AACP, FDA and HRSA partner to introduce study that positively impacts patient health

The American Association of Colleges of Pharmacy (AACP), in partnership with the U.S. Food and Drug Administration (FDA) and the Office of Pharmacy Affairs in the Health Resources and Services Administration (HRSA), has completed a baseline evaluation of the integration of the "Science of Safety" into the curriculum of the Doctor of Pharmacy degree at accredited colleges and schools of pharmacy. The "Science of Safety" is defined as the systematic study of the intended and unintended impact of drugs and medical devices on health at all stages of the drug product life-cycle. The "Science of Safety" deals with anything that might be learned about risk in pre-clinical animal toxicology and safety studies, clinical studies in humans, safety studies needed for FDA approval and post-marketing epidemiological research.

“Taking a life-cycle approach to medical product safety is critical in identifying, in a timely fashion, previously unknown medical product risks”

This assessment of the knowledge and skills of pharmacy professionals related to medication safety will determine the extent to which these professionals might be utilized to have a positive impact on public health, a goal shared by AACP, pharmacists, FDA and HRSA.

"Taking a life-cycle approach to medical product safety is critical in identifying, in a timely fashion, previously unknown medical product risks," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "With this report, we now have a better understanding of how the life-cycle approach to medication safety is included in the pharmacy curriculum. This baseline will help us identify areas of the curriculum that are working, as well as areas which may need some improvement."

The goal of this project was to provide feedback to educators and the pharmacy profession on the teaching of the "Science of Safety" within current pharmacy school curricula. The final report, which can be found on the AACP Web site, offers direction and recommendations for enhancements to curricula to educate pharmacy graduates on topics/subjects currently not included.

In addition, findings will be used by the FDA and HRSA to identify ways to partner with the profession to support implementation of Title IX of the FDA Amendments Act of 2007 and expand upon the work of HRSA's Patient Safety & Clinical Pharmacy Services Collaborative (for more information visit www.hrsa.gov/patientsafety).

AACP Executive Vice President Lucinda L. Maine, Ph.D., R.Ph., noted, "Our analysis revealed that pertinent information on the safety of medications can be found throughout the curriculum of our member schools but we don't frame it necessarily in terms of the regulatory product life-cycle. This report provides a new lens through which we can critically assess the knowledge and skills of contemporary pharmacy graduates with respect to the safe use of medications by patients."

Both the FDA and academic pharmacy seek to positively impact patient health by ensuring appropriate use of medications toward a goal of achieving desired health outcomes for patients. The FDA and pharmacy professionals seek to minimize risk to patients by identifying, understanding, reporting, managing and communicating risk. Consequently, many of FDA's concerns regarding the safety of medication use parallel that of the pharmacy profession and pharmacy educators.