BACKGROUND

A.  Definitions

1. Adverse drug events (ADEs): Defined as an injury resulting from medical intervention related to a drug (Kohn et al., 2000). ADEs, compared with medication errors, are a more direct measure of patient harm.
2. Medication errors: Refer to any “preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional, patient, or consumer” (National Coordinating Council for Medication Error Reporting and Prevention, n.d.-a, para. 2).
3. Adverse drug reaction: Any noxious or unintended and undesired effect of a drug that occurs at normal human doses for prophylaxis, diagnosis, or therapy. Inappropriate prescribing of high-risk medication to older adults and medication errors are all considered iatrogenic (World Health Organization, 1972). They are also preventable causes of harm to patients (Lavan & Gallagher, 2016).
4. Drug–drug interactions: When one therapeutic agent alters either the concentration (pharmacokinetic interactions) or the biological effect of another agent or pharmacodynamic interactions (Levinson, 2018).
5. Medication adherence: Defined as the extent to which a person’s medication-taking behavior corresponds with agreed recommendations of a healthcare provider (Sabaté, 2003). It is also a two-way form of communication in which a patient and medical provider assume active roles in fulfilling the set therapeutic regimen (Lo et al., 2016).
6. Drug–disease interactions: Undesired drug effects (exacerbation of a disease or condition caused by a drug) that occur in patients with certain disease states. Common drug–disease interaction is aspirin given in peptic ulcer disease and beta blockers given in diabetes (Salvi et al., 2012).
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 physiological changes of aging require dose adjustment for some drugs (Levinson, 2018; Steinman & Holmes, 2014).
8. Pharmacodynamics: The response of the body to the drug that is affected by receptor binding, postreceptor effects, and chemical interactions. 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; Steinman & Holmes, 2014).
9. Medication reconciliation: Defined by The Joint Commission (2010) as “the process of comparing the medications a patient is taking (and should be taking) with newly ordered medications” (p. 4). It is a process of comparing the patient’s current medication regimen against the physician’s admission, transfer, and/or discharge orders to identify discrepancies (The Joint Commission, 2010).

B.  Epidemiology

1. Older adults are the greatest consumers of medications, with older Americans taking three OTC medications and up to six or more prescription medications (Petrovic et al., 2012). Half of all prescriptions are prescribed to older adults, with those in office practices taking six or greater medications. Medicare patients (>65 y.o.) have the highest rates of ADEs, representing 75.3 per 10,000 discharges.
2. Older adults experience a 10.7% prevalence rate of hospital admissions caused by ADRs; however, a confounding factor in the accuracy is the different methods and studies employed to gather the data (Kongkaew et al., 2013).

C.  Etiology

Older adults, especially frail older adults, become increasingly susceptible to ADEs as they age (Hubbard et al., 2013). Physiological change and characteristics of aging predispose older adults to experience adverse events. ADEs increase the costs, length of hospital stay, and mortality yet often go unreported, and nearly half are likely preventable (Levinson, 2018; Salvi et al., 2012). Persons older than age 65 experience medication-related problems for five major reasons:

1. Age-related physiological changes that result in altered pharmacokinetics and pharmacodynamics (Levinson, 2018; Rochon, 2019; Steinman & Holmes, 2014)
2. Polypharmacy (multiple medications) that are often prescribed by multiple providers (Fulton & Riley Allen, 2005; Qato et al., 2016)
3. Therapeutic failures—over or underdosing of medications (more than or less than a therapeutic dosage; Fillit et al., 2016; Marcum et al., 2012)
4. Medication consumption for the treatment of symptoms that are not disease dependent or specific self-medication and/or prescribing cascades (Rochon, 2019)
5. Iatrogenic causes such as:
   • ADRs, including drug–drug or drug–disease interactions (Heuberger, 2012).
   • Inappropriate prescribing for older adults (Hamilton et al., 2011).
   • Problems with medication adherence (Lo et al., 2016; Marcum et al., 2012; Steinman & Hanlon, 2010; Steinman & Holmes, 2014).
   • Medication errors (Charles et al., 2014; Steinman et al., 2011).

ASSESSMENT TOOLS AND STRATEGIES

A.  Assessment Tools

1. Beers Criteria: American Geriatrics Society (2019) Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Use to assess medication list for medications that should generally be avoided in older adults (American Geriatrics Society, 2019).
2. STOPP Criteria: Screening Tool of Older Persons—used to identify potentially inappropriate medications (Gallagher et al., 2011; Hamilton et al., 2011)
3. START Criteria: Screening Tools to Alert Doctors to the Right Treatment—use criteria to identify medications that are underutilized and potential prescription omissions (Gallagher et al., 2011; Lang et al., 2012).
4. Drug–Drug Interactions: Tables 24.1 and 24.2. Review list of common medications known to interact with other medications or using computer decision-support and computer drug–drug interaction alerts (Clyne, Bradley, Hughes, Fahey, & Lapane, 2012).
5. Cockroft–Gault Formula—Exhibit 24.1. Useful for estimating creatinine clearance based on age, weight, and serum creatinine levels (Terrell et al., 2006). A creatinine clearance of less than 50 mL/min places older adults at risk for ADEs (Fouts, Hanlon, Pieper, Perfetto, & Fernberg, 1997).
6. Brown Bag Method—used to assess all medications. Ask older adult to place all medications, OTCs, and herbal remedies in a bag and bring it to the hospital/other care setting to ensure med list is accurate (Nathan et al., 1999; Weiss et al., 2016).
7. Drug Regimen Unassisted Grading Scale (DRUGS) Tool—Used at transfer to other levels of care. Standardized method for assessing potential medication adherence problems. This requires a higher level of functioning (Edelberg et al., 1999; Hutchison, Jones, West, & Wei, 2006).
8. Functional capacity—Evaluate activities of daily living (ADL) and independent activities of daily living (IADL), Use Mini-Cog or Mini-Mental State Exam (MMSE) and evaluate ability to self-administer medications (see Chapter 9, Assessing Cognitive Function in the Older Adult and Chapter 10, Assessment of Physical Function in the Older Adult).

B.  Assessment Strategies

Figure 24.4

National Coordinating Council (NCC) for Medication Error Reporting and Prevention (MERP) index for categorizing medication errors.

Note: Harm, impairment of the physical, emotional, or psychological function or structure of the body and/or pain resulting therefrom; Monitoring, To observe or record relevant psychological signs; Intervention, May include change in therapy or active medical/surgical treatment; Intervention Necessary to Sustain Life, Includes cardiovascular and respiratory support (e.g., CPR, defibrillation, intubation, etc.)

Source: National Coordinating Council for Medication Error Reporting and Prevention. (n.d.-b). Types of medication errors. Retrieved from https://www.nccmerp.org/types-medication-errors.

See Figure 24.4

1. Identify aging changes in pharmacokinetics and pharmacodynamics when assessing medications in older adults (Levinson, 2018; Steinman & Holmes, 2014).
2. Perform a Comprehensive Geriatric Assessment: Geriatric evaluation and management reduced inappropriate and unnecessary medications. A comprehensive assessment is important as it is a more global assessment that ensures a more specific plan for each single patient (Avelino-Silva et al., 2014; Petrovic et al., 2012).
3. Perform a comprehensive medication history (FitzGerald, 2009)
   • Currently prescribed drugs, doses, route of administration, frequency taken, and duration of treatment
   • Over-the-counter drugs and herbal remedies
   • Drugs taken in the recent past
   • Previous drug hypersensitivity reaction and the nature (rash or anaphylaxis)
   • Previous adverse drug reactions and nature
   • Adherence to therapy (what medications are you having difficulty with? Or how many pills have you missed this week/month?)
   • Obtain up-to-date medication list from primary provider or pharmacy
   • Check with pharmacy regarding prior ADRs and last order dates for each medication
   • Inspect drugs and their container for name, dosage, and number of meds taken since dispensed
   • The comprehensive medication assessment must include a formal evaluation of the ability to manage medications on an individual basis (Topinková et al., 2012). Perform at discharge and at times between transition between units
   • Regular medication review to evaluate list for PIMs/PIPs (Beers Criteria and STOPP Criteria); consider drugs to discontinue (Gallagher et al., 2011).
4. Evaluate for patient-related and medication-related risk factors for ADRs (see Box 24.1).
5. Perform medication reconciliation at admission, discharge, transfers, and transitions to other levels of care in consultation with a pharmacist, geriatric expert, or computer-based program (Frankenthal et al., 2014).
6. At discharge from hospital, use appropriate tools to assess individual’s ability to self-administer medications (Ho, Bryson, & Rumsfeld, 2009).

INTERVENTIONS AND NURSING CARE STRATEGIES

A.  Reducing ADEs (during and post hospitalization)

1. Patient/Family-centered care and decision-making include collaboration with interdisciplinary team members. Patients should be given the necessary information and the opportunity to exercise the degree of control they choose over healthcare decisions that affect them. Patients involved in decision-making are less likely to make decisions that may lead to ADRs, such as abruptly discontinuing a medication that should be tapered off (Parchman, Zeber, & Palmer, 2010).
2. Comprehensive Geriatric Prescribing:
   • Evaluate prescriptions for benefit versus harm.
   • Choose the safest and best medication for the individual based on geriatric assessment and goals of care.
   • Prior to prescribing, consider the individual’s comorbidities such as liver or kidney disease or a disease that may interact with a drug (Salvi et al., 2012).
   • Prescribing principles. Although bedside nurses are not involved in prescribing, they are involved in reviewing and signing off medications, and thus should be aware of prescribing principles.
   • Monitoring for appropriate prescribing and alerting the prescriber to potential problem areas; monitoring for and reporting lab/drug levels to primary provider; monitoring for toxicity and medication effectiveness; and seeking consultation when necessary (Rochon, 2019).
     • Reduce the dose. “Start low and go slow,” providing the lowest possible dose and slow upward titration to obtain clinical benefit; many ADEs are dose related (Rochon, 2019). Primary provider should be notified if the dosage ordered is higher than the recommended starting dose (e.g., digoxin maximum dose less than 0.125 mg for treatment of systolic heart failure).
     • 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 (Rochon, 2019; e.g., therapeutic activity kit for agitation).
     • Recommend safer drugs. Avoid drugs that are likely to be associated with adverse outcomes (review Beers Criteria).
     • Assess renal function using the Cockroft–Gault formula (for renally cleared drugs) to determine accurate dosage prior to prescribing, such as for many routinely prescribed intravenous (IV) antibiotics. Dosage recommendations are available based on this formula and are presented in common prescribing resources.
     • Optimize drug regimen. When prescribing medications, focus 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).
   • Initiation of new medication. Assess risk factors for ADRs, potential drug–disease and drug–drug interactions, correct drug dosages, and follow-up to evaluate response to new medication.
   • Avoid the prescribing cascade. Avoid the prescribing cascade by first considering any new symptom as being an adverse effect of a current medication prior to adding a new medication.
   • Avoid inappropriate medications. Review Beers and STOPP criteria for PIMs, drug–disease interactions, and potential drug–drug interactions (see AGS website in references).
   • Evaluate for patient concern regarding difficulties in adherence to medication (Steinman & Hanlon, 2010).

B.  Computerized Order Entry and Decision-Support Systems

1. Monitor and attend to alerts for potential drug–drug interactions
2. Pharmacist-based support of CPOE and electronic prescriptions direct to pharmacy
3. Reminder systems for monitoring (Charles et al., 2014)

C.  Monitoring (Steinman et al., 2011)

1. Evaluate patient for adverse effects and efficacy after a new medication is started.
2. Educate patients about anticipated benefits and potential problems associated with a new drug. Partner with the patient to actively engage as a partner to assess drug effectiveness, adherence, and adverse effects. Partner with the patient to actively engage as a partner to assess drug effectiveness, adherence, and adverse, especially with patients taking drugs with narrow therapeutic ranges.
3. Report questionable dosing amounts or schedule and medication allergy prior to medication administration. (See also Documentation of Drug Allergies post hospital.)
4. Monitor for drug interactions and inform primary provider of new or recent medications that may be related to the cause.
5. Use health information technology (HIT) to monitor labs where available, for example, lab tracing systems.
6. Use team-based approaches to monitor medications.
7. Risk assessment tools—individualize monitoring based on individual risk.
8. Report generated when lab tests are not performed with follow-up mechanism.
9. Policy standards that mandate ability to track and report overdue lab tests easily.

EXPECTED OUTCOMES

A.  Patients will:

1. Experience fewer adverse outcomes from medication-related events.
2. Demonstrate understanding of their medication regimens upon discharge from the hospital and keep an updated medication list.
3. Become active members of medication decision-making and monitoring.

B.  Healthcare providers will:

1. Use a range of interventions to prevent, alleviate, or ameliorate medication problems with older adults, including nonpharmacological and complementary therapies.
2. Improve prescribing practices by documenting indications for initiation of new drug therapy, maintaining a current medication list, and documenting response to therapy as well as the need for ongoing treatment and follow-up monitoring.
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 for collaboration and medication safety (e.g., pharmacist, geriatrician, geriatric/gerontological, or psychiatric clinical nurse specialist, nurse practitioner, or consultation-liaison service, social worker, case manager, or interdisciplinary team).

C.  Institution will:

1. Provide a culture of safety that encourages safe medication practices.
2. Provide education to healthcare providers regarding prevention, identification, and reporting of ADRs.
3. Make information on ADRs accessible to patients.
4. Enhance surveillance and reporting of ADRs using a national surveillance system. Consider use of computerized physician order entry system and drug interaction software.
5. Track and report morbidity and mortality related to medication problem.
6. Provide a system for medication reconciliation, and follow up its effectiveness regarding rehospitalization rates caused by ADRs.
7. Review for careful documentation of iatrogenic medication and other iatrogenic events for continuous quality improvement (CQI).
8. Provide ongoing education related to safe medication management for physicians, other licensed independent providers, pharmacists, and nursing staff.

FOLLOW-UP

A.  Healthcare providers will:

1. Provide consistent and appropriate care and follow-up in the presence of a medication-related problem.
2. Monitor and evaluate with physical exam and/or laboratory tests (as appropriate) on a regular basis to ensure that the older adult is responding to therapy as expected.
3. Review the medications list, including OTC and herbal remedies, regularly and reconcile medications at transitions in care.
4. Monitor high-risk medications more frequently for potential adverse events.

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 institution’s culture of safety.

RELEVANT PRACTICE GUIDELINES

Medications at Transitions and Clinical Handoffs (MATCH) Toolkit for Reconciliation. (Agency for Healthcare Research and Quality (2012). Medications at transitions and clinical handoffs (MATCH) toolkit for reconciliation [AHRQ Publication No 11(12)-0059]. Rockville, MD. Retrieved from https://www.ahrq.gov/patient-safety/resources/match/index.html

ABBREVIATIONS

ADE            Adverse drug event

ADL            Activities of daily living

ADR            Adverse drug reactions

CPOE          Computerized Provider Order Entry

CPR             Cardiopulmonary resuscitation

CQI             Continuous quality improvement

DRUGS      Drug Regimen Unassisted Grading Scale

FDA            U.S. Food and Drug Administration

HIT              Health information technology

IADL          Instrumental activities of daily living

INR             International normalized ratio

IV                Intravenous

MATCH      Medications at transitions and clinical handoffs

MERP         Medication Error Reporting and Prevention

MMSE         Mini-Mental State Exam

NCC            National Coordinating Council

NCHS         National Center for Health Statistics

OTC            Over-the-counter

PIMs            Potentially inappropriate medications

PIPs             Potentially inappropriate prescriptions

WHO           World Health Organization

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Updated: November 2020

Boltz PhD, RN, GNP-BC, FGSA, FAAN, M., Capezuti PhD, RN, FAAN, E., Zwicker DrNP, APRN, BC, D., & Fulmer PhD, RN, FAAN, T. T. (2020). Evidence-Based Geriatric Nursing Protocols for Best Practice (6th ed.). Springer Publishing. Retrieved November 4, 2020, from https://www.springerpub.com/evidence-based-geriatric-nursing-protocols-for-best-practice-9780826188144.html#description

Chapter 24: Zwicker, D., Carvajal, C. & Fulmer, T. (2021) Reducing Adverse Drug Events in the Older Adult.   In M. Boltz, E. Capezuti, D. Zwicker & T. Fulmer (eds.).  Evidence-Based Geriatric Nursing Protocols for Best Practice (6th ed. pp 409-437).   New York: Springer.