Ethical, Legal, Financial Rationale for the Transition to Preferred Drug Form

1. 1 Ethical, Legal, & Financial Rationale for the Transition to Preferred Drug Formulations(Speaker Insights) Today we will be discussing the ethical, legal, and financial rationale for transitioning to preferred drug formulations. The first few slides will help you understand the rationale and objectives of why you are presenting this information to the hospital C-Suite. The remainder of the slide deck will provide you with an actual deck of slides that you can use directly with the C-Suite.Today we will be discussing the ethical, legal, and financial rationale for transitioning to preferred drug formulations. The first few slides will help you understand the rationale and objectives of why you are presenting this information to the hospital C-Suite. The remainder of the slide deck will provide you with an actual deck of slides that you can use directly with the C-Suite.

2. 2 Objectives: Why are you Doing This? Patient safety is an issue that impacts your institution from an economic, legal, and ethical standpoint every day. Patient safety starts with a top-down approach(C-Suite) and should be an institutional objective. C-Suite executives may not be aware of the true impact of patient safety on your institution. Obtaining buy-in and support from decision makers will jump-start a proactive approach to patient safety. Convey to the C-Suite that one way to improve patient safety is to reduce medication errors through the use of manufacturer produced ready-to-use formulations. These points should come to mind when evaluating the rationale for presenting on patient safety to your C-Suite. Although, in each individual facility, the situation may be different. The impact of lapses in patient safety have a dramatic impact on the ethical, legal, and economic functioning of your institution. Many C-Suite executives regard patient safety as a prime responsibility, but few have all of the information needed to make key hospital-wide decisions regarding improvements in patient safety. Guarding the patient, particularly from medication oversights, is a prime responsibility of the pharmacy. You, as pharmacists, are regarded as the prescription experts. Therefore, any and all decisions and actions related to pharmaceutical errors fall under your jurisdiction. Medication error reductions are one patient safety improvement that you can implement with the use of manufacturer pre-mixed medications that is endorsed by numerous societies and organizations. The economics of this topic ultimately become realized in the reduction of patient morbidity and mortality. Associated costs have been identified and will be presented in this presentation. Patient safety is a hospital system-wide initiative that requires C-Suite involvement from the inception. The senior executives must support any and all programs related to patient welfare for it to be a success. The ability to obtain support and recommendations from these executives will rally multiple departments and personnel around your patient safety initiatives.These points should come to mind when evaluating the rationale for presenting on patient safety to your C-Suite. Although, in each individual facility, the situation may be different. The impact of lapses in patient safety have a dramatic impact on the ethical, legal, and economic functioning of your institution. Many C-Suite executives regard patient safety as a prime responsibility, but few have all of the information needed to make key hospital-wide decisions regarding improvements in patient safety. Guarding the patient, particularly from medication oversights, is a prime responsibility of the pharmacy. You, as pharmacists, are regarded as the prescription experts. Therefore, any and all decisions and actions related to pharmaceutical errors fall under your jurisdiction. Medication error reductions are one patient safety improvement that you can implement with the use of manufacturer pre-mixed medications that is endorsed by numerous societies and organizations. The economics of this topic ultimately become realized in the reduction of patient morbidity and mortality. Associated costs have been identified and will be presented in this presentation. Patient safety is a hospital system-wide initiative that requires C-Suite involvement from the inception. The senior executives must support any and all programs related to patient welfare for it to be a success. The ability to obtain support and recommendations from these executives will rally multiple departments and personnel around your patient safety initiatives.

3. 3 Questions to Consider whenPreparing your Presentation Do you find your C-Suite proactive or reactive towards safety initiatives? Has a safety culture taken hold at your institution? Does your leadership haveall of the information neededto make a decision? In gathering information for your C-Suite discussion, a few telling questions need to be addressed to determine the degree and amount of materials and information you will need to gather. If you find your group is proactive towards patient protection, the support and resources may already be in place for you to enhance or expand your efforts. If, on the other hand, they are reactive towards these issues, (they react only when an event occurs) the value of this endeavor has neither been demonstrated nor embraced. A culture of patient well-being can best be described as a hospital system-wide approach that should involve every department and employee. It is a convention that measures, acknowledges, and rewards any and all attempts to promote or improve patient safety, whether mandated from regulatory authorities, or based on individual hospital improvement goals. Finally, information drives many corporate decisions. Whether that information is from benchmarks or data collected from within your facility, it is imperative that you collect and analyze patient safety data from both a national perspective and from your own institution. For example, comparing preventable infection rates or medication error rates to national norms will help you determine where your hospital ranks and what, if any, corrective actions need to be implemented. If you determine that the admixing of medications by unit staff has led to an increased level of blood stream infections or pharmaceutical errors related to concentrations above US norms, a need for either additional staff training or a migration to more premix medications may be warranted.In gathering information for your C-Suite discussion, a few telling questions need to be addressed to determine the degree and amount of materials and information you will need to gather. If you find your group is proactive towards patient protection, the support and resources may already be in place for you to enhance or expand your efforts. If, on the other hand, they are reactive towards these issues, (they react only when an event occurs) the value of this endeavor has neither been demonstrated nor embraced. A culture of patient well-being can best be described as a hospital system-wide approach that should involve every department and employee. It is a convention that measures, acknowledges, and rewards any and all attempts to promote or improve patient safety, whether mandated from regulatory authorities, or based on individual hospital improvement goals. Finally, information drives many corporate decisions. Whether that information is from benchmarks or data collected from within your facility, it is imperative that you collect and analyze patient safety data from both a national perspective and from your own institution. For example, comparing preventable infection rates or medication error rates to national norms will help you determine where your hospital ranks and what, if any, corrective actions need to be implemented. If you determine that the admixing of medications by unit staff has led to an increased level of blood stream infections or pharmaceutical errors related to concentrations above US norms, a need for either additional staff training or a migration to more premix medications may be warranted.

4. 4 What do you Consider ImportantInformation for a Call to Action? ASHP Safety Summit Consensus Conference USP <797> Joint Commission CMS �Never Events� Recent �Safety� Issue There currently exists several bodies of evidence that support increasing and improving patient protection measures within your institutions from various authorities. This information should be used in support of your patient safety programs. The C-Suite should be made aware of each and every initiative and goal within these recommendations and guidelines�they will form the basis of why you want to implement these programs within your hospital. More importantly, if a recent safety issue has arisen at your medical center, the ability to evaluate and recommend corrective actions is a very important part of your presentation to chief executives. The ability to personalize your session with case studies and corrective measures employed by either you or other hospitals will immediately define the relevance of your material.There currently exists several bodies of evidence that support increasing and improving patient protection measures within your institutions from various authorities. This information should be used in support of your patient safety programs. The C-Suite should be made aware of each and every initiative and goal within these recommendations and guidelines�they will form the basis of why you want to implement these programs within your hospital. More importantly, if a recent safety issue has arisen at your medical center, the ability to evaluate and recommend corrective actions is a very important part of your presentation to chief executives. The ability to personalize your session with case studies and corrective measures employed by either you or other hospitals will immediately define the relevance of your material.

5. 5 Why are you the Most Qualified Personto Relay this Information? Pharmacy is the lead in medication delivery safety Leverage expert stature/training Have implemented/are implementingsystem-wide medication safety initiatives Valued and trusted member of institution Clearly the training and experience that the pharmacy department brings to the table on medication safety is paramount within the hospital, and as such, pharmacy should be the lead in efforts towards medication safety. Most of you are currently implementing, or have implemented, patient protection initiatives at your organization or others. If you are bringing new or improved policies or procedures to the C-Suite on medication safety, rely on this experience and expertise with first-hand examples and case studies. Surveys of consumers and hospital staff continue to rate pharmacists as valued and trusted members of the healthcare team. This goodwill and respect can be leveraged in helping you obtain some face time for a dialogue with senior executives on awareness of patient protection and reducing pharmaceutical errors. Clearly the training and experience that the pharmacy department brings to the table on medication safety is paramount within the hospital, and as such, pharmacy should be the lead in efforts towards medication safety. Most of you are currently implementing, or have implemented, patient protection initiatives at your organization or others. If you are bringing new or improved policies or procedures to the C-Suite on medication safety, rely on this experience and expertise with first-hand examples and case studies. Surveys of consumers and hospital staff continue to rate pharmacists as valued and trusted members of the healthcare team. This goodwill and respect can be leveraged in helping you obtain some face time for a dialogue with senior executives on awareness of patient protection and reducing pharmaceutical errors.

6. 6 A Model Presentation for your C-Suite The following slides can be used in total or you can select only the ones that you need. The slides have speaker notes and are fully referenced.

7. 7 Ethical, Legal, & Financial Rationale for the Transition to Preferred Drug Formulations(Actual C-Suite Presentation) The following slides are the actual slides you can use with the C-Suite.The following slides are the actual slides you can use with the C-Suite.

8. 8 Today�s Objectives Present the recommendations and support from organizations and guidelines regarding the conversion and benefits of ready-to-use, premixed medications. Present information on the ethical, legal, and financial risks and consequences associated with medication errors and discuss how they can impact our hospital. Discuss and form consensus on the purchase, expansion, or continuance of using ready-to-use, premixed medications and the impact on medication error reduction. These points will be discussed throughout our presentation today. To help all attendees within the C-Suite comprehend the scope and nature of current patient safety recommendations regarding ready-to-use formulations, a brief review of the Joint Commission and ASHP recommendations will be discussed. Information will be presented from several sources to help us qualify and quantify the types and extent of the ethical, legal, and financial impact of medication errors on hospitals. Finally, we would like to form a consensus on next steps in moving ahead with the increased use of ready-to-use formulations within the hospital.These points will be discussed throughout our presentation today. To help all attendees within the C-Suite comprehend the scope and nature of current patient safety recommendations regarding ready-to-use formulations, a brief review of the Joint Commission and ASHP recommendations will be discussed. Information will be presented from several sources to help us qualify and quantify the types and extent of the ethical, legal, and financial impact of medication errors on hospitals. Finally, we would like to form a consensus on next steps in moving ahead with the increased use of ready-to-use formulations within the hospital.

9. 9 Topics for Discussion Joint Commission, NPSG, and ASHP drivers of medication error reduction Medication errors impact on staff morale and PR The financial impact of medication errors Our recommendations moving forward These are the topics planned for today's discussion. Presenting the recommendations and guidelines from the Joint Commission, NPSG, and ASHP will help the hospital to better understand how they compare to current national standards of care. The impact of medication errors on the hospital is not only financial, it also has implications for staff morale and public relations. In today's economic health care environment, medication errors and their financial impact are receiving more scrutiny than ever before. One error has the potential to easily impact the bottom line of a hospital in the neighborhood of 6 figures. Finally, this presentation will close with some recommendations to move forward with regard to the use of ready-to-use, premixed medications throughout the hospital.These are the topics planned for today's discussion. Presenting the recommendations and guidelines from the Joint Commission, NPSG, and ASHP will help the hospital to better understand how they compare to current national standards of care. The impact of medication errors on the hospital is not only financial, it also has implications for staff morale and public relations. In today's economic health care environment, medication errors and their financial impact are receiving more scrutiny than ever before. One error has the potential to easily impact the bottom line of a hospital in the neighborhood of 6 figures. Finally, this presentation will close with some recommendations to move forward with regard to the use of ready-to-use, premixed medications throughout the hospital.

10. 10 Ready-to-administer Products are Recommended by: The Joint Commission Medication errors place patients at increased risk of morbidity and mortality. A 2006 report of the Institute of Medicine (IOM) concluded that �when all types of errors are taken into account a hospital patient can expect on average to be subjected to more than 1 medication error each day.�17 This conclusion is consistent with the results of a prospective cohort study involving 36 US institutions that found that nearly 1 in every 5 doses of a medication involved an error.4 The IOM report also estimated that at least 1.5 million preventable adverse drug events occur annually causing $8,750 per event in added hospital cost.17 Medication errors involving parenteral medications are also common and are especially concerning as they often cause significant patient harm. An analysis of 73,769 IV-related errors reported to the US Pharmacopeia indicated that 3�5% were harmful to the patient. 14 As a consequence, many health provider, regulatory, governmental, and patient safety organizations have developed recommendations intended to reduce the incidence of medication errors. Among the many recommendations made by these organizations, the use of ready-to-administer products is a common recommendation. As noted by the Joint Commission, the use of ready-to-administer products is intended to reduce compounding and labeling errors.27 Medication errors place patients at increased risk of morbidity and mortality. A 2006 report of the Institute of Medicine (IOM) concluded that �when all types of errors are taken into account a hospital patient can expect on average to be subjected to more than 1 medication error each day.�17 This conclusion is consistent with the results of a prospective cohort study involving 36 US institutions that found that nearly 1 in every 5 doses of a medication involved an error.4 The IOM report also estimated that at least 1.5 million preventable adverse drug events occur annually causing $8,750 per event in added hospital cost.17 Medication errors involving parenteral medications are also common and are especially concerning as they often cause significant patient harm. An analysis of 73,769 IV-related errors reported to the US Pharmacopeia indicated that 3�5% were harmful to the patient. 14 As a consequence, many health provider, regulatory, governmental, and patient safety organizations have developed recommendations intended to reduce the incidence of medication errors. Among the many recommendations made by these organizations, the use of ready-to-administer products is a common recommendation. As noted by the Joint Commission, the use of ready-to-administer products is intended to reduce compounding and labeling errors.27

11. 11 Ready-to-administer Products are Recommended by: (cont.) A 2008 multidisciplinary panel representing medicine, nursing, pharmacy, and governmental and patient safety organizations A similar recommendation was made in 2008 by a safety summit convened by the American Society of Health-System Pharmacists to identify and discuss criteria for selecting priority safe intravenous (IV) medication practices. The summit utilized the National Quality Forum criteria for specificity, benefit, evidence of effectiveness, generalizability, and readiness.3 The summit included representatives of medicine, nursing, pharmacy, as well as safety, quality, and regulatory organizations. Similar to recommendations by other organizations, a recommendation of the 2008 safety summit was to �dispense IV medications and admixtures in ready-to-administer form.�3A similar recommendation was made in 2008 by a safety summit convened by the American Society of Health-System Pharmacists to identify and discuss criteria for selecting priority safe intravenous (IV) medication practices. The summit utilized the National Quality Forum criteria for specificity, benefit, evidence of effectiveness, generalizability, and readiness.3 The summit included representatives of medicine, nursing, pharmacy, as well as safety, quality, and regulatory organizations. Similar to recommendations by other organizations, a recommendation of the 2008 safety summit was to �dispense IV medications and admixtures in ready-to-administer form.�3

13. 13 Key Points Patient safety is the #1 priority of hospital CEOs, yet medication errors are common. Many of the parenteral medications involved in medication errors are available in ready-to-administer form. Errors involving parenteral medications can have a major financial impact on hospitals. This program will present some of the possible risks associated with not providing preferred drug formulations, specifically ready-to-administer sterile medications for parenteral administration. Discussion will focus on the ethical, legal, and financial risks.This program will present some of the possible risks associated with not providing preferred drug formulations, specifically ready-to-administer sterile medications for parenteral administration. Discussion will focus on the ethical, legal, and financial risks.

14. 14 Risks Ethical Legal Financial First, let�s focus on the ethical risks of not providing sterile medications for parenteral administration in ready-to-administer form.First, let�s focus on the ethical risks of not providing sterile medications for parenteral administration in ready-to-administer form.

15. 15 Ethical Risks Do No Harm �Hippocrates, 4th century BC Attributed to Hippocrates, a guiding principle for all health care providers and organizations is to do no harm. This can be a difficult challenge in caring for patients because most management decisions are fraught with benefits and risks. Nonetheless, patient safety is and must continue to be a cornerstone of healthcare providers and the health care delivery system.Attributed to Hippocrates, a guiding principle for all health care providers and organizations is to do no harm. This can be a difficult challenge in caring for patients because most management decisions are fraught with benefits and risks. Nonetheless, patient safety is and must continue to be a cornerstone of healthcare providers and the health care delivery system.

16. 16 Top 5 Priorities of Healthcare CEOs The importance of patient safety was recently affirmed in a survey of chief executive officers (CEOs) of hospitals, physician practice groups, ambulatory clinics, and health plans.13 In fact, quality and patient safety was overwhelmingly ranked the number 1 priority.13The importance of patient safety was recently affirmed in a survey of chief executive officers (CEOs) of hospitals, physician practice groups, ambulatory clinics, and health plans.13 In fact, quality and patient safety was overwhelmingly ranked the number 1 priority.13

17. 17 But Medication Errors Remain Common But quality and patient safety continue to be threatened by medication errors, which remain common in hospitals.28, 7,11, 20, 23, 29, 21, 32But quality and patient safety continue to be threatened by medication errors, which remain common in hospitals.28, 7,11, 20, 23, 29, 21, 32

18. 18 The Human Cost of Medication Errors The patient: �I was frightened to complain any more . . . I was scared that I would get more mistreated.�1 The clinician: �You get that sinking feeling probably on a daily basis almost.�2 Among the many consequences of a medication error, the human cost can be significant. In addition to increased morbidity and mortality, patients who experience a medication error may be fearful of what they see as further mistreatment. Families also suffer as they may experience guilt in not being able to protect their family member.9 Clinicians can experience guilt as well, agonizing over the harm they have caused. Clinicians can also suffer from feeling a loss of their patient�s trust and colleagues� respect, as well as fear of the impact on their career. Diminished self confidence can result.9, 10 Among the many consequences of a medication error, the human cost can be significant. In addition to increased morbidity and mortality, patients who experience a medication error may be fearful of what they see as further mistreatment. Families also suffer as they may experience guilt in not being able to protect their family member.9 Clinicians can experience guilt as well, agonizing over the harm they have caused. Clinicians can also suffer from feeling a loss of their patient�s trust and colleagues� respect, as well as fear of the impact on their career. Diminished self confidence can result.9, 10

19. 19 Risks Ethical Legal Financial Legal risks are associated with not using preferred formulations.Legal risks are associated with not using preferred formulations.

20. 20 Medication Errors can beHighly Publicized� and Costly In addition to being highly publicized, medication errors can result in high legal expenses and settlements.30, 19, 1 In addition to being highly publicized, medication errors can result in high legal expenses and settlements.30, 19, 1

21. 21 Top Medical Claims2002�2006 Of 1164 medical claims filed with one medical insurance company from 2002 through 2006, 64% involved an error in 1 of 4 categories, with approximately 8% related to medications.8 Other reports also demonstrate that medication errors are a common cause of lawsuits. A 2002 study found that adverse events (AEs) related to medications (inpatient and outpatient) represented 6.3% of all medical malpractice claims.24 Seventy-three percent of these were judged to be preventable. Another study found that when only missed/delayed diagnosis, surgery, medication, and obstetric-related lawsuits were considered, 1 in 6 were related to medications.26 Of 1164 medical claims filed with one medical insurance company from 2002 through 2006, 64% involved an error in 1 of 4 categories, with approximately 8% related to medications.8 Other reports also demonstrate that medication errors are a common cause of lawsuits. A 2002 study found that adverse events (AEs) related to medications (inpatient and outpatient) represented 6.3% of all medical malpractice claims.24 Seventy-three percent of these were judged to be preventable. Another study found that when only missed/delayed diagnosis, surgery, medication, and obstetric-related lawsuits were considered, 1 in 6 were related to medications.26

22. 22 Legal Fees and Awards The legal expenses resulting from medical malpractice lawsuits can be substantial. With respect to preventable inpatient medication-related claims, one study (claims from 1990�1999) found that the legal fees averaged $44,000 and the award $332,500.24 A more recent report found the average cost for legal fees and award for medical malpractice claims, of which 17% were related to a medication, to be $537,869.26 Another cost brought on by a lawsuit is the time to defend the lawsuit itself, which takes an average of three years.26 This can have a tremendous impact on those health care providers involved in the lawsuit and their ability to take care of patients and generate revenue for the hospital. The legal expenses resulting from medical malpractice lawsuits can be substantial. With respect to preventable inpatient medication-related claims, one study (claims from 1990�1999) found that the legal fees averaged $44,000 and the award $332,500.24 A more recent report found the average cost for legal fees and award for medical malpractice claims, of which 17% were related to a medication, to be $537,869.26 Another cost brought on by a lawsuit is the time to defend the lawsuit itself, which takes an average of three years.26 This can have a tremendous impact on those health care providers involved in the lawsuit and their ability to take care of patients and generate revenue for the hospital.

23. 23 Medications Most Commonly Associatedwith a Malpractice Claim Antibiotics Antidepressants/Antipsychotics Cardiovascular drugs Blood coagulation modifiers Opioids Anxiolytics/Sedative hypnotics Insulin Several groups of medications are those most commonly associated with a malpractice claim. These include antibiotics, antidepressants/ antipsychotics, cardiovascular drugs, blood coagulation modifiers, opioid analgesics, anxiolytics/sedative hypnotics, and insulin.24, 3 Several groups of medications are those most commonly associated with a malpractice claim. These include antibiotics, antidepressants/ antipsychotics, cardiovascular drugs, blood coagulation modifiers, opioid analgesics, anxiolytics/sedative hypnotics, and insulin.24, 3

24. 24 Medications Most Commonly Associatedwith a Malpractice Claim Antibiotics* Antidepressants/Antipsychotics Cardiovascular drugs* Blood coagulation modifiers* Opioids* Anxiolytics/Sedative hypnotics Insulin* Many of these medications are available in a ready-to-administer form. Their use might serve a valuable role in reducing medication errors and the resulting legal expenses.24, 3 Many of these medications are available in a ready-to-administer form. Their use might serve a valuable role in reducing medication errors and the resulting legal expenses.24, 3

25. 25 Risks Ethical Legal Financial Legal costs are but 1 of the financial risks of not providing preferred formulations.Legal costs are but 1 of the financial risks of not providing preferred formulations.

26. 26 Hospitals are Responding to theEconomic Challenges The importance of financial considerations has never been greater as hospitals are implementing cost-cutting measures as a consequence of declining revenues. As you can see in the chart, both total margins and operating margins have decreased well over 50% recently. This is the reality of today's health care financial situation.2 The importance of financial considerations has never been greater as hospitals are implementing cost-cutting measures as a consequence of declining revenues. As you can see in the chart, both total margins and operating margins have decreased well over 50% recently. This is the reality of today's health care financial situation.2

27. 27 Hospitals are Responding to the Economic Challenges�Reducing Overhead Nearly all hospitals have made changes to address economic challenges. Among the more common changes are reducing staff and reducing services. Of concern is the impact of a reduction in staff may have on both the quality and safety of patients. Implementing programs or purchasing products that reduce staff time while meeting patient quality and safety goals are gaining momentum.2 Nearly all hospitals have made changes to address economic challenges. Among the more common changes are reducing staff and reducing services. Of concern is the impact of a reduction in staff may have on both the quality and safety of patients. Implementing programs or purchasing products that reduce staff time while meeting patient quality and safety goals are gaining momentum.2

28. 28 Hospital Pharmacies are AlsoMaking Changes 2009 survey of pharmacy directors to: Assess the impact of the current economy on pharmacy services in hospitals and health systems 66% had been required to reduce their drug budget >50% had taken some action to manage expenses 37% had reduced staff within the last 6 months 29% had postponed/reduced/eliminated planned facility improvements to comply with USP Chapter <797> In March 2009, the American Society of Health-Systems Pharmacists conducted a survey of department directors to assess the impact of the current economy on pharmacy services in hospitals and health systems. Sixty-six percent of the survey respondents (n=541) indicated that they had been required to reduce their drug budgets, while more than half had taken some action to manage expenses. Thirty-seven percent had reduced staff within the last 6 months. Twenty-nine percent had postponed, eliminated, or reduced in scope planned facility improvements to comply with USP Chapter <797>.6 In March 2009, the American Society of Health-Systems Pharmacists conducted a survey of department directors to assess the impact of the current economy on pharmacy services in hospitals and health systems. Sixty-six percent of the survey respondents (n=541) indicated that they had been required to reduce their drug budgets, while more than half had taken some action to manage expenses. Thirty-seven percent had reduced staff within the last 6 months. Twenty-nine percent had postponed, eliminated, or reduced in scope planned facility improvements to comply with USP Chapter <797>.6

29. 29 But Patient Safety Remainsa Major Problem In the 1999 landmark report To Err Is Human: Building A Safer Health System, the Institute of Medicine estimated that 44,000 to 98,000 people died each year due to preventable medical errors. The total cost due to preventable medical errors was estimated to be $17 to $29 billion (including additional care required by the errors, lost income and household productivity, and disability).15 Years later, the Institute for Healthcare Improvement estimated that 15 million cases of medical harm occur in US hospitals each year.16 That�s more than 40,000 each day. A subsequent survey conducted by HealthGrades estimated that 913,215 safety events occurred in approximately 38 million hospitalizations involving Medicare beneficiaries in 2005�2007. The excess cost associated with these patient safety events was estimated at nearly$7 billion.12 Although medication errors were not included in the HealthGrades analysis, the results indicate that patient safety in US hospitals remains a major problem. In the 1999 landmark report To Err Is Human: Building A Safer Health System, the Institute of Medicine estimated that 44,000 to 98,000 people died each year due to preventable medical errors. The total cost due to preventable medical errors was estimated to be $17 to $29 billion (including additional care required by the errors, lost income and household productivity, and disability).15 Years later, the Institute for Healthcare Improvement estimated that 15 million cases of medical harm occur in US hospitals each year.16 That�s more than 40,000 each day. A subsequent survey conducted by HealthGrades estimated that 913,215 safety events occurred in approximately 38 million hospitalizations involving Medicare beneficiaries in 2005�2007. The excess cost associated with these patient safety events was estimated at nearly$7 billion.12 Although medication errors were not included in the HealthGrades analysis, the results indicate that patient safety in US hospitals remains a major problem.

30. 30 Financial Impact of Medication Errors From a hospital perspective, medical errors, including medication errors, are a significant financial burden. A review of medical records from 3 community hospitals showed that medication errors are a common cause of excess cost and length of stay. The charts of 123,281 patients discharged from 3 hospitals in Portland, Oregon, in 2002�2004 found that a total of 11,936 patient safety events were voluntarily reported. These events accounted for an additional $8.3 million in costs and 4854 days of hospital stay.22 There were 4543 patient safety events related to medications (38% of total) at an additional cost of $4.1 million (49% of total). This amounted to an average of $2.0 million per year in additional costs due to medication-related patient safety events. The average cost per event was $913 and average days per event was 0.52 days.22 From a hospital perspective, medical errors, including medication errors, are a significant financial burden. A review of medical records from 3 community hospitals showed that medication errors are a common cause of excess cost and length of stay. The charts of 123,281 patients discharged from 3 hospitals in Portland, Oregon, in 2002�2004 found that a total of 11,936 patient safety events were voluntarily reported. These events accounted for an additional $8.3 million in costs and 4854 days of hospital stay.22 There were 4543 patient safety events related to medications (38% of total) at an additional cost of $4.1 million (49% of total). This amounted to an average of $2.0 million per year in additional costs due to medication-related patient safety events. The average cost per event was $913 and average days per event was 0.52 days.22

31. 31 Financial Impact of IntravenousMedication-related Adverse Events Another study focused on IV medication-related AEs. The computerized medical records of 4604 adult patients in intensive care units at one academic and 1 non-academic hospital in 2003�2004 were reviewed. Three hundred ninety-seven IV medication-related AEs were identified. In the non-academic hospital, the IV medication-related AEs were not associated with significantly different costs ($188) or lengths of stay (-0.3 days) compared with controls. In the academic hospital, costs were significantly higher ($6,647) and lengths of stay significantly longer (4.8 days) than controls. The differences between the non-academic and academic hospitals were significantly different. However, there were no differences in IV medication-related AE severity or preventability between the 2 hospitals, and patient characteristics differed slightly. The investigators surmised the differences between the 2 hospitals was due to differences in practices after IV medication-related AEs occurred.21 Another study focused on IV medication-related AEs. The computerized medical records of 4604 adult patients in intensive care units at one academic and 1 non-academic hospital in 2003�2004 were reviewed. Three hundred ninety-seven IV medication-related AEs were identified. In the non-academic hospital, the IV medication-related AEs were not associated with significantly different costs ($188) or lengths of stay (-0.3 days) compared with controls. In the academic hospital, costs were significantly higher ($6,647) and lengths of stay significantly longer (4.8 days) than controls. The differences between the non-academic and academic hospitals were significantly different. However, there were no differences in IV medication-related AE severity or preventability between the 2 hospitals, and patient characteristics differed slightly. The investigators surmised the differences between the 2 hospitals was due to differences in practices after IV medication-related AEs occurred.21

32. 32 The Financial Cascade of Medication Errors The added cost, length of stay, and other consequences associated with medication errors are part of a cascade that negatively impacts the financial health of a hospital. The excess cost is comprised of more than just additional room charges. Compared with controls, patients who experience a medication error utilize significantly more hospital services, eg, diagnostic imaging, respiratory therapy, nutrition, dialysis, and medications.21 The use of these and other services add to staff workload. Similarly, an increased length of stay adds to increased utilization of services and staff workload. Patient flow may also be disrupted as a result of the unanticipated increased length of stay. Patients are also at an increased risk of a subsequent patient safety event. Making financial matters worse, reimbursement for death or disability related to a medication error may now be denied by the US Centers for Medicare and Medicaid Services as part of their �never events� initiative.5 Insurance companies may adopt similar payment limitations. Finally, patients who become dissatisfied may no longer seek care with health care providers or the hospital responsible for the medication error. They may also seek litigation to compensate for increased pain and suffering and/or malpractice as we have seen. The net consequence of these is a negative impact on hospital finances.The added cost, length of stay, and other consequences associated with medication errors are part of a cascade that negatively impacts the financial health of a hospital. The excess cost is comprised of more than just additional room charges. Compared with controls, patients who experience a medication error utilize significantly more hospital services, eg, diagnostic imaging, respiratory therapy, nutrition, dialysis, and medications.21 The use of these and other services add to staff workload. Similarly, an increased length of stay adds to increased utilization of services and staff workload. Patient flow may also be disrupted as a result of the unanticipated increased length of stay. Patients are also at an increased risk of a subsequent patient safety event. Making financial matters worse, reimbursement for death or disability related to a medication error may now be denied by the US Centers for Medicare and Medicaid Services as part of their �never events� initiative.5 Insurance companies may adopt similar payment limitations. Finally, patients who become dissatisfied may no longer seek care with health care providers or the hospital responsible for the medication error. They may also seek litigation to compensate for increased pain and suffering and/or malpractice as we have seen. The net consequence of these is a negative impact on hospital finances.

33. 33 Summary Medication errors can leadto a host of ethical, legal, and financialnegative consequences Medication errors can lead to ethical, legal, and financial consequences, and are currently not 100% preventable in all institutions. However, there does exist numerous guidelines, programs and products available that can help you reduce the risk of medication errors occurring in your institution.Medication errors can lead to ethical, legal, and financial consequences, and are currently not 100% preventable in all institutions. However, there does exist numerous guidelines, programs and products available that can help you reduce the risk of medication errors occurring in your institution.

34. 34 A Solution One approach to reduce medication errors is to use sterile medications in a ready-to-administer form as recommended by numerous independent groups and/or Maintain or expand the current portfolio of manufacturer, ready-to-administer medications The use of ready-to-administer parenteral medications is 1 widely recommended strategy to be employed towards your goal of a medication error-free institution. You can also discuss with the C-Suite the need to maintain or expand the use of manufacturer ready-to-administer medications, particularly as more and more become available.The use of ready-to-administer parenteral medications is 1 widely recommended strategy to be employed towards your goal of a medication error-free institution. You can also discuss with the C-Suite the need to maintain or expand the use of manufacturer ready-to-administer medications, particularly as more and more become available.

35. 35 References 1. About Lawsuits. IV medication error payout. Available at: http://www.ivteam.com/iv-medication-error-payout/. Accessed July 14, 2009. 2. American Hospital Association. The Economic Crisis: The Toll on the Patients and Communities Hospitals Serve. Available at: http://www.aha.org/aha/content/2009/pdf/090427econcrisisreport.pdf. Accessed June 26, 2009. 3. ASHP. Proceedings of a summit on preventing patient harm and death from i.v. medication errors. Am J Health-Syst Pharm. 2008;65;2367-2379. 4. Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL. Medication Errors Observed in 36 Health Care Facilities. Arch Intern Med. 2002;162(16):1897-1903. 5. Centers for Medicare and Medicaid Services. CMS improves patient safety for medicare and medicaid by addressing �never events.� Available at: http://www.workforce.com/tools/misc/fs11_never_events_081001.pdf. Accessed June 11, 2009. 6. Chen D. Impact of the current economy on pharmacy services in hospitals and health systems. American Society of Health-System  Pharmacists. Available at: http://www.ashp.org/economy-survey. Accessed July 13, 2009. 7. Consumers Union. To err is human�To delay is deadly. Available at: http://www.safepatientproject.org/safepatientproject.org/pdf/safepatientproject.org-ToDelayIsDeadly.pdf. Accessed July 10, 2009. 8. CRICO/RMF. High risk areas. Medication. Available at: http://www.rmf.harvard.edu/high-risk-areas/medication/index.aspx. Accessed July 13, 2009. 9. Delbanco T, Bell SK. Guilty, Afraid, and Alone�Struggling with Medical Error. N Engl J Med. 2007;357(17):1682-1683.

36. 36 References (cont.) 10. Gallagher TH, Waterman AD, Ebers AG, et al. Patients' and Physicians' Attitudes Regarding the Disclosure of Medical Errors. JAMA. 2003;289(8):1001-1007. 11. Gershman MD, Kennedy DJ, Noble-Wang J, et al. Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy. Clin Infect Dis. 2008;47(11):1372-1379. 12. HealthGrades. The Sixth Annual HealthGrades Patient Safety in American Hospitals Study. Available at: http://www.healthgrades.com/media/dms/pdf/PatientSafetyInAmericanHospitalsStudy2009.pdf. Accessed July 14, 2009. 13. HealthLeaders Media Industry Survey 2009. Available at: http://www.healthleadersmedia.com/pdf/survey_project/2008- 2009/CEO_final.pdf. Accessed July 10, 2009. 14. Hicks RW, Becker SC. An Overview of Intravenous-related Medication Administration Errors as Reported to MEDMARX�, a National Medication Error-reporting Program. J Infus Nurs. 2006;29(1):20-27. 15. Institute of Medicine. To Err Is Human: Building a Safer Health System. Available at: http://www.iom.edu/Object.File/Master/4/117/ToErr- 8pager.pdf. Accessed July 14, 2009. 16. Institute for Healthcare Improvement. Protecting 5 Million Lives From Harm. Available at: http://www.ihi.org/IHI/Programs/Campaign/Campaign.htm?TabId=6. Accessed July 14, 2009. 17. Institute of Medicine. Report brief-July 2006. Preventing medication errors. Available at: http://www.iom.edu/Object.File/Master/35/943/medication%20errors%20new.pdf. Accessed June 11, 2009.

37. 37 References (cont.) 18. Lacaria K, Balen RM, Frighetto L, Lau TTY, Naumann TL, Jewsson PJ. Perceptions of the Professional Pharmacy Services in a Major Canadian Hospital: A Comparison of Stakeholder Groups. Longwoods Review. 2004;2(1):8-19. 19. Legal Eagle. Overdose: Nurse charged in patient�s death, hospital held liable. Available at: http://www.nursinglaw.com/overdose.pdf. Accessed July 14, 2009. 20. Maragakis LL, Chaiwarith R, Srinivasan A, et al. Sphingomonas paucimobilis bloodstream infections associated with contaminated intravenous fentanyl. Emerg Infect Dis. 2009;15(1):12-18. 21. Nuckols TK, Paddock SM, Bower AG, et al. Costs of intravenous adverse drug events in academic and nonacademic intensive care units. Med Care. 2008;46(1):17-24. 22. Paradis AR, Stewart VT, Bayley KB, Brown A, Bennett AJ. Excess Cost and Length of Stay Associated With Voluntary Patient Safety Event Reports in Hospitals. Am J Med Qual. 2009;24(1):53-60. 23. Parshuram CS, To T, Seto W, Trope A, Koren G, Laupacis A. Systematic evaluation of errors occurring during the preparation of intravenous medication. CMAJ. 2008;178(1):42-48. 24. Rothschild JM, Federico FA, Gandhi TK, Kaushal R, Williams DH, Bates DW. Analysis of medication-related malpractice claims: causes, preventability, and costs. Arch Intern Med. 2002;162(21):2414-2420. 25. Saad L. 2008 Gallup Honesty and Ethics Poll. Nurses Shine, Bankers Slump in Ethics Rating [press release]. Available at: http://www.gallup.com/poll/112264/Nurses-Shine-While-Bankers-Slump-Ethics-Ratings.aspx. Accessed on June 11, 2009. 26. Studdert DM, Mello MM, Gawande AA, et al. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 2006;354(19):2024-2033.

38. 38 References (cont.) 27. The Joint Commission Accredited Program: Hospital. National Patient Safety Goals. The Joint Commission Website. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/09_hap_npsgs.htm Accessed July 10, 2009. 28. US Centers for Disease Control and Prevention. Deaths from intravenous colchicine resulting from a compounding pharmacy error-- Oregon and Washington, 2007. MMWR Morb Mortal Wkly Rep. 2007;56(40):1050-1052. 29. Valentin A, Capuzzo M, Guidet B, et al. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009;338:1-8. 30. Vogler ME. Jury awards $2M in wrongful death suit to family of Methuen woman. Available at: http://www.eagletribune.com/punews/local_story_023011843.html. Accessed July 14, 2009. 31. Wen P. 1 in 10 patients gets drug error. Study examine six community hospitals in Mass. Available at: http://www.boston.com/news/local/articles/2008/02/14/1_in_10_patients_gets_drug_error/. Accessed July 10, 2009. 32. Wheeler DW, Degnan BA, Sehmi JS, Burnstein RM, Menon DK, Gupta AK. Variability in the concentrations of intravenous drug infusions prepared in a critical care unit. Intensive Care Med. 2008;34(8):1441-1447.