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MEDICATION
Nursing Standard of Practice Protocol: Reducing Adverse Drug Events

DeAnne Zwicker and Terry Fulmer
Evidence-Based Content - Updated April 2008

The information in this "Want to know more" section is organized according to the following major components of the NURSING PROCESS:

• Goal
• Overview
• Background
• Assessment Tools and Strategies
• Interventions and Nursing Care Strategies
• Expected Outcomes
• Follow-up Montitoring
• Relevant Practice Guidelines
• References

 

Goal

Reduce adverse drug events in older adults. 

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Overview

Adverse drug events, whether from drug–drug or drug–disease interactions, inappropriate prescribing, poor adherence, or medication errors, lead to serious or potentially fatal outcomes for older adults. More than half of adverse drug events may be preventable. ^{1, 2, 3} 

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Background

A. Definitions

1. Adverse Drug Event (ADE): Injury occurring during the patient’s drug therapy, whether resulting from appropriate care or from unsuitable or suboptimum care. Includes: ADEs during normal use of medicine and any harm secondary to a medication error. ADEs can have different outcomes: worsening of existing pathology or lack of expected health-status improvement. ⁴

2. Iatrogenic ADEs: Any undesirable condition in a patient occurring as the result of treatment by a health care professional; pertaining to an illness or injury resulting from a medication or drug.

3. Adverse drug reaction (ADR): Any noxious or unintended and undesired effect of a drug that occurs at normal human doses for prophylaxis, diagnosis, or therapy. According to Committee of Experts on Safe Medication Practices, ADEs are preventable, ⁴ including medical errors and nonadherence.

4. Medication nonadherance: The number of doses not taken or taken incorrectly that jeopardizes the patient’s therapeutic outcome. ⁵

5. Drug–drug interactions: Changes in a drug’s effects by another drug taken during the same period. The interactions are basically pharmacokinetic or pharmacodynamic. ⁶

6. Drug–disease interactions: Undesired drug effects (exacerbation of a disease or condition by a drug) that occur in patients with certain disease states (e.g., beta blocker given to patient with depression, worsens the depression).

7. Pharmacokinetics: The time course of absorption, distribution across compartments, metabolism, and excretion of drugs in the body. The metabolism and excretion of many drugs decrease and the physiologic changes of aging require dosage adjustment for some drugs. ⁶

8. Pharmacodynamics: The response of the body to the drug, which is affected by receptor binding, post-receptor effects, and chemical interactions. ⁶

9. Pharmacodynamic problems occur when two drugs act at the same or interrelated receptor sites, resulting in additive, synergistic, or antagonistic effects. The effects of two or more drugs together can be either additive (combination of drugs “add up” to increase effect), synergistic (one agent magnifies the effect of the other), or antagonistic (one medication inhibits the effect of the other).

10. Medication Reconciliation: the process of comparing a patient’s medication orders to all of the medications that the person has been taking. ⁷

B. Epidemiology

1. It is estimated that the majority of older adults older than 65 (79%) are on medications, with 39% taking five or more prescription drugs and up to 90% taking over-the-counter drugs. ⁸ People older than 65 consume more than one-third of all prescription drugs and purchase 40% of all over-the-counter medicines. ⁹

2. In a large study of women 65 years of age and older, 12 % took 10 or more medications and 23 % took at least five prescribed medications. ¹⁰

3. An estimated 35% of older persons experience ADEs and almost half of these are preventable. ³

4. Prevalence of ADR-related hospitalizations ranges from 5% to 35%. ¹¹

5. Serious ADRs that occur during hospitalization are at 6.7% and, when extrapolated, are the fourth to sixth leading cause of in-hospital mortality for all causes of death and likely an underestimate because ADRs related to nonadherence or errors in administration therapeutic failures are not included. ¹²

6. ADEs are estimated to cost the health care system $75 billion to $85 billion annually ¹³ and result in 106,000 deaths annually. ¹²

C. Etiology
Adults become increasingly susceptible to ADEs as they age. Physiological changes characteristic of aging predispose older adults to experience ADEs resulting in four times more hospitalizations in older versus younger persons. People older than 65 experience medication-related problems for seven major reasons:

1. Age-related physiologic changes that result in altered pharmacokinetics and pharmacodynamics. ^{2, 51}

2. Multiple medications (i.e., polypharmacy) that are often prescribed by multiple providers. ^{14, 15}

3. Incorrect doses of medications (over or under a therapeutic dosage) ^{14, 16, 17}

4. Medication consumption for the treatment of symptoms that is not disease-dependent or specific. (i.e., self-medication or prescribing cascades). ^18,19

5. Iatrogenic causes such as:

a. ADEs: drug–drug or drug–disease interactions. ^12,20,21,22

b. Inappropriate prescribing for older adults. ¹³

6. Problems with medication adherence. ^{23, 24, 25}

7. Medication errors ²⁶

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Assessment Tools and Strategies

A. Assessment Tools

1. Use appropriate assessment tools as indicated for each individual's needs and specific setting:

a. Beers Criteria: 2002 Criteria for Potentially Inappropriate Medication Use in Older Adults: Independent (see Table 12.1 in protocol book). 2002 Criteria for Potentially Inappropriate Medication Use in Older Adults: Considering Diagnoses or Condition (see Table 12.2 in Protocol book). ¹³

b. Common Drug–Drug Interactions (see Table 12.3 in Protocol book). List of some commonly known interactions.

c. Cockroft-Gault Formula: to estimate renal function (see Figure 12.1 in Protocol book).

d. Functional Capacity (ADL, IADL, Mini-Cog, or MMSE). See protocols Assessment of Function and Assessing Cognitive Function.

e. Brown Bag Method. ²⁷ (Method used to assess all medications an older adult has at home, including prescriptions from all providers, OTC medications, and herbal remedies (all medications are to be brought in a "brown bag"). Should be used in conjunction with a complete medication history (see Table 12.4 in Protocol book).

f. Drugs Regimen Unassisted Grading Scale (DRUGS) Tool. Assessment of self-administration ability. ^{28, 29} Typically used at time of transfer to other levels of care.

B. Assessment Strategies

1. Comprehensive medication assessment should be performed at admission, discharge, and intervals in between. ^22,30. Obtain a detailed medication history and confirm its accuracy, ^{31, 32} detailing the type and amount of prescriptions, OTCs, vitamins, supplements, and herbal remedies, 8,10 alcohol and illicit drugs, using appropriate assessment tool (e.g., Brown Bag method). ²⁷

2. Assess renal function using Cockroft-Gault formula for assessing renal function prior to administering renal-clearing drugs (see Figure 12.1 in protocol book).

3. Reconciliation of medications ordered at admission and at discharge in consultation with a pharmacist; ^7,33 geriatric expert, or computer-based program. ^{34, 35}

4. Review medication list using Beers criteria for potentially inappropriate medications, particularly those with high severity and for potential drug–drug and drug–disease interactions (see Tables 12.1 and 12.2 in protocol book). ^{13, 36}

5. At discharge from hospital, use appropriate tools to assess individual's ability to self-administer medications:

a. Assess functional capacity: ADLs, IADLs, Mini-Cog. (See chapters in protocol book Assessment of Function and Assessing Cognitive Function)

b. Assess individuals (at admission or initial encounter and at discharge) who administer their own medicines with DRUGS tool to identify potential areas of self-administration difficulty (see Resources) ^{28, 29, 37}

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Interventions and Nursing Care Strategies

A. Reducing ADEs (during and post hospitalization)

1. Patient empowerment. Patients should be given the necessary information and the opportunity to exercise the degree of control they choose over health care decisions that affect them. If patients are involved in decision making, they are less likely to make decisions that may lead to ADRs, ¹ such as abruptly discontinuing a medication that should be tapered off.

2. Comprehensive Medication Assessment on admission as indicated in assessment (see Table 12.4 in protocol book).

3. Collaborate with the interdisciplinary team to effect change in reducing the numbers of ADEs and ADRs, many of which are preventable. ¹⁴

4. Prescribing Principles. Monitoring for appropriate prescribing and alerting the prescriber to potential problem areas helps reduce medication-related problems. Prescribing a medication is multifaceted: deciding that a drug is truly indicated; choosing the best drug; determining appropriate dose for the individual; monitoring for toxicity and effectiveness; and seeking consultation when necessary. ² These principles support recommendations to:

a. Reduce the dose. "Start Low and Go Slow," or give the lowest possible dose when starting a medication and slow upward titration to obtain clinical benefit; many ADEs are dose-related. ^{2, 22} Primary provider should be notified if the dosage ordered is higher than the recommended starting dose (e.g., digoxin maximum dose <0.125 mg for treatment of CHF). ¹³

b. Discontinue unnecessary therapy. Prescribers are often reluctant to stop medications, especially if they did not initiate the treatment. This practice increases the risk for an adverse event. ²

c. Attempt a trial of nonpharmacological interventions/treatments prior to requesting medication for new symptoms. ²

d. Recommend safer drugs. Avoid drugs that are likely to be associated with adverse outcomes (review Beers Criteria Table 12.1 in protocols book) ²²

e. Assess renal function using Cockroft-Gault formula (for renally cleared drugs) to determine accurate dosage prior to prescribing such as many routinely prescribed IV antibiotics. Dosage recommendations are available based on this formula in PDR and other common prescribing resources.

f. Optimize drug regimen. When prescribing medications, the focus should be on risk versus benefit where the expected health benefit (e.g., relief of agitation in dementia with psychosis) exceeds the expected negative consequences (e.g., morbidity and mortality from falls that result in hip fracture)^{38, 39}

g. Initiation of new medication. Assess for potential drug–disease and drug–drug interactions and correct dosages, the most common causes of ADRs, before starting new drugs. ^{1, 22, 40}

h. Avoid the prescribing cascade. Avoid the prescribing cascade by first considering a new symptom as being a consequence of a current medication prior to adding a new medication. ^{2, 19}

i. Avoid inappropriate medications in older persons. Review criteria for potentially inappropriate medications, drug–disease interactions, and potential drug–drug interactions (see Tables 12.1, 12.2, and 12.3 respectively in protocol book) ¹³

B. Specific interventions for prevention of Iatrogenic Adverse Drug Reactions (in hospital and after discharge)

1. Consider any new symptom as a possible ADE before requesting/ administering new medication for the symptom, avoiding the prescribing cascade (example in context).¹¹

2. Monitor medication orders for wrong drug choices (high-risk inappropriate medications, drug–disease and drug–drug interactions), wrong dosages, or administration errors. ^{11, 26, 41} Consider use of technological handheld devices such as PDA for quick access to Beers criteria, drug–drug or drug–disease interactions, and geriatric assessment tools (see www.ConsultGeriRN.org, Resources section, for drug interaction software/PDA tools).

3. Improve prescribing practices by documenting indication for initiation of new drug therapy, maintaining a current medication list, documenting response to therapy, as well as the need for ongoing treatment ^{42, 43} and evaluating co-morbidities.⁴³

4. Institutional implementation of computer-assisted technology for medication order entry: has the potential to prevent an estimated 84% of dose, frequency, and route errors; and from 28% to 95% of ADEs can be prevented by reducing medication errors through computerized monitoring systems. ⁴⁴ Identifying and reporting of ADRs can also be performed using computer-assisted National Surveillance system. Institutions must facilitate a culture of safety to reduce ADRs/ADEs.

C. Interventions at Discharge

1. Reconciliation of medications at discharge ^{33, 45, 46, 47} helps to reduce ADR/ADEs and therefore rehospitalization.

2. Assess abilities and limitations and health literacy in self-administration of medications using appropriate tools at discharge ⁴⁸ and recognize that self-administration and nonadherence can induce ADRs. ⁴³

3. Assess for adherence issues that may develop after discharge, which can help to reduce ADEs. ^{24, 45} and rehospitalization. ^{28, 49} Recommend devices that can assist in enhancing adherence behavior ²³ and interventions to address cost and other adherence issues.

4. Patient/Caregiver Education. Provide patient and caregiver education using relevant nursing content and principles ⁴⁸ including assessment of factors that might affect adherence. Nurses are the primary source for providing education to patients at discharge; therefore, their role is key to preventing medication-related consequences after hospitalization, including rehospitalization. Discharge education and counseling includes:

a. Education tailored to the age group and needs of the individual. ⁴⁹

b. Educate the patient/caregiver about benefits and risks ³⁰ and potential medication side effects. ²

c. Teach safe medication management. ⁴⁸

d. Consider an interactive computer program (Personal Education Program [PEP]) designed for the learning styles and psychomotor skills of older adults to teach about potential drug interactions that can result from self-medication with OTC agents and alcohol. ⁵⁰

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Expected Outcomes

A. Patients will:

1. Experience fewer iatrogenic outcomes from medications.

2. Understand their medication regimens.

B. Healthcare providers will:

1. Use a range of interventions to prevent, alleviate, or ameliorate medication problems with older adults.

2. Improve prescribing practices by documenting indication for initiation of new drug therapy, maintaining a current medication list, documenting response to therapy, as well as the need for ongoing treatment. ^{42, 50}

3. Evaluate nature and origins of medication-related problems in a timely manner.

4. Increase their knowledge about medication safety in older adults.

5. Increase referrals to appropriate practitioners (e.g., geriatrician, geriatric/gerontological or psychiatric clinical nurse specialist, nurse practitioner, or consultation-liaison service).

C. Institutions will:

1. Provide education to health care providers regarding prevention, identification, and reporting of ADRs. ¹¹

2. Make information on ADRs accessible to patients. ¹¹

3. Enhance surveillance and reporting of ADRs using a National Surveillance system. ^{11, 47} Consider use of computerized physician ordering system. ^{11, 34}

4. Track and report morbidity and mortality due to medication-related problems.

5. Provide a system for medication reconciliation and follow-up its effectiveness with regard to rehospitalization rates due to ADRs.

6. Review for careful documentation of iatrogenic medication and other iatrogenic events for CQI.

7. Provide ongoing education related to safe medication management for physicians and staff. 

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Follow-up Monitoring

A. Health care providers will:

1. Provide consistent and appropriate care and follow-up in presence of a medication-related problem.

2. Evaluate with physical exam and laboratory tests (as appropriate) on regular basis to ensure that the older adult is responding to therapy as expected. ³⁷

B. Institutions will:

1. Provide ongoing assessment of staff competence in assessing and intervening for prevention of ADEs.

2. Embed reduction of ADEs in the culture of safety. 

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Relevant Practice Guidelines

A. Bergman-Evans, B. (2004). Improving medication management for older adult clients. Iowa City, IA: University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core; 2004 Oct. [Level I]. Available at www.guideline.gov; NGC Guideline # 003993.

B. Health Care Association of New Jersey (HCANJ). (2006) . Medication management guideline. Hamilton, NJ: Health Care Association of New Jersey (HCANJ); Available at www.guideline.gov. Note: Geared for post-hospital institutions for adult patients. NGC Guideline # 004951

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For Definition of Levels of Quantitative Evidence Click Here

Reprinted with permission from Springer Publishing Company. Zwicker, D. & Fulmer, T. (2008). Reducing adverse drug events. In E. Capezuti, D. Zwicker, M. Mezey, & T. Fulmer (Eds.) Evidence-based geriatric nursing protocols for best practice (3rd ed, 257-308), New York: Springer Publishing Company, Inc

 

References

1. National Coordinating Council for Medication Errors Reporting and Prevention (2001). Taxonomy of medication errors. Retrieved September 1, 2006, from http://www.nccmerp.org/pdf/taxo2001-07-31.pdf. Evidence Level VI: Expert Opinion. 

2. Rochon, P. A. (2006). Drug prescribing for older adults. Retrieved September 15, 2006, from http://www.utdol.com/utd/store/index.do Evidence Level V: Literature Review. 

3. Safran, D. G., Neuman, P., Schoen, C., Kitchman, M. S., Wilson, I. B., Cooper, B., et al. (2005). Prescription drug coverage and seniors: Findings from a 2003 national survey. Retrieved August 22, 2006, from http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.152. Evidence Level IV: Survey/Nonexperimental Study.

4. Committee of Experts (COE) on Safe Medication Practices (2005). Glossary of terms related to patient and medication safety. Retrieved September 1, 2006, from http://www.who.int/patientsafety/highlights/COE patient and medication safety gl.pdf.

5. National Council on Patient Information and Education (NCPIE) (1997). The other drug problem: Statistics on medicine use and compliance. Retrieved November 1, 2006, from http://www.medscape.com/viewarticle/406691 print. Evidence Level VI: Expert Opinion.

6. Merck Manual Professional (2005). Drug therapy in the elderly. In Clinical Pharmacology (section). Retrieved September 29, 2006, from http://www.merck.com/mmpe/sec20/ch306/ch306a.html. Evidence Level VI: Expert Opinion.

7. Santell, J. P. (2006). Reconciliation failures lead to medication errors. Joint Commission Journal on Quality & Patient Safety, 32(4), 225–229

8. Hanlon, J. T., Fillenbaum, G. G., Ruby, C. M., Gray, S., & Bohannon, A. (2001a). Epidemiology of over-the-counter drug use in community-dwelling elderly. United States perspective. Drugs & Aging, 18(2), 123–131. Evidence Level V: Literature Review.

9. Kohn, L., Corrigan, J., & Donaldson, M. (2000). To Err Is Human: Building a safer health system. Washington, DC: National Academy Press. Evidence Level VI: Expert Opinion.

10. Kaufman, D. W., Kelly, K. P., Rosenberg, L., Anderson, T. E., & Mitchell, A. A. (2002). Recent patterns of medication use in the ambulatory adult population in the United States. The Sloane Survey. Journal of the American Medical Association, 287, 377–344. Evidence Level IV: Nonexperimental Study/Survey.

11. Gurwitz, J. H., Field, T. S., Harrold, L. R., Rothschild, J., Debellis, K., Seger, A. C., et al. (2003). Incidence and preventability of adverse drug events among older persons in the ambulatory setting. Journal of the American Medical Association, 289(9), 1107–1116. Evidence Level IV: Cohort Study, Retrospective Review.

12. Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. Journal American Medical Association, 279(15), 1200–1205. Evidence Level I: Meta-analysis/Systematic Review.

13. Fick, D. M., Cooper, F. W., Wade, W. E., Waller, J. L., Maclean, J. R., & Beers, M. H. (2003). Updating the Beers criteria for potentially inappropriate medication use in older adults. Archives of Internal Medicine, 163(22), 2716–2724. Evidence Level VI: Expert Consensus Panel.

14. Hanlon, J. T., Schmader, K. E., Ruby, C. M., & Weinberger, M. (2001b). Suboptimal prescribing in older inpatients and outpatients. Journal of the American Geriatrics Society, 49(2), 200–209. Evidence Level V: Review.

15. Hajjar, I., & Kotchen, T. A. (2003). Trends in prevalence, awareness, treatment and control of hypertension in the United States, 1998–2000. Journal of the American Medical Association, 290, 199–206. Evidence Level IV: Nonexperimental Study/Survey.

16. Astin, J. A., Pelletier, K. R., Marie, A., & Haskell, W. L. (2000). Complementary and alternative medicine use among elderly persons: One-year analysis of a Blue Shield Medicare supplement. Journals of Gerontology Series A-Biological Sciences & Medical Sciences, 55A, M4–M9. Evidence Level IV: Survey.

17. Sloane, P. D., Zimmerman, S., Brown, L. C., Ives, T. J., & Walsh, J. F. 
(2002). Inappropriate medication prescribing in residential care/assisted living facilities. Journal of the American Geriatrics Society, 50, 1001–1011. Evidence Level II: Single Experimental Study.

18. Neafsey, P. J., & Shellman, J. (2001). Adverse self-medication practices of older adults with hypertension attending blood pressure clinics: Adverse self-medication practices. Internet Journal of Advanced Nursing Practice, 5(1),15. Evidence Level IV: NonExperimental Study.

19. Rochon, P. A., & Gurwitz, J. H. (1997). Optimising drug treatment for elderly people: The prescribing cascade. British Medical Journal, 315, 1096–1099. Evidence Level V: Review.

20. Gurwitz, J. H., Field,T. S.,Avorn, J.,McCormick,D., Jain, S., Eckler,M., et al. (2005).The incidence of adverse drug events in two large academic long-term care facilities. American Journal of Medicine, 118, 251–268. Evidence Level II: Single Experimental Study.

21. Hohl, C. M., Robitaille, C., Lord, V., Dankoff, J., Colacone, A., Pham, L., et al. (2005). Emergency physician recognition of adverse drug-related events in elder patients presenting to an emergency department. Academic Emergency Medicine, 12(3), 197–205. Evidence Level IV: Nonexperimental study.

22. Petrone, K., & Katz, P. (2005). Approaches to appropriate drug prescribing for the older adult. Primary Care Clinics in Office Practice, 32, 755–775. Evidence IV: Nonexperimental Study.

23. Fulmer, T. T., Feldman, P. H., Kim, T. S., Carty, B., Beers, M., Molina, M., et al. (1999). Enhanced medication compliance. Journal of Gerontological Nursing, 24, 6–14.

24. Fulmer, T., Kim, T. S., Montgomery, K., & Lyder, C. (2000). What the literature tells us about the complexity of medication compliance in the elderly. Generations, 24(4), 43–48.

25. Haynes, R. B., Yao, X., Degani, A., Kripalani, S., Garg, A., & McDonald, H. P. (2005). Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews 2007, Issue 1. Accessed January 30, 2007, from www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/
CD000011/frame.htmlEvidence Level V: Review.

26. Doucette, W. R., McDonough, R. P., Klepser, E., & McCarthy, R. (2005). Comprehensive medication therapy management: Identifying and resolving drug-related issues in a community pharmacy. Clinical Therapeutics, 27(7), 1104–1111. Evidence Level V: Observational Study.

27. Nathan, A., Goodyer, L., Lovejoy, A., & Rahid, A. (1999). “Brown bag” method review as a means of optimizing patients’ use of medication and of identifying potential clinical problems. Family Practice, 16(3), 278–182. Evidence Level IV: Nonexperimental Study. 

 

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Last updated - April 2008