Collaborating with the FDA to Manage Drug Shortages

Part of AACN Critical Care Webinar Series

Presenter(s): Jouhayna Saliba, Pharm.D

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Webinar Summary

Drug shortages can adversely affect patient care as it relates to medication delivery, compromise or delay of procedures, and result in medication errors. The Drug Shortages staff at the FDA works collaboratively with other organizations and manufacturers to keep the public and healthcare professionals informed of the most current drug shortages.

The FDA makes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays and discontinuations. The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. The FDA also works with other firms that manufacture the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.

In this webinar, pharmacist Jouhayna Saliba will discuss the importance of early recognition, prevention and mitigation of drug shortages, reviewing data and best practices to help participant identify and potentially alleviate these problems within their organizations.

Objectives

  • Identify why drug shortages occur after reviewing the drug supply chain and data shortages information.
  • Describe the focus of the Drug Shortages Staff of the FDA on the early assessment, recognition, and intervention for prevention and mitigation of this problem within your organization.
  • Explore the collaborative relationship and communication between the FDA, manufacturers, various professional organizations (physicians, pharmacists, and nurses) and other key stakeholders in managing drug shortages.

Presenter

Jouhayna Saliba, Pharm.D

Jouhayna Saliba, Pharm.D

Captain Jouhayna Saliba, Pharm.D. is currently the Manager and leader of the Drug Shortage Staff (DSS) at the Food and Drug Adminstration (FDA). Her early career includes staff pharmacist positions in retail, outpatient and inpatient settings. Captain Saliba joined the Army as a staff pharmacist at the Walter Reed Army Medical Hospital, and assumed progressive leadership responsibilities over the past 20 years. She has numerous publications, honors, awards, and presentations to her credit. Most notably was her recent involvement in efforts to prevent over 150 shortages due to increased notifications by leading efforts to respond quickly to ensure adequate supplies continue to be available to patients that need them. Captain Saliba is the recipient of the Outstanding Service Medal for leadership in preventing a national shortage of albuterol inhalers.

Continuing Education Disclosure Statement

Successful Completion

Learners must attend/view/read the entire activity and complete the associated evaluation to be awarded the contact hours or CERP. No partial credit will be awarded.

Disclosure

This activity has been reviewed by the Nurse Planner. It has been determined that the material presented here shows no bias. Approval of a continuing education activity does not imply endorsement by AACN or ANCC of any commercial products displayed or discussed in conjunction with the activity.

Accreditation

The American Association of Critical-Care Nurses (AACN) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s (ANCC's) Commission on Accreditation, ANCC Provider Number 0012 (60 min contact hour). AACN has been approved as a provider of continuing education in nursing by the California State Board of Nursing, California Provider number CEP01036 for 0.6 contact hours (50 min contact hour).

AACN programming meets the standards for most states that require mandatory continuing education contact hours for license and/or certification renewal. AACN recommends consulting with your state board of nursing or credentialing organization before submitting CE to fulfill continuing education requirements.