Census data shows that the average number of people in the United States turning 65 each day is approximately 10,000. More people will turn 65 every day for the next 20 years, making this one of the fastest growing segments of the U.S. population. It is reasonable to think that the number of people seeking medical attention for pain-related conditions in this age group will increase at a corresponding rate. We all know that safe and appropriate medication use is important in all patients, but in the older patient population it can be particularly challenging for a variety of reasons, including:
- – Changes in body composition
- – Changes in metabolic and physiologic dynamics and kinetics
- – Increased incidence of co-morbid conditions
- – Increased likelihood of multi-drug therapeutic interventions
- – Cognitive changes and medication compliance
In 1991, Mark H. Beers, MD, and others explored the issue of safe and appropriate medication use in the older patient population, and published an article on research performed targeting development of specific criteria for appropriate medication use, in what is mostly comprised of a sizeable elderly patient population – residents of nursing homes.1
The need for this kind of criteria seemed to be self-evident, as Dr. Beers referred to the population of institutionalized elderly patients as the group that had the highest use of medications in the country at that time, with the average patient in a skilled nursing facility having more than eight medications prescribed for them at any given time2,3, which was more than twice the prescription rate of non-institutionalized older people at that time.
Basic characteristics of this patient population that existed back in 1991 still exist today. These patients often have a higher likelihood of co-morbid conditions, are often more “frail”, and often end up with polypharmaceutical-based treatment plans. In his original work Dr. Beers makes the case that although medications are often an important component of a therapeutic regimen, there could be circumstances in this particular patient population that tips the benefit/risk ratio into a negative balance, changing what may have seemed an appropriate choice of treatment into an inappropriate one.
In this 1991 publication, Dr. Beers and colleagues performed a two-round survey of 13 nationally recognized experts to reach consensus on explicit criteria defining the inappropriate use of medications in a nursing home population. Ultimately, 30 factors were agreed upon by the experts, identifying inappropriate use within commonly used medication categories for this age group, including:
- – Sedative-hypnotics
- – Antidepressants
- – Antipsychotics
- – Non-steroidal anti-inflammatory drugs (NSAIDS)
- – Oral hypoglycemics
- – Analgesics
- – Dementia treatments
The researchers concluded that “The appropriate use of medications in nursing home residents is an issue of increasing importance in the care of the elderly, and reducing inappropriate use may be one of the best and most cost-effective ways to improve the quality of care and limit waste in long-term care. However, there is a need to establish guidelines defining inappropriate use of medications in this population.”
The hope of this preliminary publication was to ultimately use these criteria to develop treatment guidelines for this patient population.
In 1997, Dr. Beers published an update of his original research in the Archives of Internal Medicine.4 This article described research that was intended to update the original work, to address whether adverse outcomes were likely to be clinically severe when medications were used inappropriately, and to correlate the information with clinical diagnoses when possible. The hope was that this research could help serve epidemiologic studies, drug utilization reviews, healthcare providers, and educational efforts, when exploring medication safety in the older patient population.
This particular research project brought together a consensus panel of six nationally-recognized experts in the area of appropriate medication use in the elderly patient population. The panel agreed on the validity of 28 criteria describing potentially inappropriate medication use in the elderly as well as 35 criteria defining potentially inappropriate medication use known to have any of 15 defined clinical conditions.
Criteria were identified on the basis of the disease/medical condition, medications commonly used as treatments, specific topics to alert to healthcare providers for these medications, and severity of the alert (i.e., high or low). Examples included common conditions and treatments in the elderly patient population such as:
- – Heart failure
- – Diabetes
- – Incontinence
- – Constipation
- – Arrhythmias
- – Syncope/falls
Unlike the initial work, these criteria were intended to be applicable to a more generalsegment of the older patient population, as opposed to just nursing home residents. The results of this updated research intended to make the criteria more broadly applicable, identifying:
- – Medications that should generally be avoided in the elderly
- – Dose ranges for medications that should not be exceeded
- – Clinical conditions which would make the use of certain medications likely inappropriate
In 2003, Dr. Beers and others published an update of what are now referred to as “The Beers Criteria” for potentially inappropriate medication use in older adults5. This update explored in addition to the medical and safety concerns, an additional focus of the economic burden of toxic effects of medications, and drug-related problems, with a panel of 12 national experts from diverse parts of the U.S. with expertise in pharmacology, geriatric medicine, and psychiatry.
In this update, the researchers point to the magnitude of this issue with the statement that 30% of hospital admissions in elderly patients may be linked to drug-related problems or drug toxic effects6. The authors also point to the statistic that, “If medication-related problems were ranked as a disease by cause of death, it would be the fifth leading cause of death in the United States.” This fortified the author’s message that “the prevention and recognition of drug-related problems in elderly patients and other vulnerable populations is one of the principal healthcare quality and safety issues for this decade.”
The update article also referred to a published study of potentially inappropriate medication (PIM) use. Using the Beers Criteria in a Medicare-managed care population found a PIM prevalence of 23% (541/2336). Those receiving a PIM had significantly higher total, provider, and facility costs, and a higher mean number of inpatient, outpatient, and emergency department visits, than comparisons after controlling for sex, Charlson Comorbidity Index, and total number of prescriptions7.
By the time this update was published in 2003, the Beers Criteria had gained significant attention, and had already been adopted by the Centers for Medicare and Medicaid Services (CMS) back in July 1999. It had been used extensively for evaluating safe and appropriate medication use in older adults.
The 2003 update of the Beers Criteria had three major goals:
- – To evaluate the 1997 criteria to include new products and information from the literature
- – To assign or re-evaluate a relative rating of severity for each medication
- – To identify any new medical conditions or clinical considerations not addressed in the 1997 revised criteria
As in previous iterations of the criteria, the approach used was the Delphi Method8, which is a technique used to arrive at a group consensus of experts. There were 5 phases in the data collection for this study:
- – Review of the literature
- – Creation and mailing of the round 1 questionnaire
- – Creation of the second-round questionnaire based on round 1 and expert panel feedback
- – Convening of the expert panel and panel responses to the second-round questionnaire
- – Completion and analysis of a third and final mailed questionnaire that measured the severity ratings of the PIMs to create the final revised list
The criteria reviewed covered two types of statements: (1) medications or medication classes that should generally be avoided in persons 65 years or older because they are either ineffective, or they pose unnecessarily high risk for older persons and a safer alternative is available, and (2) medications that should not be used in older persons known to have specific medical conditions.
Results of the consensus were that new conditions and diagnoses were added in the revisions to the criteria including depression, Parkinson’s disease, anorexia, malnutrition, syndrome of inappropriate ADH, and obesity. Fifteen medications were removed or modified from the previous criteria and several new medications were added.
The authors reinforced that “The application of the Beers Criteria and other tools for identifying PIM use will continue to enable providers to plan interventions for decreasing both drug-related costs and overall costs and thus minimize drug-related problems. Such tools are also vitally important to managed care organizations, pharmacy benefit plans, and both acute and long-term health care institutions. However, to remain useful, criteria must be regularly updated and must take into account the ever increasing, evidence-based literature in the area of medication use in older adults.”
Although some argue that explicit criteria may sometimes be too simplistic, the researchers also point out that the criteria were not intended to regulate practice or clinical judgment. Proponents of use of explicit criteria like the Beers Criteria now include the Institute of Medicine (IOM), the CMS, The Agency for Healthcare Research and Quality (AHRQ), and the American Association of Health Plans (AAHP).
In 2012, The American Geriatric Society (AGS) joined the above organizations in the endorsement of the Beers Criteria with the release of the newest update published in the Journal of the American Geriatric Society9. This update was accomplished by again using a Delphi survey of an 11 member interdisciplinary panel of experts in geriatric care and pharmacology, with the specific aim of updating the Beers Criteria using a comprehensive, systematic review and grading of evidence of drug-related problems and adverse events in the older patient population.
The AGS stated that the 2012 criteria are “intended for use in all ambulatory and institutional settings of care for populations aged 65 years and older” in the U.S., with the primary target audience being practicing clinicians.
The main goal of the 2012 AGS Beers Criteria is to improve the care of older adults by reducing their exposure to potentially inappropriate medications, as both an educational tool and quality measure. The purposes of this version of the criteria were identified to include:
- – Improving selection of prescription medications by clinicians and patients
- – Allowing for evaluation patterns of drug use within populations
- – Allowing for targeted education of clinicians and patients on proper drug use
- – Providing a means for evaluation of:
- – Health outcomes
- – Quality of care
- – Utilization data
As the various updates of the Beers Criteria have evolved, they now include a fairly comprehensive scope of common clinical conditions and medications used for treatment of the elderly, including pain. For example, recommendations for medications such as meperidine and non-steroidal anti-inflammatory drugs are covered, all with the intention to provide clinicians and patients a way to make safer choices when medications are considered as part of the therapeutic regimen for older patients.
One of the most important aspects of the new criteria is that they can be easily digested and implemented into clinical practice. The current recommendations are made in a clear and meaningful way:
- – On the basis of clinical condition or disease
- – On the basis of medications commonly used to treat the condition or disease
- – The recommendation for use or avoidance
- – The quality of evidence used to arrive at the specific recommendation
- – The strength of that recommendation, based on literature review
With a high degree of clinical resonance, clinical support approaches like the Beers Criteria can significantly impact the quality of care, and safe and appropriate use of medications to treat this important special patient population.
- 1. Beers MH, Ouslander JG, Rollingher I, Reuben DB, Brooks J, Beck JC. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med. 1991 Sep;151(9):1825-32.
- 2. Avorn J, Dreyer P, Connelly K, Soumerai SB. Use of psychoactive medication and the quality of care in rest homes. Findings and policy implications of a statewide study. N Engl J Med. 1989 Jan 26;320(4):227-32.
- 3. Ostrom JR, Hammarlund ER, Christensen DB, Plein JB, Kethley AJ. Medication usage in an elderly population. Med Care. 1985 Feb;23(2):157-64.
- 4. Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly. An update. Arch Intern Med. 1997 Jul 28;157(14):1531-6.
- 5. Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24.
- 6. Hanlon JT, Schmader KE, Kornkowski MJ, et al. Adverse drug events in high risk older outpatients. J Am Geriatr Soc. 1997;45:945-948.
- 7. Fick DM, Waller JL, Maclean JR, et al. Potentially inappropriate medication use in a Medicare managed care population: association with higher costs and utilization. J Managed Care Pharm. 2001;7:407-413.
- 8. Dalkey N, Brown B, Cochran S. The Delphi Method, III: Use of Self Ratings to Improve Group Estimates. Santa Monica, Calif: Rand Corp; November 1969. Publication RM-6115-PR.
- The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2012 Apr;60(4):616-631.