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Improving the Patient Experience Through Pharmacy
- 1. Improving the Patient Experience Through Pharmacy Rick Burnett Chief Operating Officer Kenneth Maxik Director, Patient Safety & Pharmacy Compliance August 19, 2015
- 2. Speakers Rick Burnett, PharmD, FACHE Chief Operating Officer Kenneth Maxik, MBB, MBA, FACHE Director, Patient Safety & Pharmacy Compliance
- 3. Today's Objectives 1. How pharmacy impacts the patient experience 2. Key patient safety and pharmacy compliance techniques 3. Evidence for creating a medication safety program 4. Impact of CMS proposed changes
- 4. Poll Question Which best describes who Pharmacy reports to at your facility?
- 5. Evolving Healthcare Delivery System Past • Treating sickness • Inpatient care • Silos • Fee per service • Dispensing Current • Wellness • Ambulatory care • Integrated Team • Value • ?
- 6. Pharmacy Touches Everything Select/ Prescribe Dispense Administer MonitorOutcomes Procure/ Store
- 7. Dispense Human Resources Information Technology Finance Environmental Services Bio-engineering
- 8. Administer • Nursing • Anesthesia • Respiratory Therapy
- 10. Outcomes
- 11. Procure/Store Proper Storage & Security Materials Management Facilities Management
- 13. Pharmacy Touches Everything Select/ Prescribe Dispense Administer MonitorOutcomes Procure/ Store Medical Staff Nursing Anesthesia Respiratory Therapy Laboratory Microbiology Quality Assurance Risk Management Materials Management Facilities Management Human Resources Information Technology Finance Environmental Services Bio-engineering
- 14. PATIENT Pre-Admission Admitting Patient Stay Discharge Planning Post Discharge Pharmacy touches the entire patient experience
- 15. There are approximately 7,000 deaths annually associated with medication errors. If two out of 100 admissions have a medication error, the cost to the system is $2 billion annually.
- 16. Sterile CompoundingThe Case For Medication Safety
- 17. The Case for Sterile Compounding
- 18. CMS Conditions of Participation The regulations at §482.23(c) and §482.23(c)(1) promote safety in the preparation and administration of drugs and biologicals to hospital patients by requiring preparation and administration in accordance with: Federal and State law Accepted standards of practice (Rev. 137, 04-01-15)
- 20. Poll Question How confident are you that your medication error reporting system is capturing all reportable events?
- 21. How Good Are We Measuring? Voluntary Reporting System Reported Events 50 per Month Observation and Chart Review Single Unit (CCU) 0.86 errors per Patient Day 28 Average number of errors per day
- 22. How Good Are We Measuring? 54321 100 80 60 40 20 Appraiser Percent 95.0% C I Percent 54321 100 80 60 40 20 Appraiser Percent 95.0% C I Percent Date of study: April 2010 Reported by: Name of product: Physician Order Review Misc: Assessment Agreement Within Appraisers Appraiser vs Standard
- 23. Procure/ Store Preparing and Dispensing Inputs Outputs Select/ Prescribe Administration Suppliers Customer Ordering and Transcribing Monitoring and Evaluation Medication Management Process • Patient • GPO • Wholesaler • Direct Purchase • Medical Staff • Medications • Disease State • Drug Information • Contract Pricing • Five Rights • Regulatory documentation • QA Information • Patient • Medical Staff • Regulatory Agency Taxonomy of Medication ErrorsTaxonomy of Medication Errors
- 24. Risk Mitigation Strategy Selection & Procurement Process Storage Medication Name/Class Select medications based on the dependability and reliability of the manufacturer Physically separate look-alike/sound-alike medications Address the potential for adverse medication events when medications are frequently changed Build in system alerts and use warning labels regarding problematic drug names, packaging, and labeling Consider whether product is labeled correctly Consider labeling medications with both the generic and brand name Develop policies and processes for handling drug outages Handle boxes that contain chemotherapy agents with chemotherapy-protective gloves; store in negative pressure room Develop policies and procedures for inspecting all storage areas
- 25. At-Risk Identification Performance Criteria Assessment Behavior Identified Patient Information A. Preparing more than one patient’s medications/more than one medication at one time B. Not checking patient identification using two identifiers (e.g., name, medical record number, birth date) C. Using an estimated patient weight compared to an actual weight D. Prescribing/dispensing/administering medications without checking patients’ laboratory values and vital signs E. Not checking a patient’s allergies before prescribing/dispensing/administering medications F. Not waking the patient for assessments/medications G. Not viewing/checking the patient’s complete medication profile (or medication administration record [MAR]) prior to prescribing/dispensing/administering medications
- 26. Sterile Compounding Who Compounds? Training and Competency Environmental Control
- 27. Current Skill Requirements Traditional Skill Requirements SUPPLY CHAIN P&L MANAGEMENT STAFF SUPERVISION FORMULARY MANAGEMENT QUALITY IMPROVEMENT REGULATORY AND ACCREDITATION HCAHPS EMAR CPOE SMART PUMPS 340B USP 797 - 800 BIOSIMILARS MED THERAPY MGMT ISMP STANDARDS STRATEGIC PLANNING P&L MANAGEMENT PATIENT ASSISTANCE PROGRAM MGMT RETAIL PHARMACY FORMULARY MANAGEMENT PERSONNEL DEVELOPMENT CDM MANAGEMENT PATIENT SAFETY INFORMATION TECHNOLOGY LEADERSHIP REVENUE CYCLE REGULATORY AND ACCREDITATION SUPPLY CHAIN CLINICAL ACCOUNTABILITY AND EXECUTION QUALITY IMPROVEMENT
- 28. Quality of Care Patient Safety Medication Safety Wellness Patient Satisfaction Education Pharmacy: A Powerful Piece of the Patient Experience Risk Management Cost HCAHPS VBP Reimbursement Readmissions Rx Patient Hospital
Editor's Notes
- [RICK] Imagine you have a child that is critically ill with a high fever and your doctor tells you “Get them to the emergency room right away” so off you go to the emergency room where the attending physician writes for an antibiotic and then you wait for almost 20 hours to get the antibiotic. Or imagine that your grandfather needs to go to the hospital because his diabetes is out of control. He’s stabilized, started on a new drug and discharged. But than grandpa goes home and to starts complaining of heart palpitations, and his legs start to swell. He’s readmitted three weeks later and after three days of tests is told his symptoms were the side effect of a new drug he was started on at discharge. A side effect he was never told about when he was discharged and which wasn’t included on his readmission medication reconciliation history. Or imagine that your doctor tells you that you have just been diagnosed with an aggressive form of cancer. She tells you to make arrangements to start chemotherapy right away. You set up your appointment, go to the center to start your treatment, and are told that the drug you need is on back-order and you’ll need to come back in three days. Can you imagine how these patients must have felt? Or their families? Can you imagine how you would feel hearing about these stories at your team meetings? I can, because they are all real. During our time together I’m going to try and help you better understand how pharmacy can play a larger role to improve the patient care experience at your hospital. First; We are going to make the case that the current view many hospitals have of their pharmacy department is too narrow and must change in order for hospitals to succeed in today’s value driven market; Second; My colleague Ken Maxik is going to provide insights on how medication safety plays a significant role in the patient experience and provide some pointers on how to improve programs at your facilities. Third; We will discuss the data around medication safety programs and the impact on patient experience results And finally, the impact of proposed CMS changes regarding medication safety.
- [BECKERS TO LAUNCH POLL QUESTION] Before we get started I’d like to run a brief poll to better understand who has administrative oversight for pharmacy services at your facility. So if you could, please take a few seconds to answer the following poll question. Which best describes who Pharmacy reports to at your facility? COO CNO VP of Ancillary/Clinical Services Other Hospital Executive Does not apply
- [RICK] As you know, health care is in the midst of a big paradigm shift. Under the old paradigm hospitals focused primarily on treating sickness with most care being delivered in an inpatient setting with reimbursement provided based on a fee per service model. Currently the emphasis is on looking at the total health of the patient with heavy emphasis on patient education and wellness as a means to try and keep patients health and out of the hospital. Quality of care is also emphasized and those that deliver on quality will be rewarded through higher payments via value based purchasing incentives. So what does this all have to do with pharmacy? For many organizations the primary view of pharmacy is focused on supply chain. Orders come down to the pharmacy and the medications are dispensed but I’d like to challenge that thought process..
- [RICK] Pharmacy is a link in something much bigger called the medication use cycle. For our pharmacists in the audience this diagram is very familiar. But I’d like to take some time and to make the case to show how complex the process can be and all the players that are involved.
- [RICK] Of course a key role of a pharmacy is to dispense drugs. And to run the pharmacy itself you needed to work with HR to hire people, finance to pay them and buy drugs, and IT to make the computer systems work. But it doesn’t stop there. Unfortunately, many hospital leaders feel this is the primary role of pharmacy. This is why many institutions erroneously measure pharmacy productivity only by doses dispensed or orders processed. But as we will see pharmacy has a bigger role that touches many departments.
- [RICK] After the drug is dispensed it needs to get to the patient. This means you need to have in place multiple supply chain delivery systems to get new drugs up when they are needed and take the old drugs back for processing. Most in are audience are familiar with the processes. But in addition to the above, you also have to make sure SMART pumps dictionaries are up to date, that par levels are set appropriately in your dispensing cabinets and that the drug information in the bar code data base can be read by the bar code reader. And pharmacy is a part of that.
- [RICK] And once the patient gives the drug the patient needs to be monitored. That means managing pharmacokinetic dosing protocols and working with microbiology to make sure you have the panels that match with your antibiotic formulary. Pharmacy also has to work with nursing to provide information and education about new drugs and the adverse effects. And pharmacy is a part of that.
- [RICK] As health care providers we want to make sure that patients are having good outcomes and that drugs are being prescribed in the most safe, cost-effective manner. This means conducting medication use evaluations, establishing adverse drug reaction surveillance programs, managing medication error reporting systems, and performing root cause analysis and failure mode effects analysis to keep patients safe and improve quality. And pharmacy has a part in that.
- [RICK] All this is going on why trying to figure out where you’re going to get your drugs when everything seems to be short or on back-order and then making sure everything is stored under proper conditions with the proper level of security all why staying in budget. And pharmacy is a part of that.
- [RICK] And in order to know what drugs to dispense, administer, monitor, and order the medical staff have to approve a formulary and all the medication protocols. They also need to have input into the order sets used for CPOE. Which means pharmacy needs to research literature and conduct pharmaco-economic analysis so the medical staff can make well informed decisions. And pharmacy is a part of that.
- [RICK] Now for the most part the patient doesn’t see all this. To them it is invisible until the time they receive their medication. But the process is extremely important when you think about the impact the medication use cycle has on your patients’ care. Think about this: The medication use cycle will touch just about every patient that walks into the hospital. I’ll say it again: The medication use cycle will touch just about every patient that walks into the hospital. Not everybody gets an x-ray, or physical therapy, or has a surgical procedure, but almost every patient will receive a medication. And in order for the patient to have the best experience from their drug therapy this process must be carried out flawlessly with thousands of transactions occurring each day. And the lynch pin that is at the center of this complex cycle is pharmacy. So as you think about your pharmacy, don’t think about it as a room in basement that fills orders, makes IVs, and does a few pharmacokinetic consults. Think of pharmacy services as a type of clinical treatment center, for example your Drug Therapy Services, similar to how you would view Interventional Cardiology, Surgery, or Oncology Services. So now let’s shift gears and walk in the patient’s shoes and see how pharmacy can impact their experience.
- 14
- [KEN] So what is or can be the impact on patient care of not only the pharmacy, but the medication management system in general, and we have come a long way, but most remember we are on a journey. What we are going to review is some background of what brought us to where we are today, and some thoughts on moving forward. On November 29, 1999 the Institute of Medicine released a report called To Err is Human. The authors concluded that more people die every year from medical errors than motor vehicle accidents, breast cancer, or AIDS, and when you extrapolate the results from this reports and others the numbers came out between 44,000 and 98,000 deaths due to medical errors. When we review the sub-category of medication errors, there are approximately 7,000 deaths annually associated with medication errors; both in and outside the hospital. In an additional study, it was notes that two out of 100 admissions have a adverse drug event, the cost to the system is $2 billion annually.
- [KEN] As we mentioned previously we had the cases related to Heparin excess doses in 2006 and 2007, and as we have seen when these type of events occur, they usually hit the local and in some cases the national news media. And, unfortunately, these type of cases continue to occur in today’s healthcare systems. Some more recent cases have involved a mix up between high alert medications and other relate to errors associated with look- alike sound – alike medications.
- [KEN] And the next area that has been receiving attention both within the industry and the news media are events related to sterile compounding. This type of event was highlighted based upon sterility of products coming from the New England Compounding Center. This event brought about a regulatory change through the Food and Drug Administration and the creation of a 503b compounding facility. It does make you pause and consider why is it that as an industry such a tragic patient events are needed to move us to improve the quality of the services provided.
- [KEN] And these events also brought about a regulatory change related to the Center for Medicare and Medicaid Services in the definition of Accepted Standards of Practice Hospital policies and procedures for the preparation and administration of all drugs and biologicals must not only comply with all applicable Federal and State laws, but also must be consistent with accepted standards of practice based on guidelines or recommendations issued by nationally recognized organizations with expertise in medication preparation and administration. Examples of such organizations include, but are not limited to, and here in the definition they include: • National Coordinating Council for Medication Error Reporting and Prevention (www.nccmerp.org); • Institute for Healthcare Improvement (http://www.ihi.org/ihi) ; • U.S Pharmacopeia (www.usp.org) ; • Institute for Safe Medication Practices (www.ismp.org ); Among others. And as of January this definition also includes Critical Access Hospital: Interpretive Guidelines §485.635(a)(3)(iv)
- [KEN] So how do we move the needle and what type of results can we expect. We are all aware of high reliability industries, and those that are frequently referenced are the airline and nuclear power industries, but what is a high reliability organization, what type of results can be expected and what are some steps to move in that direction? First within a high reliability organization, Everyone who works in these organizations, both individually and together, is acutely aware that even small failures in safety protocols or processes can lead to catastrophic adverse outcomes. Workers in these organizations are always searching for the smallest indication that the environment or a key safety process has changed in some way that might lead to failure, if some action is not taken to solve the problem. Chassin, M, Loeb, M: The Ongoing Quality Improvement Journey: Next Stop, High Reliability Health Affairs on June 1, 2011 There was a study published ASQ – in the Quality Management Journal (QMJ) July 2015. This study compared 34 U.S. health care organizations that received the Baldrige National Quality Award or was eligible for a site visit, with 153 geographically closest competitors. The conclusion was that the Baldrige Award recipients matched or exceeded their competitors’ measures of health care quality and outperformed them in measures of favorable patient experience. When you examine the resulting data for 39 measures that U.S. hospitals publicly report to the Centers for Medicare and Medicaid Services, Hospitals that used the Baldrige Health Care Criteria for Performance Excellence had higher means and lower standard deviations, indicating a measurable positive patient experience, than the non-Baldrige hospitals in all 10 measures. We will cover in a minute, what are some ways we can move in this direction. But first, let me ask you a question?
- [KEN] [BECKERS TO LAUNCH POLL QUESTION] How confident are you that your medication error reporting system is capturing all reportable events? Highly Confident Confident Somewhat Confident Not Confident
- [KEN] So, if the old adage of what gets measured gets done is taken into consideration. Then we have to ask ourselves as healthcare workers How Good Are We Measuring the Adverse Medication information data? Most of us today utilize a voluntary reporting system for capturing data, and are aware of the flaws with such a system. However, we wanted to know what sort of variance this creates, so we looked at one facility with a census of around 350, and they were reporting 50 events per month. We then conducted a prospective review for events on a single unit, and determined a error rate of 0.86 errors per patient day. This translated into a error rate of 28 events per day on just one unit. This meant that every patient on that unit was involved in a medication event.
- [KEN] In another review we looked at pharmacists as our first line of defense in protecting patients from receiving a medication error. So, we asked them to review physician orders; both paper and electronic, and determine if the order was incomplete. In this Attribute System Analysis that was conducted over two weeks timeframe, we noted that the pharmacist; Appraiser in the graph, was good at being consistent with themselves, but not good consistency between the five reviewers. And, when we compared the reviewers with what we had predefined as the correct answer, there was a poor correlation. This brought us to the conclusion that if we wanted to improve the process we first needed to look at improvements in the front end of the process. Training for individuals would need to be conducted along with a rewrite and review of the policy and procedure to allow for a standardized approach to the definition used in determining if a written order is complete. So while we have great intentions, we still need to do a better job.
- [KEN] When looking at an event we want to review all of the areas of the process, and many of you will recognize this as a SIPOC diagram, starting with the Suppliers to the process, which could be the wholesaler or medical staff – next we review the system inputs which are the items that need to go through the process in order to turn the inputs into the desired output. The Medication Management Process has bee broken down into the six steps that are listed here going from Selection and Procurement to Monitoring and Evaluation. And by following this process we will create an output that the customer needs and is willing to pay for. In our case it may also be payment by a third party. We can look and determine that one of the first risk mitigation strategies is around the formulary system; selection and procurement. After all, it is more difficult to make a medication error if the medication is not on the formulary, your shelf, or in the computer system. Each of the sub-process steps will contain multiple risk mitigation strategies. Let’s look at a sample based upon high alert medications.
- [KEN] I know this slide is difficult to read, however, I just wanted to provide a brief overview of how an organization can set up a Risk Mitigation Strategy tool. Along the first column is placed either the medication name or medication class that your organization has decided will be treated as a High Alert Medication. Then across the top lines are various strategies that can be used in order to reduce risk at a specific point in the process. For example, Selection and Procurement. What I find frequently when going to organizations is that the same strategy is used for all medications. For example if we had a medication event, then we add a second check. As we noted in the SIPOC diagram on the other slide, let’s looks at the entire medication management system and determine where we can put mitigation strategies into place.
- [KEN] Another mechanism that is available to assist in moving an organization toward high reliability is utilizing current staff members to aid in identifying at risk behavior. At – risk behavior is when people deviate from accepted process safe standards, and they usually do this in order to save time, or because of the need to have a work around. An example of engaging in at risk behavior would be if you are driving a car and sending a text message. Now we all know that this is a habit that we should not do. However, we also know that we have done this on numerous occasions and have not had any negative consequences of our actions, and this is the issue surrounding at risk behavior. There is a separation frequently in time from engaging in the behavior, and the time an event occurs. So we put together a simple form for staff to use in order to identify at risk behavior, it does not take long, and is fashioned after the LEAN philosophy of Gemba, for those of you who are working in Lean organization. We ask each staff member to spend two hours per year observing the work getting done, and identify at risk behavior in the workplace. This information is collected and then can be reported back to staff during meetings or huddles.
- [KEN] As was noted previously sterile compounding could be an entire webinar on its own. So, for today, let’s look at some high level areas. First, who do we allow to compound, how have we trained them and identified their competency? Are they working in an environment that causes them to be compliant with requirements? At one facility I was at they had received a report from their third party contractor and placed it into the filing cabinet. When I asked to look at the report, the room had not passed the environmental testing, and had listed the colony forming units on the report. Review your documentation and implement preventive and corrective action as needed. I hope that we can see the impact that medication safety has on the patient experience, but also how moving to a high reliability organization, will improve the patient experience and financial impact for the organization. And with this I will hand it back to Rick.
- [RICK] The skills needed to run pharmacy are becoming more a more complex. As an early careerist, the focus of pharmacy management was primarily on managing the staff, dispensing medications, and conducting a few quality improvement activities to satisfy Joint Commission. Today’s environment is much more complex. The ability to understand and manage technology continues to increase. There is actually now a subspecialty of pharmacy called pharmacy informatics and my old Alma matter the University of Illinois now offers a Masters in this discipline. Regulatory requirements are another area to consider. I serve as the Director of Professional and Legal affairs for the Gulf Coast Society of Pharmacists. At a recent conference I learned that pharmacy is now the most regulated profession out of all the health disciplines. The regulations that effect pharmacy are many and are continuously changing from federal requirements, state laws, USP 797/800, 340B, and on and on not to mention all the compliance standards for accreditation agencies. Recently the Drug Supply Chain Security Act went into effect. In addition drug therapies will become more complex. Biosimilars are just hitting the market and pharmaco-genomic therapies will not be far behind. When I hear about the complexities of these drugs I long for the days of arguing which H2 antagonist was the best one to have on formulary. Now finding a director with all these skill sets is becoming increasingly difficult. Most people either know a little about a lot or a great deal about one area. And finding a director willing to take a leadership role is difficult and will become more difficult especially as the current generation of pharmacy directors retire. This is because generation x and millennials for the most part do not want the leader chair opting for jobs which offer a better work life balance. The point I’m trying to make with this slide is that pharmacy is very complex. And in order to deliver for the patients hospitals need to make the proper investments in people, technology, and infrastructure to make sure the patient has a safe, positive experience during their treatment keeping in mind that not all the results will impact the pharmacy P&L directly.
- [RICK] So from our brief time I hope that 1) you will make the paradigm shift away from thinking of pharmacy as dispensing drugs and instead view pharmacy as a key player in the patients treatment 2) that you have a better understanding of how pharmacy can impact the patient experience and that 3) pharmacy is getting more complex and having the right skill sets and leadership are key and see that pharmacy can have a financial ROI which extends beyond the pharmacy financial statement. Before I close out I’d like you to take some time to reflect on the talking points. Now take out a piece of paper and rate your hospital as it relates to pharmacy’s role in the patients experience and rate it as excellent, average, poor, or perhaps I really don’t know or haven’t thought about it. If you answered excellent, congratulations. But if you answered average, poor or even I haven’t thought about it, make it a point to talk to have a discussion about what can be done to get the best most out of your investment in pharmacy resources to give your patients the best experience possible.
- Becker’s moderator to call out questions.