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Drug Safety vs. Medication Safety: Is There a Difference?
July 29, 2020
Published by Nancy Globus
In the pharmacy and pharma industry world, people often interchange the terms “drug safety” and “medication safety.” As I enter my twentieth year in the “safety” realm of pharmacy practice, I figured it is high time to look at definitions, similarities and differences.
Defining Drug Safety
OK, boring stuff first: definitions. Drug safety, which can be considered an interchangeable term with pharmacovigilance, is the science related to the detection, collection, assessment and monitoring of adverse effects associated with medicinal products. Drug safety is largely concerned with Adverse Drug Reactions (ADRs), which can be defined as “a response to a drug that is noxious and unintended and occurs at doses normally used … for the prophylaxis, diagnosis or therapy of a disease.” We could spend all day discussing the nuances among the terms “adverse event,” “adverse effect,” “adverse reaction,” and even the archaic term “side effect,” but the overall theme is the same: unwanted and not preventable.
Next, we need to define the term “medication error.” This plays a large role in medication safety and how it differs from drug safety. According to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), a medication error is “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.” The key word is “preventable,” and I further define “medication safety” as “medication error prevention.”
Similar to the “all squares are rectangles, but not all rectangles are squares” way of thinking, we can conclude that all errors are ADRs, but not all ADRs are errors. Even then, there are caveats. For example, an error can occur but not reach the patient or it could reach the patient and not cause harm.
Drug Safety and Medication Safety Activities
Drug safety activities are undertaken by a complex network of inter-related professionals at the drug manufacturers and the regulatory agencies, such as FDA. These activities include screening the literature and clinical trial data, analyzing patient and healthcare practitioner reports and communicating the findings to the medical community. This ensures that everyone is as informed as possible about the safety profile of a drug product. There is constant communication between the pharmacovigilance departments at pharma companies (often a subset of medical affairs) and the regulatory agencies.
As a medication safety pharmacist, I stratify medication error prevention activities into practitioner or health-system related and product or industry related.
If we go back how the NCC MERP defines medication errors, we see that the causes of medication errors are multifactorial and include, “prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.” Product labeling, packaging and nomenclature are where I focus my efforts, and future articles will address this in greater detail.
Supporting Safety Professionals
Whether your interest is mainly in “drug safety” or “medication safety,” (or both!), the ACMA is there to support you: our Board Certified Medical Affairs Specialist (BCMAS) program is the first and only accredited board certification for medical affairs professionals in the world. It provides 20 comprehensive preparatory modules that cover every facet of medical affairs, including drug safety. Additionally, our evaluative services offered under the ACMA Approve™ umbrella take a risk-based approach to medication error prevention, helping the industry build safety into their products.