagues for advice on how to find alternate medication sources or how to repackage medications quickly and safely, for example.

Consider alternate drugs
Use alternate medications if borrowing from another hospital is not possible. For example, if hydrocortisone is in short supply, the pharmacist can try methylprednisolone because both are anti-inflammatory drugs, Foley says. Here are some steps to take when using alternate drugs:

 If the alternate drug differs from the drug normally used, send the drug to nursing staff or physicians with a label explaining the differences, says Foley. His staff work one-on-one with physicians and nurses, explaining to them the differences between the original drug and the alternate drug and any possible side effects.
 Make sure every pharmacist knows about the alternate drug so that they can fill the orders correctly when sending the medications to the floor, Foley says. Southern New Hampshire Medical Center holds staff meetings for nurses to make sure they understand how to administer the alternate drug. The center also hangs posters at nursing stations and other staff areas explaining how to use the alternate drug and any differences between it and the original.
 E-mail physicians and nurses explaining how to fill an order for the alternate medication, says Anderson. In the e-mail, include any differences in dose requirements between the drugs. Pharmacists usually make up conversion tables to explain the differences in doses between the alternate drug and the original drug, he says.

Speak with your staff
Don't alert all of your staff right away about a shortage or use alternate medications immediately, because the shortage may not affect every staff member or be as severe as you originally thought.

Anderson first consults with physicians who may be affected during a shortage to see what they would need to perform their jobs, he says.

For example, if the manufacturer alerted the hospital about a shortage of steroids used in the trauma department, Anderson would speak with the trauma team to see which drugs they would need to be able to function during a shortage.

He would then talk with the purchasing manager and a few physicians in the trauma department to determine the best solution: whether to borrow from another hospital, purchase in bulk, or find alternate drugs, he says.

"We'll try to jump through lots of hoops to get the drugs they need for their patients," Anderson says.

Ration your drugs
Southern New Hampshire Medical Center is currently dealing with a shortage of methadone injections, a low-profit medication, Foley says.

One company stopped making the drug, which caused the shortage. Another company will begin making the drug in early 2004, so the hospital will have to deal with a dip in production until then, he says.

The methadone injection is important because physicians use it to treat heroine-addicted pregnant mothers, Foley says. Because it saves two lives at once, the hospital needs the drug, he says.

Foley's team is responding by encouraging physicians to use the oral form of the drug until more injections become available, Foley says.

"It's like gas rationing," Foley says. "It can be done, but it takes a group effort."



Sample drug-shortage policy

Policy: When a drug shortage occurs, the director of pharmacy will be responsible for coordinating a program of therapeutic interchange with a suitable alternative agent.

Procedure
I. Definition
A drug shortage is defined as a supply issue that affects how the pharmacy prepares a product or influences patient care because a prescriber must choose an alternative therapy. A drug shortage is a sustained unavailability of specific formulary products from all manufacturers/distributors of the products.

II. Anticipated shortages
In a case in which pharmacy personnel are aware that a shortage of a formulary drug is scheduled to occur but will not affect patient care at the hospital for a period of more than 60 days, the clinical coordinator will prepare a review of all therapeutic options to the soon-to-be unavailable drug. The director of pharmacy will bring the review to the next scheduled meeting of the pharmacy and therapeutics (P&T) committee of the medical staff for review and action.

III. Unanticipated shortages
In a case in which a shortage of a formulary drug occurs with no notice or will affect supplies before the next meeting of the P&T committee, the director of pharmacy will consult with the chair of the P&T committee to develop an ad hoc therapeutic substitution:

A. The clinical coordinator will complete a review of available alternatives to the unavailable formulary agent and recommend a therapeutic interchange for the unavailable drug.

B. The automatic interchange of drugs will be approved by the chair of the P&T committee and communicated to affected staff as follows:

1. Memoranda regarding the automatic interchange sent to the directors of all medical staff departments and to chief residents in medicine and surgery.

2. Notice of change posted in the medical staff lounge.

3. Notice of change sent to all nursing clinical managers and other management personnel who may be responsible for staff who could be affected by the shortage.

4. Notice posted on the pharmacy department's Web site, which will provide details of the review, options reviewed, and reasons for the final choice of interchange agent.

5. Notice of change sent to all pharmacy staff.

C. The director of pharmacy will bring the interchange review and related material to the next scheduled meeting of the medical staff's P&T committee. The committee may choose to endorse or reject the interchange. If the committee chooses to reject the interchange, it will designate a new interchange agent or procedure for notifying the physician of the shortage. In such a case, the pharmacy will inform staff of the new interchange using the process outlined in Section III B of this policy and procedure.

Source: The Compliance Guide to the JCAHO's Medication Management Standards, © 2003, HCPro, Inc. Visit www.hcmarketplace.com/Prod.cfm?id=1921 to order the book or call customer service at 800/650-6787.

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