Medication Errors and Adverse Drug Events in Nursing Homes: Problems, Causes, Regulations, and Proposed Solutions

Medication Errors and Adverse Drug Events in Nursing Homes: Problems, Causes, Regulations, and Proposed Solutions Jacob Dimant, MD, CMD PREVALENCE SCOPE AND COST OF THE PROBLEM The Institute of Medicine (IOM) report To Err is Human: Building a Safer Health System has focused national attention on quality of care and the prevalence of medical errors in the healthcare system. According to the report, medical errors are responsible for a large number of deaths and additional morbidity in healthcare facilities and increased cost to the healthcare system.1 A large proportion of medical errors are medication-related.2 Medication-related errors and other adverse drug reactions are known collectively as adverse drug events (ADEs), defined as “any injury resulting from the medical use of a drug.”3,4 ADEs occur across the entire healthcare delivery system and are most common in older people, particularly those in hospitals and nursing homes.5,6 ADEs are the adverse events most common in hospitalized patients2 and the second most common adverse event in nursing home residents.6 In a report to Congress published in January 2000,7 the United States General Accounting Office (GAO) reviewed available studies and concluded that the magnitude of health risk, as well as the cost, is uncertain because of limited incidence data and the difficulty inherent in recognition and identification of ADEs. However, studies reviewed in the report showed a rate of 0.56 ADEs per 100 patients admitted to hospitals in Colorado and Utah and 0.72 in New York.8,9 In nursing homes, two studies reported an incidence of 0.44 to 0.71 per patient month.10,11 Another study in 332 nursing home residents showed an incidence of 134 ADEs per 100 admissions.12 A recently published study conducted in 18 Massachusetts nursing homes4 found an incidence of 1.89 ADEs per 100 resident/ months and potential ADEs in an additional 0.65 per 100 resident/months. Only a small percentage of ADEs result in serious health problems,4 but because exposure to medications is so high, even a low rate of ADEs presents a health problem of great magnitude, including additional morbidity, mortality, and hospitalizations.13–16 For example, one study determined that 14% of hip fractures are related to use of psychotropic medications.14 ADEs have major health consequences in nursing Crown Nursing and Rehabilitation Center and Augustana Lutheran Home, Brooklyn, NY Jacob Dimant, MD, CMD, Crown Nursing and Rehabilitation Center, 3457 Nostrand Ave., Brooklyn, NY 11229.

Copyright ©2002 American Medical Directors Association SUPPLEMENT

home residents, including sedation, delirium, confusion, hallucinations, falls, malnutrition/dehydration, and incontinence. Sixteen percent of residents in a recent study had ADR-related hospitalization for which polypharmacy seemed to be a risk factor.15 Additional hospital costs attributable to ADEs are estimated to cost $1.56 to $4 billion annually.3,16 Total costs in the ambulatory setting are estimated at $76.6 billion annually (including $47.4 billion resulting from hospital admissions and $14.4 billion resulting from long-term care admissions),17 and total costs in nursing facilities are estimated at $7.6 billion annually.18 THE RELATIONSHIP BETWEEN ADVERSE DRUG EVENTS AND MEDICATION ERRORS An error is defined in the IOM report1 as a “failure of a planned action to be completed as intended or the use of a wrong plan to achieve a desired outcome.” A medication error is an error related to the prescribing, dispensing, administration, or monitoring of a drug. An ADE is defined as “any injury resulting from the medical use of a drug.”3,4 ADEs include adverse drug reactions (ADRs) and medication errors that cause an ADR. Only a small number of medication errors – 1 to 2% – actually cause an ADE, and an additional 7% are responsible for a potential ADE.19 Conversely, about onequarter to one-half of ADRs are probably related to medication errors and are, therefore, preventable.4,16,20 In a recent nursing home study, 51% of 546 ADEs were judged to be preventable in addition to the 188 potential ADEs that were defined as preventable and caused by error.4 An ADR can be defined as “any unintended response to a drug that is noxious and occurs in doses for diagnosis, prophylaxis, or therapy”.21 ADRs may be predictable (based on the drugs inherent properties) or unpredictable (idiosyncratic, allergic reactions, hypersensitivity, etc.). Other ADRs are related to interactions of the drug with another drug, food, or with the individual’s specific illness or impairment or to excessive or prolonged use. Occasionally, a drug’s ADR profile may be a factor in the prescribing decision, eg, using an antidepressant with an expected sedative effect for a patient with agitated depression. The risk of developing an ADR is related to the inherent pharmacological properties of each specific drug, the individual’s severity of illness and presence of comorbidities, and the overall treatment intensity, including the number and type of drug administered20,22 and, posDimant S47

sibly, age.23,24 Other factors that increase risk include high volume of drug use, difficulty in administration, or the drug’s narrow therapeutic index. ADRs are associated more commonly with certain classes of drugs, such as analgesics, antibiotics, anticoagulants, psychotropics, and cardiovascular drugs, possibly related to higher volume of use.4,22 A recent study estimated that the use of NSAIDs is associated with 16,500 deaths annually in the US.25 Certain medications are more frequently associated with ADRs in the elderly, either independently or under certain conditions. A panel of experts has compiled a list of such medications26 that serves as a basis for regulations discussed later in this article. PUBLIC CONCERNS AND GOVERNMENT REGULATIONS Quality of care in skilled nursing facilities, including inappropriate use of drugs, particularly psychopharmacologic drugs, has been a public and government concern even before Medicare and Medicaid were enacted in 1965 and continues to be of concern today.27,28 Inappropriate drug use, including overuse, underuse, polypharmacy, excessive dose or duration, lack of adherence to renal dosing guidelines, lack of assessment, lack of monitoring for efficacy and safety, and lack of recognition of ADRs, has been amply documented by academic studies and government reports.29 –37 The relationship of these deficient practices to negative outcomes has also been documented.15,38 Before 1965, nursing facilities were regulated by state and local governments.27 The Medicare and Medicaid acts of 1965 authorized the Department of Health, Education and Welfare (DHEW) to establish national standards for participating facilities. The first federal oversight of skilled nursing facilities was enacted in 1974.39 These regulations established the role of the medical director as well as the requirement (unprecedented in other healthcare settings) for a monthly consultant pharmacist review of each patient’s drug regimen. Even before that time, drug utilization review was mandated.27 Despite these regulations, inappropriate use of medications in nursing homes continued to be documented.27,29 In response, in 1985 HCFA published indicators for surveyor assessment of the performance of the drug regimen review (Appendix N) instructing surveyors to compare the average number of medications per patient in a facility with a national average (6.1 at that time) and establishing a list of “apparent irregularities” for pharmacists to identify and for surveyors to investigate. Examples of apparent irregularities include the concomitant use of several drugs of the same class, overdosage of psychopharmacologic agents, and lack of appropriate drug monitoring.40 New regulations authorized by OBRA ‘87 took effect in October 1990 and, as revised and amended, are still in effect41 and address the following areas: F329: Unnecessary drugs states that each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is a drug that is used: 1. in excessive dose (including duplicate therapy; or 2. for excessive duration; or 3. without adequate monitoring; or S48 Dimant

4. without adequate indications for its use; or 5. in the presence of adverse consequences that indicate that the dose should be reduced or discontinued; or 6. any combination of the reasons above.” F329 Guidance to Surveyors states that the use of psychopharmacological drugs can be therapeutic and enabling for residents suffering from mental illnesses such as schizophrenia or depression. The goal of the regulation and guidelines is to stimulate appropriate differential diagnosis of behavioral symptoms so that the underlying cause of the symptoms is recognized and treated appropriately and to prevent use of drugs when behavioral symptoms are caused by conditions such as environmental, psychosocial, or treatable medical conditions. F329 guidance address the following issues: 1. Prohibition of use of long-acting benzodiazepines unless an attempt with a shorter-acting drug has failed. 2. Use of benzodiazepine or other anxiolytic/sedative drugs only when other reasons for distress have been ruled out; the use results in maintenance or improvement of functional status; daily use is less than 4 consecutive months unless an attempt of gradual dose reduction is unsuccessful; and use is in specific conditions, including anxiety disorder, organic mental syndromes with persistent agitated behavior, documented quantitatively and objectively, which are not attributable to preventable reasons and which cause distress, dysfunction, or danger to the resident or danger to others; and panic disorder or symptomatic anxiety associated with other psychiatric disorder. Maximum doses for several medications are also listed. 3. Use of drugs for sleep induction only when possible reasons for insomnia have been ruled out, the use results in maintenance or improvement of functional status, daily use is less than 10 continuous days unless an attempt of gradual dose reduction is unsuccessful, and the dose is equal or less than the dose listed. 4. Initiation of listed miscellaneous hypnotic/sedative/anxiolytic drugs such as barbiturates should not occur. A gradual dose reduction is attempted at least twice within 1 year in residents admitted on these drugs before concluding that reduction is contraindicated, with exceptions for single dosing before medical procedures and phenobarbital for seizure disorders. 5. A list of daily antipsychotic oral dosages, which should not be exceeded in residents with organic mental syndromes. 6. A requirement for monitoring of antipsychotic drug side effects with emphasis on tardive dyskinesia, postural hypotension, cognitive/behavioral impairment, akathisia, and Parkinsonism. 7. A statement of support for identification and treatment of depression; and 8. A list of drugs potentially inappropriate in older people, including a list of drugs with high potential for severe adverse outcomes (Talwin, long-acting benzodiazepines, Elavil, Sinequan, meprobamate, Norpace, digoxin dosage over 0.125 mg daily, Aldomet, Diabinese, GI antiJAMDA – March/April 2002

spasmodics, barbiturates, Demerol (oral) and Ticlid; a list of diagnosis/drug combinations with high potential for severe adverse outcomes (sedative/hypnotics in COPD, NSAIDs (except COX-2 inhibitors) in active or recurrent gastritis, PUD, or GERD, Reglan in seizures or epilepsy, aspirin, NSAIDs, Persantine or Ticlid in blood-clotting disorders, including taking anticoagulants, anticholinergic drugs in BPH, and tricyclic antidepressants in arrhythmias). F330/331 Antipsychotic Drugs states that “Based on a comprehensive assessment, the facility must assure that (1) residents who have not used antipsychotic drugs are not given these drugs unless therapy is necessary to treat a specific condition and (2) residents who use antipsychotic drugs receive gradual dose reduction and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.” The F330/331 guidance provides a list of specific psychiatric conditions and requires that when treating organic mental syndromes with associated psychotic or agitated behaviors, the symptoms are quantitatively and objectively documented and assessment takes place to determine the need for intervention and possible environmental, psychosocial, or medical causes of the symptoms; that the symptoms are persistent and not attributable to preventable reasons; and that they cause danger to the resident or others, distress, or functional impairment. The guidance prohibits treatment when certain conditions are the only indication, including wandering, poor selfcare, restlessness, impaired memory, anxiety, depression without psychotic symptoms, insomnia, unsociability, indifference to surroundings, fidgeting, nervousness, uncooperativenes, and nondangerous agitation. The guidelines also require gradual dose reduction unless contraindicated, which is defined as a failed attempted reduction twice within 1 year. F332/333 Medication Errors addresses the preparation and administration of drugs not in accordance with physician orders, manufacturers specifications, or professional standards (including state regulations and practice standards established by national organizations, boards, and councils). F428 Drug Regimen Review requires that the drug regimen of each resident be reviewed at least once a month by a licensed pharmacist. The F428 guidance suggests that, depending on the resident’s condition and the drugs taken, it may be necessary to perform this review more frequently. F429 Drug Regimen Review requires the pharmacist to report any irregularities to the attending physician and the director of nursing. The F429 guidance refers to Appendix N Part One (see below) and states that “the facility is encouraged to share the pharmacist’s report with the medical director.” The guidance provides a list of miscellaneous drugs that are potentially inappropriate in older persons, including a list of drugs with high potential for less severe adverse outcomes (Butazolidin, Tigan, Indocin, Persantine, reserpine, Benadryl, ergot mesyloids, and antihistamines) and a list of diagnosis/ drug combinations with high potential for less severe adverse outcomes (corticosteroids in diabetes, aspirin or potassium supplements in active or recurrent gastritis, PUD or GERD, SUPPLEMENT

antipsychotics and Reglan in seizures, narcotic drugs including propoxyphene in BPH except short-term therapy, bladder relaxants in BPH, anticholinergic antihistamines, anti-Parkinson medications, GI antispasmodics, anticholinergic antidepressants and narcotics including propoxyphene in constipation, and drugs that cause or worsen insomnia, such as decongestants, theophylline, desipramine, SSRIs, Ritalin, MAO inhibitors, and beta agonists in residents with insomnia). F430 Drug Regimen Review requires that the pharmacist’s reports be acted on. A new guidance (revised 4/00) clarifies that the director of nursing and the attending physician are not required to agree with the pharmacist’s report, nor are they required to provide a rationale for their acceptance or rejection of the report, but they must act on the report. The facility is encouraged to provide the medical director with a copy of the report and to involve the medical director in reports that have not been acted on. Appendix N, Part One40 requires that in performing a drug regimen review, the pharmacist must identify and report “apparent irregularities,” which are potential drug therapy problems that may need to be corrected by the physicians and/or nursing staff. Examples given include multiple orders of the same drug, PRN orders administered every day for more than 30 days, prescribing three or more laxatives concurrently, use of more than two antipsychotic or hypnotic drugs concurrently, frequent loss of seizure control while taking anticonvulsants, thyroid medications given without some assessment of thyroid function, hypertension without at least weekly blood pressure measurement, anticoagulants without clotting assessment at least monthly, insulin or oral hypoglycemics without blood sugar assessment at least every 2 months, iron preparations without CBC during the first month of therapy, diuretics without potassium determination within 30 days of initiation of therapy, and many others. The Investigative Protocol: Adverse Drug Reactions21 instructs surveyors to assess compliance with F329 and F429 by determining, in residents who receive medications listed above, if the facility identified the risk, determined and documented that the benefit of a drug outweighs the risk, and periodically assessed that the drug continued to be a valid therapeutic intervention. If an ADR occurs, surveyors are instructed to determine if it was identified, reported, and responded to. The OBRA regulations had the effect of markedly reducing the use of psychopharmacologic agents,28, 42 but there is no agreement that this brought about a marked improvement in drug prescribing,37 resident outcomes, or quality of life. Recently, HCFA raised the bar for nursing facilities and longterm care professionals with the release of guidelines to surveyors for determining immediate jeopardy (Appendix Q).43 These guidelines list deficient practices that may constitute or cause immediate jeopardy, defined as “a situation in which noncompliance with requirements of participation has caused, or is likely to cause, serious injury, harm, impairment or death to a resident.” Each issue lists associated triggers, the finding of which will cause a surveyor to consider if further investigation is needed to determine the presence of immediate jeopardy. Dimant S49

Many of the listed issues and triggers are the result of medical errors. Issue D is listed as “failure to protect from undue adverse medication consequences and/or failure to provide medications as prescribed.” The associated triggers include the following: ● ● ● ● ● ●

Administration of medication to an individual with a known history of allergic reaction to that medication; Lack of monitoring and identification of potential serious drug interaction, side effects, or adverse reactions; Administration of contraindicated medications; Patterns of repeated medication errors without intervention; Lack of diabetic monitoring resulting or likely to result in serious hypoglycemic or hyperglycemic reaction; Lack of timely and appropriate monitoring required for drug titration.

If an immediate jeopardy situation is found, surveyors are instructed to determine if the entity created the situation, allowed it to continue, or had an opportunity to implement corrective or preventive measures but did not do so; in other words, surveyors will look to see if the facility has in place appropriate systems and processes for detection and prevention of, and intervention for, medication errors. Errors, adverse drug events, and other medication-related negative outcomes can be prevented by adherence to care delivery systems and processes that include the detection and assessment of conditions and risks, the prescribing, transcribing, dispensing, and administration of drug therapy, continual monitoring, and a quality control and improvement system to detect and correct negative trends in a timely fashion. Clearly, the IOM report, Appendix Q, and the publicity these issues have been receiving lately indicate that the time has come for medical directors and attending physicians to take charge and find ways to improve the system. MEDICATION ERRORS IN NURSING HOMES Medication errors occur in every step of the pharmaceutical care process: prescribing, transcribing, dispensing, and administering. The majority of serious medication errors occur at the prescribing step, with fewer at transcribing, dispensing, and administration.4,20 Of 464 preventable ADEs and potential ADEs in Gurwitz’s study,4 315 (68%) occurred at the ordering stage and 325 (70%) occurred at the monitoring stage. Only 0.7% occurred at the transcription stage, 0.5% at dispensing, and 3% during administration. Of the 315 ordering errors, 63% were a wrong dose, 22% failed to consider a drug interaction, and 9% were wrong drug choice. Of the 325 monitoring errors, 26% were failure to order monitoring, and 41 had a delayed response or failure to respond to signs or symptoms of drug toxicity or to laboratory evidence of toxicity. Unfortunately, prescribing and monitoring errors are rarely detected and reported in nursing homes. Directors of nursing in 18 Massachusetts nursing homes considered medication errors to include only transcription, dispensing, and administration errors.44 Errors in prescribing include errors of omission (not prescribing a medication when one is indicated) and errors of S50 Dimant

commission (prescribing the inappropriate medication, overor under-dose and wrong form or route, frequency, or duration). Furthermore, these errors also include failure to consider presence of an allergy or interactions with other medications, food, or other diseases or conditions that the patient may have; failure to consider the risk/benefit ratio of a medication; failure to consider alternative medications; failure to consider and warn the patient/staff of potential adverse reactions; and failure to request, order, or perform appropriate precautions and monitoring for potential adverse drug reactions. The prescribing process is a continuous process, which includes constant monitoring and reassessment of efficacy, assessment that the drug continues to be a valid therapeutic option, recognition and assessment of, and intervention for ADRs. Therefore, errors in prescribing include failure to assess efficacy and need for continuation of a medication and failure to recognize, assess, and treat ADRs. Moreover, an error can include the erroneous recognition of an ADR as a new illness, leading to additional, unnecessary drug therapy, which often results in additional complications.45 This situation is not uncommon with psychopharmacologic drugs. Errors in transcribing relate to the transmission of inaccurate information from the prescriber to the pharmacist. Errors in dispensing include dispensing the wrong medication, dosage, or form or supplying wrong information to the nursing staff. It also includes the dispensing of medications to which the patient has an allergy or medications that interact with other medication the patient is receiving, to the extent that such information is available to the dispensing pharmacist. Errors in administration include failure to administer the medication, administering the wrong medication, dosage, form, route, or frequency, incorrect timing of administration (too early or late), administering for a wrong period of time, failure to follow special precautions required by the manufacturer (such as with or without food or fluid, crushing medications that should not be crushed, not having the patient in proper positioning), failure to perform appropriate precautions and monitoring for potential ADRs, and failure to observe and diagnose ADRs. In hospitals and long-term care facilities, these errors stem from lack of appropriate nursing systems and processes. At home, these errors stem mostly from lack of patient or caregiver education and noncompliance. CAUSES OF PRESCRIBING ERRORS IN NURSING HOMES Factors that may increase the risk of medication errors include high volume of drug use, similar or confusing drug names, or a drug’s narrow therapeutic index. Certain drug classes such as analgesics, antibiotics, anticoagulants, psychotropics, and cardiovascular drugs are more commonly associated with medication errors, possibly related to higher volume of use. However, recent studies found few, if any, drug- or patient-specific risk factors for medication errors.22 The same authors identified major system failures in hospitals as the underlying cause of errors, most commonly related to inadequate availability of drug knowledge and patient information.46 Similarly, 60% of prescribing errors in another hospital JAMDA – March/April 2002

were related to knowledge and its application regarding drug therapy and patient factors that affect drug therapy.47 These findings suggest that improvement efforts should focus on medications-related systems and processes. In nursing homes, the majority of root causes of prescribing problems resulting in medication errors are not specific to the process of prescribing but are rather of a generalized system, process, or management nature,48 which can cause other negative outcomes as well. Beers49 showed that certain physician characteristics are related to prescribing practices, underscoring the lack of systems to assure physician competence and performance evaluations and physician accountability. Lack of recognition and assessment have been related to undertreatment of pain, depression, and other conditions in nursing homes.34,50 A recent study showed that long-term care residents receiving anti-epileptic drug therapy lacked assessment for the specific cause of the seizure51 highlighting the lack of processes that assure appropriate recognition, assessment, and diagnosis of problems and symptoms by physicians before prescribing drug therapy. Another recent review and analysis of 29 studies showed that physician-pharmaceutical industry interactions may affect professional behavior, including nonrational prescribing.52 Levenson53 identified three broad categories of system problems related to medication prescribing: attitudes and roles, processes, and information management. Examples of deficient practices within these broad categories included lack of training in principles of geriatric assessment, care, prescribing and nonpharmacological options, physician attitudes such as refusal to consider nonpharmacological care or fear of regulatory or other consequences, lack of facility processes for communication among providers, coordination of care and addressing family and patients demands and attitudes, and lack of proper information available at the time of prescribing. In 1998 the American Medical Directors Association (AMDA) convened a National Forum on Quality Pharmaceutical Care in Long Term Care and published the consensus of the group in a white paper.54 Key issues identified in the White Paper include poor transfer information from hospitals, physician hesitancy to accept pharmacist recommendations, “unreasonable” demand by regulatory agencies to stop medications and lack of interdisciplinary approach and monitoring for efficacy, side effects, or ADRs. Additional concerns identified included documentation, monitoring, prescribing, and communication issues. More recently, a work group of AMDA state presidents, convened in Denver, Colorado, attempted to reach a consensus on the causes of prescribing errors in nursing facilities.55 This group again identified that most underlying causes were related to medical system, process, or management issues. Physician management issues included attitudes (refusal to be held accountable, consider nonpharmacologic care, or accept pharmacists’ recommendations), time pressure, low reimbursement, excessive and conflicting regulatory and documentation burden, or fear of regulatory consequences. Important system and process issues included lack of timely interfacility information transfer, lack of processes for recognition and assessment, and lack of interdisciplinary communication systems including communicaSUPPLEMENT

tion among various physician providers. Prescribing-specific issues included lack of processes to evaluate and monitor drug therapy or deal with patient/family pressures, lack of information and training in issues such as geriatric pharmacology, lack of communication with the consultant pharmacist, lack of timely accurate sources to obtain drug-related information, and pharmaceutical marketing. Additional factors frequently cited by physicians include a multitude of formularies and other barriers to prescribing (for example, managed care prior approvals or the requirement for use of special prescription pads for narcotic medications in certain states), high cost of certain medications forcing less than optimal choice, suboptimal care coordination among providers and team members, and the need to deal with prevailing tendencies in nursing homes to provide episodic rather than comprehensive care. PAST EFFORTS TO IMPROVE PRESCRIBING AND PREVENT ERRORS A multitude of strategies for improvement in physicians’ prescribing patterns (and improved outcomes as a result) have been tried in the past, targeting education and training, facility systems and processes, and information systems. Efforts have been made to alter physicians’ prescribing behavior with a multitude of interventions.56 Educational strategies involving traditional, cognitive-oriented continuing education, such as didactic sessions, do not appear to alter physicians’ behavior and health care outcomes, as opposed to interactive, participatory or performance-based strategies that can affect change in professional practice and, on occasion, health care outcomes.57 A variety of such interventions have been studied in long-term care and other settings, including targeted education and academic detailing,58 – 63 use of opinion leaders64 and providing physicians with feedback of their own practices compared with their peers.65– 68 These approaches were somewhat successful in changing prescribing patterns, but in most instances, when studied, the effect did not last over time. Targeting facility processes and information systems was more successful in bringing about change and improvement. Strategies such as simplifying the drug regimen69 or using combination drugs, extended release drugs, or other formulations70 may reduce the number of drug administrations and chances for errors. Formularies and other administrative controls, such as requiring preapproval for certain drugs, have been used mostly to reduce cost, but they can be used effectively to prevent use of inappropriate or high-risk medications.71,72 Establishing facility systems, policies, and procedures to assure appropriate assessment and care planning, prescribing (Table 1), and timely communications among members of the care team was proposed as an important tool to achieve improvement and regulatory compliance48,73,74 and has been shown to improve the prescribing process in nursing homes.75 Implementation of practice guidelines or standardized procedures, particularly when incorporated into facility processes, can improve the process,76 –79 but no specific study related to the prescribing process has been done in nursing homes. Communication systems among all members of the care team are extremely important in the provision of Dimant S51

Table 1. The Process of Drug Prescribing in the Nursing Home ASSESSMENT Step 1: Recognize the problem: identify the presence of a symptom, disease, condition or impairment This may stem from patient information, complaints, observations, examination or results of diagnostic or laboratory tests. The recognition of a clinical problem which may need further assessment and intervention relies on the presence of patient information, the clinical skills of the patient care team including the attending physician and the nursing staff, and a system that assures timely communication among members of the care team. Step 2: Perform an assessment and identify diagnosis and/or cause, or document why additional assessment or work-up are not done The assessment process must be comprehensive and include a review of previous patient information, a physical, mental and functional assessment, completion of the MDS, use of specific assessment instruments such as MMSE, depression scale or fall assessments and additional diagnostic and laboratory tests. Establish a process that assures the timely completion of the above steps. Step 3: Gather information and assessment of current and past administration, response and adverse reactions to treatments and medications This is a critical process which is prone to errors particularly at hand-offs, such as transfer of the patient among facilities, units or various health care professionals. In this step, communication of information among the institutions or care team members is crucial, and systems must be designed to assure timely and complete transfer of information. Step 4: Document the reason why the disease, condition, symptom or impairment need to be treated or the reasons why treatment is not provided (patient choice, ethical considerations, etc.) Document the resident or surrogate involvement in the decision-making process. Step 5: Document if a nonpharmacologic treatment appropriate or has been tried and failed PRESCRIBING Step 6: Consider the available alternative pharmacologic agents, review applicable formulary, and document the reasons for choosing a specific agents These may include patient condition, side-effect profile, presence of sensitivity or allergy, patient choice, quality of life considerations, ease of administration Step 7: Document the treatment objective: What is expected to be accomplished, and what is a realistic goal i.e. Cure, maintenance, palliation, etc. Step 8: Document that benefit vs. risk has been considered Particularly for drugs with narrow therapeutic index and drugs with high risk for severe ADR’s, or when the resident has a comorbidity that may be affected by the proposed drug. Step 9: Document that drug-drug interaction has been considered. Step 10: Order the specific agent to include dosage, route of administration, frequency of administration and duration of treatment Assure that handwriting is legible. Sign, date and time the order. Step 11: Order appropriate precautions (with or without food, fluids, patient positioning, vital signs, etc.) and monitoring Including vital signs, drug levels required to maintain appropriate dosage, laboratory tests to monitor for ADR’s, etc, and specific ADR’s to be expected. Assure that handwriting is legible. Sign, date and time the order. MONITORING Step 12: Assess and document effect of drug periodically during or the end of treatment, and monthly for chronic drugs Compare to goals and objectives of treatment. Step 13: Assess for presence of ADRs Pay particular attention to events, symptoms, conditions and outcomes (such as falls) that could possibly be related to an ADR. When an ADR is identified, document its scope and severity, reduce or discontinue the responsible drug (or document reason for continuation) and provide necessary care. Copyright 姝2000, Jacob Dimant, MD

all aspects of care, including drug prescribing, and can vary from simple use of morning reports as a communication tool80 to use of modern information systems. Obtaining patientspecific information from other facilities is a difficult task that cannot usually be accomplished at a facility level alone. Recently, a group of medical directors in Long Island, New York, developed a multifacility system to obtain information from hospitals upon admission of patients to nursing homes, resulting in improved flow of interfacility information.81 Information technology82,83 holds the most promise. Applications of this technology have included computerized physician order entry,84 – 86 on-line decision support such as drug information, drug selection, dosage and frequency guidance,87 alerts such as warning on allergies, interactions and potential ADRs,88 reminders or automated ordering of precautions, S52 Dimant

monitoring and techniques of administration,72 implementation of practice guidelines,89 standardized procedures, regulatory requirements, formularies, therapeutic equivalents exchanges, and administrative controls72 and drug utilization review.90 Automating the process helps in eliminating transcription errors, providing feedback,72 reducing costs89,91 and providing data for trend analysis and other quality control and improvement activities. Use of this technology has been shown to improve drug prescribing and significantly reduce medication errors and ADEs.86 –90 In the future, Intelligent integration of patient data bases, drug data bases, electronic medical records and information available via the Internet can be used for multiple applications that could improve efficiency and reduce the chances for errors. Other strategies include emphasizing nonpharmacologic JAMDA – March/April 2002

therapies to substitute for medications92–94 and improving pharmacist’s participation. A consultant pharmacist has been a member of the care team in nursing homes since 1974. Pharmacist intervention has been shown to modestly improve outpatient geriatric prescribing.95 In a recent hospital study, pharmacist participation on physician rounds in the ICU was associated with a substantially lower rate of ADEs caused by prescribing errors.96 This suggests that a pharmacist’s involvement as close as possible to the prescribing process, rather than a retroactive drug regimen review, may be associated with similar improvements in nursing homes. STRATEGIES FOR THE MEDICAL DIRECTORS TO ADDRESS MEDICATION ERRORS It is clear from the above discussion that physicians hold the key to implementing any solutions that can bring large scale improvement in each facility as well as on a national level.97 Strategies for improvement must target physicians practicing in long-term care. Medical directors must be in the forefront of designing and implementing such solutions, a difficult but not an impossible task.98 Successful implementation of medication error preventing practices is an organizational change that requires strong leadership, effective processes, and appropriate choice of interventions.99 This highlights the need for medical directors to exercise strong leadership in providing the education, information, feedback, system and process design, and quality control and improvement to the facility and the attending physicians. There are many avenues where the medical director can be instrumental in bringing about a fundamental change in the way facilities and physicians operate. Because many of the problems that cause prescribing and medication errors are not specific to medication systems per se, but are of a systemic, process or management nature, interventions should not be limited to drug-related systems and issues but should address the entire scope of medical services and its interface with the care team. These include assuring physician accountability, providing physicians with information and education, and designing administrative and clinical processes for physicians work as well as developing processes directly related to prescribing. In designing these processes, collaboration between the medical director and the pharmacists is usually helpful. Establishing facility systems and processes to assure appropriate assessment and care planning, prescribing, and timely communications among members of the care team is crucial to prevention of medication errors. INFORMATION AND EDUCATION The medical director must take the lead to educate and inform physicians on principles of geriatric care and geriatric pharmacology, provide timely, objective information on new treatments and drugs, inform physicians on developments in federal and state regulations as they relate to resident care and drug therapy, provide drug cost information, and generally serve as a role model to physicians. To be effective, education should be performance-based. For example, it is helpful to regularly provide physician feedback and comparative data on drug utilization and prescribing profiles of their performance SUPPLEMENT

compared to their peers and local and national benchmarks. Physicians tend to respond to such data, particularly when their performance deviates markedly from that of their peers. Many national and local benchmarks are available from the American Society of Consultant Pharmacists. When feasible, physicians should be encouraged to use new information technology, such as palm devices to review patient data as well as drug information at the point of prescribing. For example, the Physician Desk Reference (PDR) is available to download to a palm device and can thus be easily consulted at the time of prescribing. MEDICAL STAFF POLICIES, SYSTEMS AND PROCESSES One of the important functions of the medical director is to develop and implement a system to credential and privilege attending physicians and perform periodic competency and performance evaluations based on objective criteria, including performance audits. Much of the comparative data mentioned above can be used as part of the performance evaluation. This system is the basis for the medical director’s ability to hold physicians accountable. Poor communication among various members of the team, including members of the medical staff, has been identified as one of the root causes of medication errors and other problems. There must be a process in place to assure efficient communication among attending physicians, covering physicians and consultants, as well as all other members of the care team. Clinical problems often develop when the attending physician is not in the facility. A process to assure coverage, including cross coverage by other physicians, on-call coverage and coverage by mid-level practitioners, must be in place. This is particularly important in facilities with subacute or patients with complex medical problems. There are inherent problems with telephone and verbal orders given when the physician is not in the facility, has no access to clinical information, or ordering is done by a covering physician who may not have any comprehensive information about the patient and must rely on an often sketchy information given by a nurse on the telephone. Therefore, telephone-initiated prescribing is less likely to follow a logical process (see Table 1). Additionally, this step is fraught with the possibility of transcription errors, and, finally, there is often no documentation and no-follow up by the physician. Some of this can be corrected by developing and implementing information systems that allow physicians to view patient data at their home or office at the time of ordering, requiring orders to be transmitted by facsimile or e-mail, requiring physicians to document at the time of providing an order, and requiring an assessment in-person by a physician or a midlevel practitioner within a reasonable time after a telephone or verbal order is given for a significant clinical problem. The practice of wholesale co-signatures of telephone and verbal orders by medical directors, designed to comply with regulations, should be discouraged. Dimant S53

CLINICAL POLICIES, SYSTEMS AND PROCESSES The principles and process of prescribing is described in detail in Table 1. This process can be integrated into the facility clinical policies and procedures together with pertinent CPGs and regulatory requirements. A portion of the process may be automated, depending on available technology and resources in the facility. As mentioned before, lack of appropriate patient-specific information is one of the root causes of medication errors. The facility and the medical director have a responsibility, at least to attempt to, develop a process that ensures timely transfer of patient information to and from institutions that transfer residents to and from the facility. Unfortunately, the facility may have little control over the process as it relates to other providers. The AMDA Clinical Practice Guidelines (CPGs) address many of the system issue that are at the core of the medication errors problem.50,92,93,100,101 The guidelines are process oriented and include helpful material for implementing processes for recognition, assessment, diagnosis, management/treatment, and documentation. One of the AMDA CPGs is devoted to the implementation process.102 The implementation of CPGs can assure an appropriate, orderly assessment and management process that reduces the chance for errors. CPGs can and should be integrated into facility clinical policies and processes. Regulatory requirements can be similarly integrated. This is done easily when automated systems are available. A complete assessment of the cause of clinical problems must be done before prescribing. Unfortunately, symptoms are often treated without an attempt to assess the underlying cause. This is particularly true with symptoms such as behavior or insomnia, which are often a manifestation of another underlying clinical problem. As discussed above, guidance to surveyors emphasizes the need for appropriate assessment for environmental, psychosocial, or medical condition as the cause of the symptom before prescribing a medication. Thus, there is a need for a process to assure complete and comprehensive physical, mental, and functional assessment by attending physicians and mid-level practitioners on admission and periodically thereafter. Here again, AMDA CPGs can serve as guidance. An example of a process that can be implemented easily is requiring universal use of a Mini-Mental State Exam tool or a Geriatric Depression Scale as part of each resident’s mental status assessment or the completion of a standardized pain assessment tool before and periodically after prescribing analgesics.50,92,93,103 Assessment must also address possible nonpharmacologic interventions before prescribing. PRESCRIBING AND DRUG-RELATED POLICIES, SYSTEMS AND PROCESSES A formulary can address cost as well as quality issues. Drug cost is becoming an important factor in prescribing decisions under Medicare’s prospective payment system (PPS) as well as capitated reimbursement by managed care and, in certain states, the Medicaid program. A formulary can be a tool in S54 Dimant

addressing cost while assuring quality pharmaceutical care by providing the most cost-effective drug and excluding others or by providing for use of therapeutic exchanges. But a formulary should not be seen as a cost control measure alone as it can be used effectively for quality control tool and as a regulatory compliance tool. A formulary can assure the exclusion of inappropriate drugs, drugs prohibited by regulations, or drugs that have high potential for ADRs, particularly when a more appropriate therapeutic equivalent exists. Therefore, a formulary should be developed in every facility, even when not driven by cost-control. In developing a formulary, the medical director must collaborate with the pharmacist whose expertise is usually indispensable. A formulary can be either closed and strongly enforced or a list of preferences, as circumstances in each facility dictate. A negative formulary, listing only drugs that are not available or require specific approvals, can also be used. Formulary development is often complicated by conflicting formularies imposed by various third-party payers which may have to be accommodated. However, relying on large outside formularies, such as the state’s Medicaid formulary, usually fails to address the needs and circumstances of the population served by the facility. Criteria for drug selection should include evidence-based efficacy, safety (including ADR profile), frequency, route and ease of administration, regulations, and cost. In assessing cost, it is important to keep in mind that direct drug cost alone may not predict the entire cost of care, and the possible cost of caring for complications needs to be addressed as well. A formulary must be managed and updated constantly as scientific advances and regulatory issues develop. Administrative controls and barriers, such as requiring a medical director or a consultant preapproval for the use of certain medications, were initially developed as cost control measures, but they can be used to promote quality, for example by preventing prescription of inappropriate medications or medications that have high risk of ADRs. Computerized automated systems can reduce errors in prescribing, monitoring and transcribing by implementing direct physician order entry and providing on-line clinical decision support, formulary and administrative controls management, and a data base for quality improvement activities. On line clinical decision support may include provision of drug and patient information at time of prescribing, information on medication selection within a class based on efficacy, cost or safety, dosage and frequency guidance (including adherence to renal dosing guidelines), allergy and interaction warnings, reminders/alerts for required precautions, techniques of administration, laboratory and other monitoring to be ordered including drug levels, and potential ADRs. Precautions, monitoring or techniques of administration can be automatically ordered (Table 2). Formulary implementation, administrative controls and CPG enforcement and regulatory compliance can be achieved by prevention of use, or warning, for medications that are nonformulary, require prior approval, or are inappropriate. The process of providing generic substitutions and therapeutic equivalents can also be automated. An automated system can provide a data base for drug utilization JAMDA – March/April 2002

Table 2. Examples of Laboratory Monitoring That Can be Automated Medication

Test

To Be Done at Least

Thyroid preparations Anticoagulants Insulin Oral hypoglycemics Diuretics NSAIDs

TSH/T4 INR Fasting blood sugar Fasting blood sugar Potassium CBC BUN/Creatinine CBC

Within 30 days of initiation or change of therapy, then once yearly Weekly within 30 days of initiation or change of therapy, then once monthly Monthly Every 60 days Within 30 days of initiation or change of therapy, then every 3 months After 30 days of continuous therapy, then every 6 months 48–72 hours after initiation of therapy, then every 3 months Within 30 days of continuous therapy, then every 6 months

B12, Folate, Iron

Adapted with permission from Dimant J. Policy and Procedure Manual for Nursing Home Medical Directors. Crown Nursing Home Press, NJ, 1991.

review and for generating prescribing or cost profiles and trends. With an automated system, many errors, including prescribing, transcribing and monitoring, can be prevented at the source rather than discovered retrospectively. Many systems are now available at pharmacy providers and are used in facilities. Not all systems incorporate all the capabilities described above. The medical director, in collaboration with the pharmacist, may be called on to assist the facility in developing, implementing, or improving such systems and needs to be familiar with available capabilities and to provide education and information to physicians. Medical directors should work closely with consultant pharmacists in providing information and education and developing drug-related systems and processes. The drug regimen review (DRR), performed monthly by the pharmacist, is a valuable feedback tool for physicians and medical directors and a source of data for utilization and quality review. The DRR is usually a good source for detecting and reporting ADRs and medication errors. The pharmacist may be particularly helpful to physicians and medical directors in developing, implementing, and managing formularies, therapeutic equivalents exchange policies, and strategies for simplifying drug regimen by using combination drugs, extended release drugs, or other formulations that reduce administrations and improve resident acceptance. In addition, the pharmacist serves as a resource to facility staff providing education and assisting in drug dispensing, handling, storage, administration, and compliance with F332/333. An efficient communication process between the pharmacist, physicians, and all care team members is important for sharing the pharmacist’s expertise with the physician and the team. Ideally, the pharmacist should be involved as early as possible in the prescribing process to provide necessary information and a prospective, rather than retrospective, DRR. Part of this process can be automated. Although this may not be achievable with current resources, medical directors and pharmacists need to collaborate to try to modify the pharmacist’s work process to perform DRRs as close to prescribing as possible. The product of a DRR is a set of recommendations to the physician or to the nursing staff. Recommendations to the physicians may include prescribing a drug, discontinuing a drug for lack of indication or efficacy, changing to another SUPPLEMENT

drug (more appropriate or cost-effective), changes in dosage, gradual reduction of dosage, a different route, timing, or frequency of administration, precautions, or monitoring or an ADR that was not recognized. As part of the DRR process, the pharmacist should focus on drugs with high potential for ADRs or other interactions, particularly drugs listed in F329, F429, and Appendix N. Federal regulations require the physicians to respond to the pharmacist’s DRR recommendations. A process for physicians to review and to respond to in a timely manner to pharmacist’s DRRs recommendations must be developed, and the medical director must address the constant hostility and resentment physicians have shown toward that process, perhaps by demonstrating positive outcomes of the process to physicians. The prescribing process includes ordering appropriate precautions to identify expected ADRs, to monitor for the presence of ADRs, and to monitor for efficacy and the need for continuation of the drug. A process for monitoring efficacy is difficult to develop because there are many variables. In some instances, control of symptoms indicates efficacy; in others, diagnostic or laboratory tests are indicated. However, lack of symptoms does not always indicate that a drug needs to be continued, and sometimes only stopping the drug can provide the answer. Nonetheless, physicians should be required to demonstrate and document periodically that an existing drug needs to be continued. Automated systems may be helpful in ordering appropriate precautions, required drug levels, or other laboratory monitoring. Medical necessity for these tests needs to be documented as well. Too many times a symptom is mistaken as another illness rather than an ADR. Awareness and a high index of suspicion are required of all members of the team to assure identification of ADRs. MacLean74 published model multidisciplinary policies for ADR management. These policies require physicians to document the risk/benefit for drugs with ADR potential (F329 and F429), assign the pharmacist to focus on these drugs, particularly when newly prescribed, and provide information on potential ADRs and a standardized care plan insert to the nursing staff along with a specified procedure on holding a drug and notifying physicians when an ADR is suspected. There is also a specified form for physician to document and report ADR management, which includes an assessment, Dimant S55

Table 3. A Process Assessment Tool for Drug Prescribing in Nursing Facilities YES

NO

N/A

ASSESSMENT Diagnosis, symptom, condition or impairment identified Assessment of the problem documented Cause of the problem documented Diagnostic workup ordered, done and documented Results of tests documented and abnormalities addressed Reason why diagnostic workup not done documented PRESCRIBING Reason for treatment is documented Goals and objectives of treatment are documented Consideration of non pharmacologic means documented Resident/surrogate involved in decision-making process Reason for choosing specific class/drug documented Risk of drug (potential ADR’s, etc.) considered and documented Consideration of drug interactions documented Order includes: dosage and form (tab, liquid, etc.) route of administration frequency of administration duration of treatment order signed and dated Telephone/verbal order signed within 48 hours Resident examined within 48 hours of verbal/telephone order Precautions/monitoring ordered at time of prescribing MONITORING Efficacy and need to continue drug considered each periodic visit Potential for ADR’s assessed each periodic visit Presence of ADR’s assessed and addressed each periodic visit MEDICATION REGIMEN Presence of untreated condition Evidence of polypharmacy (over 9 prescription medications) More than one medication in a class (duplicate therapy) Excessive dosage of any medication present Drugs with high potential for severe ADR’s used Per F329 and F429 If yes, exception or justification documented PSYCHOPHARMACOLOGIC MEDICATIONS Anxiolytic/sedative drugs (including benzodiazepines) used for unapproved indication Attempt at reduction of anxiolytic/sedative drugs within the last 4 months Drug for sleep induction used for more than 9 days if yes, clinical contraindication to discontinuation documented Specific condition documented for use of antipsychotic drugs Antipsychotic drugs used for organic mental syndromes (dementia) with behavior if yes, is the behavior documented is the cause for the behavior assessed and documented documentation that behavior causes distress or danger to resident/others has there been 2 attempts at gradual dose reduction within the last year dosage exceeds regulatory guidelines Adapted with permission from Dimant J. Policy and Procedure Manual for Nursing Home Medical Directors. Crown Nursing Home Press, NJ 1991

type, management plan, justification if continuation of drug is necessary and other options. These policies and forms are posted at AMDA’s web site (www.amda.com). QUALITY CONTROL AND IMPROVEMENT The guidance to surveyors recommends that the pharmacist’s DRR recommendations be reported to the medical director. These reports should be reviewed along with physicians’ responses and discussed regularly with physicians as an educational and enforcement tool. Valuable information can be gained on prescribing patterns. The pharmacist is in a S56 Dimant

position to generate statistical data related to DRR recommendations. These data can be analyzed to generate both horizontal and longitudinal trends.104 Medical directors need to understand the parameters of the DRR recommendations and insist on receiving data analysis and trends from the pharmacist. The pharmacist, particularly when the pharmacy is automated, should also provide monthly drug utilization review (DUR) for specific drugs or classes of drugs, such as antipsychotic or hypnotic medications, antibiotics, and GI drugs, compared with local and national benchmarks, and analyzed JAMDA – March/April 2002

for trends and patterns in drug use. The DUR can identify physician-specific prescribing and cost patterns and trends and can be instrumental in identification of inappropriate use of drug classes or specific drugs. Medication error reports should be reviewed by the medical director as well and the data collected and analyzed for trends. The Joint Commission requires facilities to have a system for reporting all ADRs. This should be done in all facilities irrespective of Joint Commission status. The data collected should be analyzed for trends by the medical director and the pharmacist. In addition, process audits (Table 3) should be performed on a regular basis. The facility quality indicators (QIs) should be reviewed quarterly and compared with peer group, state, and national benchmarks.105 QIs related to medications include the following: ● ● ● ● ●

Prevalence of symptoms of depression without antidepressant therapy Prevalence of residents who take nine or more medications Prevalence of antipsychotic drug use in the absence of psychotic or related condition Prevalence of anxiolytic/hypnotic drug use Prevalence of hypnotic drug use more than 2 times in the last week

Note that when the facility has higher than peer group findings of the above indicators, it points to the presence of a potential problem. Occasionally, the problem is related to the assessment or documentation process and not necessarily to prescribing patterns. The review of data generated by DRRs, DURs, medication error reports, ADR reports, process audits, and QIs can be used to recognize the presence of prescribing problems such as inappropriate drug use in the facility and may also be helpful in identifying the root causes. ROLE OF AMDA IN HELPING MEDICAL DIRECTORS AND PHYSICIANS ADDRESS THE PROBLEM The American Medical Directors Association is the professional association of long-term care medical directors and physicians. The IOM report recommended an advocacy and educational role for professional associations to help prevent medical errors, including medication errors. AMDA has done a great deal of work helping members with medication errors, including education, the development of a number of CPGs, and work with regulators on the development of drug-related regulations. There is much more that can be done, including additional education for medical directors and long-term care physicians on geriatric care principles and geriatric pharmacology; disseminating information via JAMDA and Caring for the Ages (AMDA official publications); developing policies, procedures, and tools to address drug-prescribing processes and outcomes in long-term care, support the development of information systems and computerized prescribing; and working continually with regulatory agencies as regulations develop. SUPPLEMENT

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