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Transforming Together - Advance Notice
- 1. 1 Advance Notice of Product Changes
- 2. 2 • Highly automated & synchronized with each step following precisely after the other • Tightly controlled • Highly efficient and productive Capsule Manufacturing Process Advance Notice
- 3. The hospital internal production and supply chain increasingly resembles yours 6 New norm in hospitals Dramatically increased presence of technology & automation in hospital pharmacy Systems are not designed to cope with sudden unannounced changes Advance Notice
- 4. Specifications of your product are the criteria on which all subsequent hospital processes are based 4 Your commercial product becomes the “raw material” for the pharmacy production and supply chain PRODUCT SPEC Advance Notice Changes: The Reality
- 5. Product Changes Impact Professional practice safety improved by 5 Established routines that everybody follows Efficient protocols for emergency situations
- 6. Hospital supply chain similar to manufacturer supply chain Product changes cascade throughout hospital production and supply chain Pharmacy must disrupt/stop their processes to assess and adapt to the change New product may not be adaptable Introduction of system-wide risks due to changes to established processes—greater risk of medication errors Increased workload to manage the change Redirection of resources from other critical functions Decreased supply chain efficiency 6
- 7. Hospitals need Notice of product change Every time In advance What Hospitals Need 7
- 8. 8 Notice of Product Change Package and/or Label Appearance, shape Container: vial, ampoule Stability Weight and/or specific gravity What Hospitals Need Inform hospitals of upcoming product change
- 9. 9 As soon as change is known by supplier What Hospitals Need Before it arrives at distributor Before it arrives at hospital receiving dock Before it enters hospital distribution channel In advance
- 10. 10 Manufacturers must notify of any product changes Must notify distributors of changes that have supply chain impact Hospitals also need notification What Hospitals Need
- 11. 11 Hospitals need to be informed of every change to products they use Please don’t assume a change is insignificant. What Hospitals Need Make green tag pruple Every time
- 13. Product Changes Impact Affects all aspects of the hospital supply chain from Technology & Automation Impact Technology & automation used throughout hospital for pharmacy production and pharmacy/medication supply chain Patient Care Impact Healthcare Professionals rely on established protocols/processes that improve professional practice safety 17
- 14. Product Changes Impact Technology and automation used throughout hospital In pharmacy: – Robot (RIVA) – Packager (solid oral, baggers, oral liquids) – Box Picker – Optical verifier, barcode reader – Compounding pumps In nursing units, ER, OR: – Automated dispensing cabinets In other stakeholder practices: – Smart Pump 14 This is just the start More technology coming soon
- 15. If product goes through automation process: Product Changes Impact Assess and implement physical changes • Recalibration and process re-validation • Software changes − technology or pharmacy information systems • Process documentation − changes to compounding worksheets • Cascade assessment − packager and optical verifier • Storage re-configuration • Staff notification and training Time and resources • Revert to manual process − packaging or dispensing 15 Within Pharmacy
- 16. If product goes through automation process: Assess and implement physical changes • Automation used in the medication supply chain – Automated dispensing cabinets (ADCs) • Safe Medication Administration Look-alike issues and storage • Staff notification Product changes impact 16 Outside Pharmacy
- 17. Inside Pharmacy Impact Healthcare workers managing change Unexpected changes in products may introduce a greater risk of process error 17 • Before changes are recognized (i.e. storage conditions) • During transitions when automated in-process checks are lost • After changes are implemented and lack of awareness still exists
- 18. Examples of machines and critical specifications – what suppliers need to advise us of: 18 Inside Pharmacy Impact
- 19. 19 Examples of machines and critical specifications – what suppliers need to advise us of: Outside Pharmacy Impact
- 20. What is a Good Advance notification ? 26
- 21. Provides hospital with time to: plan and assess change impact implement change validate change Advance notification of product change Minimizes introduction of system-wide risk that could impact patient care 27
- 22. Category of product changes & impact assessment 22 High Impact Changes Requires impact assessment and changes to hospital production and supply chain Change in drug concentration Vial to Ampoule Size of packaging Low Impact Changes No impact to hospital supply chain or patient care New logo Change in supplier name
- 23. Acceptable advance notification for high impact change • Most suppliers hold 60 days inventory in supply chain • Notify when new product first arrives in your stock 30 Good advance notification
- 25. Patient Care Impact Product change affects the practice of other healthcare workers within the system 25 Pharmacy works in close collaboration with other healthcare workers to provide support for optimal patient outcomes Professional practice safety improved by – Established routines that everybody follows • care paths and medication order sets – Efficient protocols in emergency situations • familiar with product and location on crash carts
- 26. Patient Care Structural Support – Practice Dependent Upon: Emergency drug trays • Formal notification required for any minor change (size, location, colour) • Formal notification and training required for any significant change (concentration) Specialized medication kits and trays (i.e. anaesthesia, OR) • Formal notification of any changes Smart Pumps • Although pharmacy reprograms pump, may require official communication to medicine administrators Look-alike storage management (Safe medication practice) • Informal notification 26 Patient Care Impact
- 27. Patient Care Information Support • Changes to injectable products will lead to formal process changes in these areas – Parenteral administration monographs – Medication order sets • Hospital inter-departmental collaborative consultation requires – more time to complete process – formal committee approval process – extensive formal change management process 27 What notification are members getting now? Patient Care Impact
- 28. Training sessions 3x per day to accommodate different shifts (including weekends and casual nurses) 28 What does a formal change look like?
- 29. Some product changes have significant impact on the practice of other healthcare workers within the system – Format Change • Vial to amp – Changes to medical devices – Requires extensive formal change management program (i.e. syringe technology) 29 Patient Care Impact
- 30. Changes in products introduces greater risk for other healthcare workers during transitions from old format to new format: During the process of reprogramming of smart pump Medication order sets are unavailable during the revision process Dispensing is manual until products can be made compatible with automation Reconstitution on patient care unit Look-alike label introduction 30 Introduction of risks
- 31. Summary Progressive product changes are welcome – we just need notice! 31 Efficient hospital practices are built on defined routine processes Hospitals need advance notification (2 months minimum) to identify and manage the change Suppliers providing advance notification of product change makes a big positive difference to supply chain process, structure, patient care delivery
- 32. We Can Get to a Better State Let’s Transform , Together
Editor's Notes
- This diagram is a schematic of a capsule manufacturing process, one which you may be very familiar with, and one of the most simple processes of pharmaceutical manufacturing. Sterile injectable manufacturing is even more complex. It is a highly engineered process with each step carefully controlled and timed, each step detailed in strictly controlled and validated standard operating procedures that allow very little variability. Any changes at any one of the steps in the process would require a stoppage, require assessment of impact on subsequent steps, require rewriting of operating procedures, and require re-validation of the new production process. Production could not restart before the whole new process receives final approval. If an unexpected change to an ingredient, a packaging component, or a test chemical arrives, the whole system grinds to a halt because the basis for automation has been undermined. When things operate consistently as planned, and according to procedure, the works is highly efficient, highly productive, provides a safe environment for the workers, and produces a consistent reliable quality product at the end of the line.
- In recent years, the level of automation in hospital pharmacy has grown exponentially as a way to cope with increased demands for more services from other healthcare workers, but with the same level of resources—both human and financial. In hospital pharmacy, changes in provincial regulations, particularly in Ontario, require traceability of medication from the hospital receiving dock all the way to patient administration, and that increases the need for barcode-based automation of the complete supply chain. As such, the hospital production and supply chain is increasingly resembling yours. Each step is automated, highly controlled and dependent on the previous step being performed exactly as expected. A change to your product, without sufficient notice to reconfigure and revalidate the system, wreaks havoc on hospital production and supply chain.
- Your product, supplier, is the raw material that feeds into the hospital production system. If you make a change—sometimes obvious, sometimes only subtle—it changes the flow of the well engineered system and it MUST grind to a halt to properly and safely accommodate that change. When a hospital decides to purchase a pharmacy product, whether it be a vial, tablet, or bottle, it develops a defined process to move that particular product through pharmacy production and throughout the hospital supply chain. Almost any feature can come into play, the weight, the size, the colour…. The specifications of your drug product becomes an intrinsic component of the hospital production and supply chain process. Any change in any specification can cause a disruption. Suddenly your product no longer “fits” the system. With advance notification, these points of disruption can be identified in advance. And when your changed product arrives, the system downtime can be minimized.
- And it effects more than hospital pharmacy production. Any hospital staff that are involved in patient medication administration will be trained in the relevant hospital policies and procedures. Professional practice is improved by consistently following established routines and protocols. The 10,000 hours to excellence. Then, if a crisis arises, everyone knows exactly what to do, and when, and they know what their colleagues will do, to reach the best outcome for the crisis. These processes are known by staff as “lead the way” especially in emergency situations. Like the light on the floor of a plane that leads you to the exit in case of an emergency.
- The changed product may be incompatible with the production or supply chain system due to unacceptable risk, such as look-alike, impacting workload and productivity. When the changed product is not adaptable or compatible with established documented hospital processes, then the hospital has no choice but to find another product that does. For the supplier, there is a financial risk as it will result in lost product sales.
- Hospitals need notification of any changes to your product. Hospitals need that notice in advance of the product arriving at their doors. Advance notification needs to happen every time.
- In your world, any change in the specifications of your raw materials or packaging materials may have significant impact on your manufacturing process. The scenario is exactly the same for the hospital supply chain. The specifications of your particular product become an intrinsic part of the hospital supply chain and any change will have an impact. Please don’t make assumptions that the change is not important and selectively provide the information. Every hospital process is different, maybe only slightly, but that slight difference could be significant. Please provide everything you can. Notifying hospitals of a product change is not an exercise in marketing. It is an exercise in safe medication management.
- The sooner hospitals are informed of any impending change, the better. Adaptation to the product change requires planning in hospital pharmacy that includes an integrated approach with other Healthcare workers to: Identify the impact on supply chain efficiency and system risk Implement a safe process for the introduction of the new product Validation of the new process Monitoring the change for success All this takes time because of the need to collaborate with other healthcare workers.
- As a supplier, you must inform Health Canada of product changes or at least document the change as part of your change control process. As a trading partner, you must also inform your distribution partners of product or package changes in advance. Informing your hospital customers, must become part of your notification process and be a normal step within your supplier change control process.
- Hospitals need to be informed of every change to product and packaging. Every product change has the potential of disrupting the established hospital supply chain. Every product change must go through the same assessment for impact, just as it is conducted for a new product, whether the new product arrives as result of a contract change, or a shortage of the contracted product. Different hospitals will experience different impacts as a result of that change. Every hospital’s operations are just a little bit different and what may be fine in one location is not fine in another.
- And now we will expand on the impact of product changes on technology and automation.
- Product changes affect virtually all aspects of the hospital supply chain from pharmacy production to the administration of medication to patients. Chances are that a product change will require recalibration of one of the many pieces of equipment that hospitals use in their production and supply chain. The other major impact can be on patient care due to the introduction of risk by changes made necessary to established processes and clinical protocols. Hospital process changes for the new product are complex and resource intensive.
- Beginning with the first counting machines in the 1960s, pharmacy automation has continued to grow rapidly. Many hospital pharmacies now include robotics, automated packaging and labelling machines, storage and retrieval systems, optical verifiers and compounding pumps. In some hospitals, automated dispensing cabinets can be found on all patient care areas and smart pumps in every patient’s room. The global pharmacy automation market reached nearly 3 billion dollars in 2012 and is expected to grow to nearly 4.9 billion in 2018. This is the future. And the future is now. One little change to your product can require a change to many of these pieces of equipment, and that takes time. And it takes time to validate that the medication management system has remained safe to deliver the right drug for the patient.
- Products that are processed through automation within the physical pharmacy are subject to system failures when changes occur. When the pharmacy is made aware of a product change, an assessment must be done to determine any process changes required to ensure product compatibility. Pharmacy-based changes include recalibration of equipment. As we have mentioned, the equipment list is long. This is in addition to changes to software systems and compounding worksheets. Without advance notice to provide the time to prepare, pharmacy staff have to stop automated production and revert to manual processes for packaging, compounding and/or dispensing.
- Medication within the pharmacy distribution supply chain that is stored outside the pharmacy also requires an assessment when a product change occurs. In addition to changes to automated dispensing cabinet software, pharmacy staff may need to reconfigure storage space within the ADC due to changes in package size. Changes in package size may not be compatible with the available space in the ADC. In addition, changes in packaging or labelling that result in look-alike products can lead to selection of the wrong drug for a patient. Placement of look-alike products in the cabinets requires careful consideration and planning and will be different from one hospital to the next. Considerable resources are redirected to inform and educate prescribers and nurses of product changes.
- When hospital pharmacy doesn’t receive advance notice of product changes, and when a new product enters the system designed to provide the proper safety checks and balances for the old product, the risk of error increases. Without prior notification, when the new product is received at the hospital, there is the potential for that change to go unrecognized and potential for an error to occur. An example would be incorrect storage. While changes are being made to the system, to make the new product format compatible with automation, pharmacy staff have to revert to manual processes, and the benefit of automated in-process safety checks is lost. The proper functioning of IV automated compounders is based on the specific gravity of a particular product. Any change that impacts this characteristic can lead to a significant disruption in production during which the robot cannot be used. Even a change in the vial or label results in the need to reconfigure and revalidate the IV automated robotic compounders. Reverting to manual compounding significantly increases workload. After the needed changes have been successfully implemented and education has occurred, it is difficult to ensure that 100% of staff are aware and remember that a change has occurred. This can leave room for a medication error to happen.
- Just to give you an idea, this chart shows you only some of the critical product specifications related to three kinds of technology used within hospital pharmacy production centres across Canada. For the IV robots the change can be as significant as weight…or seemingly insignificant as over-wrap. For an automated packaging machine, a change in weight can require recalibration of the canister. The optical verifier is a critical quality assurance step and a change in the contour of a tablet will identify the new product as not acceptable.
- Within the physical pharmacy, there are numerous systemic quality checks to ensure the “right drug” flows through the system. When automation supports the distribution of medications outside of the physical pharmacy, and into patient care environments, whether it is nursing wards or the operating room, then the need to ensure a proper implementation of product changes escalates. Pharmacy must apply the proper checks and balances to the automated dispensing process so it dispenses correctly—100 percent of the time. Changes to your product can disrupt those safety checks and balances that were established for the original product. Where other healthcare workers rely on the quality of pharmacy distribution, pharmacy staff must be absolutely sure the automated process will run smoothly, consistently, and safely using the new product.
- So what does good notification look like?
- Any change to the established norm in the hospital healthcare delivery system can introduce risk. Hospitals are required to conduct risk assessments when change occurs. When your original product first arrived at the hospital, it went through a risk assessment to identify and mitigate any risk that could result from changes to pharmacy procurement, operations, production and distribution and any changes to other healthcare worker’s professional practice. It took time to identify and assess every step in the hospital supply chain that your original product would take. The introduction of your original product required communication and training of pharmacy staff and other healthcare workers. Now, when you change your contracted product in the middle of a contract period, sometimes even just in minor ways, this same process must be repeated. Hospitals need advance notification of the change to give them time to conduct this process; to identify, plan, implement and validate the change.
- Product changes fall into two broad categories: High impact changes and Low impact changes. Low Impact changes do not impact hospital supply chain. No assessment of impact required. This would include examples like new lot number, change to your manufacturing site, or a supplier name change. Hospitals may have some administrative changes such as updating computer systems, but there is no impact at the level of patient care. High Impact changes impact the hospital within pharmacy, outside of pharmacy in the distribution channel, and perhaps all the way to the patient. It takes considerable amount of time to reach out to everyone and conduct the assessment and establish and implement the change management process. For example, a change in drug concentration might require a change to a clinical protocol and to pharmacy production worksheets. Or a change from a vial to an ampoule might require a reconfiguration of automated dispensing cabinets.
- Since the time to adapt to a major impact change is long, a good advance notification is 60 days before the product reaches the public distribution channels. 60 days is only a good advance notification period, it is the minimum. If you want to go from “good to great”, then 90 days is more ideal. The changes that you, the supplier, make to your product don’t happen overnight. There is an extensive planning and development process. There is commonly 60 days of inventory held in Canada for most products. So as a general rule, when the new product arrives in your Canadian inventory, the notification of the product change should be communicated. If, due to unusual circumstances, there is less than 60 days of Canadian based inventory, then the change should be communicated earlier. Good advance notification of changes ultimately reduces the impact on patient care.
- Product changes can impact patient care either indirectly or directly. The change management process must be carefully managed to ensure safety of the patient, and this requires time.
- The continuum of care, from physician prescribing and pharmacy preparing, to nurse administering is very complex. Patient care is enhanced and the safety of the patient is protected in hospitals by establishing professional practice routines, and nowhere is this more true than for medication management. Pharmacy is only one component of the hospital supply chain and continuum of care that ultimately ends with the patient. Pharmacists work on teams with other healthcare professionals to establish care paths that include medication order sets that are very detailed and specific. Protocols for emergency situations and codes are established in advance, and drilled so the team members know exactly what to do without hesitation. Literally, time is of the essence. Being familiar with the product, what it looks like, how it functions, where it is located on the crash cart are all important features to reduce hesitation in a crisis situation.
- Pharmacy provides drugs and drug management services to other healthcare workers in the hospital in non-clinical ways—that is what we mean by structural. If there is a change to the arrangement of products in any tray supplied by pharmacy, then a change management process kicks in. This is true for any tray, but Emergency Drug Trays are critical. As a result of a change in size, a reconfiguration in the layout of the tray may be required. A change in colour may cause confusion and selection of the wrong drug—resulting in a look-alike error Or a change in the way concentration is stated on the label can cause confusion and hesitation. A formal notification process must be used to ensure all other healthcare workers are aware of the change. A formal notification process is an extensive communication protocol to ensure appropriate consultation. It is a complex and time consuming task to bring together the healthcare professional on the multi-disciplinary team. Changes may require a policy change, subsequent committee approval and formal retraining of all relevant personnel. Then the change must be formally communicated and implemented, sometimes system-wide. It is not a simple task to ensure everyone is informed. .
- Pharmacy provides safe medication management and professional clinical services throughout the hospital. The safe medication management of injectable drugs in hospitals is governed by detailed parenteral administration monographs. With a change in product, they need to be reviewed and any subsequent changes identified. Any revision to the monograph needs to be reviewed by a multi-disciplinary team and then be formally approved through the appropriate hospital governance committees. Care paths are protocols that contain medication order sets developed by multi-disciplinary healthcare professionals that include pharmacists. They are very detailed and specific. Again, with a product change, they must be reviewed by pharmacy and any changes must then go through the team and committee approval process. Again, it is not a simple task to communicate the changes throughout the hospital and ensure everyone is informed and ensure new practices are adopted. Patient care does not “pause” in the meantime until the new processes are in place. Advance notification of high impact changes is important so the extensive preparations can be done in advance and minimise the time required to appropriately address the change.
- The complexity of the staffing model in hospital results in complex communications and numerous repeated training sessions. For example, if a change requires a practice change related to the use of Smart Pumps, then pharmacy must work with nursing educators to make sure the change of practice gets communicated and implemented to all shifts, all full-time, part-time and casual staff. Safe transition of change is a big challenge for hospitals. ISMP, in a recent March publication, addresses the issues and recommends several strategies to support a safe transition. An example is to raise awareness of the labelling transitions through: Educational events Mock code events Safety huddles; and Bulletins [Ref: ISMP Canada Safety Bulletin , March 30 , 2016]
- A change in format of an injectable drug from a vial to a ampoule will require an extensive change management process. It is the same drug, same concentration, but the vial has become the standard for packaging in Canada, and there is a strong preference by nursing for the vial over the ampoule, and pharmacy will meet a lot of resistance to change from nursing staff. A change to an ampoule may also require some retraining. A change in the medical device that delivers a drug also requires extensive retraining for those people involved in the administration.
- When an unexpected product arrives at the pharmacy door, healthcare professionals are not able to use the current standard, documented, validated processes on which they rely to provide safe medication management for the patient. There is a higher risk of error that may occur during that transition period as healthcare providers must deviate from their normal processes. What is listed on the slide is just a small example of places where risk can creep into the system. The more time hospitals have to plan for the transition, to identify and mitigate all the risks that arise during transition, the better we all are. Your new, changed product is adopted with minimal delay. Healthcare providers can practice in a professional environment that promotes and supports safe medication management And the patient remains safe.
- Efficient and safe hospital practices are built on a strong foundation of routine-defined processes. When that routine is disrupted, errors can occur. When a changed product arrives at the door without adequate notification, it disrupts the stable medication management system, sometimes throughout the whole hospital. Pharmacy needs advance notification, 60 days or more, to smoothly manage the disruption that a changed product can bring into the hospital. Advance notification will minimize disruption, and allow the product to be easily absorbed into the system without incident.
- Lets transform together to a better state.