Applying the Evidence for Clinical Pharmacy Services to Pharmacy Practice

1. Applying the Evidence for Clinical Pharmacy Services to Pharmacy Practice Provided by: Michael G. Liebl, BS, PharmD, BCPS Clinical Manager, Pharmacy Services The Methodist Hospital Houston, TX 77030 Pager: 281-735-5815 Phone: 713-441-6973 Email: mliebl@tmhs.org

2. Program Learning Objectives At the completion of this program, the participant will be able to: • Review the pharmacy and medical literature that evaluates clinical pharmacy services. • Identify key clinical pharmacy services demonstrated to improve morbidity and mortality outcomes. • Estimate the relative pharmacoeconomic benefit of certain clinical pharmacy services. • Relate the findings from the pharmacy and medical literature to an institution's provision of clinical pharmacy services.

3. Disclosures: • No financial interest in any entity or individual cited in the presentation • Regarding disclosures for non-commercial content and conclusions within: • Active memberships in ACCP, ASHP, TSHP, GCSHSP & SCCM • My primary position: Manager, clinical pharmacy services • Previous role: Clinical pharmacist MICU & CVICU • Conducted and involved in clinical pharmacy research studies that evaluating the value of clinical pharmacy services • I have a significant (and financial) relationship with a clinical pharmacist

4. A timeline of our clinical pharmacy ancestry in the words of leaders of the movement W. Arthur Purdum ...within the new minimum standard lies the key to our first objective: improving and extending the usefulness of the hospital pharmacist. …Today we are still recognized as a complementary service department and we must continue our efforts until pharmacy is regarded asessential. 1950

5. Fast Forward to 2008 and ask the tough questions… • Is there an essential, established need for advanced clinical pharmacy services? • If yes, how great is the need? Is there a cost for not providing them? • What type of clinical services make the greatest difference? • What training is required to provide these services? • How many providers for a given institution? • Can the value of these services be measured? • Is the difference realized significant to stakeholders? • Patients • Administrators • Quality / regulatory agencies • Others • Has the call for advanced clinical pharmacy services been endorsed by: our profession, administrators, quality / regulatory agencies & patients?

6. So, where to begin…Is there an essential, established need for advanced clinical pharmacy service?...what is the problem or the void in healthcare?

7. Medications:Estimated as the #4 Killer Annually Heart disease 743,460 dead Cancer 529,904 dead Stroke 150,108 dead Medications 137,000 dead Pulmonary disease 101,077 dead Accidents 90,523 dead Pneumonia 75,719 dead Lazarou, et al. JAMA 1998;279:1200-5

8. How common are ADRs & ADEs? # of Events (1000 pt days) % of Patients with ADRs Comments Cornish P. Arch Int Med 2005; 165: 424-429. – Admission % of Patients with error: 53% 38% with moderate to severe adverse event potential Weiner B, Venarske JL, Yu M & Mathis K. Spine 2008; % of meds with error pre: 62% % of meds with error post: 39% 42% with moderate to severe adverse event potential Bowman L. Can J of Hosp Pharm 1994; 5: 209-216. (Wishard, IN) 23.1% 10% severe LOS 6.6 days; ~70% type ”A” Events Classen DC. JAMA. 1997; 277: 301-6 2.4% Mortality 2%, LOS 2 days at a cost of $2,000/event Moore N. Br J Clin Pharmacol 1998; 3: 301-8. 5.6 NR LOS 8.5 days; 7.6% of all hosp days Lazarou J. JAMA 1998; 279: 1200. (Meta-analysis of ADRs) NR 6.7% (total) 0.32% (fatal) Estimated as the 4th - 6th leading cause of death Vargas E. CCM 2003; 31: 694-98. NR 9.2% LOS 3.9 days Cullen D. CCM 1997; 25: 1289-97. 9.7 NR NR Holdsworth M. Arch Pediatr Adolesc Med 2003; 157: 60-65. 7.5 6% LOS 15.3 days Chaudhry S, Olofinboba K, J Gen Intern Med 2003; 18: 595-600. NR 4.9% 1.9% of ADRs attributed to increased morbidity Forester A. Ann Intern Med 2003; 138: 161-167. NR 7.9% Hospital readmissions due to medication events

9. Could these be the most dangerous (and expensive) medical devices?

10. How Hazardous Is Health Care? Annual Cost: Lives Lost Source: Roger Resar, MD (Mayo Clinic) IHI Symposium 2001

11. Neil M. Davis “…After studying the Institute of Medicine’s To Err Is Human, a suggestion for improving might be that there should be a person who has expert knowledge about drugs and drug therapy to review the entire drug selection and monitoring aspects of patient care. In a world where there were no such people as pharmacists, they would have to be invented. Perhaps, on that planet, they would be called “medicationists”. Well, our world does have drug experts. They are called pharmacists, so there is no need to create a new professional to fill that void.” 2000

12. Clinical Pharmacy Services That Impact Patient Care Outcomes • Specifics on individual services rendered • Admitting Pharmacist Services • Pharmacist Rounding • ICU • Acute Care • Anticoagulation Services • Pharmacokinetic Services • High-risk populations • Transplant • Oncology

13. Admitting Pharmacy Services:Addressing Medication Errors From the Start • Consistent finding of error rates • Consistent estimation of harm potential • Consistent finding of a meaningful improvement (reduction in error rate) with pharmacist involvement in the process *Two phases reported for this evaluation: Pre-intervention & post-intervention

14. Clinical Pharmacist Impact: Inpatient Rounds RRR: Relative Risk Reduction ARR: Absolute Risk Reduction NNT: Number needed to treat = [(1/ARR)x100]

21. How many clinical pharmacists does one need? • How few is too few? • Opportunity loss costs? • When are there too many? • Diminishing marginal return? • Where does one prioritize service?

22. Neil M. Davis …The time needed for clinical activities can be gained from better utilization of pharmacy technicians, bar coding, automation and a well-designed, fully integrated CPOE. For some facilities, all of this will still not be enough to substantially reduce the error problem and more pharmacists will have to be hired. …Institutions will have to attract and retain pharmacists… Junior high and high school students must be exposed to the benefits of pharmacy as a career choice to ensure that there is an adequate pool of bright and motivated students. 2000

23. Inpatient pharmacy staffing relationship to outcomes:Mortality Rates

24. Donald E. Franke ...We see today that there are stirrings of a more objective approach towards sound drug therapy and…the pharmacist plays an increasingly important role. …It seems to me that this trend which is gaining momentum constantly, offers great opportunities for pharmacists to increase our professional responsibilities through cooperative efforts with colleagues in the medical profession, we can increase our value as professionals benefiting not only to pharmacy but also to medicine, our hospital and patients. These are indeed goals to which we should strive. …I am confident that the hospital pharmacist will…occupy an increasingly important position not only in the selection and procurement of pharmaceuticals but also as a valued consultant to the physician. 1952

25. Sister Mary John …We are beginning a new era…more medical cases will increase the volume of drugs dispensed and paid for by a third party who will want prices to reflect costs. Hospital revenue must equal expenditures…so unnecessary expenditures must be curtailed. ...It is the pharmacist’s major duty to maintain rational therapeutics in his hospital. He must keep himself well informed about drugs so that he can withstand the flood of unsubstantiated claims often made for new products. …To challenge scientifically, one needs an equality of knowledge. The doctor, so skilled in the basic sciences, is still vulnerable to the high pressured salesmanship of even nonpharmacists. 1957

26. Benefit Cost Pharmacoeconomics • Description and analysis of the costs of drug therapy to health care systems and society – it identifies, measures and compares the costs and consequences of pharmaceutical products and services. • Perspective is important… • Cost center • Department • Institution • System • Patient • Society • A few issues are black and white (red or green in the example); • Most are grey

27. Recent Cost of Adverse Events Data (ICU) • Setting – 10 bed MICU and a 10 bed CCU at Brigham & Women’s Hospital & Harvard Medical School • Authors cited existing patient safety parameters already in place: • CPOE • Pharmacist on rounds • Nursing coverage nearly 1:1 • Just culture • Intensivist physician staffing in place

31. Finding: Costs of the pharmacist were NOT overcome by savings from identifiable drug costs • Setting: • 480 bed Community Teaching Hospital • 12 bed MICU, 11 Bed Surgical ICU • Study Concerns: • Part time position – 2 hrs per day • Rotated days of the week • Rotated hours of the day (intentionally) • Excluded protocol management (intentionally) • No interventions to add new drugs for untreated diseases • TDM • No interactions with MDs on rounds Am J Hosp Pharm. 1991 Oct;48(10):2154-7

32. # of Dispensing Pharmacist / 100 Occupied Beds # of Pharmacy Admin. / 100 Occupied Beds # of Clinical Pharmacist / 100 Occupied Beds Pharmacy Staffing Associations and total costs of care in US Hospitals

33. ROI or Cost to Benefit Ratio for Clinical Pharmacy ServicesWhat Should Be Expected? Please write down a number

34. Endorsements of Clinical Pharmacy Services:(Not a comprehensive list...) • ASHP & ACCP • SCCM – Standards for pharmacy services in the ICU that include various levels of clinical pharmacy activities: Fundamental, Desirable & Optimal • AHRQ – Several chapters (5, 7,8, & 9) on the benefit to quality and cost for hospitals in areas such as ADE reduction, Medication error reduction, Anticoagulation. • Society for Hospital Medicine (SHM) & ASHP Joint Position Paper • Infectious Diseases Society of America • The Joint Commission • UNOS • Leapfrog Group

35. Where will the clinical pharmacists of tomorrow come from? • What experience or training is required? • Who will train them?

36. Joe Smith …Let me summarize this recommendation for an entry level residency program in hospital pharmacy. 1st training in clinical (general) practice becomes the focus of the program. 2nd a Pharm.D. degree should be a prerequisite for entry into the program. 3rd the training program should provide meaningful experience in the other important services and in the overall management of the department. 4th this generalist entry-level residency should be a prerequisite for advanced specialized residency programs. It is this level of training that we should set our sights on for all pharmacists who are preparing for a future in hospital pharmacy practice. …Beyond this entry-level training program, there is a growing need for highly specialized clinical training programs. I believe that there is now a much greater demand for highly specialized clinicians than we can supply, and the demand will likely increase. …The leaders of a clinical profession must be committed to, almost obsessed with, the idea of clinical practice. And, most important, they will need to project that idea into images that create excitement in other people about that activity. 1988

37. ACCP White Paper Estimated Needs: Increase to 7,500 residency slots up from 1,250 offered today in mostly general practice (PGY-1) PGY2 offerings should increase similarly

38. An Institutional, Case-Based Application • Setting: • 1,300-bed Tertiary Care, Private Teaching Hospital • Adult medical / surgical population with oncology, transplant, psychiatry, women’s health and advanced heart failure populations • Teaching Affiliations • Medical, Nursing & Pharmacy Schools • Patient Payor Mix • Medicare / Medicaid: ~52% • Private pay: ~45%

39. Pharmacy Department Overview: • Highly automated: Robotics, automated dispensing cabinets, CPOE, electronic medication tracking system, and knowledge based medication administration pending • Technician driven order entry • Clinical pharmacy specialists in all major inpatient servicelines, nearly all with PGY1 and/or PGY2 training and several with board certification • Intensity of coverage M-F; 7AM – 5PM. Basic service commitments on the weekends • Code blue team response: 24/7 • On-site Drug information Center & formulary management • PGY1 and PGY2 Pharmacy Residency Provider • Active Doctor of Pharmacy externship program • Active pharmacy and medical research initiatives • ACPE Provider

40. * Clinical Pharmacist - Resource Distribution *Ratio: Less 4.5 FTE for Weekend, Holiday & Vacation Coverage

41. Applying the Evidence: Medication History Accuracy Improvements Internal Data: Sirimaturos M, Venarske J & Yu M.

42. Applying Evidence: TMH Pharmacists’ Clinical Interventions: 2006 • Pharmacists documented approx 16,853 interventions in 2006 • Intervention quality was sustained with a noted increase in the % of level two and level three interventions (up from 38% and 2% respectively) • Interventions by level: • Costs avoided per intervention by significance level*: • Level 1 – $70 • Level 2 – $500 • Level 3 – $4,685 • Projected costs avoided approximately: $6.2 Million dollars Example: Patient identified with a platelet count decrease of greater than 50% from baseline & was maintained on heparin therapy. Pharmacist recommended antibody screen & treatment. Subsequent testing demonstrated patient was positive for Heparin antibodies and diagnosed with HIT. *Cost avoided values derived from internal benchmarking, published pharmacoeconomic & ADE avoidance literature & medical malpractice claims higher in patients with preventable ADEs.

43. Estimated Clinical Pharmacy Consultation Services Provided* • Anticoagulation • Warfarin – 150 pts • Heparin – 130 pts • Falls Prevention – 60 pts • Polypharmacy – 30 pts • Discharge counseling – 200 pts • Pharmacokinetic – 2 pts • TPN – 25 pts • Renal dosing – 38 pts • Severe Sepsis – 20 pts • Other – 10 pts *Based Upon Consult Orders Received per Month

44. ? ? A Pharmacoeconomic Estimation of Clinical Pharmacy Services: ROI Range Estimate: 2.5 – 4

45. In closing, have we answered the questions? • Is there an essential, established need for advanced clinical pharmacy services? • If yes, how great is the need? Is there a cost for not providing them? • What types of clinical services make the greatest difference? • Can the value of these services be measured? • Is the difference realized significant to stakeholders? • Patients, Administrators, Quality / regulatory agencies • Others • Has the call for advanced clinical pharmacy services been endorsed by: our profession, administrators, quality / regulatory agencies & patients? • What training is required to provide these services? • How many providers for a given institution?

46. R. David Anderson …pharmacists who are not in constant face-to-face contact with physicians, nurses & particularly patients where they are being treated & who are unable to see exactly how drugs work…are destined to know little more than a myriad of unorganized details. …The pattern most idealized of a professional pharmacist would be one who has a close association with patients; a comprehensive awareness of previous medication habits; knows allergies, sensitivities, & idiosyncrasies; extracts information about them from charts, laboratory, x-ray, and other data; has access to drug-oriented information; is able to correlate that information with knowledge about the patient’s physiology & disease; & recommends to physicians, nurses, & others the proper course to follow where drugs are indicated. He emphasizes and insures safety and effectiveness of drugs. …The hypothetical professional pharmacist would serve as a counselor, advisor, teacher… & patient care team member …The model which comes closest to conformance with this professional ideal is the clinical pharmacist. 1976

47. Questions & Discussion