A recent nursing facility study targeted early recognition of adverse drug effects, which can seriously harm elder residents.

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edications are the most important technology in preventing illness, disability, and death in the older population. However, medications have the potential to cause serious harm on a wide scale. Seniors are especially vulnerable to adverse drug effects (ADEs) due to the number of medications they take and the biologic changes of aging and disease. In addition:
• Persons aged 65 and older make up less than 15% of the population yet account for 33% of prescription drug consumption
• 20% of the Medicare population has 5 or more chronic conditions, sees 14 different physicians in a year, fills 50 prescriptions annually, and accounts for 66% of total program spending¹
•  ADEs cost $200 billion annually,^2-4 which approximates the total drug spending in the US; seniors account for 60% of the costs.⁵
       Of the nearly 2 million ADEs (a conservative estimate) suffered by older persons each year, nearly one-third are preventable. Of the life-threatening, fatal ADEs that occur, more than one-half are preventable. Errors associated with ADEs occur most often at the prescribing and monitoring stages of the medication use process.⁶ Recommendations by experts to reduce the risk include systems to promote early recognition of ADEs and improved patient education on the signs and symptoms of ADEs.^7,8

Focus on Patient Safety

       In February 2001, the Agency for Healthcare Research and Quality (AHRQ) announced the availability of funds for research demonstration and dissemination projects on the use of clinical informatics and information technology to reduce medical errors and improve patient safety. The American Society of Consultant Pharmacists (ASCP) Foundation partnered with the Center for Gerontology and Health Care Research at Brown Medical School to prepare an application in response to the AHRQ request for applications. The study proposed to evaluate the use of the ASCP Foundation’s Geriatric Risk Assessment Med Guide™ (GRAM™) software and quantify its effect on reducing the incidence of falls and delirium due to adverse medication effects in nursing facility residents. It was 1 of 22 projects funded in September 2001.

Geriatric Risk Assessment Med Guide

       Geriatric Risk Assessment Med Guide is a unique clinical software tool that correlates medication effects with physical, functional, and psychosocial decline in older patients. Initially known as the MDS-Med Guide, GRAM was developed based on the federally mandated Minimum Data Set (MDS) and Resident Assessment Protocols (RAPs), which are required in all Medicare- and Medicaid-certified nursing facilities.⁹ Geriatric Risk Assessment Med Guide can assist in the problem identification and clinical decision-making process when evaluating complex medication regimens of geriatric patients, regardless of where they reside.
       Specifically, GRAM identifies medications that may cause, aggravate, or contribute to common geriatric problems and correlates medication effects with signs, symptoms, syndromes, and indicators that describe mood, behavior, cognition, psychosocial well being, and physical functioning (MDS items). Additionally, GRAM identifies medication monitoring recommendations (relevant indicators of adverse medication effects) for problems under which the medication regimen puts the patient at greatest risk. This enables early recognition of medication problems that can be avoided, managed, or reversed.
       The GRAM software generates the following reports for nursing facility and ambulatory (non-nursing facility) patients, based on the patient’s specific medication regimen:
• Geriatric Problem/RAP-Med Report. This report identifies the patient’s medications that have the potential to cause, aggravate, or contribute to 15 common geriatric problems (see Table 1).

Table 1

The report provides a brief description of the problem; the patient’s medications that may cause, aggravate, or contribute to the problem; and “indicators” that may signify the presence of the problem and can serve as monitoring recommendations for potential adverse medication effects. In the nursing facility, this report can assist in the resident assessment process by identifying the RAP problems for which the residents’ medication regimen puts them at greatest risk.
• Specific Problem/Triggered RAP-Med Report. This report contains the same information as the Geriatric Problem/RAP-Med Report for specific problems selected. It can be used for nursing facility residents who have triggered 1 or more RAP problems or if the patient has a new-onset problem.
• Med-Geriatric Problem/RAP Report. This report is used to identify problems associated with a specific medication, such as medications potentially inappropriate for use in the geriatric population.

Study Objectives

       The aims of the AHRQ/GRAM study were to determine:
1) The extent to which the use of the GRAM software increases the incorporation of monitoring recommendations to detect ADEs into the resident care plan
2) The extent to which the use of GRAM reduces the incidence of delirium and falls
3) The extent to which the use of GRAM reduces the incidence of hospitalizations due to potential ADEs
4) The extent to which the use of GRAM reduces RAP triggers for delirium and falls
5) The impact of the use of GRAM on the efficiency, productivity, workload, and satisfaction of the consultant pharmacists and staff of the nursing facilities.
       Adverse drug effects continue to occur in nursing facilities despite the fact that The US Centers for Medicare and Medicaid Services (CMS, formerly the Health Care Financing Administration or HCFA) requires monthly retrospective drug regimen review of each resident by the consultant pharmacist, that the pharmacist report any “irregularities” to the attending physician and director of nursing, and that these reports “be acted on.”¹⁰ Although consultant pharmacist-conducted drug regimen review improves optimal patient outcomes and reduces the incidence and costs associated with ADEs, the cost of medication problems in nursing facilities is substantial, estimated at $4 billion annually.²
       Most efforts to reduce medication errors have focused on prescribing, dispensing, or medication administration; few have targeted the monitoring stage of the medication use process. A US Office of the Inspector General report entitled “Prescription Drug Use in Nursing Homes” states that “. . .patients may be experiencing unnecessary adverse medication reactions as a result of inadequate monitoring of medications.”¹¹ The AHRQ/GRAM study is unique in that it focuses on the monitoring stage of the medication use process to foster early recognition of potential adverse medication effects that can be avoided, managed, or reversed.
       The GRAM study targets the prevention of delirium and falls, 2 of the most common preventable ADEs in nursing homes. Gurwitz et al estimated that one-third of preventable ADEs in nursing facilities were neuropsychiatric (including delirium, hallucinations, and over-sedation), and 20% were falls.¹² Treatment of delirium is based on the identification and management of the precipitating factor (frequently medications), and prevention plays the most important role. Prevention of falls is based on a multidisciplinary approach that targets the various risk factors for falling, including medications.¹³

Components of the Intervention

       The AHRQ/GRAM study was a randomized, controlled trial involving 26 nursing facilities (13 intervention and 13 “usual care”) served by 2 pharmacies in Ohio. The GRAM database was integrated into the pharmacies’ commercial pharmacy software system, which generates GRAM reports based on the residents’ medications. Two GRAM reports were used in the study: The GRAM RAP-Med Report, for use in the resident assessment process and the GRAM Triggered RAP-Med Report, for use by the consultant pharmacist when reviewing the drug regimen of residents who have triggered the falls and/or delirium RAP.
       Medication Monitoring Care Plans and Flow Records were developed for falls and delirium and implemented for newly admitted residents receiving medications that may cause, aggravate, or contribute to these problems. The Delirium Medication Monitoring Care Plan and Flow Record (see Figure 1)

Figure 2

contain specific MDS items that are indicators of delirium and may be caused by ADEs. The Falls Medication Monitoring Care Plan and Flow Record (see Figure 2)

Figure 1

contain specific MDS items that may be caused by ADEs and contribute to the risk for falls. In-service programs for nursing staff were conducted to review medications and medication effects that cause, aggravate, or contribute to the risk for falls and delirium and reinforce the importance of early observation for signs and symptoms of ADEs.

Pharmacy Responsibilities

       The pharmacy generated GRAMRAP-Med Reports for all new admissions and upon request for residents undergoing an annual or quarterly assessment and provided Medication Monitoring Care Plan and Flow Records for newly admitted residents receiving medications that may cause, aggravate, or contribute to falls and/or delirium. The documents were delivered to the MDS coordinator within 24 hours of admission. The pharmacy also requested a list of residents who triggered the falls and/or delirium RAP since the last consultant pharmacist visit and generated GRAM Specific RAP-Med Reports for these patients, which were provided to the consultant pharmacist prior to the patients’ next visits to the facility.

Nursing Facility Responsibilities

       The MDS nurse used the RAP-Med Report in the admission assessment to identify problems for which the resident’s medication regimen put him or her at greatest risk. The Medication Monitoring Care Plan and the Medication Monitoring Flow Record for falls and delirium were implemented on admission; in most facilities, the nurse assistant was responsible for charting observations on the flow records. In addition, the MDS nurse met with the consultant pharmacist monthly to review their recommendations to prescribers for residents who triggered the falls and/or delirium RAP.

Consultant Pharmacist Responsibilities

       The consultant pharmacist provided a targeted drug regimen review for residents who triggered the falls and/or delirium RAP. The consultant pharmacist:
• Observed and/or assessed the resident on each visit
• Evaluated the resident’s medications for the potential to cause, aggravate, or contribute to the risk for falls and/or delirium
• Made and documented appropriate therapeutic recommendations to the prescriber based on the evaluation
• Reviewed the Medication Monitoring Care Plan and Flow Record for new admissions and made recommendation to revise as needed
• Reviewed prescriber recommendations and any changes to the Medication Monitoring Care Plan and Flow Record with the MDS nurse.

Data Requirements and Collection

       The evaluation of the study will rely on the use of existing data. Minimum Data Set data will be obtained from the state and used to identify new-onset delirium, the presence of indicators of delirium, and the occurrence of a fall. Hospitalization data will be obtained from CMS and used to determine the incidence of hospitalizations due to adverse medication effects, hospitalizations due to falls, and drug-induced delirium. Pharmacy claims data and pharmacist intervention data will be obtained from the pharmacy provider.

Conclusion

       The study was completed December 31, 2004, and the data were being analyzed at press time. The research has not been without obstacles. The greatest obstacle was key nursing personnel turnover and the need to orient and train new staff.
       The early response to the intervention from nursing facility staff, especially MDS nurses, was very positive. The GRAM RAP-Med Report is generally viewed as a valuable tool in the resident assessment process. Many nurse assistants embraced the added responsibility of observing for adverse medication effects and charting their findings in the flow records. The observations charted on the flow records provide documentation for use in the admission assessment. The consultant pharmacists now incorporate findings from the resident assessment into their therapeutic recommendations. One MDS nurse reported that a physician, upon seeing the GRAM RAP-Med Report, discontinued several unnecessary medications that were implicated in the risk for the RAP problems.
       We believe the study will demonstrate the value of GRAM as a tool to enhance the problem identification process when evaluating complex medication regimens in nursing facility residents; raise awareness of medications as a potential cause or aggravating factor contributing to a resident’s physical, functional, or cognitive decline; inform the resident assessment process; and foster incorporation of medication monitoring information into the resident’s plan of care.

(Acknowledgement: This study was funded by the Agency for Healthcare Research and Quality, US Department of Health and Human Services, grant #R18HS11835-01.)