World Standards Week 2025: Advancing Quality and Patient Safety Standards to Shape Pharmacy Practice and Innovation

Pharmacy Times: With the rise of biologics, cell and gene therapies, and other advanced treatments, what kinds of standards are increasingly necessary for ensuring these products reach patients who need them?

Towfic: Standards used in the development of innovative medicines, like biologics and cell and gene therapies, are especially important for quality assurance. Biologics, cell and gene therapies, and other advanced treatments are complex therapies with unique quality attributes, and the ability to access and use standards is essential for these new and emerging therapies. From establishing assays for critical quality attributes in early research to providing a globally recognized and credible source trusted by regulators, standards can help accelerate drug development, ensure the global supply chain delivers safe and effective treatments, and guide manufacturers with rigorous, fit-for-purpose methodologies.

Pharmacy Times: Pharmacists often face shortages in the supply chain. How can standards play a role in ensuring access to quality medicines during times of disruption?

Towfic: During times of shortages or disruptions, it is even more important for both patients and pharmacists to be confident in the quality of medicines. Public standards provide a global benchmark for quality and can help accelerate market entry for manufacturers. Some standards, such as those for compounded preparations, enable healthcare settings to maintain an established compounded formulation for critical medicines with quality ingredients, labeling considerations, and beyond-use dates. These standards can help contribute to continued patient access during a disruption in supply.

Natural disasters often cause public health emergencies and disrupt supply chains. For example, as a result of shortages caused by Hurricane Helene, USP provided health care practitioners with a resource for operational considerations during public health emergencies and complementary USP monographs to help patients access the essential medicines they rely on.

Pharmacy Times: October is also Health Literacy Month. Beyond counseling, how can standards support pharmacists in ensuring that medication labeling, instructions, and digital health communications truly meet patients’ needs for understanding?

Towfic: Health care professionals play a critical role in promoting patient understanding and health literacy. Approximately 90 million American adults (47%) have limited health literacy, which can lead to poor health outcomes, increased costs, and higher risk of adverse medication use.

USP health literacy standards are designed to help healthcare professionals, including pharmacists, communicate medication information clearly to patients. Standards like USP <17> Prescription Container Labeling and USP <1265> Written Prescription Drug Information – Guidelines equip pharmacists with tools to optimize the formatting of medication guides and prescription containers, using clear language, logical organization, and patient-friendly layouts to help ensure that patients receive clear and useful information about their medications.

Pharmacy Times: USP just began its 2025 to 2030 cycle, ushering in new priorities and enhanced approaches. What are some key areas of interest relating to standard setting for pharmacy for USP over the next 5 years?

Towfic: USP has set ambitious goals for our 2025 to 2030 cycle, building on existing standards and engagement with the healthcare practitioner community to identify critical needs. Standards to support pharmacogenomics uptake, interoperability in electronic health systems, and safe compounding across new settings, such as medical spas, are examples of new areas of focus for our work. We will also continue to incorporate the role of technologies in our standards, building the capability of stakeholders to confidently utilize technology in their daily work to help ensure quality and patient safety.

We welcome feedback. You can connect with me on LinkedIn or reach out to us at [email protected].