The Inside Track on Drug Naming Safety Standards
Developing a pharmaceutical product along with its associated naming and getting it through the regulatory approval process is a complex, time-consuming process. Companies spend months working with experts from design, marketing, legal, and medication safety and regulatory areas to create a package that is distinct and memorable, yet safe. Unfortunately, many products, both brand or over-the-counter (OTC) continue to carry packaging and labeling aspects that contribute to error and patient harm.
Progress has been made to bring safety to the drug naming process. Recently, new safety guidances have been released by the FDA for both prescription and over-the-counter drug name safety. Guidance outlines recommended methods for evaluating risks of medication error posed by similarity of a proposed proprietary name versus other drug names. For example, FDA recommends that sponsors obtain medication error report information from their internal safety databases, publicly available VAERS (Vaccine Adverse Event Reporting System) or FAERS (FDA Adverse Event Reporting System) data, published literature, and resources available through patient safety organizations such as ISMP. FDA also provides an electronic system to evaluate the orthographic and phonetic similarity of a proposed proprietary name to other names. Along with technological improvements like electronic prescribing and bar code scanning, success is also being realized in reducing the potential for drug name-related errors.
This program will take the participant down the “drug naming pathway" to learn the inner workings and decisions involving behind the scenes. Not widely known by most healthcare practitioners, learners will hear first-hand from several experts including a global pharmaceutical company, the Food and Drug Administration, and the European Medicines Agency about the role each plays in the drug name development process. Speakers will address the challenges that sometimes become evident during the initiation process and throughout drug approval.
Physicians, Pharmacists, Nurse Leaders
Patient and Medication Safety Officers
Clinical Pharmacy Staff
Quality and Risk Management Leaders
Following completion of this activity, participants will be able to:
Describe the types of problems that created a need to improve drug naming safety
State several steps in the development of a drug name for a pharmaceutical company
Identify the benefits of safety testing prior to drug name approval
Discuss the FDA and EMA role in drug naming for medication safety
Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, President, ISMP
Dorothy Linvill-Neal, Global Head, Name Creation & Regulatory Strategy, Novartis Pharmaceuticals Corporation
Ana Zanoletty, Name Review Group (NRG) Secretariat, Labeling office, Committees and Quality Assurance Department, Human Medicines Division, European Medicines Agency (EMA)
Danielle Harris, PharmD, BCPS, Deputy Director, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
This activity is funded by Novartis.
Pharmacists and Pharmacy Technicians
This CE activity is jointly provided by ProCE, LLC and the Institute for Safe Medication Practices (ISMP). ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-9999-21-166-H05-P/T has been assigned to this knowledge-based home study CE activity. This CE activity is approved for 1.25 contact hour (0.125 CEU) in states that recognize ACPE providers. This CE activity is provided at no cost to participants. Statements of completion will be issued online at www.ProCE.com upon completion of the evaluation and post-test with a score of 70% or higher. Proof of completion will be posted in NABP CPE Monitor profiles. No partial credit will be given.
This activity has been approved for up to 1.25 California State Nursing contact hours by the provider, Debora Simmons, who is approved by the California Board of Registered Nursing, Provider Number CEP 13677. Credit will only be issued to individuals that are individually registered and attend the entire program.