“Enabling safer patient care: automatic identification standards for
     pharmaceuticals and medical devices”


     1. E...
3.3.2.More than 30% of all adverse drug events are preventable and appear to be
              consequences of medication e...
verification of the 5 or 8 patient rights at the different stages.
         4.1.3.Automating the prescription and administ...
identification number matches the database content and there is no prior dispensing
              record, the Healthcare p...
independent standards permit full interoperability and compatibility and enable the
                realisation of all hea...
Director - Technical & Regulatory
111 Westminster Bridge Road
London SE1 7HR
T: +44 (0) 20 7960 4370(DDI)
F: +44 (0) 20 79...
Upcoming SlideShare
Loading in …5
×

UK: Response to UK House of Commons Inquiry into Patient ....doc

282 views
245 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
282
On SlideShare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
1
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

UK: Response to UK House of Commons Inquiry into Patient ....doc

  1. 1. “Enabling safer patient care: automatic identification standards for pharmaceuticals and medical devices” 1. Executive summary 1.1. Medication errors and counterfeit medical products are a serious risk to public health. Automatic Identification and Data Capture (AIDC) systems and traceability systems enabled by global, open, and proven standards provide the opportunity to make the healthcare supply chain safer, reduce medication errors and fight counterfeiting. GS1 recommends supporting and accelerating the development, adoption and implementation of standards-based AIDC systems (bar codes or RFID) and traceability systems throughout the healthcare sector in the UK. 2. Introduction to GS1 2.1. GS1 is a neutral, not-for-profit standards organisation developing global supply chain standards and facilitating the adoption and implementation of such standards. GS1 UK is the GS1 Member Organisation in the UK. 2.2. In 2007, the Department of Health recommended that the GS1 system should be adopted throughout the Health Care system in England, both for manufactured products and for coding systems. The take up and use of this coding is promoted by the ‘Coding for Success’ Project, which is due for review at the end of this year. 3. What are the risks to patient safety? 3.1. Medication errors pose a significant risk to public health and have a serious social and economic impact. They may result in additional treatments, disabilities and even deaths. Counterfeited pharmaceutical products and medical devices also put people’s lives at risk and are an increasing global threat. 3.2. Adverse events due to medical errors in general. 3.2.1.Estimates from the UK indicate that about 10% of inpatient episodes result in errors of some kind, about half [of which] are preventable. Each year, about 850,000 patient admissions result in a patient safety incident, costing the National Health Service (NHS) approximately £2 billion in extra hospital days.1 3.2.2.Estimates from the US indicate that between 44,000- 98,000 people in America die each year as the result of medical errors2. Estimates of cost for the US include the expense of additional care that is necessitated by the errors, as well as lost income and household productivity from resultant disability. These have been estimated at $17-29 billion annually3. 3.3. Adverse events due to medication errors. 3.3.1.The right medication needs to be given to the right patient in the right dose at the right time by the right route (the 5 patient rights). Adverse events from medication errors represent a significant problem for Healthcare worldwide, as indicated by several studies in different countries. 1 Department of Health 2007 Staple Court, 11 Staple Inn Buildings 2 Institute of Medicine “To err is Human” 1999 London WC1V 7QH 3 T +44 (0)20 7092 3500 Healthcare Distribution Management Association 2004 F +44 (0)20 7681 2290 E info@gs1uk.org Helpdesk (Freefone) 0808 178 8799 GS1 UK is a company limited by guarantee and registered in England and Wales under company number 1256140. www.gs1uk.org Registered office Staple Court, 11 Staple Inn Buildings, London WC1V 7QH. VAT number 287940215.
  2. 2. 3.3.2.More than 30% of all adverse drug events are preventable and appear to be consequences of medication errors (prescription, transcription, processing, or administration)4. 3.3.3.An adverse event study in Spain indicated that 9.3% of hospital stays incurred a serious adverse event, with medication errors being the main cause (37.4% of such events)5. 3.3.4.Estimates in New Zealand indicate that, each year, about 5,000 patients are subject to medication errors. As a result of these errors about 150 patients die, over 400 are permanently disabled and nearly 3,500 are disabled for less than one year.”6 3.4. Medical errors with medical devices. 3.4.1.The five patient rights become eight patient rights: the right patient, the right device, the right location, the right time, the right condition, the right procedure, the right anatomical site, and the right user (healthcare professional). 3.5. Counterfeit drugs & medical devices 3.5.1.The World Health Organisation advises against using a single average figure for global proportion of counterfeit medicines because, besides being necessarily imprecise and inaccurate, a single global ratio blurs the real picture and can mislead the public. WHO considers it is reasonable to estimate that the prevalence of counterfeit medicines ranges from less than 1% of sales in developed countries, to over 10% in developing countries, depending on the geographical area7. 3.5.2.The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. 3.5.3.In 2007, the UK was confronted with the largest counterfeit penetration. In May 2007, there were 4 class 1 recalls (cancer, heart, and anti-psychotic) and 40,000 packs were seized by the MHRA. 4. To what extent are these risks avoidable and what measures can be taken to improve patient safety? 4.1. Risk of medication errors 4.1.1.Medication errors often represent the failure of a complicated healthcare system and can occur anywhere in the distribution system, although predominantly during prescription and administration, respectively 39% and 38%8. Dispensing and transcription errors account for 11% and 12%. Whilst nurses or pharmacists often intercept about half of the errors originating during prescribing, before they reach the patient, only 2% of administration errors are intercepted9. 4.1.2.In most hospitals, the current drug distribution system heavily relies on human 4 “Creation of a better medication safety culture in Europe: Building up safe medication practices” - Expert Group on Safe Medication Practices, Council of Europe - 2007 5 Estudio Nacional sobre los efectos adversos ligados a la hospitalización (ENEAS 2005). Informe. Febrero 2006. Ministerio de Sanidad y Consumo. Madrid 2006 6 Anderson 2007 7 “Counterfeit Medicines: an update on estimates”, WHO, 15 November 2006 8 “Systems analysis of adverse drug events” – ADE Prevention Study Group, Leape, Bates, Cullen et al. – JAMA 1995 and “Using chart review to screen for medication errors and adverse drug events” – Kaushal – Am J Health System Pharm 2002 9 “System analysis of adverse drug events” – Lepe, Bates, Cullen, et al – JAMA 1995; 274:35-43 Patient Safety Inquiry Page 2 of 6 www.gs1uk.org
  3. 3. verification of the 5 or 8 patient rights at the different stages. 4.1.3.Automating the prescription and administration processes using Automatic Identification & Data Capture technologies (bar codes and RFID) has proven to significantly reduce medication errors. A few examples: 4.1.3.1.The Department of Veteran’s Affairs in the USA introduced bar code systems for medication administration in its nationwide network of hospitals in 1999. For example, the VA Medical Center in Topeka has reported that bar coding reduced its medication error rate by 86% over a nine-year period10. 4.1.3.2.Chelsea and Westminster Healthcare NHS Trust, UK introduced a robotic dispensing system in May 2003. A study in the hospital pharmacy found that dispensing errors were reduced with 67% from 2.7% to 0.9% of prescriptions11. 4.1.3.3.Brigham & Women’s Hospital, Boston, USA introduced bar code scanning in the preparation, dispensing, and delivery process. Results in error reductions were remarkable: wrong medication and wrong dose/strength were reduced respectively by 53% and 58% and the wrong dose form was even eliminated12. 4.1.3.4.The introduction of bed side bar code scanning at the Gerle Ziekenhuizen in Maastricht, the Netherlands, resulted in a reduction of 74% in administration errors (from 3.10% to 0.84%)13. 4.1.4.Global standards are needed to enable the efficient and effective roll-out of coding systems throughout the healthcare sector. Healthcare is by nature a global sector, with supply chains that often cross borders. Local needs are incorporated into global standards, but local standards hinder interoperability and compatibility. Additional R&D and manufacturing resources would have to be devoted to meeting heterogeneous local standards. 4.2. The role of the public perception of risk in determining NHS policy. 4.2.1.Press interest, public interest and Government interest in patient safety has overwhelmingly concentrated on hospital acquired infections. Medical errors are somewhat overshadowed and perhaps overlooked. In terms of numbers of patients affected, both problems are similar in extent; affecting approximately 10% of patients. Medical error, however, is estimated to cause three or four times the death rate. Coding systems offer a very cost effective mechanism which can dramatically reduce the number of patients killed or harmed. 4.3. Risk of counterfeiting. 4.3.1.Counterfeit drugs are extremely profitable and the risk of detection can be minimal. 4.3.2.The introduction of unique identification for each and every pack of drugs will enable authentication and traceability systems utilising readily available technology. This would significantly improve the safety of pharmaceuticals and patients. It will make it much more difficult for counterfeiters to intrude into the Healthcare supply chain, or at least make it uneconomic. Unique identification allows the dispensing Healthcare professional to cross-check a pack of drugs online in a database. When the 10 “Strategies to Reduce Medication Errors - How the FDA is working to improve medication safety and what you can do to help”, Michelle Meadows, FDA Consumer magazine May-June 2003 11 Chelsea and Westminster Healthcare NHS Trust, K. Robertson Ref. “Coding for success – Simple technology for safer patient care” - UK Department of Health - 16 February 2007 12 “Lessons learned with Bar-coding and eMAR”, Tom Cooley, Brigham and Women's Hospital at GS1 Healthcare Conference 13 - 15 June 2006, Minneapolis, USA 13 “Het effect van elektronisch voorschrijven en elektronische toedienregistratie met barcodescanning op het optreden van medicatie toedienfouten”, Elsbeth Wesselink, Gerle Ziekenhuizen, 10 November 2006 Patient Safety Inquiry Page 3 of 6 www.gs1uk.org
  4. 4. identification number matches the database content and there is no prior dispensing record, the Healthcare professional can dispense this pack of drugs. Counterfeiters would first of all need a legitimate identification number that is registered in the database to enable authentication. In the worst case, two packs of drugs with the same serial number would be present in the supply chain, in which case stakeholders would be alerted about this intrusion when the second pack is being cross-checked. 4.3.3.Counterfeiting is a global threat. Technical solutions to fight counterfeiting need to be internationally aligned based on global standards to ensure compatibility. 4.4. Is there a safety culture and are there systems for incident reporting and safety improvement? 4.4.1.The Parliamentary Office of Science and Technology produced a useful analysis of Managing Human Error (June 2001, Number 156). The report argues that while we cannot eliminate error, we can learn from it and we can design systems that minimise it. It cites bar coding as an example of reducing error in hospitals by reducing task complexity. 4.4.2.The NAO report ‘A Safer Place for Patients’ concluded that medical errors are under- reported and that after falls – medication error, record documentation and communication failure were the main causes of injury. 5. What Should the NHS Do? 5.1. ‘Are the measures taken to improve patient safety supported by clinical and cost effectiveness?’ 5.2. Press interest, public interest and Government interest in patient safety (probably in that order) has overwhelmingly concentrated on hospital acquired infections. Effort and resource has generally reflected interest. 5.3. We do not wish to deny the importance of dealing with the very real problems of MRSA and C difficile. We simply point out that medical errors are somewhat overshadowed while they are estimated to cause three or four times the death rate. 5.4. In spite of considerable efforts, reducing the acquired infection rate is proving very difficult. In contrast, we offer a very cost effective mechanism which can dramatically reduce the number of patients killed or harmed by medical errors. In fact, introducing a comprehensive coding system will not only save patients’ lives but also NHS money. 6. Recommended actions 6.1. Leveraging ‘Coding for Success’, the report published by the Department of Health recommending the adoption of Automatic Identification and Data Capture (AIDC) based on the GS1 coding system to improve patient safety: 6.1.1.Continue to support and accelerate the development, adoption and implementation of standards-based AIDC systems (bar codes and/or RFID) throughout the healthcare sector. 6.1.2.Support and drive the development, adoption and implementation of traceability systems, where appropriate. The GS1 Global Traceability in Healthcare Work Team, since December 2007, has been working with global stakeholders to develop the GS1 Global Traceability Standard for Healthcare (GTSH). The draft GTSH has begun the process of approval and ratification; when this is achieved the GTSH will be available for implementation (goal: early 2009). The work team is now focussed on developed Traceability in Healthcare Implementation Guidelines. 6.1.3.Continue to support the development, adoption and implementation of global standards enabling AIDC technologies and traceability. Global, open and technology- Patient Safety Inquiry Page 4 of 6 www.gs1uk.org
  5. 5. independent standards permit full interoperability and compatibility and enable the realisation of all health and economic benefits related to AIDC and traceability. 7. About GS1 and GS1 UK 7.1. GS1 is a neutral, not-for-profit standards organisation. GS1 is a user-driven organisation dedicated to the development of global supply chain standards and to the facilitation of adopting and implementing of such standards. GS1 is driven by more than a million companies, who execute more than five billion transactions a day with the GS1 System of standards. This makes it the most widely used supply chain standards system in the world. GS1 standards are open, global and voluntary. 7.2. GS1 is truly global, with local Member Organisations in 108 countries, and with Global Offices in Brussels, Belgium and Princeton, USA. 7.3. GS1 UK is the GS1 Member Organisation in the UK. GS1 Standards are used by the overwhelming majority of retailing and manufacturing companies in the UK. Though its origins are in retail, GS1 is increasingly providing coding for the health service here and in most other developed countries. 7.4. GS1 Healthcare is a global, voluntary user community consisting of representatives from all stakeholders, including manufacturers, wholesalers, distributors, hospitals, pharmacies, regulatory bodies, industry associations and GS1 Member Organisations. Its mission is to lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies 7.5. For more information, please visit www.gs1.org/healthcare 7.6. In 2007, the Department of Health recommended that the GS1 system should be adopted throughout the Health Care system in England, both for manufactured products and for coding systems. The take up and use of this coding is promoted by the ‘Coding for Success’ Project, which is due for review at the end of this year. 8. Contacts GS1 UK Roger Lamb, Healthcare Manager Staple Court, 11 Staple Inn Buildings London, WC1V 7QH T 020 7092 3500 E roger.lamb@gs1uk.org www.gs1uk.org GS1 Global Office Ulrike Kreysa, Director Healthcare Blue Tower, Avenue Louise 326, bte 10 1050 Brussels, Belgium T +32 2 788 78 11 F +32 2 788 78 99 E ulrike.kreysa@gs1.org www.gs1.org ABHI Mike Kreuzer Patient Safety Inquiry Page 5 of 6 www.gs1uk.org
  6. 6. Director - Technical & Regulatory 111 Westminster Bridge Road London SE1 7HR T: +44 (0) 20 7960 4370(DDI) F: +44 (0) 20 7960 4361 E: michael.kreuzer@abhi.org.uk Patient Safety Inquiry Page 6 of 6 www.gs1uk.org

×