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  1. Safe Use Initiative

A Community Based Study of Adverse Effects of NSAIDS on the Kidney and Risk Mitigation to Reduce Preventable Harm

Performer: Albany College of Pharmacy and Health Sciences
Principal Investigator:
Amy Barton Pai, PharmD

Project Duration: 9/30/15-9/29/17

Regulatory Science Challenge

Over-the counter (OTC) analgesics such as ibuprofen and naproxen are widely used by Americans. These non-steroidal anti-inflammatory drugs (NSAIDs) are available in large quantities in pharmacies, wholesale stores, gas stations and convenience stores. More than 111 million people in the U.S. take prescription NSAIDs each year including many older Americans. NSAIDs can significantly disrupt blood flow to the kidneys and precipitate community-acquired acute kidney injury (CA-AKI) in high risk patients. Episodes of acute kidney injury can lead to hospitalizations, new-onset chronic kidney disease, or more rapid progression of existing chronic kidney disease. Most cases of NSAID-induced acute kidney injury can be prevented by recognizing and counseling high-risk patients on appropriate use. Most patient education material including the medication guide is focused on the bleeding risks associated with their use, but many patients are unaware of the kidney risks associated with NSAID use.

Project Description

Albany College of Pharmacy and Health Sciences plans to develop new research on safe NSAID use to reduce preventable harm from both prescription and over-the-counter use of these agents. The project will evaluate adverse renal risks among a large population of patients in primary care settings. An informed community-based education pilot program engaging federal and private sector partners will be developed and piloted to educate providers, patients and pharmacists to improve awareness of NSAID risks.

Project Goals

  • Evaluate a nationwide cohort of patients in the DARTNet Practice Performance Quality Improvement Registry in collaboration with American Academy of Family Physicians National Research Network (AAFP NRN) to determine NSAID prescribing patterns and potential association with kidney function decline and CA-AKI
  • Develop and implement an innovative community-based NSAID avoidance education program that will target providers, patients and pharmacists
  • Conduct a pilot evaluation of the impact of the three pronged education intervention on provider NSAID prescribing patterns and electronic medical record documentation, patient awareness and pharmacist counseling efforts


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