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
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are widely available over the counter in pharmacies, wholesale stores, gas stations, and convenience stores for the treatment of fever and pain. In addition, more than 111 million people in the U.S., including many older Americans, take prescription NSAIDs each year. In certain high-risk patients, NSAIDs can significantly disrupt blood flow to the kidneys and precipitate community-acquired acute kidney injury (CA-AKI). CA-AKI can lead to hospitalization, new-onset chronic kidney disease, and more rapid progression of existing chronic kidney disease. Many patients are unaware of NSAID-associated risks and the importance of appropriate use to prevent NSAID-induced CA-AKI. Current patient education materials, including the medication guide, may focus too narrowly on bleeding risks associated with NSAID use and thereby fail to describe the potential for CA-AKI.
Albany College of Pharmacy and Health Sciences implemented a research project to assess NSAID use and the potential for reducing preventable harm from both prescription and over-the-counter use. The project evaluated adverse renal risks among a large population of patients in primary care settings. An informed community-based pilot program was developed to educate providers, patients, and pharmacists and determine if NSAID risk awareness could be improved.
- 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 to determine NSAID prescribing patterns and associated effects on kidney function.
- Develop and implement an innovative community-based NSAID education program to target providers, patients, and pharmacists.
- Evaluate effects of the education program on provider NSAID prescribing patterns and electronic medical record documentation, patient awareness, and pharmacist counseling efforts.
The final report from the researchers to the FDA included the following results:
- Patients exposed to NSAIDS were older, having more co-morbidities and kidney impairment than the general population. Primary care providers commonly prescribed NSAIDS to patients at high risk for NSAID-related kidney injury.
- A majority of patients preferred educational materials in print form. Patients who viewed educational materials in print form achieved higher scores related to NSAID and kidney risk knowledge than those who viewed a video.
- More than half of patients (65%) exposed to education materials regarding NSAID-related kidney risks reported they would avoid future NSAID use.
Jang SM, Jiang R, Grabe D, Pai AB. Assessment of literacy and numeracy skills related to non-steroidal anti-inflammatory drug labels. SAGE Open Med. 2019 Mar 7;7:2050312119834119. doi: 10.1177/2050312119834119. PMID: 30873281; PMCID: PMC6407168.
Pai AB, Engling J, Chapman C, Volk R, Costello G, Codd C, Ashjian E, Wright-Nunes J. Patient-selected media and knowledge of risk to kidneys of nonsteroidal anti-inflammatory drugs. J Am Pharm Assoc (2003). 2019 May-Jun;59(3):329-335. doi: 10.1016/j.japh.2019.01.012. Epub 2019 Mar 2. PMID: 30833128.