How It Would Work

The bar code, at a minimum, contains the drug's National Drug Code number, which uniquely identifies the drug, its strength, and its dosage form (e.g., 10 mg. capsule). The rule also covers blood and blood components.

Figure 1

Unit doses of certain medications can be bar coded for point-of-care scanning

The bar code, when used in conjunction with a bar code scanning system and computerized database, works as follows:

• A patient is admitted to the hospital. The hospital gives the patient a bar-coded identification bracelet to link the patient to his or her computerized medical record.

• Every prescription drug and certain over-the-counter drugs would have a bar code on its label. The bar code would reflect the drug's National Drug Code number.

• The hospital must have bar code scanners or readers that are linked to the hospital's computer system of electronic medical records.

• Before a healthcare worker administers a drug to the patient, the healthcare worker scans the patient's bar code. This allows the computer to pull up the patient's computerized medical record.

• The healthcare worker then scans the drug(s) that the hospital pharmacy has provided to be administered to the patient. This scan informs the computer which drug is being administered.

• The computer then compares the patient's medical record to the drug(s) being administered to ensure that they match what is prescribed for the patient.

• If there is a problem, the computer sends an error message, and the healthcare worker investigates the problem.

• The problem could be one of many things:

• • Wrong dose of drug

  • Wrong drug

  • Wrong time to administer the drug

  • The patient's chart has been updated and the prescribed medication has changed

Reducing Errors

The requirement for bar codes adopts a technology that is widely used in other industries to reduce the number of medication errors in hospitals and other health care settings. The required bar code contains the National Drug Code (NDC) number, unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label.

The design allows manufacturers to include additional information, and more information could also be added to the bar code standards as information technology progresses. When used with bar code scanners and computerized patient information systems, bar code technology can prevent many medication errors including administering the wrong drug, administering a drug to a patient who is known to be allergic, administering the wrong dose, administering the drug at the wrong time, or using the wrong route of administration (for example, by injection rather than by mouth).

Reducing Costs, Saving Lives

Medication errors represent a significant economic cost to the United States. According to the Institute of Medicine and other experts, thousands of deaths and millions of hospitalizations result from medication errors. The expected annual benefit from preventing adverse events due to medication errors is equivalent to $3.9 billion. Some hospitals report a 50 percent or greater reduction in errors from bar code usage. Bar codes may also help prevent other types of medication errors, such as in prescribing and transcribing, because they will encourage health care organizations to adopt computerized systems for handling prescriptions.

The rules apply to all prescription drug products, including biological products and vaccines (except for physician samples), and OTC drugs that are commonly used in hospitals and dispensed in a hospital pursuant to an order. Standardized bar codes would also be required on prescription drug products used in other settings such as retail pharmacies.

More Benefits

Bar codes make it easier for hospitals and other health care facilities to enter medication order entries into a patient's electronic medical records, help in inventory control and billing, and conserve hospital or healthcare staff resources or free those resources so that they can be devoted to patient care.

In the retail setting, pharmacists can use the bar codes, in conjunction with computerized prescription orders, to confirm that the right drug is being dispensed to the right patient. Pharmacies will benefit from standard codes that will be used by all prescription manufacturers.

Drug manufacturers will benefit from uniform standards, rather than having to worry about conflicting requirements from different purchasers that would add to the cost of adopting bar coding. It is likely that, once the FDA standards are finalized, many manufacturers may quickly begin incorporating the bar codes on their products - even before the rule takes effect.

As part of this Patient safety initiative, FDA proposed 2 new rules. The first (“Bar Code Label Requirements for Human Drug Products and Blood”) will require “bar codes” on all prescription and some over-the-counter drugs and vaccines, which FDA hopes will improve patient safety by reducing medication errors. The bar code, used with a bar code scanning system and computerized database, would work as follows: Every hospitalized patient would have a bar-coded identification bracelet to link the patient to his or her computerized medical record, and every prescription drug and certain over-the-counter drugs would have a bar code on its label, reflecting the drug's National Drug Code number. Before healthcare workers administer a drug to a patient, they scan the patient's bar code, and the bar code of the drug(s) that the hospital pharmacy has provided to be administered to the patient. The computer then compares the patient's medical record to the drug(s) being administered to ensure that they match what is prescribed for the patient. If there is a problem (such as: wrong drug, wrong dose of drug, wrong time to administer the drug, etc.), the computer sends an error message, and the healthcare worker investigates the problem. FDA estimates that the bar code rule, once implemented, will result in a 50% increase in the interception of medication errors at the “dispensing and administration” stages. This will result in 413,000 fewer adverse events over the next 20 years. Patients would avoid pain, suffering, and extensions of hospital stays with an estimated present value of $41 billion over those 20 years. Hospitals are expected to avoid litigation associated with preventable adverse events, reduce malpractice liability insurance premiums, improve inventory control, and increase receipts from more accurate billing procedures. Prescribers would be able to avoid inadvertant errors in the prescribing, transcribing, dispensing, administration and recording of medications they intend for their patients.

The second rule (“Safety Reporting Requirements for Human Drug and Biological Products”) increases reporting requirements for safety problems involving medicines, which FDA proposes will more quickly identify potential medication errors that may occur. Many of the provisions in the proposal were developed jointly (through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) by the regulatory authorities in the United States, the European Union, Canada, Switzerland, and Japan, together with the pharmaceutical and biologic industry, to improve the quality and consistency of safety information reporting to regulatory authorities globally. These new international standards will improve the quality and usefulness of patient safety data submitted to regulatory authorities by industry, and also reduce industry's reporting burden by allowing them to use the same definitions and follow one common set of procedures in reporting safety information worldwide. FDA estimates that if the incidence of just the hospitalizations related to adverse drug reactions can be reduced by only 2 percent, the annual cost savings to the nation would be $368 million. Prescribers would be informed more quickly of new information about medications they prescribe, so they could adjust their practice patterns more quickly to protect patients and reduce liability risks.

Conclusion

Momentum for unit-of-use bar coding is growing throughout the healthcare industry. Early adopters have proven the benefits of tracking systems and the effectiveness of current bar code technology. Users at all points in the supply chain should begin reviewing their business processes and start designing systems to take advantage of unit-of-use bar codes. There is no reason to wait for FDA mandates or to fear that action taken now will be incompatible with future rules. Modern bar code reading systems and thermal printers enable users to implement cost-effective controls that have the flexibility to support any of the data structures and bar code symbologies under consideration by the FDA

Correspondence to

S S Biradar Lecturer Dept of Pharmaceutics KLES College of Pharmacy Vidyanagar HUBLI -31 Karanataka email:biradarappu4u@rediffmail.com