1. Medication-Related Problems in the Nursing Home Setting Steven M. Handler, MD, MS, CMD Department of Medicine, Division of Geriatric Medicine and Department of Biomedical Informatics

2. Objectives Describe the medication use process in the nursing home setting Describe the medication use process in the nursing home setting Provide a conceptual framework for medication-related problems Provide a conceptual framework for medication-related problems Discuss the epidemiology and impact of medication- related problems Discuss the epidemiology and impact of medication- related problems Present current and future solutions for medication- related problems Present current and future solutions for medication- related problems

3. Kohn, National Academy Press. 2000 To Err is Human: Building a Safer Healthcare System This report focused national attention on the quality of care and prevalence of medical errors in the healthcare system This report focused national attention on the quality of care and prevalence of medical errors in the healthcare system Largest proportion of medical errors are medication- related Largest proportion of medical errors are medication- related Overwhelming majority of patient-safety initiatives introduced to address concerns raised in this report have been geared toward acute-care Overwhelming majority of patient-safety initiatives introduced to address concerns raised in this report have been geared toward acute-care

4. Medications: A Love-Hate Relationship Geriatricians and their patients rely heavily on pharmacotherapy to palliate symptoms, improve functional status and quality of life, cure or manage disease, and prolong survival Geriatricians and their patients rely heavily on pharmacotherapy to palliate symptoms, improve functional status and quality of life, cure or manage disease, and prolong survival Medications are the most frequently used and misused form of therapy Medications are the most frequently used and misused form of therapy The benefits of medication therapy in older adults are counterbalanced by the problems that they pose The benefits of medication therapy in older adults are counterbalanced by the problems that they pose

5. Prescribing Complex medical patients Complex medical patients Polypharmacy is the rule rather than the exception Polypharmacy is the rule rather than the exception Lack of evidence-base for prescribing most medications Lack of evidence-base for prescribing most medications Frequent lack of facility- specific medication formularies/Part D issues Frequent lack of facility- specific medication formularies/Part D issues

6. Documenting/Order Communication Use of paper records and faxing of medication requests to pharmacies is the rule rather then the exception Use of paper records and faxing of medication requests to pharmacies is the rule rather then the exception Frequent use of verbal (oral) orders Frequent use of verbal (oral) orders Process that often requires the nurse to act as an “agent” of the prescriber Process that often requires the nurse to act as an “agent” of the prescriber

7. Dispensing Often no on-site pharmacy Often no on-site pharmacy Cycle/batch filling of medications monthly in blister packs Cycle/batch filling of medications monthly in blister packs Often several different pharmacies deliver medications to patients Often several different pharmacies deliver medications to patients Pharmacy delivery schedule is often once a day and an e-box is available for emergent medication needs Pharmacy delivery schedule is often once a day and an e-box is available for emergent medication needs

8. Administering Medication pass is one of many tasks that nursing staff are asked to do Medication pass is one of many tasks that nursing staff are asked to do Paper-based MARs are error prone Paper-based MARs are error prone Patients are often difficult to locate and/or identify Patients are often difficult to locate and/or identify

9. Monitoring Loosely coupled system leading to poor monitoring Loosely coupled system leading to poor monitoring Minimum monitoring frequency for many medications doesn’t exist Minimum monitoring frequency for many medications doesn’t exist Consultant pharmacist monthly review (retrospective) Consultant pharmacist monthly review (retrospective)

10. Handler SM, Am J Geriatr Pharmacother, 2004

12. Definitions of Medication Error (ME) 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, or consumer 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, or consumer American J of Health-System Pharmacy 1998; 55(2):165-6 preparation or administration of medications which is not in accordance with physician orders or manufacturers instructions (F-Tag 332) preparation or administration of medications which is not in accordance with physician orders or manufacturers instructions (F-Tag 332) an error in the prescribing, order communication, dispensing, administering, or monitoring phase(s) of the medication use process. an error in the prescribing, order communication, dispensing, administering, or monitoring phase(s) of the medication use process.

13. ME Reporting in Nursing Homes Setting: Setting: A single nonprofit, community-based NH A single nonprofit, community-based NH Methods/Case-Finding: Methods/Case-Finding: ME reports submitted over a 21-month period ME reports submitted over a 21-month period Outcome: Outcome: ME reports containing the step in medication use process where the ME occurred, the type of ME, and the therapeutic class involved ME reports containing the step in medication use process where the ME occurred, the type of ME, and the therapeutic class involved Results: Results: 88 ME reports were submitted (4.7/mo.) with 68% occurring at the administration stage and 20% at the dispensing stage 88 ME reports were submitted (4.7/mo.) with 68% occurring at the administration stage and 20% at the dispensing stage Conclusions: Conclusions: There is gross underreporting of MEs in the NH setting and the reasons for this is not well characterized There is gross underreporting of MEs in the NH setting and the reasons for this is not well characterized Handler S, et. al., Am J Ger Pharmacother 2004;2:190-196.

15. Suboptimal Prescribing in Older Adults 1.Overutilization (i.e., polypharmacy) 2.Inappropriate utilization 3.Underutilization Hanlon JT, et al. J Am Geriatr Soc 2001;49:200-9.

16. Overutilization of Medications Can be defined in the following two ways: Can be defined in the following two ways: 1.The concomitant use of multiple drugs, which is measured by a simple count of medications (Defined by CMS as > 9 medications) 2.The administration of more medications than are clinically indicated Stewart RB. DICP 1990;24(3):321-3; Montamat SC, et al. Clinics in Geriatric Medicine 1992;8(1):143-58

17. Medication Use in U.S. NHs (n=328) Med. TypeMean / % Routine 6.69 +/- 1.12 Prn2.61 +/- 1.35 9+ meds27.1% Neuroleptics16.9 % Antidepressants34.5 % Anxiolytics10.1 % Hypnotics 2.3 % Tobias DE, Sey M. Consult Pharm 2001;16:54-64.

18. 18 Inappropriate Use of Medications  Can be defined in the following two ways: 1.Prescribing medications that have more potential risk than potential benefit 2.Prescribing that does not agree with accepted medical standards Gurwitz JH. JAMA 1994;272(4):316-7; Schmader K, et al. Journal of the American Geriatrics Society 1994;42(12):1241-7; Beers MH, et al. Archives of Internal Medicine 1991;151(9):1825-32.

19. Underutilization of Drugs Undiagnosed and untreated condition (e.g., depression) Undiagnosed and untreated condition (e.g., depression) Diagnosed condition but omitted treatment (e.g., failure to use a Beta-blocker after a heart attack) Diagnosed condition but omitted treatment (e.g., failure to use a Beta-blocker after a heart attack) Underuse of preventive treatment (e.g., vaccinations) Underuse of preventive treatment (e.g., vaccinations)

21. Administration Errors in Nursing Homes Setting: Setting: 36 healthcare institutions, 12 of which were NHs in two states (Colorado and Georgia) 36 healthcare institutions, 12 of which were NHs in two states (Colorado and Georgia) Methods/Case-Finding: Methods/Case-Finding: Direct observation of healthcare provider during the administration of medications Direct observation of healthcare provider during the administration of medications Outcome: Outcome: MEs operationalized as a discrepancy between doses administered and ordered MEs operationalized as a discrepancy between doses administered and ordered Results: Results: The mean error rate was 19% (605 of 3216 doses administered) and did not differ across institutions The mean error rate was 19% (605 of 3216 doses administered) and did not differ across institutions Most frequent errors by category: Wrong time (43%)> omission (30%)> wrong dose (17%) Most frequent errors by category: Wrong time (43%)> omission (30%)> wrong dose (17%) Barker KN, et al. Archives of Internal Medicine. 2002;162(16) :1897-903.

23. Monitoring Errors in NHs Monitoring errors are probably the most common type of error in [most clinical] settings, but are much more difficult to identify, and no study was found… Monitoring errors are probably the most common type of error in [most clinical] settings, but are much more difficult to identify, and no study was found… Institute of Medicine. Preventing Medication Errors. 2006

25. Adverse Events (AEs) are negative patient events that are expressed as symptoms, signs or laboratory abnormalities (Naranjo, Shear et al. 1992). Adverse Events (AEs) are negative patient events that are expressed as symptoms, signs or laboratory abnormalities (Naranjo, Shear et al. 1992). When a relationship between the adverse event and a drug is suspected and plausible, then an Adverse Drug Event (ADE) is assumed. When a relationship between the adverse event and a drug is suspected and plausible, then an Adverse Drug Event (ADE) is assumed. When an ADE is determined to be causally related to a drug, then an Adverse Drug Reaction (ADR) is assumed. Thus, an ADR will be defined as a noxious and unintended patient event caused by a drug (Venulet and ten Ham 1996; Edwards and Aronson 2000). When an ADE is determined to be causally related to a drug, then an Adverse Drug Reaction (ADR) is assumed. Thus, an ADR will be defined as a noxious and unintended patient event caused by a drug (Venulet and ten Ham 1996; Edwards and Aronson 2000). WHO/Naranjo Model of Adverse Drug Reactions

26. Cooper, South Med J. 1999; 92:485-90/Bootman, Arch Intern Med. 1997; 157:2089-96 Consequences of ADRs Increased morbidity, mortality, and decline in functional status: Increased morbidity, mortality, and decline in functional status: Falls and fractures Falls and fractures Malnutrition Malnutrition Dehydration Dehydration Incontinence Incontinence Sedation/Confusion Sedation/Confusion Delirium Delirium Cognitive impairment Cognitive impairment Increased hospitalization: Increased hospitalization: 332 NH residents followed for 4y 332 NH residents followed for 4y 64 ADE-associated hospitalizations 64 ADE-associated hospitalizations Increased cost: Increased cost: For every dollar spent on drugs in NHs, $1.33 in health care resources are consumed in the Tx of drug-related problems For every dollar spent on drugs in NHs, $1.33 in health care resources are consumed in the Tx of drug-related problems Increased Health- Services Utilization

27. ADRs in the NH-Setting Setting: Setting: 2 academic NHs 2 academic NHs Methods/Case-Finding: Methods/Case-Finding: Chart review, staff reports, and computerized signals Chart review, staff reports, and computerized signals Outcome: Outcome: ADR ADR Results: Results: Over a 9-month period, 815 ADRs were identified, an incidence rate of 9.8 ADRs per 100 patient ‑ months Over a 9-month period, 815 ADRs were identified, an incidence rate of 9.8 ADRs per 100 patient ‑ months Nearly 27.6% of the ADRs were fatal, life threatening or serious, and 42% were preventable. Nearly 27.6% of the ADRs were fatal, life threatening or serious, and 42% were preventable. Among the 338 preventable adverse drug events, errors occurred most commonly at the ordering (n= 198 [59%]) and monitoring (n= 271 [80%]) stages Among the 338 preventable adverse drug events, errors occurred most commonly at the ordering (n= 198 [59%]) and monitoring (n= 271 [80%]) stages Gurwitz JH, et al. American Journal of Medicine. Mar 2005;118(3):251-258.

29. Therapeutic Failure (TF) Failure to accomplish the goals of treatment resulting from inadequate or inappropriate drug therapy and not related to the natural progression of disease Failure to accomplish the goals of treatment resulting from inadequate or inappropriate drug therapy and not related to the natural progression of disease Can occur when: Can occur when: Omit a dose of a necessary medication Omit a dose of a necessary medication Prescribe too low a dose of a necessary medication Prescribe too low a dose of a necessary medication A drug-drug interaction reduces the dose of a medication A drug-drug interaction reduces the dose of a medication Take a sub-therapeutic dose of a medication (i.e., patient non-adherence) Take a sub-therapeutic dose of a medication (i.e., patient non-adherence) Grymonpre R, et al. J Am Geriatr Soc 1988;36:1092-1098; Hallas J, et al. Dan Med Bull 1991;38:417-20.1992 Hallas J, et al. Dan Med Bull 1991;38:417-20.1992

30. TFs in Older Hospitalized Inpatients Setting: Setting: Single 1,100 bed acute care facility Single 1,100 bed acute care facility Methods/Case-Finding and causality: Methods/Case-Finding and causality: Chart review and Bergman algorithm Chart review and Bergman algorithm Outcomes: Outcomes: TFs TFs Results: Results: 31 TFs among a total of 162 patients whom experienced an medication-related problem over a 4- month period 31 TFs among a total of 162 patients whom experienced an medication-related problem over a 4- month period Grymonpre RE, et al. J Am Geriatric Soc 1988;36(12):1092-8.

32. Adverse Drug Withdrawal Events (ADWE) a clinical set of signs or symptoms that are related to the removal of a drug a clinical set of signs or symptoms that are related to the removal of a drug Gerety JAGS, 1993 41(12): 1326-32.

33. ADWEs in the NH Setting Setting: Setting: Single VA-affiliated NH Single VA-affiliated NH Methods/Case-Finding and causality: Methods/Case-Finding and causality: Chart review Chart review Outcomes: Outcomes: ADWEs ADWEs Results: Results: 201 ADRs in 95 residents, while 62 residents experienced 94 ADWEs over an 18-month period 201 ADRs in 95 residents, while 62 residents experienced 94 ADWEs over an 18-month period Gerety M et al. J Am Geriatric Soc 1993;41:1326-1332

34. Potential Solutions Improve medication monitoring for residents taking narrow therapeutic index medications or medications that have frequently been associated with adverse drug reactions Improve medication monitoring for residents taking narrow therapeutic index medications or medications that have frequently been associated with adverse drug reactions Improve your understanding and incorporation of the F-329 and F-428 interpretative guidelines into clinical practice Improve your understanding and incorporation of the F-329 and F-428 interpretative guidelines into clinical practice Report medication-related problems in your facilities to improve intra and inter-institutional learning and prevent future recurrence of similar events Report medication-related problems in your facilities to improve intra and inter-institutional learning and prevent future recurrence of similar events Participate in an ongoing medication monitoring study that we are conducting for members of the AMDA Research Network, ASCP, or NCGNP. Participate in an ongoing medication monitoring study that we are conducting for members of the AMDA Research Network, ASCP, or NCGNP.