2002.10.01: October 1, 2002: Headlines: COS - Kenya: Medicine: FDA: US Medicine: Kenya RPCV Paul Seligman said FDA plans to issue a proposal requiring Bar Coded Labels For Drugs
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2002.10.01: October 1, 2002: Headlines: COS - Kenya: Medicine: FDA: US Medicine: Kenya RPCV Paul Seligman said FDA plans to issue a proposal requiring Bar Coded Labels For Drugs
Kenya RPCV Paul Seligman said FDA plans to issue a proposal requiring Bar Coded Labels For Drugs
FDA held a public meeting at the end of July to get feedback on what should be included in the proposed rule. Dr. Paul Seligman, director of pharmacoepidemiology and statistical science at FDA, said the staff at the department has been reviewing comments since the July meeting. Dr. Seligman said FDA plans to issue a proposal in an expeditious manner and noted that the proposal is a "priority for the department and the [HHS] secretary."
Kenya RPCV Paul Seligman said FDA plans to issue a proposal requiring Bar Coded Labels For Drugs
FDA May Require Bar Coded Labels For Drugs - Mary Ellen Butler
Dr. Paul Seligman
WASHINGTON-In an effort to reduce medication errors, the Food and Drug Administration is developing a proposal to require bar code labeling of pharmaceutical products.
Bar codes are a familiar site to most Americans when they shop at the grocery store, but most single-dose packages of drugs used in hospitals are not bar coded. According to FDA, the lack of a bar code at this stage of the process leads to medication errors at the bedside.
FDA is considering a number of issues as it formulates the regulation including which products should be barcoded, what information the codes should include, what bar code symbols should be used, where the bar code should be placed on the package, and how soon the requirements should become effective.
FDA held a public meeting at the end of July to get feedback on what should be included in the proposed rule. Dr. Paul Seligman, director of pharmacoepidemiology and statistical science at FDA, said the staff at the department has been reviewing comments since the July meeting. Dr. Seligman said FDA plans to issue a proposal in an expeditious manner and noted that the proposal is a "priority for the department and the [HHS] secretary."
He added that since FDA understands it will take some time to implement the rule, officials want to get that process started by making their proposal public as soon as possible.
VA As A Model
The Department of Veterans Affairs, which piloted a bar coding system in the early 1990s at its Topeka, Kans., medical center and instituted the use of the Barcode Medicine Administration System (BCMA) across its nationwide hospital system in June 2000, is serving as a model for FDA during this rulemaking process.
Under VA's system, before medications are dispensed, a nurse scans a patient's wristband with a handheld device and then scans the label on the medicine to ensure the patient is getting the right medication. The system also allows the provider to be sure the patient received the right dose at the right time.
VA's system operates in real time so the providers receive instant updates if there is a change in the patient's medication. VA is now expanding its software to include validation of IV medications, and hospitals are scheduled to implement the new software across VA by Nov. 30.
Kay Willis, chief of pharmacy at the VA medical center in North Chicago, told participants at the July meeting that VA recommends uniform barcode standards that would include the national drug code, lot number and expiration date. In her statement she urged the pharmaceutical industry to adopt uniform barcode standards and to implement the technology as soon as is practical.
Dispute In Details
There is widespread agreement that barcoding should be implemented on drug products in an effort to reduce medication errors, and that FDA regulation will be a way to standardize that process. However, the real debate on this issue seems to exist in the details of the proposal.
For example, one of the issues that the FDA regulation will need to address is what information to include in the bar code. There is general agreement that any barcode should include the National Drug Code (NDC), which contains information on product identification and dosage. In addition, groups like the American Society of Health System Pharmacists (ASHP) are advocating for including not only the NDC, but the lot number and expiration dates.
Kasey Thompson, director of the Center for Patient Safety at ASHP, said the lot number can help identify drug products in a recall and could also be useful in the midst of a public health crisis where mass vaccination or drug treatments were needed. The expiration date is important to keep hospitals from inadvertently administering out-of-date drugs, Thompson said.
However, while providers would like to see lot numbers and expiration dates included, industry groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) say the addition of the last two elements would be too cumbersome for the industry since these numbers would frequently change.
Alan Goldhammer, associate vice president for regulatory affairs at PhRMA, said FDA's initial focus should be on including the NDC only in barcodes. Goldhammer explained that the other elements could be included in the barcode but that the difficulty in printing variable elements would push back the implementation time to as much as five years. However, he said the industry could fully implement barcoding of drugs with only the NDC in three years, and in less time with certain drugs.
Timing is another issue that FDA regulators will need to consider since the regulation will need to specify a timeline for implementation of the requirements. Some groups favor a phased-in approach in which the barcoding with only the NDC would be required in the short-term and lot number and expiration date information would be required at a later time.
However, there are still discrepancies in estimates on how fast the industry could implement any form of barcoding. While PhRMA estimates full implementation of an NDC-only barcode in three years, some provider groups like the American Hospital Association have said that implementation could occur almost immediately with the NDC only and in about a year to 18 months for other variable information.
Other issues will also need to be resolved in the FDA proposal, such as the type of symbols used in the bar code. This will be a challenge because there are a number of symbologies available but some will not fit on the small packages of certain single-dose drugs. In addition, hospitals are concerned that the symbologies used be compatible with current scanning devices.
Thompson said that flexibility in the regulation to allow the use of new technologies will benefit both hospitals and manufacturers. "What hospitals want is something they can use," he said.
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Story Source: US Medicine
This story has been posted in the following forums: : Headlines; COS - Kenya; Medicine; FDA
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