Safety Reporting: Why We Do What We Do
Pharmacovigilance (PV) professionals speak eloquently about reporting adverse events for our clients, as it is a critical component of drug development and maturing and monitoring the safety profile of the drug. PV plays a pivotal role in protecting consumer safety, whether the drug is over-the-counter or a complex and life-saving cancer therapy.
Drug safety reporting is a dynamic process that includes a robust benefit-risk analysis as the safety profile of the product is developed and can change over time. Because of drug safety reporting, the consumer can use drugs for all therapeutic indications with confidence that research and monitoring has provided accurate drug safety profiles with clear specifications for treatment, and appropriate warnings regarding potential complications associated with the product.
An overlooked benefit of drug safety reporting, however, is the positive effects on clinical practice. The information gained from drug safety reporting is often used to change clinical practice to benefit the patient. For example, drug dosages can be adjusted to provide therapeutic benefit without causing undue harm or the course of therapy can be shortened without any untoward impact to the outcome. Clinicians can afford patients diverse therapies tailored to the individual which improves quality of life and expected outcomes of the disease process. Evidence based practice is a significant aftermath of the research and development process.
Licensed healthcare professionals are held to standards for their profession that include specifics about protecting patients from harm. Specific to professional nurses, The Code of Ethics for Nurses with Interpretive Statements is the social contract that nurses have with the U.S. public. It exemplifies the profession’s promise to provide and advocate for safe, quality care for all patients and communities. This professional relationship with patients extends to clinical research and the responsibility to report all safety information accurately and with the ultimate goal of informing the public, advocating patient safety, and improving quality of life.
PV professionals participate in safety reporting of adverse events not only because it is required by law and is a service contracted by our clients, but because we are healthcare professionals whose first duty is always to protect the patient. We do what we do because people, who most of us will never meet, need us to do it and many would be adversely affected if we abandoned our responsibility. In effect, we are the superheroes of PV!! Wear your superhero banner proudly, since family, friends, acquaintances, and strangers rely on you to protect them when they are most vulnerable and unable to protect themselves.
You can explain what you do and how you do it, but never forget why you do what you do!
Fowler, M. (2015). Guide to the code of ethics for nurses with interpretive statements: Development, interpretation, and application. (2nd Ed.). American Nurses Association, Silver Springs, MD.
Perschil, C. (2017). Oncology nurses drive change in cancer care with clinical trials. ONS Voice. https://voice.ons.org/news-and-views/oncology-clincial-trial-nurses-impact-cancer-care.
Weschler, D. (2013). Subject advocacy and the clinical trials nurse. Nursing 2018 (43, 3. p. 1-3). Doi: 10.1097/01.NURSE.0000427099.98269.b7.
Tags: adverse events, clinical trials, drug safety, FDA, Pharmacovigilance