NOTE: If you attended the live CE activity that was held on July 20, 2021 AND received CE credit (i.e. a Pharmacist or Pharmacy Technician CE statement of credit with ACPE UAN 0221-9999-21-166-L05-P/T), you are NOT allowed to also receive credit for this home-study on-demand web activity.
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.
The intended audience for this activity includes Physicians, Pharmacists, Nurse Leaders, Patient and Medication Safety Officers, Frontline Practitioners, Community Pharmacists, Clinical Pharmacy Staff, Quality and Risk Management Leaders, Pharmacovigilance staff.
At the completion of this activity, the participant 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)
It is the policy of ProCE, LLC to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants any significant financial interest or affiliation with companies that manufacture or market products discussed during their presentation. Michael Cohen, Danielle Harris and Ana Zanoletty have no relevant commercial or financial relationships to disclose. Dorothy Linvill-Neal disclosed salary from Novartis Pharmaceuticals. Conflicts identified were resolved with a peer review process.
Release Date: July 20, 2021
Expiration Date: July 20, 2023
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 is supported by an educational grant from Novartis.
The material presented in this CE activity does not reflect the views of ProCE, LLC or the commercial sponsor. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.