Should We Broaden the Applicability of the Beers Criteria?

✎ Dr. Karen Martin, PharmD, RPh, MBA, PAHM, BCGP

doi: 10.70390/3m89d3qz

For over thirty years, the Beers Criteria have shaped how clinicians approach medication safety in older adults. But is it time to rethink their scope?

History of the Beers Criteria

In the 1980s, Dr. Mark Beers became concerned about inappropriate medication prescribing in nursing home residents. Based on his research, and with the help of 13 fellow expert geriatricians, he published the Beers Criteria in the Archives of Internal Medicine in 1991. These criteria highlighted lists of potentially inappropriate medications (PIMs) that prescribers should generally avoid in this population, as their risks outweigh their benefits.[1,2]

Dr. Beers published the second version of the criteria in 1997, expanding it to apply to all adults 65 years or older, regardless of their health status or place of residence.

The American Geriatrics Society (AGS) has been the steward of the criteria since 2012. Beginning in 2015, the criteria exempted older adults in hospice or a palliative care setting. AGS published the most recent, seventh revision in 2023. Through the years, the categories of PIMs have grown from two to five, including those that should be avoided in certain diseases, conditions, care settings, or with other drugs.

The Beers Criteria remain one of the most widely recognized and trusted guidelines for prescribing to older adults. They have formed the basis of quality measures developed by several healthcare organizations, including the Centers for Medicare and Medicaid Services (CMS), National Committee for Quality Assurance (NCQA), and the Pharmacy Quality Alliance (PQA). [3]

My Clinical Experience with the Beers Criteria

I became deeply familiar with the Beers Criteria in the 1990s while consulting and performing drug regimen reviews for long-term care facilities. “Beers” became the buzzword for those of us practicing in the geriatric arena. I found it to be a helpful resource regarding drug therapy in older adults. In many of my review notes, I referred to the criteria to suggest safer alternatives for specific residents.

I found that my recommendations were accepted more frequently when I offered the physician a specific alternative. I relied heavily on evidence-based lists created by organizations, such as NCQA and PQA, to recommend a drug that could be used instead of a PIM, as well as stressing nonpharmacologic treatment where appropriate. 

Defining an Older Adult is Problematic

It’s been 30 years since the Beers Criteria were developed by geriatricians. A lot has changed since then, including how we treat disease and life expectancy. The Stanford Center on Longevity claims that half the children aged 7 years and younger today can expect to live to 100 years old. [4]

Is 65 truly old? Without specific evidence, many people now say the old 65 is the new 75 or 80. Some might even define mid-life as 50-75 years. Most older adults reside in their own homes. In fact, data from the Center for Disease Control and Prevention states that only 2.5% of Americans over 65 live in a nursing home. [5]

There is widespread discussion about longevity and aging well. The distinction between chronological versus biological age is an interesting one and has become an increasing focus for researchers. Then there’s subjective age, where attitudes about health and aging can make someone feel much younger than their chronological age. In addition, people are becoming more actively engaged in decisions regarding their health [6,7,8]. Using the age of 65 years as a cut-off for anything (except a senior discount) seems somewhat arbitrary. 

Caution About the Quality of Evidence Used for the Criteria

The authors acknowledge that the criteria have limitations. Most concerning, older adults were underrepresented in the clinical trials used in their development . Additionally, the potential risks of drug-related harm can vary significantly between two older adults of the same age. In selecting a PIM, prescribers must use their clinical judgment, along with shared decision-making. Furthermore, the criteria are not meant to be punitive.

Many of the recommendations are rated as strong, although they are mostly based on evidence rated as moderate. The workgroup relied heavily on systematic reviews and observational studies. Additionally, they incorporated expert opinion and clinical judgment into their recommendations.

Meta-analyses conveniently combine studies, but even those graded as good quality often include many poor-quality studies. Observational studies are subject to bias, confounding and chance. Randomized controlled trials (RCTs) are the only design that can prove cause and effect, but only when properly powered, randomized and blinded, with a suitable control comparison, and adequate follow-up.

Despite the criteria’s flaws, we should take a conservative approach to safety. The bar for safety outcomes is set much lower than that for efficacy outcomes. 

What We Know About the Use of PIMs in Younger Adults

The Beers Criteria caution against the use of some drug categories even in younger adults. For instance, cumulative exposure to highly anticholinergic drugs (e.g., first-generation antihistamines) can increase fall risk, delirium, and dementia. For other categories, almost without exception, the rationale for avoiding these drugs could be applied to all adults. 

One needs only to consult a drug reference or package insert for any of these PIMs to observe a long list of adverse effects, with a high incidence when compared to placebo. These statistics come directly from clinical trials, many of which support FDA approval. 

Researchers have studied some categories of drugs extensively for safety outcomes. For example, a case in point is the anticoagulants. As a result, the direct oral anticoagulants (DOACs) are preferred over warfarin, per guidelines, in many instances. [9]

Consequently, I would argue that evidence points to adverse safety signals for PIMs for all age groups. Why use these drugs when new, safer alternatives are available? Numerous organizations publish lists, making it easy to substitute better tolerated medications.

Call to Action and Conclusion

It may be time for some questions as we consider the Beers Criteria more than 30 years after its inception. Does it make sense to revisit the use of age as its basis? Should the criteria be applicable to all adults, particularly since we have alternative drugs with better safety profiles? Are we doing a disservice to adults younger than 65 years by implying that PIMs are safe and without significant side effects for them? As an exercise, I reread the criteria, mentally removing the word “older”, and concluded the recommendations are justifiable for all adults.

Certainly, we need better representation of older adults in clinical trials, whatever the definition of an older adult may be. Ideally these would be RCTs where safety is an outcome of interest. Only then can we get a better handle on whether age is truly a determining factor when making drug therapy selections. 

Drawing on the intent of the Beers Criteria, we should improve prescribing for all adults, advocate for better insurance coverage, and ensure affordability of newer agents. We should rarely prescribe PIMs for anyone, and then only after carefully weighing benefit versus harm.  

References

1. By the American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2018. 

2. Rochon PA, Hilmer SN. The Beers Criteria then and now. J Am Geriatr Soc. 2023;72:3-7.

3. Hanlon JT, Semla TP, Schmader KE. Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures. J Am Geriatr Soc. 2015 Dec;63(12):e8-e18.

4. The New Map of Life - Stanford Center on Longevity. (2022, June 21). Stanford Center on Longevity. https://longevity.stanford.edu/the-new-map-of-life-report/

5. Wynn P. Nursing Home Requirements: Who’s Eligible? US News & World Report. Published 2023. https://health.usnews.com/senior-care/articles/nursing-home-requirement‌

6. Weir, K. Ageism is one of the last socially acceptable prejudices. Psychologists are working to change that. https://www.apa.org. https://www.apa.org/monitor/2023/03/cover-new-concept-of-aging

7. Rutledge J, Oh H, Wyss-Coray T. Measuring biological age using omics data. Nat Rev Genet. 2022 Dec;23(12):715-727.

8. Damluji AA, Nanna MG, Rymer J, Kochar A, Lowenstern A, Baron SJ, Narins CR, Alkhouli M. Chronological vs Biological Age in Interventional Cardiology: A Comprehensive Approach to Care for Older Adults: JACC Family Series. JACC Cardiovasc Interv. 2024 Apr 22;17(8):961-978. 

9. Carnicelli AP, Hong H, Connolly SJ, Eikelboom J, Giugliano RP, Morrow DA, Patel MR, Wallentin L, Alexander JH, Cecilia Bahit M, Benz AP, Bohula EA, Chao TF, Dyal L, Ezekowitz M, A A Fox K, Gencer B, Halperin JL, Hijazi Z, Hohnloser SH, Hua K, Hylek E, Toda Kato E, Kuder J, Lopes RD, Mahaffey KW, Oldgren J, Piccini JP, Ruff CT, Steffel J, Wojdyla D, Granger CB; COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation) Investigators. Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: Patient-Level Network Meta-Analyses of Randomized Clinical Trials With Interaction Testing by Age and Sex. Circulation. 2022 Jan 25;145(4):242-255.