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Benefits of barcoding in the pharmaceutical industry

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Ulrike Kreysa
Group Manager Healthcare Solutions
GS1 Solutions
GS1 Global Office
Brussels
Belgium
E:ulrike.kreysa@gs1.org
W:www.gs1.org

One of the main concerns in healthcare today is patient safety. In 2000, the Institute of Medicine (IOM) published its report To Err is Human(1) and an increasing number of publications are reporting on medical errors, which happen across the world.(2–4) Automatic identification technology (barcoding) is one of the tools that is acknowledged in reducing such errors.(5) It contributes to improving efficiency and increasing accuracy of data entry into automated systems. The possibility of capturing data via barcode scanners, in conjunction with computerised databases, enables healthcare professionals to verify whether the right drug was used at the right time for the right patient in the right dose on the right route (“five patient rights”). Barcoding has the potential not only to be cost-effective but also to save lives while producing a strong return on investment.

Medical errors and usage of barcodes
A barcode is a graphic representation of data that is machine-readable. Barcodes are a fast, easy and accurate way of capturing and entering data. They do not contain descriptive data, but are just a reference number to a computer file with the relevant data.

In a hospital, barcodes can be used to improve processes in the following areas:

  • Patient registration and admission for:

–    Patient forms.
–    Patient labels and wristbands.
–    Patient records.
–    Patient accounting and billing.

  • Patient safety, clinical care delivery and patient tracking by using barcodes for:

–    Pharmaceuticals down to unit dose level.
–    Medical devices down to unit of use level.
–    Identification of hospital staff and patients.
–    Order requisitions, test/results and patient charts/medical records.

  • Product, supply and material management for:

–    Inventory control/tracking.
–    Materials tracking and logistics.
–    Tracking of reusable/refurbished
equipment and supplies.
–    Reverse supply chain (eg, product recalls and warnings).

Taking into account the significant benefits of automatic product identification, the Department of Health and Human Services in the USA has issued a final rule requiring electronically readable barcodes on the packaging of hospital-administered pharmaceutical products, biologicals and blood products. This will be introduced in April 2006.(6)

Mandates for automatic product identification already exist in 40 countries worldwide – others are in the phase of developing regulations for barcoding of healthcare products, acknowledging the advantages for patient safety.(7,8) While studies conducted in Veteran Affairs hospitals (USA) in the 1990s showed that the use of barcodes reduced medication administration error rates by up to 86%, only a small number of hospitals have recently started to use this technology to improve patient safety. Current estimates indicate that only 2–6% of hospitals in the USA are using barcodes to reduce medication administration errors.(9) It is expected that the number of hospitals will increase significantly in the near future, with more products carrying a barcode and more publications reporting the benefits of barcodes.(10–12)

Global standards for pharmaceuticals and medical devices
The healthcare industry has recently recognised the need for global standards in healthcare, and in May 2005 leading global companies from the pharmaceutical and medical device industries formed the global GS1 Healthcare User Group (GS1 HUG(™)).(13) Its mission is to lead the healthcare industry to the effective utilisation and development of global standards, with the primary focus on automatic identification to improve patient safety. The group currently has 34 members from manufacturers, hospitals, regulatory bodies and associations who are committed to working towards a global solution to enhance automatic product identification for the benefit of patients worldwide. The main focus areas are as follows:

  • Prevention of medical errors.
  • Product authentication.
  • Tracking and tracing.
  • Increasing total supply chain efficiency.

The work of the GS1 HUG(™) will improve the performance of the healthcare supply chain for pharmaceuticals and medical devices, through the collaborative development and endorsement of recommended voluntary GS1 standards and best practices. The group includes representatives from all types of stakeholders in the healthcare supply chain – more participants from hospitals are very welcome to join and contribute. Working groups are developing global voluntary guidelines for the marking of pharmaceuticals and medical devices; special teams are also working on marking of vaccines and biologicals, instruments and implants. The GS1 HUG(™) is particularly concentrating on ensuring that appropriate data structures are selected in order to meet common business needs and to help ensure data standardisation in healthcare. If standardisation is applied globally, systems to improve patient safety will be developed and implemented quicker than if individual countries were to pursue separate solutions. The next GS1 HUG(™) meeting will take place in Rome from 21 to 23 March 2006. For participation and other details please contact the author.

Traceability and counterfeiting
Other aspects that have to be considered are the effects of barcoding on streamlining the supply chain and inventory control. In combination with electronic messaging, full supply chain control and effective traceability of the products is possible. This will help to prevent counterfeiting – a topic which, today, worries the healthcare industry and regulatory bodies and is increasing in importance across the world.

Counterfeiting is a bigger issue in developing countries,(14) but even in the USA the number of cases investigated by the FDA has increased significantly in the last year.(15) Increasingly, in Europe too, concerns are raised that, through the more open markets and the rise of “drugs through the internet”, fake products can enter the supply chain.(16) However, ­traceability and integrity of the supply chain can be ensured through additional data for product identification, such as expiration date, lot/batch number and serial number. Only when these data are available throughout all processes and partners in the supply chain will it be possible to combat counterfeiting effectively. With new barcode symbologies (eg, Data Matrix and RSS), it is possible to carry all this information even on very small items and packages.

Most importantly, the use of barcodes on drugs and medical devices will be an important step to improve patient safety. Furthermore, it allows the tracking of medicinal products before, during and after a medical procedure. Data can also be captured in the electronic patient record with little manual input, enabling traceability in the case of recalls but also better calculation of costs for the treatment.

References

  1. Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human: building a safer health system. Committee on Quality of Health Care in America, Institute of Medicine; 2000.
  2. Stein R. For Americans, getting sick has its price. Washington Post, Friday, November 4, 2005; Page A02.
  3. National Patient Safety Agency (NPSA), the Medical Defense Union and Medical Protection Society, September 2005. Medical Error. NHS, reference number 0240AUG05.
  4. Second Annual Patient Safety in American Hospitals Report. Released May 2005 by Health Grades, Inc.
  5. Bates D. Using information ­technology to reduce rates of medication errors in hospitals. BMJ 2000;320:788-91.
  6. Federal Register. Bar code label requirements for human drug products and biological products. 2004;69(38):9119 (26 February 2004).
  7. Japan Federation of Medical Devices Associations (JFMDA). Guidelines for standardizing product codes and barcodes for medical/surgical materials in Japan. August 1999.
  8. Ministry of Health Spain, Circular 1/2004 (Anexo II) of the AEMPS, 9 February 2004.
  9. Center for Business Innovation. (18–19 November 2004). The ­evolution of bar coding and patient safety: update 2004. Third Annual Summit on Patient Safety and Information ­Technology (panel discussion).
  10. Work M. Demonstrating benefits in a community hospital through the use of wireless, mobile barcode technology in medication administration: a case study. 2004. Available from: http://www.carefusion.com/includes/CaseStudies.asp
  11. Wright AA, Katz IT. Bar coding for patient safety. N Engl J Med 2005;353:329-31.
  12. Hay C. La belle histoire des CHU et du code à barres. Décodez 2005;89.
  13. Healthcare industry works together to improve patient safety. GS1 HUG, 18 July 2005. Available from: http://www.gs1.org/hug
  14. WHO, Fact Sheet No. 275, November 2003, Substandard and counterfeit medicines. Available from http://www.who.int/mediacentre/factsheets/fs275/en
  15. Combating counterfeit drugs: a report of the Food and Drug Administration annual update, 18 May 2005. Available from: http://www.fda.gov/oc/initiatives/counterfeit/update2005.html
  16. Harper J. Report on counterfeit medicines. 2005.


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