Pharmacists from all practice settings are likely familiar with the American Geriatric Society’s (AGS) Beers Criteria of Potentially Inappropriate Drugs, last published in 20121 and recently revised and updated in 2015.2 The AGS Beers Criteria—Beers Criteria for short—have proven useful in identifying drugs to potentially avoid in older adults, to reduce adverse drug events and drug-related problems, and to improve medication selection and overall medication safety in older adults. The Beers Criteria are designed for use in any clinical setting and can also be used as an educational quality measure and research tool. The latest version of the Beers Criteria uses a more comprehensive, systematic review and grading of evidence.
An interdisciplinary expert panel convened by AGS reviewed more than 6,700 clinical trials and research studies from a pool of over 20,000 articles published since the 2012 AGS Beers Criteria. In addition, a period of public comment was made available to important stakeholders and supporting organizations before final release on October 8, 2015. Companion papers were also published, including instructions on how best to use the guidelines3 and supplemental guidelines4 (e.g., alternative medications and drug–disease interaction).
Pharmacists will also find helpful tables within the new Beers Criteria paper, such as renal dosing guidelines and a review of evidence-based methods used in the consensus paper development. The full guideline and companion publications are available at http://geriatricscareonline.org/toc/american-geriatrics-society-updated-....
A review of changes included in the 2015 guideline is beyond the scope of this review. The updated AGS Beers Criteria continues to emphasize that medications listed are potentially—but not definitely—inappropriate for all older adults. For example, the Beers Criteria are not applicable to patients in palliative and hospice care; they are intended to supplement or to support clinical judgment. Examples of changes in 2015 include removal of the long-standing recommendation to avoid nitrofurantoin in patients with a creatinine clearance under 60 mL/min, and with continued recommendation to avoid chronic use of nitrofurantoin because of the risk of pulmonary fibrosis, liver toxicity, and peripheral neuropathy. According to the new guideline, nitrofurantoin can be used safely and effectively in patients with a creatinine clearance of 30 mL/min or greater.
Another new recommendation is to avoid the use of proton pump inhibitors (PPIs) for more than 8 weeks in older adult patients. Patients with high risk of gastrointestinal disease are excluded from the 8-week limit, such as chronic users of NSAIDs, those with Barrett’s esophagus or hypersecretory states, or those who need PPI maintenance therapy.
New to the criteria are drugs that should be avoided or have their dose adjusted based on a patient’s renal function, as well as a table of selected drug–drug interactions documented to be associated with harm in older adults. The nonbenzodiazepine, benzodiazepine receptor agonist hypnotics (e.g., eszopiclone, zaleplon, zolpidem) have been added to the list of drugs to avoid in older adult patients with dementia or cognitive impairment. The 2015 AGS Beers criteria include helpful and specific drug–disease combinations that serve as caveats for use.
For example, amiodarone should still be avoided as first-line treatment for atrial fibrillation unless a patient has heart failure or substantial left ventricular hypertrophy. Digoxin is to be avoided as first-line therapy for heart failure or atrial fibrillation, and dosing should not exceed 0.125 mg daily for any indication. Antipsychotic drugs should also be avoided as first-line treatment of delirium because of conflicting evidence for effectiveness, as well as the potential for adverse drug effects in older adults.
“The new Beers criteria give pharmacists practicing in a variety of settings an evidence-based tool to recognize high-risk medications in a vulnerable patient population,” Nicole J. Brandt, PharmD, MBA, CGP, BCPP, FASCP, a member of the AGS Beers Criteria expert panel, told Pharmacy Today. Brandt, a professor of geriatric pharmacotherapy at University of Maryland School of Pharmacy and president-elect of the American Society of Consultant Pharmacists, also serves as director of clinical and educational programs at Peter Lamy Center Drug Therapy and Aging.
Brandt encourages pharmacists to be familiar not only with the criteria but also with the published companion papers that describe how the criteria are to be used in practice, as well as the levels and quality of evidence used to develop the criteria. She noted that the updated criteria along with the companion guideline of medications to be used as potential alternatives to high-risk medications in older adults, as well as potentially harmful drug–disease interactions in this population, will serve pharmacists well in offering prescribers guiding principles that can potentially be integrated into electronic medical records systems.
“The net effect will be improvement in patient safety, and be of benefit to consumers, payers, and health systems providing care” for older patients, Brandt said.
“The new Beers list is more useful than previous versions since it eliminates many drugs that are no longer used in clinical practice,” Kimberly Sasser Croley, PharmD, CGP, FASCP, FAPhA, clinical pharmacist at Laurel Senior Living Communities, told Today.
“The recommendation to limit the use of PPIs to no more than 8 weeks in most patients should provide pharmacists with great opportunities for intervention, especially during care transitions,” said Croley.
Croley also stressed that the guidelines are not meant to be rigidly applied to every patient and that sound clinical judgment must be exercised.
Pharmacists will find the 2015 AGS Beers Criteria useful, if not imperative, in the care of older adult patients. Pharmacists should be aware of the latest evidence, as well as the caveats and rationales informing these new recommendations. An understanding of the rationale behind the expert guidelines can help pharmacists appreciate why specific medications are included in the list, as well assist in developing effective interventions in collaboration with prescribers of medications in this high-risk population.
Two of the guiding principles of the American Geriatric Society’s (AGS) 2015 Beers Criteria are as follows: 1) The criteria should be a starting point for a comprehensive process of identifying and improving medication appropriateness and safety, and 2) access to medications included in the 2015 AGS Beers Criteria should not be excessively restricted by prior authorization and/or health plan coverage policies.
Historically, the Beers Criteria have been well suited for clinical decision support systems and the development of quality metrics. However, they work best when suggestions for alternative therapies accompany alerts about high-risk medications. The Beers Criteria are reasonable to use for performance measurement across large groups of patients and providers but should not be used to judge care for any individual patient.
According to Julie Kuhle, BSPharm, vice president of measure operations at Pharmacy Quality Alliance and an expert in how quality metrics are developed and implemented by third-party payers and national quality initiatives, the Beers Criteria are used by the National Committee for Quality Assurance (NCQA) and the Pharmacy Quality Alliance (PQA) to designate the quality measure Use of High-Risk Medications in the Elderly (HRM).
“The previous update of the Beers Criteria was done in 2012, and the HRM measure was revised by the PQA and NCQA based on that update,” Kuhle told Today. “A number of stakeholders use the HRM measure for quality measurement. For example, [CMS uses] the HRM measure to monitor and evaluate the quality of care for Medicare beneficiaries by prescription drug plans. Poor performance with the HRM measure may negatively affect a health care plan’s quality ratings,” she said.
Kuhle noted that PQA will review the 2015 Beers Criteria to determine what changes will be made to PQA’s HRM measure. The measure only includes medications from Table 2: 2015 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults and only includes products that are prescription drugs, whereas the AGS recommendation indicates the term “avoid,” she pointed out.
In addition, Kuhle said, the measure is calculated using only prescription claims data, so it cannot consider caveats based on diagnosis. “For example, a medication with the recommendation ‘avoid use as an antihypertensive’ will not be included because the diagnosis of hypertension is not available for use in the measure,” Kuhle said. The measure considers inclusion of medications with caveats if the caveat can be measured reliably from prescription drug claims data.
Kuhle also noted that CMS uses this measure in the Star Ratings program for Part D prescription drug plans. Once changes are made to PQA’s HRM measure, based on the 2015 AGS Beers Criteria, PQA will notify CMS of the change. When this measure was updated in 2012, CMS notified plans and the public on multiple occasions about when the newly updated measure may be implemented. “Each year, CMS proposes changes to the Star Ratings through the Request for Comments and Call Letter processes, and plans and other stakeholders have the opportunity to comment before the proposals are finalized,” Kuhle said.