Transcript Hospital
Why hospitals should implement GS1 standards What can we learn from the Irish Haemophilia Project? Feargal Mc Groarty, Project Manager, National Centre for Hereditary Coagulation Disorders, St James’s Hospital, Ireland Agenda • • • • Why standards? Our story The benefits Conclusions The obvious Standards improve patient safety… by protecting from counterfeiting… Counterfeit medicines may look the part…… But they are manufactured in squalid …and are have been found to contain harmful ingredients conditions…… including.. The end product Africa's Malaria Battle: Fake Drug Pipeline Undercuts Progress A study published in 2012 by the Lancet medical journal and conducted by a unit of the National Institutes of Health found that 35% of 2,300 malaria drug samples tested in sub-Saharan Africa were of "poor quality"—either fake, expired or badly made. Such pills "are very likely to jeopardize the unprecedented progress and investments in control and elimination of malaria," the paper's authors concluded. Source: http://online.wsj.com/news/articles/SB10001424127887324474004578444942841728204 But…it’s not just pharmaceuticals and it’s not just Third World countries So, why do we need to secure our supply chain….! • • • • Anti counterfeiting Band protection Patient safety End to End traceability All these projects have one thing in common….Standards ‘The nice thing about standards is that there are so many to choose from’ (Andrew Tannenbaum, the Vrije Universiteit, Amsterdam) to which has been added ………… ‘and if I can’t find one I like, I’ll make up my own!’ (Paul Amos, Information Standards Board for Health and Social Care in England, UK). Link First Barcode scanned in Retail in 1974 First Barcode scanned in Healthcare…..1991…but The blindingly obvious! Medicines are supposed to save lives… Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. (Lepakhin V. Geneva 2005) Pharma Drug manufacturing..the not so obvious Drug development….excellent! Quality and Validation…excellent! Pharma Supply Chain… excellent! And then after 17 years development what do they do…? When the drug gets to the patient…. Not counterfeit but just as dangerous! Would barcode scanning have prevented this? Absolutely! How did this happen? American College of Obstetrics and Gynaecologists – August 2012 “The main causes (of medication error) are human factors including…. • Fatigue • Inattention • Memory Lapse • Lack of Knowledge • Failure to communicate Do these suffer from any of the causes listed? Medical devices…..same problem Poly Implant Prothèse (PIP): French company, Founded 1991 (liquidation 2011) produced breast implants Globally Approximately 400,000 women may have PIP gel implant products implanted. 2001: PIP began to use unapproved in-house manufactured industrial grade, instead of medical-grade, silicone its implants. 2009: Concerns surfaced in France when surgeons started reporting an abnormally high rupture rates; resulted in a flood of legal complaints and PIP's bankruptcy. 2010: March PIP placed into liquidation, losses of 9 million EUR after the French medical safety agency recalled its implants. 2011: December 23, following death of a woman, French government recommended 30,000 French women seek removal of PIP implants They were correctly identified 22 BUT: Recalls and patient contact hindered by lack of traceability No UDID, No Implant Register http://en.wikipedia.org/wiki/Poly_Implant_Proth%C3%A8se Implants…… 2012: MHRA recognise a small number of patients with large metal on metal full hip replacements could develop complications. 28 February MHRA issued patient Management/monitoring advice to surgeons and doctors to monitor patients every year for the lifetime of their metal on metal total hip replacements 25 Jun Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice Patient identification improved by National Joint Registry but traceability in hospitals lacking http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Productspecificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on23 metalhipimplants/index.htm Therefore….. • The lack of barcodes hinders the undoubted efficiencies that that could be gained by the use of global standards….. Business Case for Bar code scanning • Up to 30% of Healthcare budgets may be spent one way or another on handling information, collecting it, looking for it, storing it. • The typical error rate for human data entry is 1 error per 300 characters • The error rate can be as good as 1 error in 36 trillion characters for barcode scanners Benefits of Barcodes • • • • • Improve Operational Efficiency Save Time Reduce errors Cut Costs Benefit from Customer or Regulatory Requirements Solution GS1 Standards But if you still need persuading on why hospitals should implement standards……. New McKinsey & Company report on benefits of a single global standard New McKinsey report “Strength in unity: The promise of global standards in healthcare” Highlights the cost savings and patient safety benefits of adopting a single global supply chain standard in healthcare Available at: http://www.gs1ie.org/healthcare Source: http://www.mckinsey.com 29 New McKinsey & Company report on benefits of a single global standard “We found that 25% of clinical staff’s time is spent looking for things, and 10-15% of their time in the OR is spent looking for instruments.” Hospital administrator “Imagine a world where Doctors and Nurses could spend less time with paperwork and more time with patients” Source: http://www.mckinsey.com 30 Vision for Healthcare Scan – GTIN, GSRN, GLN The Scan at the Patient Bedside supports AUTOMATED: •Payment of Invoice •Inventory check of stock levels and replenishment •Traceability – ability to Recall >> Links Clinical Systems with Non-Clinical Systems Scan – GTIN, GSRN, GLN Standardised, Integrated, Easy to Use 31 What are the Regulators saying? EU Falsified Medicines Directive (FMD) • • • • Product Code Batch Expiry Serial Number US FDA Global Unique Device Identification (UDI) Database • • • • Product Code Batch Expiry Serial number (where applicable) 32 Example from Irish Healthcare… National Centre for Hereditary Coagulation Disorders (NCHCD) • Located at St James’s Hospital, Dublin, Ireland • Manages patients with inherited and acquired bleeding disorders • Approximately 2000 patients with Haemophilia • Approximately 200 patients with severe haemophilia (require intensive care/treatment) • Over 75% Patients with severe Haemophilia self medicate at home What is Haemophilia and why is traceability important? • Haemophilia is a Chronic Disease, it is a bleeding disorder caused by a deficiency of a clotting factor • Incidence is between 1:5,000 and 1: 10,000 Males • The treatment of haemophilia involves the replacement of the clotting factor (previously prepared from pooled plasma) using a concentrated preparation “Clotting Factor Concentrate” (CFC) • Patients required to self treat at home • Lack of prompt response can lead to prolonged hospitalisation, decreased quality of life and misuse or wastage of expensive plasma and recombinant products What triggered the initiative? Catastrophic Event Failure of Supply ChainInfection of patients with Hepatitis C and HIV due to contaminated blood products. Infected medication remained in the supply chain after recall - leading to subsequent infection Over 70 people died in Ireland alone Lindsay Report 2001 Main Recommendations – Improve communication between treatment centres – Accurate product tracing – Enact a validated product recall Medication Supply chain…..where we were Redesign the Supply Chain Medication Manufacturer Patient Home Cold Chain Supplier Patient Hospital Medication Cold Chain Supplier Manufacturer Hospital Patient Patient Home Piece missing! Manufacturer Cold Chain Supplier Medication Hospital Patient Patient Home Manufacturer Cold Chain Supplier Medication Hospital Patient Patient Home Manufacturer Cold Chain Supplier Medication Hospital Patient Patient Home The Final Piece! Manufacturer Cold Chain Supplier Medication GS1 Barcodes Hospital Patient Patient Home Solution – Adopt the Retail Track and Trace Model based on GS1 Standards • Unique identification (barcode) of patient – PMGSRN • Unique identification (barcode) of medication - Serialised GTIN • Unique identification (barcode) of locations (Hospital/Home/Pharmacy/Transport) - GLN Solution 18 Identify Product Name (GTIN) Batch Number Expiry Date Serial Number 19 Capture Solution for tracking and tracing products within the Hospital Bar coded medication is delivered to the Hospital by TCP Prepare product (GTIN) Hospital (GLN) Stock Fridge (GLN) Patient receives CFC Check Product V Patient and issue Issue Fridges (GLN) Share Recall Reports Recall Reports Delivery to the home and “In home” usage Cold Chain receives home patient orders with GTIN & delivery location details GLNs Electronic prescription Data sent to the EPR and stock management system with product usage information Patient scans product. Verification received from EPR Details of all movements are sent to the stock management system Cold Chain Supplier verifies delivery of product to Patient - recording batch and expiry details GLN, GTIN Cold Chain Supplier verifies Order at dispatch - recording batch and expiry dates GLNs, GTIN Patient usage trends Original 2004 SJH Patients Factor VIII Average Usage Per Month Original 2004 SJH Patients Factor IX Usage 500 700 696 690 480 690 476 466 460 680 675 440 670 420 660 652 650 380 630 360 2005 2006 2007 402 400 640 2004 418 2004 2005 2006 2007 Smartphones with scanning App How it works The system is designed to be simple to use but comprehensive – designed in consultation with patient focus group Log-in Secure Login by • Username/Password or •Scanning unique GS1 ID on Card Patient Details Patient detail confirmation includes product of choice Scan Product Barcode on Vial box is scanned to check •product detail (prescription) •expiry date •Recall status Validation – FAIL! If incorrect product or product out of date or RECALLED, system will alert using a visible and audible alarm Validation – OK ! If the Product passes the validation checks then the user is prompted to continue. There is also the ability to retrospectively record treatment Infusion Detail User records reason for infusion Specific bleed sites can be used to trigger e-mail alerts to the treatment centre •Head Injury •Iliopsoas Bleed •Haematuria •Haemoptysis •Haematemesis •PR Bleed Infusion Authorisation Again, the app prompts the patient to proceed. Process Complete Process concludes, system synchronises data wirelessly to web application Share Patient infusion logs Outcomes/ROI Validated Cold Chain delivery Service using Datamatrix Bar coding on medication packaging • Since Cold Chain delivery started all products verifiably delivered between 20-50 Celsius • Documentation errors reduced from 12 to zero in the year post service implementation • € 5 Million worth of medication stock has been removed from the supply chain • Stock rotation in 2011 saved €600,000 worth of stock • Mock Recall identified location of all (100%) Medication within 10 minutes along with quantities of alternate stock available Initial Outcomes from smartphones • Realtime recall alert • Timeliness of infusion • Prescription compliance (2000iu instead of recommended 1750iu) • Automatic compliance (no manual record keeping) • Electronic diary • Realtime Alerts for specific bleeds • Patient empowerment • Significant savings (over €70,000 within 3 months with 20 users) Where we are What next……? GS1 Standards help enable traceability of surgical instruments at St James’s Hospital (as part of National HSE programme) Issue(s) • • St James’s Hospital – 1,000-bed hospital in Dublin, Ireland Ineffective traceability of surgical instruments from theatre through to hospital sterilisation process Time wasted on manual processes (searching for instruments, documentation etc.) Solution • • • Implementation of an integrated tracking and traceability system Identification of Instrument Trays using GS1 numbers Implementation of GS1 Standards, including GTIN, GLN and Global Traceability Standard Results 75 Effective traceability of surgical instruments during sterilization process • Reduced manual effort and increased efficiency due to automation • Increased inventory management – better stock visibility • Increased traceability from theatre through sterilisation • Improved workflow through automation/scanning • Process to share loan sets much more efficient and effective Cost: Setup cost: €47k, Ongoing maintenance: €7.5k p.a. Return: 17% increase in workload with less staff What does it mean for you? The Clinical Staff More time for Clinical duties Less time spent looking for items, patients, staff etc.. Less time spent with paperwork, transcribing notes etc.. Reduction in manual workload Ease of reporting when required to look back post-event BUT this will only work if implemented Solutions are standardised and integrated (ie can talk to each other) 77 What should you be thinking of as solutions are implemented? Solutions should be based on Standards (this will become a feature on tenders) Hardware – Scanners should be able to read 2D Datamatrix Software should be GS1 compliant (ie can process the information in the 2D datamatrix) Products should be labelled with GS1 compliant barcodes 78 In Summary • You play a critical role in driving • • • • effective implementations Think about the Standards Ask for the standards Stay informed by staying in touch with GS1 Use the knowledge base that GS1 now has…don’t reinvent the wheel! 79 Our patients….! Acknowledgements All staff in National Centre for Hereditary Coagulation Disorders…in particular - Dr. Barry White (Clinical Director) - Evelyn Singleton (National Haemovigilance officer) - Rachel Bird (National Haemophilia system data manager) Thank you for listening Any Questions ?