Drugs

FDA/IMSN Summit with international drug regulators to discuss medication safety issues

Dates:

June 19-20th, 2018

Location:

FDA White Oak Campus
Silver Spring, MD

I. BACKGROUND

The FDA and IMSN have expressed a willingness to leverage their combined strengths to host a meeting at FDA for international drug regulators to discuss medication safety issues with regulated pharmaceutical products. To achieve a reduction of overall harm related to medication errors, harmonization at the global level is desirable. Many of the product container labeling, and packaging issues are common across the countries. Also, in many countries and regions throughout the world, domestic drug manufacturing does not exist and it is common for drugs to be imported, often with features that can result in safety issues. To maximize safety, it would be beneficial to identify safety issues, and harmonize labeling requirements as much as possible with a focus on reducing medication errors. Some regulators have already undertaken such efforts, and have met with some success in reducing medication errors related to approved labeling. This meeting will provide an opportunity to share experiences and discuss ways to improve medication safety globally.

Therefore, the FDA and IMSN will co-host the summit with international drug regulators to discuss the benefits, challenges, and possible approaches to harmonizing best practices for labeling, best practices for regulatory review of labeling to promote medication safety, and possible harmonization of pharmacovigilance efforts related to capture of medication error-related information.

Goals and Objectives

The purpose of this summit is to provide a forum for open discussion among international drug regulators on medication safety issues with regulated pharmaceutical products and how to minimize medication errors with labeling and packaging. Some of the topics intended for discussion include:

  • Understanding and improving drug labeling and packaging issues around the globe. Review helpful existing guidance documents (FDA, EMA, Health Canada/ISMP Canada, ISMP US, United Kingdom, MHRA, Australia, etc.)
  • Harmonization of a minimum set of safe medication practices as they impact labeling and packaging.
  • Improving processes that involve premarket testing of new drugs and biological products, including vaccines, to reduce medication errors.
  • Coordinating efforts between safe practice centers and the pharmacovigilance community to improve practitioner reporting of medication errors and disseminate information about them at all levels of the practice community, including leadership, nurses, pharmacists, physicians, risk managers.
  • Ensuring availability of ready-to-use products such as unit dose products, prefilled syringes and premixed IV solutions, and other safe packaging methods aimed at decreasing nursing and pharmacy workloads and errors.
  • Promoting the use of safety technologies to reduce medication errors.

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Who Should Attend

This event is not open to the public. This summit is invitation only for international drug regulators.  It is intended for a diverse group of scientists from FDA and international drug regulators regarding ongoing efforts on research and discussions of medication safety issues with regulated pharmaceutical products. 

The primary audience includes leading international drug regulatory authorities involved in drug development and the safe use of drugs. There will be an exchange of information to maximize safety and harmonize labeling requirements as much as possible with a focus on reducing medication errors.

Contact

Cheryl Campbell – cheryl.campbell@fda.hhs.gov

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Page Last Updated: 09/12/2018
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