1. Andrew M. Peterson, PharmD, PhD Dean, Mayes College of Healthcare Business and Policy University of the Sciences Prescribing Practices

2. Presentation Format Case-based approach Topics –Medication Compliance –Medication Errors –Underlying theme Identify trends in laws and regulations that can impact your prescribing practice Describe emerging technologies and how they are influencing the medication use process

3. Medication Compliance Objectives Differentiate among the concepts of medication adherence, compliance and persistence Identify four predictors of medication compliance Articulate three reasons for medication non- compliance specific to the elderly Given a specific case, identify at least two strategies to improve medication compliance

4. Medication Compliance Non- compliance to medical therapy is a major threat to public health in the United States Non- compliance to prescribed medication costs nearly 125,000 lives per year. 10% of hospital and 23% of nursing home admissions are linked to compliance. $300 billion annually 1/3 of all prescriptions NOT picked up –Non- compliance to pharmacotherapy is estimated to be 50% overall wide ranges reported in the literature for different disease states (30-70%) Sources: Noncompliance with Medication Regimens. An Economic Tragedy. Emerging Issues in Pharmaceutical Cost Containing. Washington, DC. National Pharmaceutical Council. 1992;1-16.; Luscher TF. Vetter W. Adherence to medication. Journal of Human Hypertension. 4 Suppl 1:43- 6, 1990 Feb; McGhan WF, Peterson AM. Pharmacoeconomic impact of patient noncompliance. IMPACT – US Pharmacist. October 2001.

5. Case Description

6. Definitions Compliance –the extent to which patients are obedient and follow the instructions of a health care professional 1 Adherence –the extent to which a person’s behavior – taking medication, following a diet, and/or executing lifestyle changes corresponds with agreed upon recommendations from a health care provider 2 Persistence –how long a patient remains on therapy, introducing length of treatment as a factor Sources: 1. Meichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. Boston: Plenum Press; 1987: 20, 52, 26-29; 2. World Health Organization. Adherence to long term therapies: evidence for action. 2003. www.who.int/chronic_conditions/adherencereport/en. Viewed Nov 2003.

7. Measuring Compliance Objective Measures –Direct Blood levels –Indirect Pill Counts –Manual, Electronic Pharmacy Refill Data Health Outcomes Subjective Measures –Patient self reports –Practitioner reports

8. Variables Potentially Related to Compliance Patient variables –Patient characteristics –Diagnosis/symptoms/severity –Knowledge/Health Beliefs Treatment variables –Treatment complexity –Dosing –Adverse effects Relationship variables –Inadequate communication/poor rapport –Method of teaching/environment –Follow-up/assessment Adapted from: Meichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. Boston: Plenum Press; 1987: 20, 52, 26-29.

9. Patient Characteristics Age 1 –Elderly – average compliance is 45% –Adolescents – 40-60% –Pediatrics patients (parent as caregiver) – 34-82% Sex 2,3 –Kidney transplant patients, Dunn et al found that men were significantly more noncompliant than women. –In contrast, Schweizer et al found no significant differences in compliance due to gender in more than 600 transplant recipients Race Intelligence Education Sources: 1. Meichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. Boston: Plenum Press; 1987: 20, 52, 26-29. 2. Dunn J, Golden D, Van Buren CT, Lewis RM, Lawen J, Kahan BD Causes of graft loss beyond two years in the cyclosporine era. Transplantation. 1990;49:349-353. 3. Schweizer RT, Rovelli M, Palmeri D, Vossler E, Hull D, Bartus S. Noncompliance in organ transplant recipients. Transplantation. 1990;49;374-377.

10. Compliance Rates by Diagnosis ConditionReported Rates of non- compliance Arthritis55-71% Asthma20% Diabetes40-50% Epilepsy30-50% Hypertension40% Schizophrenia41% Source: Noncompliance with Medication Regimens. An Economic Tragedy. Emerging Issues in Pharmaceutical Cost Containing. Washington, DC. National Pharmaceutical Council. 1992;1-16.

11. Health Beliefs and Compliance 77% of patients compliant when curing a disease 63% of patients compliant when preventing a disease Over extended periods of time, compliance rates dropped dramatically to approximately 50% for either prevention or cure Sackett DL, Snow JC. The magnitude of compliance and noncompliance. In: Haynes NRB, Taylor DW, Sackett DL, eds. Compliance in Healthcare. Baltimore: Johns Hopkins University Press; 1979:11-22.

12. Predictors of Compliance Questions to ask your patient –Do you ever forget to take your medicine? –Are you careless at times about taking your medicine? –When you feel better do you sometimes stop taking your medicine? –Sometimes if you feel worse when you take the medicine, do you stop taking it? Moriskey et al: –75% with high scores had BP under control at year 2 (p<0.01) –α=0.61 Morisky DE. Green LW. Levine DM. Concurrent and predictive validity of a self- reported measure of medication adherence. Medical Care. 1986:24:67-74.

13. Compliance Predictability by Variable Variables Utility as a Predictor Explanation Patient demographics (age, sex, race, socio- economic status) Weak Literature lacks consensus Usefulness depends on therapeutic area and patient population Patient/provider relationship Regimen characteristics Patient health services use Moderate General consensus in literature Effect may vary by therapeutic area and population Time since initiation Medication compliance history Strong Always the strongest predictors and easy to measure Adapted from Benner J. ISPOR 2007

14. Factors Affecting Elderly Compliance Cognitive Ability Prospective Memory Changes Functional Literacy

15. Cognitive Impairment Predicts Noncompliance STUDY –220 Japanese community dwelling elders –MMSE scores estimated impairment –Pill counts as compliance –Logistic regression to determine predictors of non- compliance Variables: Age, sex, eyesight, hearing, number of drugs, frequency, packaging, medication calendar, drug knowledge and cognitive ability RESULTS –Average age: 75.7 years –27% MMSE ≤23 (impaired) –34.6% noncompliant –Odds Ratio Cognitive Impairment – 2.94 (1.32-6.58) Okuno et al, 2001 – Eur J Clin Pharmacol

16. Prospective Memory Changes Affect Compliance Cognitive performance declines with age –Korten et al, 1997 – Psych Med Decline not seen in language, visio-spatial ability or abstract reasoning –Small et al, 1999 – Neurology Difficulty with prospective memory increases with additional tasks –Martin, 2001 – Int J Behavioral Development Poor memory performance amplified when executive function required –D’Yewalle, 2001 – Am J Psychology Difficulty still exists even when task was habitual –Einstein, 2001 – Psychol Science

17. Basic Question… “Did I take it today or do I think I took it because I have been for the past x years?”

18. Compensation for Memory Changes

19. Omitting/Repeating Doses Unintentionally omitting or repeating a dose Small interruptions to routines –phone call, doorbell Larger interruptions to routines –Shopping, dining out Intentionally omitting doses

20. Compensation for Memory Changes Boron JB, et al. Medication adherence strategies in older adults. Proceedings of human factors and ergonomics society – 50 th annual meeting; 2006. Association Location Mental Planning Pain Physical Reminder Pill Box Visibility

21. Functional Literacy Physical Challenges Eyesight changes Manual dexterity Cognitive Challenges Dose selection Understanding directions Drug / disease knowledge System Challenges Readability of pharmacy labels Dosage form (inhaler, injectable) Medication Management Skills

22. DRUGS (Drug Regimen Unassisted Grading Scale) –Identify medication –Open container –Remove appropriate dosage –Demonstrate appropriate timing Correlated to medication compliance

23. Identifying the Medication

26. Opening the Med and Removing Appropriate Dosage

27. Education Level 9 59%67%84% ‡ 6%50%78% * 0%5%14% * * p<.0001, ‡ p<.05; Comprehension of Warning Labels Increase with Literacy Level Data: Davis TC. LSU Health Science Center, Shreveport, LO.

28. Davis, T. C. et. al. Ann Intern Med 2006;145:887-894 Demonstrating Appropriate Timing

29. Medication Management Skills DRUGS (Drug Regimen Unassisted Grading Scale) –Identify medication –Open container –Remove appropriate dosage –Demonstrate appropriate timing Correlated to medication compliance

30. Case Description

31. Medication Errors Objectives Define the nature and significance of medication errors Describe two types of medication errors and opportunities to improve systems and prevent errors Given a specific case, identify at least two strategies to prevent a medication error from occurring

32. Case Description

33. Definitions Error - The failure of a planned action to be completed as intended or the use of a wrong plan to achieve the aim Adverse Event - An injury caused by medical management rather than the underlying condition Preventable Adverse Event - An adverse event attributable to an error VHA Medication Safety Report: 2004

35. Statistics On Medication Errors 44,000 to 98,000 Americans die from medical errors each year 7,000 die from medication errors alone 20 to 28% of adverse drug events are preventable Cost per error is $2,013 to $4,700 per admission

36. Preventing Medication Errors Consumer Actions to Enhance Medication Safety Issues for Discussion with Patients by Providers e-prescribing by 2010 Drug naming, labeling and packaging Oversight and regulation

37. Medication Error Bates: “Any error occurring in the medication use process.” NCCMERP “Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer.” –related to professional practice systems including: Prescribing/order communication Product labeling, packaging and nomenclature Compounding/dispensing/distribution Administration/education/monitoring and use

39. High Alert Medications High alert drugs are drugs that bear a heightened risk of causing significant patient harm when they are used in error. (ISMP.org; accessed Nov 6, 2009) ISMP suggestions to reduce risk: –improving access to information about these drugs –limiting access to high-alert medications –using auxiliary labels and automated alerts; –standardizing the ordering, storage, preparation, and administration –employing redundancies such as automated or independent double checks when necessary.

40. High Alert Medications Anticoagulants (warfarin, heparin & LMWH) –Current TJC National Patient Safety Goal Chemotherapy Pediatric medications Parenteral narcotics (opiates) Insulin Magnesium sulfate Potassium chloride injection concentrate Neuromuscular blockers Vasoactive substances

41. Medication Safety: Opportunities for Improvement Selection and procurement Storage Prescribing Dispensing Administration / Counseling Monitoring System vs Knowledge vs Competent?

42. Look-Alike/Sound Alike: Error Prevention Education: Information from the literature Tall Man Lettering: –NovoLOG and NovoLIN –oxyCODONE and OxyCONTIN –ceFAZolin and cefTRIAXONE –FLUoxetine and DULOXetine. Tall Man lettering on medication labels, shelving labels, medication records, etc.

44. Drug Administration Technology Automated medication cabinets –Pyxis, OmniCell –Interfaced with pharmacy profiles Pharmacy generated MARs Smart pumps –Drug library with standard concentrations –Defines soft and hard administration limits Bedside barcode administration system

46. Medication Reconciliation Avoid errors such as omission, duplication, dosing errors or drug interactions Each transition of care Five steps –Develop list of previous meds –List of newly prescribed meds –Compare the lists –Respond to differences –New list to care-givers and patient

47. Ideal Medication Error Prevention Program Addresses all components of the medication use process Uses an interdisciplinary approach to resolving problems Involves all levels of employees, practitioners and administration Identifies and addresses underlying causes Supports system improvements, reduces risk, and improves patient outcomes

48. Case Description

49. Key Issues to Remember People will make mistakes Mistakes are opportunities to learn where the process is broken Effective change requires all stakeholders’ participation

50. Conclusion