By Adam West, Course and Curriculum Manager at CriticalPoint
Letter to the Trump Administration
Earlier this month, ASHP sent a letter to the White House asking the administration to provide tailored exemptions for active pharmaceutical ingredients (APIs), prescription medications, and critical medical supplies imported to the United States if tariffs are imposed on specific countries. In addition, tariffs could lead to cost increases on key medical supplies and products (e.g., cleanroom garbing and syringes).
The letter also endorses an increase in domestic manufacturing (of drugs and medical supplies) as a way to bolster the supply chain. However, it recognizes that building the necessary infrastructure takes years of planning and development and, in order to minimize disruption, consideration should be given to the impact tariffs have on the supply chain. Therefore, keeping “business as usual” for the current supply chains with specific exemptions is the soundest interim solution for manufacturers outside the U.S. to avoid dangerous and costly ramifications to patient care.
What to keep in mind
Vimala Raghavendran, vice president of informatics product development at USP, stated that there is a significant dependence on China for antibiotics, heparin, and vitamins, although, manufacturers typically maintain several months’ worth of APIs in their inventory. For that reason, the effects of potential higher tariffs may not be immediate. Other organizations that continue to express concern noted that, in the past, similar situations with tariffs found that “most” medical supplies were exempt because of the same uncertainty we share now over critical supply chain disruptions and cost increases.
As more information becomes available on the tariffs as well as ASHP and other organizations’ pleas to the White House, it’s important that pharmacy leadership safeguard their supply chains by prioritizing a review of current policies identifying appropriate outsourced services. These policies include screening, auditing, evaluating, approving , and monitoring products from every vendor you engage with.
Manage risk of supplier
Pharmacies must have SOPs for utilizing vendors and procurement processes. Approved and Do Not Use lists must be updated regularly. Another consideration is identifying the relationship you have with your vendors. Are they the sole source supplier of critical products? Do you have secondary vendors in the event of a shortage or recall? It is essential that you create risk levels based on the nature of the identified relationship. This process helps mitigate and prioritize your needs to provide healthcare services without disruption.
Another significant factor is their status with the FDA. It is crucial to your operations and to patient safety to evaluate vendor inspection history and examine their eligibility as a vendor for hospitals who are subject to accreditation agencies. Your suppliers are required to maintain and regularly produce quarterly quality reports, which document their manufacturing processes and quality control measures. CriticalPoint recommends that pharmacies take advantage of the vendor quarterly reports to perform ongoing assessments of vendor operations and product quality. This ensures your pharmacy is well prepared for potential issues or risks affecting operations. Also, the release of reports assures the supplier’s dedication to maintaining quality and performance measures its customers expect and rely on.
Vendor qualification and evaluation
Is it fun? No. But this is top-of-list for those who are responsible for vendor qualification and evaluation of outsourcing facilities. This effort is a significant and time-intensive process. Folks who are new to this role may find it challenging when getting started. There are considerable resources available for many topics surrounding evaluation of 503B facilities, including articles and guidance documents released and updated by FDA.
A proper evaluation of 503B outsourcing facilities should assess the following:
- Quality assurance program
- Regulatory compliance history
- Preparation methods and sterilization
- Patient safety
- Supply reliability
- Cost analysis
- Risk management
- Documentation and transparency
- Customization and flexibility
- Partnership and support (beyond good customer service)
- Contracting terms and conditions (evaluate agreement compliance regularly)
- Physical assessment (onsite) where possible
There is no shame in admitting the tasks you are unable to perform during vendor qualification and evaluations. Consider using professional evaluators and consultants who have specific knowledge in areas where the pharmacy may have limited experience and resources. This is especially important for the vendors labeled as critical and primary to your pharmacy operations.
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