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Transforming Together - Barcodes
- 1. 1 Barcodes on Unit of Use
- 2. Hospitals need medications Ready-to-Administer In Unit-of-Use With Barcode 2 What hospitals need
- 3. If not, must go through additional pharmacy processes and manipulated for use Compounding Reconstitution Repackaging What hospitals need Ready-to-Administer 3
- 4. End-point of medication supply chain is the direct administration of a single dose by a nurse to the patient at the bedside What hospitals need In Unit-of-Use 4
- 5. Unique identifier that ensures What hospitals need With Barcode efficiency of distribution and inventory management verification of correct medication for patient administration tracking and traceability of each dose to the patient in the event of an issue 5
- 6. What is a good barcode? Machine readable, every time Has clear, crisp print with good contrast Can be scanned in any direction Is on opaque, non-reflective background Is not placed on a curved surface Is unique – GS1 compliant 6
- 7. GS1 compliant barcode includes • Drug identifier (GTIN) • Variable data – lot number and expiry date • Application Indicators (AI) to separate different data code functions What is a good barcode? 1D Linear Datamatrix 7
- 8. 8 Why & How Hospitals use Barcodes
- 10. 10 Needed to Receive product from suppliers Do our job efficiently and safely Locate drugs in event of a recall Track inventory Move inventory throughout the hospital Reconcile controlled substances (enable auditing and prevent diversion) Supply Chain Efficiency
- 11. • Medication should be received from manufacturer ready-to-go directly to patient • Lack of barcoded unit-of-use products has been identified as a factor in not being able to achieve greater verification of medications prior to administration Hospitals are under pressure to do more with less Supply Chain Efficiency 11
- 12. Moved to active stock Segregated from active stock Moved to reprocessing area Barcodes generated on labeler; applied by technician Must be verified for accuracy Product with barcode on unit of use Product without barcode on unit of use Supply Chain Efficiency 12
- 13. Diverts staff from direct patient care activities Impact of additional steps Introduces risk and inefficiencies Supply Chain Efficiency 13
- 14. Supply Chain Efficiency A 350 bed hospital must add barcodes to: 30% of products 200,000 doses per year 200+ FTEs required across Canada 14
- 15. 15 Supply Chain Efficiency • Injectables (have come a long way) • Inhalers • Topical administration Ophthalmic Transdermal patches Cream and ointment tubes • Suppositories Barcode on box but not on unit of administration 15
- 16. 16 • Ampoule or vial is not the final product Ready-to-administer 16 Supply Chain Efficiency
- 17. Supply Chain Efficiency Not machine readable, every time Consequences - If barcode quality does not meet hospital needs, they will seek an alternative supplier - Hospitals may require certificate of readability Challenges - Multiple barcodes on product, causes disruption in system - Barcode positioning on curved surface impedes scanner read 17
- 18. • Each dose includes all appropriate label information, but no barcode • If enough room for barcode, hospital staff will add • Otherwise need to repackage Supply Chain Efficiency Oral Solids – Unit Dose Pack 18
- 19. • Significant improvement required – currently of no value • Hospital staff must remove tablets from blister and then repackage, similar to bulk • NEED – unit dose packaging with barcode on each unit of administration Supply Chain Efficiency Oral Solids – Patient Compliance Packs 19
- 20. • Availability of high-tech packaging machines in hospitals allows bulk oral solids to be repackaged into unit dose format with a barcode • NEED – ensure a readable barcode on the bottle Supply Chain Efficiency Oral Solids – Bulk 20
- 21. • Documentation and reporting requirements • Narcotics • Controlled Drugs • Targeted Substances • Diversion prevention • Perpetual inventory • Strict tracking Supply Chain Efficiency Narcotic and Controlled Drugs – Unit Dose Pack 21
- 22. • National Institute of Occupational Safety and Health (US) has identified list of antineoplastics and other hazardous substances that require special handling to limit exposure to healthcare workers • The University of Utah Drug Information Service has published an expanded list of drugs* (hazardous or allergenic) that should not be put in automated machines • Drugs packaged in automated machines may also lead to cross-contamination risk to patients Supply Chain Efficiency *Oral Medications that Should Not be Packaged in the Prepackage Machine and Oral Medications that Require Special Handling Precautions Oral Medications that require special handling 22 Cytotoxic Hazardous Drugs
- 23. • Colleges of Pharmacy in Canada moving to enforce that these products not be processed in automated packaging machines (retail + hospital) • Hospitals must package manually to meet regulatory requirements • Very labour intensive and must don Personal Protective Equipment (PPE) to mitigate exposure • Best suited for a supplier manufacturing and packaging facility Supply Chain Efficiency Oral Medications that require special handling 23
- 24. • Standards for handling of hazardous products created through NIOSH/The University of Utah Drug Information Service • Regulators enforcing standards (Colleges across Canada) • FDA issued the Bar Code Final Rule in February 2004 requiring bar codes on the labels of all human prescription drug products, biological products, and OTC drug products that are commonly used in hospitals and dispensed pursuant to an order Supply Chain Efficiency External Forces Driving Transformation 24
- 25. • commercially available unit dose package • drugs on NIOSH list packaged in unit dose packages with barcode on each dose Supply Chain Efficiency 25 What we need
- 27. Supply Chain Traceability 27 Suppliers need to Track and Trace US Federal Drug Quality and Security Act H.R. 3204 (aka Drug Supply Chain Security Act) • Securing the drug supply chain against counterfeit drugs through tracking and tracing of every transaction – enabler: barcode or product identifier • Sunset date for manufacturers – complete supply chain by 2023 Product Identifier - National Drug Code - Serial Number - Lot Number - Expiration Date
- 28. Supply Chain Traceability 28 Suppliers need to Track and Trace • European Union Falsified Medicines Directive – need for security of supply chain based on serialization, product verification at each transaction and compliance reporting; • Sunset February 9, 2019 • Expectations expanding throughout the global supply chain
- 29. Supply Chain Traceability 29 Counterfeit Version of Drugs Discovered UK and EU: 2007 • Casodex (for prostate cancer) • Plavix (for heart disease) • Zyprexa (for schizophrenia) US: 2012 • Avastin (for various types of cancer) Canada (2005) • Norvasc (for hypertension and angina)
- 30. Supply Chain Traceability • Safeguard “authenticity of health products as they move through the medication use system” — Health Canada • Based on product verification, product traceability, and automated verification systems 30 This is a goal for suppliers and all healthcare providers
- 31. Supply Chain Traceability Hospitals also need to Track and Trace • National Association of Pharmacy Regulatory Authorities (NAPRA) standards of practice – ability to immediately determine which patients received a given drug product • Addresses specific public safety issues to trace drugs to rapidly determine which drugs had been dispensed to which patients by: • product identifier • lot or batch number • expiry date • Serialization is a future need to combat counterfeit drugs 31
- 32. Supply Chain Traceability 32 Ideal automated identifier Product Identifier Variable Data Serialization Yesterday Today Tomorrow e.g. GTIN Lot or batch # and expiry date Serial number
- 33. Supply Chain Traceability 33 External Forces driving transformation
- 34. Supply Chain Traceability Ability to “Track and Trace” • Ready to use product with barcode with variable data and serialization (tomorrow) • Motives are different • Enablers are the same What we need 34
- 36. Evidence shows that medication errors lead to negative patient outcomes, including death. In Canada, 24,000 adults die every year from adverse events in acute care settings.1 Medication errors account for almost half of these. 1Canadian Adverse Events Study: The incidence of Adverse Events Among Hospital Patients in Canada Safe Medication Management 36
- 37. Safe Medication Management Evidence shows barcoding/computerization helps mitigate these occurrences • Scan verification of medication at the bedside can help reduce patient error in hospitals by up to 41%1 • Implementing BCMA in the ED was associated with significant reductions in medication error rate (80% relative rate reduction) • A study using direct-observation methodology to monitor medication administration before and after the deployment of the EMAR and BCMA systems demonstrated a 54% reduction in medication administration errors following implementation of a multidisciplinary, collaborative approach to medication safety. 3 1. Poon EG et al. Effect of Bar Code Technology on the Safety of Medication Administration. N Eng J Med 2010; 362:1698-1707) 2. Bonkowski J et al. Effect of barcode-assisted medication administration on emergency department medication errors. Acad Emerg Med. 2013 Aug;20(8):801-6. 3. Paoletti RD et al. Using bar-code technology and medication observation methodology for safer medication administration. Am J Health Syst Pharm. 2007;64(5):536-543. 37
- 38. Safe Medication Management Evidence CLMM requires barcoding on unit of administration 11% occur at the point of dispensing (barcoding can help) 39% of errors occur at the point of prescribing (CPOE* can help) 38% occur at the point of administration (barcoding can help) 12% occur at the point of transcription (CPOE can help) Leape, LL, Bates DW, Cullen DJ, et al. Systems Analysis of Adverse Drug Events. JAMA. 1995; 274:35-43 *Computerized Prescriber Order Entry 38
- 39. Safe Medication Management Evidence is driving the creation of best practices 39
- 40. Safe Medication Management • Computerized Prescriber Order Entry (CPOE) and Closed Loop Medication Management (CLMM) Systems are fundamental to achieving a high EMRAM score • Electronic Medical Record Adoption Model (EMRAM) is internationally recognized benchmarking tool which helps improve the quality and safety of patient care • Is an indicator of the healthcare system’s integration and connectivity • Highly adopted in U.S., Ontario and British Columbia and increasingly across other provinces in Canada 40
- 41. Safe Medication Management Adapted from https://www.oha.com/CurrentIssues/keyinitiatives/eHealth/Pages/eHealthAdoptionFindingsandComparisons.aspx EMRAM Adoption 41
- 42. Safe Medication Management Medication bar coding practices significantly reduce serious errors and patient harm, while improving both the patient care environment and electronic health record documentation. ISMP Canada Safety Bulletin – Volume 13 • Issue 13 • December 19, 2013 Advocacy for the use of automated barcode technology 42
- 43. Safe Medication Management Accreditation Canada standards • Standard 18.0 – automated barcode verification help avoid look-alike errors at all points of the medication chain Canadian Society of Hospital Pharmacists (CSHP) 2015 Targeting Excellence in Pharmacy Practice • Objective 5.1 Hospitals will use machine readable coding to verify medications before dispensing • Objective 5.2 Hospitals will use machine readable coding to verify medications before administration to a patient Other standards of practice recommendations to improve patient safety 43
- 44. Safe Medication Management • With automated tracking of inventory, facilitated by a barcode on unit of use, all doses anywhere in the hospital can be retrieved and accounted for • Reduce risk that a recalled product is administered to a patient Hospitals are under pressure to reduce the risk of patient harm 44
- 45. “In the U.S., we could not scan drugs at the point of care until individual packages arrived from the manufacturer with barcodes.” – Mark Neuenschwander, “Guru of Barcoding” 45
- 46. We are facing external and internal pressures Barcoding and complete labelling on a ready-to-administer unit dose format is a global need and a necessary state for: We can’t get there without you 46
- 47. We Can Get to a Better State Let’s Transform, Together
Editor's Notes
- The widespread use of automation throughout our hospital supply chain is dependent on a readable barcode on the unit of use. Products can be tracked more efficiently with the use of automation, and most importantly, they safeguard against errors at the most vulnerable stage of the medication use process – during medication administration. But hospitals in Canada need your help to achieve this goal.
- [Read Slide]
- A product that is received from you in a ready-to-administer format with a barcode can go right into the hospital supply chain. Otherwise, it has to be segregated from active stock and go through a separate hospital pharmacy production process before getting to the patient.
- There is a fundamental difference between hospital pharmacy and community pharmacy. In community practice – a package of medication is dispensed to a patient pursuant to a prescription and generally for self-administration. However, in hospital practice, the end point of the medication supply chain is the direct administration of one single dose of drug by a nurse to the patient at the bedside.
- Products in a ready to administer format with a barcode on the unit of use are needed to support: Efficiency in distribution of medications within the hospital internal supply chain (from cases to boxes to individual units of use) Verification of the right medicines at all points of the medication supply chain, but particularly at the patient administration step Traceability of all medicines administered to patients, particularly if they have been altered by a pharmacy production process and are no longer in their original manufacturer’s format. This is a need in retail pharmacy as well as hospitals.
- It’s not enough to put a barcode on a product. It has to be readable each and every time it is scanned throughout the hospital supply chain, but especially at the point of administration to the patient. There are a number of points to consider to ensure your barcode is a GOOD barcode.
- The Global Trade Identification Number is a critical unique identifier of the product but it is important to also have the lot number and expiry date embedded into the barcode to allow for tracking and traceability. Not all hospitals are able to use this information yet but this is the evolving need going forward. With properly embedded application indicators, scanners can parse the information in the barcode and capture the information they can use. The two dimensional datamatrix barcode is ideal for small ampoules, vials, unit dose blisters and ophthalmic dropper bottles. In the future, as in other countries, we will need to also have serialization embedded in the barcode to ensure the authenticity of the products we administer to our patients and prevent diversion.
- The most fundamental use of the barcode is for supply chain efficiency. We need to track inventory so we can move it throughout the hospital, know where every dose is in the event of a recall and be able to reconcile narcotics and controlled substances.
- Lack of barcoded unit of use products has been identified as a factor in not being able to achieve greater verification of medications prior to administration. We need the pharmaceutical industry to provide barcoded products and your production facilities are the appropriate place for this to happen since following Good Manufacturing Practices, or GMP standards, you have better control systems. Hospital production facilities are not up to GMP standards and risk can be introduced when we have to repackage and relabel products. Hospitals do not have the sophistication of systems available to the pharmaceutical industry. The healthcare system is under pressure to implement systems to detect and prevent errors. To do this efficiently, we need products barcoded to the unit of use.
- This is a simple depiction of the additional steps required at the hospital pharmacy level when a product is received without a barcode on the unit of use. Like your facilities, hospitals have to develop Standard Operating Procedures to ensure consistent and accurate packaging and labeling, documentation and verification steps as part of our quality assurance.
- In addition to the inefficiency and introduction of risk associated with the additional steps required for reprocessing, hospital staff is diverted from important patient care activities. The Pharmacy Department must operate with its allotted Full Time Equivalent, or FTE, complement.
- One or two FTEs to perform these extra steps may not seem like much, but when you take this example from one hospital and extrapolate it across the country, more than 200 FTEs are diverted from patient care activities. This is likely a conservative estimate since smaller hospitals would not have the same economies of scale as a 350 bed hospital but would still require the resources.
- The good news is that there has been good improvement in the availability of injectables drugs with a barcode on the unit of use. We do, however, continue to have some issues with the readability of some barcodes which will be addressed shortly. Categories of products where there is a lot of room for improvement are listed on this slide, but especially inhalation products such as drugs in nebules, Metered Dose Inhalers, topical products and suppositories. Ideally, we would have injectable drugs available in barcoded ready-to‐administer formats, such as prefilled syringes or premixed bags.
- As I have acknowledged, when it comes to injectables, manufacturers have come a long way in including barcodes on ampoules and vials. However, the amp or vial is not the final product – a syringe full of the drug is. We’ve seen workarounds such as nurses taking the broken amps along with the syringe to the bedside for scanning – so a move toward prefilled syringes is really necessary.
- Changing practice requires positive user experience, so when nurses have difficulty determining which barcode they are supposed to scan, get frequent error messages or have to manually key in the GTIN, the task of ensuring compliance becomes more difficult. A certificate of readability is often useful to identify if there is a particular scanner that does not capture your barcode accurately, rather than simply stating that “the barcode doesn’t work!”
- Whereas unit‐dose packages are helpful to decrease the need to repackage oral solids, if your product does not have a barcode on each unit, the pharmacy will have to add one. Sometimes, if there is enough white space on the blister unit, the staff can simply print and affix a barcode (with all associated documentation and QA checks). In other situations, they will actually have to remove the product from your unit dose package and repackage it with complete labeling including a hospital generated barcode. So the bottom line is we NEED a readable barcode on each unit of administration.
- Blister packages, often called compliance packs, are one type of product that creates significant workload for pharmacy technicians. Each dose has to be removed from the blister and then either added to a cassette for automated packaging or manually packaged. Antineoplastic drugs and other hazardous products have additional steps associated with repackaging due to the need to reduce occupational exposure. Narcotic, controlled drugs and targeted substances also have additional documentation, tracking and reporting requirements.
- Most oral solids are best packaged in bulk bottles so they can be processed through high speed automated packaging machines. However, if you distribute your product in an outer box, it is important that the barcode be on the bottle as well as the box. An exception to this, is for narcotic, controlled and targeted substances.
- As mentioned previously, because of the controls, necessary documentation and reporting requirements, it would be better to be able to purchase these products in properly labelled and barcoded unit dose packages.
- A number of medications require special handling to protect both hospital staff from occupational exposure and patients from cross-contamination. Antineoplastic drugs, hormonal drugs and allergenic drugs such as antibiotics are not to be packaged using the automated packaging machines because the stresses exerted by the machine can generate particles or can cause breakage. The pharmaceutical dust that is generated contaminates both the air hospital staff inhale, as well as other tablets and capsules that are being packaged which patients will ingest.
- In addition to Occupational Health and Safety Boards, the Colleges of Pharmacy across Canada are also mandating that these products not be processed in the automated packaging machines. This is confirmed during onsite inspections. This applies to both the hospital and retail market. As you saw in the video, pharmacy staff must don personal protective equipment and perform the packaging function manually in a segregated area. Some sites have also purchased compounding aseptic containment isolators (CACI) for this function, as recommended in USP Chapter 800 guidelines for handling hazardous products. So as you can see, this is a function that is best suited to be done in your facilities.
- There are multiple external forces driving our appeal. Since 2006, all manufacturers selling products to hospitals in the U.S. have had to comply with the barcode rule. The FDA published the Bar Code Final Rule in 2004 but allowed for a two year implementation period. This requirement has advanced the availability of pharmaceutical products with barcodes in the U.S.
- It is not sustainable for our hospitals to continue to take on this additional workload. We need your help. With the many pressures coming from regulators and legislators, we need commercially available products with a barcode on the unit of use.
- Our appeal to include barcoding on the unit of use is not a Canadian anomaly. Global regulations for Track and Trace, including the US Drug Quality and Security Act and the European Union Falsified Medicines Directive, support this request. By 2023, the US Drug Supply Chain Security Act will require a unique product identifier that includes the NDC, the lot number and expiry date, as well as a serial number on your product to track and trace products through the complete supply chain. The barcode is the answer.
- The European Union, also driven by fraudulent activity in various countries, has published a Directive requiring compliance with product verification at each transaction by early 2019. There are similar mandates globally, with over 40 countries, including China, India, Saudi Arabia, and Brazil covered by track and trace regulations. Ultimately, scanning the barcode will facilitate verifying that the drug is genuine.
- UK and EU: In 2007, according to a report from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, 2.1m doses of falsified medicines labelled for the treatment of prostate cancer, heart disease and schizophrenia were imported into the country and entered the regulated supply chain, purporting to be parallel traded products. 700,000 doses reached pharmacies and patients; the remainder were traced and seized by the MHRA or recalled from the market. The case ended in a conviction. US: In 2010, the FDA's Office of Criminal Investigation opened 72 new cases of counterfeit drugs in 2010, up from just six a decade earlier. In February 2012, counterfeit versions of Roche's cancer drug Avastin found its way into hospitals and patients' groups, prompting an FDA investigation. In the US, patients can buy drugs online from some Verified Internet Pharmacy Practice Sites (VIPPS). These sites are often mimicked by criminals, who create counterfeit sites that claim to be accredited when they are not. Although, people can buy drugs online in the EU also, there are no verified sites and doctors always advise against this. Counterfeit drugs are not only dangerous to patients, but they lose the pharmaceutical industry billions of dollars every year. Here’s one close to home from 2005: For the first time in Canada -- according to police -- a pharmacist has been charged with dispensing counterfeit medical drugs to patients. RCMP charged a Hamilton, Ont., druggist with dispensing fake Norvasc -- a medication used to treat high blood pressure and angina. http://www.cbc.ca/news/canada/hamilton-pharmacist-charged-with-handing-out-counterfeit-drugs-1.568647 http://www.theglobeandmail.com/news/national/college-of-pharmacists-trying-to-shut-hamilton-drug-store/article24357177/
- Although Canada does not currently have legislation or regulations enacted, Health Canada does require the safeguarding of the authenticity of health products throughout the medication use system.
- Beyond legislation, there are also professional standards to be met. The National Association of Pharmacy Regulatory Authorities supplemental document to the Pharmacy Practice Management Systems to support standards of practice1, addresses the need for traceability of drug products. They define ‘traceability’ as the capacity to immediately determine which patients received a given drug product. Traceability is a major concern from both a safety and a risk management perspective. The need for traceability extends to all dispensed drugs, including those dispensed in the retail market. 1Approved April 2016 and effective January 1, 2019
- Our barcode needs have evolved. In 2009, through the Canadian Pharmaceutical Bar Coding Project, the Institute for Safe Medication Practices-Canada and the Canadian Patient Safety Institute endorsed adoption of the GS1 global standard for Automated Identification of pharmaceuticals in Canada – a GS1 complaint barcode containing the global trade identification number. Milestones were established for inclusion of the variable data to support traceability. Inclusion of the lot number and expiry date within a barcode were recommended in Canada by December 2017. The future use and application of medication product serial numbers was considered by the project, but deferred in order to allow time to harmonize with global requirements.
- A ready to use product with variable data within the barcode will help both suppliers and hospitals comply with Track and Trace requirements.
- The landmark Canadian Adverse Events Study, commonly referred to as the Baker Norton Study, published in 2004 followed on the heels of similar studies in the US, Britain, New Zealand and Australia. By extrapolation, the results of this study suggested that, in 2000, between 141 and 232 thousand of 2.5 million similar admissions to acute care hospitals in Canada were associated with an adverse event, and that between 9,000 and 24,000 deaths from adverse events could have been prevented. The most common types of adverse events were related to surgical procedures, and the next most common were associated with drug or fluid related events. This was the impetus for the many patient safety initiatives that followed to reduce risks to patients – including verification of barcoded medications to safeguard against errors at the most vulnerable stage of the medication use process – medication administration.
- There have been several studies which have shown that barcode scanning against an electronic medical record reduces errors and harm to patients.
- The evidence shows that almost 50 per cent of medication errors can be mitigated by the use of barcode scanning. The other 50 per cent can be reduced through automation. Really, what we’re talking about is Closed Loop Medication Management, or CLMM, which takes advantage of all the available automation to reduce patient risk and improve health outcomes. It requires an active medication order, electronic verification of the provider, usually the nurse, electronic verification of the patient and a bar coded drug to make sure that the right patient gets the right dose of the right medication, at the right time and by the right route. For example, intravenous and oral medications. Scanning the bar codes also result in the right documentation entered into the patient record.
- Standards of practice are evolving, including the need for paperless electronic medical records across the continuum of healthcare. As hospitals track their progress and benchmark against the EMR Adoption Model (EMRAM), an important indicator of the healthcare system’s integration and connectivity, the implementation of CLMM will continue to increase. The goal is to achieve Stage 7 of EMR adoption. Stage 7 healthcare organizations demonstrate superior implementation and utilization of health IT systems. Their achievement has resulted in the true sharing, information exchange and immediate availability of patient data to improve process performance, quality of care and safety. Having a fully integrated EMR ensures that everyone involved in the patient’s care has real time information and can make appropriate decisions to ensure positive health outcomes.
- As you can see from this graph, US hospitals, shown in red, are mostly at stage 5 or 6. Canadian hospitals are sitting at stage 2 or 3. We need your help to progress along this journey.
- The evidence for full implementation of medication barcoding practices exists and is supported by important patient safety advocates in Canada.
- Accreditation Canada Medication Management Standards (Standard 18.0) point to automated barcode verification systems to help avoid errors at all points of the medication chain. The Canadian Society of Hospital Pharmacists’ 2015 objectives include routine use of machine readable bar codes to verify medications before dispensing, as well as before administration to the patient. In Ontario, the OCP inspection criteria recognize the importance of barcoding, and require hospitals to have policies and procedures to ensure appropriate barcoding throughout the medication use process, as well as to ensure a safe and consistent process for the application of barcoding technology. [Category A6:73, Category C:149, 150]
- No presentation on the use of barcodes in the healthcare system is complete without a quote from Mark Neuenschwander. “In the U.S., we could not scan drugs at the point of care until individual packages arrived from the manufacturer with barcodes.” With the help and cooperation of manufacturers, US hospitals have been able to move much farther along in implementing Closed Loop Medication Management. With YOUR help, we can do the same in Canada.
- We can get to a better state. Let’s transform, together.