Crack the Code

FDA requires bar codes on most drug pack ages in attempt to reduce medication errors. How will it affect LTC?

by Margot J. Fromer

In a move that has been contemplated for more than a year, a new FDA regulation will go into effect on April 26, when the agency will require linear bar codes on most packages of drugs and biologicals.

The move is designed to prevent half a million medication errors in the next 20 years and to save $93 billion over the same period by reducing patient pain, suffering, and lost income.

"In a nutshell," said Michael Cohen, RPh, MS, ScD, president of the Institute for Safe Medication Practices, and member of the FDA Drug Safety and Risk Management Advisory Committee, "whatever touches a product has to have a bar code."

Said Health and Human Services Secretary Tommy Thompson, "Bar codes can help doctors, nurses, and hospitals make sure that they give patients the right drugs at the appropriate dosage. By giving health-care providers a way to check medications and dosages quickly, we create an opportunity to reduce the risk of medication errors."

According to Laurie Forrester, PharmD, president, Senior Med Alliance, Inc., Dallas, "With bar codes required only on the pharmaceutical manufacturers' packaging, it is a real stretch to say it will help nurses and doctors over the short term."

She said a large national investment (billions) in the next level of technology is required for bar codes to affect medication errors at the patient-care level.

An FDA press release said that the rule is designed to support and encourage widespread adoption of advanced information systems that, in some hospitals, have reduced medication error rates by as much as 85%. (Note: Manufacturers are required to affix bar codes, but hospitals and other institutions do not have to do anything about them.)

What the Regulation Entails

The regulation applies to most prescription drugs, some over-the-counter ones, and blood and blood components intended for transfusion. It applies to drug manufacturers, repackagers, private label distributors, and blood establishments.

Each bar code will contain at least the national drug code number, and companies may also include information about lot number and expiration.

After April 26, manufacturers will have two years to attach bar codes to products already FDA-approved but only 60 days after approval to add the codes to new products.

Bar codes are required only on packages that go directly from the manufacturer to a hospital pharmacy. There are two notable exceptions: Medications dispensed to patients after they've been taken out of the manufacturer's package (for example, tablets dispensed from a stock bottle before being taken to the bedside), and products used primarily in physicians' offices.

The Practicalities

The system is designed to work in the following way: Patients are given identification bracelets on which their personal bar codes are imprinted. When a nurse or other provider prepares to administer a medication, they scan both the drug and patient's bar code and compares them to verify dose, time, and route of administration.

According to FDA, the Veterans Administration tested this system, and 5.7 million doses of medication were administered with no errors.

"There are lots of holes in the regulation and built-in ways to circumvent the system," said Cohen. "For example, you hardly ever see stock bottles of tablets on a patient floor, but very often nurses take medications out of unit-dose containers and put them in little plastic cups to bring to the bedside."

Doesn't this defeat the purpose of the bar-coded unit dose? "It sure does," he said, adding that injectable medications create similar problems.

"The drugs come in prepackaged vials or syringes--all with bar codes," said Cohen. "But if the dosage ordered is not what's in the manufacturer's package, the nurse has to transfer it to a different syringe, and it goes to the patient with no bar code."

The long-term care industry has been dealing with this specific issue for some time. "This is also true for insulin, which is currently packaged with the bar code on the case but not each individual vial," explained Forrester. "The pharmacy must keep the case packaging with the individual prescriptions in order to be able to use their bar code checking technology to assure accuracy. Bar codes should be required on each unit produced by the pharmaceutical companies."

How Will It Affect LTC?

Long-term care facilities use bar-coding technology less than in the hospital environment--primarily because of the costs involved.

"Bar codes are used in the long-term care pharmacy as a quality assurance step in prepacking medications into the blister cards/strip packaging and in the dispensing process," said Forrester. "The bar codes significantly decrease the dispensing errors by the pharmacy."

Right now, though, few small- to medium-size hospitals (and even fewer long-term care facilities) have invested in the bar code reading technology. The costs (approximately $800,000 for a 100-bed facility) remains prohibitive.

"Most facilities could not afford this technology with the current Medicare/Medicaid reimbursement rates," she explained. "Without a dramatic decrease in the cost of the technology, subsidy for purchase of the technology, or regulations requiring the implementation of this technology, there will be limited incorporation in long-term care."

A Good Idea--with Problems

Bar codes for patient safety seem like an idea whose time has come. They will work in many situations--but not all.

These scanning devices are electronic and costly--a minimum of $1 million for a 250-bed hospital, said Dr. Cohen. And hospitals are not required to purchase them.

However, institutions that have been contemplating such a system will now have added incentive to purchase and implement one. "The regulation makes it easier for them to justify the expense," noted Foster.

Dr. Cohen said that the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) will eventually develop guidelines and standards about medication safety and bar codes, and they will act as de facto enforcement agents for the FDA regulation.

But until then, he predicted, there will be much confusion about how to implement the regulation.

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