IN AN EFFORT TO FUEL THE ALREADY widespread campaign to improve patient safety, the FDA finalized a rule this past February requiring bar codes on the labels of drugs and biological products. By helping ensure that health professionals administer to patients the right drugs at appropriate doses, this measure is meant to minimize medication errors. Bar coding at the unit dose level will allow for bar codes on drugs to be scanned, and compared to patients’ identification bracelets, which will link the patient to his or her computerized medical record. If there is a problem, such as a wrong drug or erroneous dose, the computer sends an error message, and the healthcare worker investigates the problem. The FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years. This equates to a 50% reduction in medication errors that would otherwise occur when drugs are dispensed or administered.

With this soon-to-be mandatory rule on our agenda, we set out to evaluate the plausibility as well as the practicality of implementing this seemingly ideal, yet still theoretical, system in our real-life 600-bed facility. The beneficial applications of bar coding were quite obvious to us. At the most basic level, the system would help to verify that the right drug, at the right dose, at the right route, and at the right time, is being administered to the right patient. Such a system would also be connected to an electronic medication administration record (MAR) that would likely be more accurate than traditional MARs generated manually. Bar codes would also result in improved inventory control, billing accuracy and reduction of rework.

Along with these advantages, we iden-tified potential barriers to implementing such a system. With contributions from every member of our staff and a review article on bar coding from the Institute of Safe Medication Practices, we drew up a considerable list of challenges and common-sense questions:

Challenges in Bar Coding

• Currently, only about a third of drugs contain manufacturer’s bar codes.
• There is a growing trend of fewer medications being made available by manufacturers in unit-dose form.
• There is no uniform standard for bar coding medications.
• No standard exists for relabeling/bar coding in-house. In the absence of such standards, hospitals are left to follow whatever commercial standards exist.
• In-house repackaging of medications and bar coding result in unreimbursed costs and, especially if done manually, may introduce new sources of error.
• Interfacing the bar-coded medication administration system with ITsystems may prove difficult and costly.
• Bar code scanners need to be readily available and set up to be user-friendly in order to minimize any disruption of a nurse’s workflow.
• Temporary “agency” or “floating” nurses may be unfamiliar with the system; therefore time and effort must be expended to orient
  newcomers.
• Patient-specific medications, such as multi-additive intravenous solutions, most pediatric dosage forms, and pharmacy-compounded products, would require bar coding by in-house pharmacy departments.

Common Sense Questions

• How do you get a bar code onto a slippery tube of ointment?
• How do you find a bar code label small enough to fit on a bottle of insulin?
• How do you deal with NDC number discrepancies?
• How do you deal with investigational drugs?
• How expensive is this process?
• How laborand time-consuming is this process?
• What are the maintenance requirements for an in-house bar coding system?

Selecting the Right System for Our Facility
We realized that in these early stages of bar code implementation, it is essentially impossible to address and resolve all the challenges on our lengthy list. We therefore decided to identify our fundamental core requirements and deal with all other issues on an ongoing basis, as our process matures. In outlining our requirements, we looked for a bar code system that would be available, user-friendly, and most importantly, safe. We considered an in-house system, but this option was not available to us without immediate capital justification. As a result, we relied on an outsource company to provide an immediate solution.

In considering the right outside repackager for our hospital, we utilized a template for a request for proposal (RFP) to IT vendors, provided by the California Healthcare Foundation. This document helped us ask the right questions in regard to vendor stability, product capabilities, and the levels of service and support that can be anticipated. Initially, we ascertained the stability and integrity of the company. We inquired about years in operation, experience in health care and with the repackaging product, number of sites where product is implemented, references (current users), ratings information, and accreditation by professional organizations. We then evaluated the quality of services by inquiring about availability of proper training and technical support, as well as the number of personnel that would be involved in implementation. In evaluating product technologies, we took into consideration the following:

• Age of technology
• Cost
• Technological platform
• Types of application devices
• Networking requirements
• Capacity for data storage
• Product interface capabilities
• Disaster recovery ability
• Safeguards for security/patient confidentiality
• Availability of customization
• Regulatory compliance
• Support for upgrades
• Site preparation and requirements
• Flexibility

By conducting our search in this structured manner, we were able to identify Macron Packaging Systems of Wayne, New Jersey, as the company that met our selection criteria. Macron is providing us with a clean facility, highend equipment, flexibility in terms of their ability to repackage various dosage forms (i.e., liquids and large capsules), and paperwork trails.

How It Works
We ship a copy of our purchase order to Macron, along with the medications that we receive from the manufacturer that are not in unit dose packages. Macron verifies the amount of drug received, matches our purchase order with the bulk product, and then assigns a lot number to our shipment. All the necessary labeling requirements are identified and a packaging record that follows the product through the packaging process is created. Our drugs are then packaged into the bar coded unit dose blister by packaging technicians in a current Good Manufacturing Practices (cGMP) environment. Macron provides packaging line clearance and cleaning on drug-to-drug and lot-to-lot changeovers, which control for drug mix-ups or cross-contamination.

Throughout the process, regular quality checks are conducted to ensure both package integrity and that every bar code is electronically verified as readable. At the conclusion of packaging, our order is closed out and shipped back to us within 72 hours. The packaging record is maintained according to FDA requirements. The service has been friendly, reliable, timely, and efficient. Implementing the bar code system has thus far been a simple, costefficient process. We are not utilizing the bar codes yet, but we have the capability, and are poised to activate that feature at any time.

Cheryl L. Krempa, RPh, MBA, is the Director of Pharmacy at Newark Beth Israel Medical Center, an affiliate of the Saint Barnabas Health Care System. Ms. Krempa has been Director of Pharmacy at NBIMC for the past five years. She is a past-president of the New Jersey Society of Health-System Pharmacists and a current member of the American Society of Health-System Pharmacists.