Academic journal article American Journal of Pharmaceutical Education

Teaching the Science of Safety in US Colleges and Schools of Pharmacy

Academic journal article American Journal of Pharmaceutical Education

Teaching the Science of Safety in US Colleges and Schools of Pharmacy

Article excerpt


Since 2000, a series of publications have argued for change in healthcare and healthcare education. These include the Institute of Medicine's (IOM's) report "To Err Is Human: Building a Safer Health System," which defined the economic and clinical consequences of medication error and misuse (1); "Crossing the Quality Chasm: A New Health System for the 21st Century," which called for fundamental changes in the structure and provision of healthcare (2); and "Health Professions Education: A Bridge to Quality," which identified gaps in healthcare education and general recommendations for change. (3) "Roadmap to 2015: Preparing Competent Pharmacists and Pharmacy Faculty for the Future," (4) made an argument for pharmacy education to serve as a resource and catalyst for furthering research in the areas of patient safety and quality. In 2006, IOM released "The Future of Drug Safety--Promoting and Protecting the Health of the Public," which recommended how the FDA might improve the nation's drug safety and how other elements of the federal government might help ensure the safe use of medical products. (5) One key recommendation in this report was an appeal to improve the science of safety.

This paper presents the findings of the report "A Baseline Evaluation of the Integration of the 'Science of Safety' into the Curriculum of the Doctor of Pharmacy Degree in US Colleges and Schools of Pharmacy." The concept of science of safety is introduced and recommendations are presented for improving the science of safety curricula in US colleges and schools of pharmacy. Detailed description of the methodology used to develop the report is presented in the final report. (6)

What Is the Science of Safety?

The FDA describes the science of safety as an emerging discipline that seeks to understand and prevent adverse events. (7) This explicit definition should have a common meaning for various disciplines within the field of pharmacy. However, initial discussions with educators and others did not find this to be the case. One reason was because pharmacists and scientists/health science professionals tend to view the construct, science of safety, within the framework of their own discipline. Therefore, toxicologists commonly view science of safety as the study of toxic substances in animals, pharmacoepidemiologists see it as exploring the risk of drugs used in populations, and clinicians perceive it as identifying and preventing adverse drug events in practice settings. The concept of science of safety also can be confused with issues like equipment safety, laboratory safety, occupational safety, and consumer product safety. Because the science of safety can mean many things, it was important to clearly define the term for educators.

This research defines science of safety as the systematic study of the negative impact of drugs and devices on humans at all stages of the drug product lifecycle (Figure 1). This definition is based on source documents from the IOM (7) and FDA. (8) Key elements of science of safety include the following:

* It deals with the systematic exploration of the safety of medications and devices

* Its purpose is to help scientists and practitioners understand, explain, and predict physical risk from exposure to medications and devices

* It examines risk throughout the entire product lifecycle, from drug discovery to postmarketing

Thus, science of safety can refer to knowledge learned at any step of the product development and marketing process including in preclinical animal toxicology and safety studies, clinical studies in humans, safety studies needed for FDA approval, and postmarketing epidemiological research. It includes translational research enabling healthcare professionals and other individuals to better identify, understand, report, manage, and communicate the risk of drugs and devices in patient populations. It also includes advances in the molecular origins and progression of disease, adverse consequences of treatments, and patient-specific and population-specific causes and responses. …

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