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Pharmaceuticals are becoming increasingly more important to healthcare and the way conditions are treated. Every day it seems like new vaccines and specialty drugs are coming to the market offering new therapy options for physician and patients. These new drugs not only represent new opportunities for the health system but also introduce new challenges for the supply chain, including special storage, handling and transport requirements.
Not having the proper handling protocols, processes and protective gear in place could put your supply chain at risk. It’s important that the supply chain leadership take an active role to ensure the pharmaceutical supply chain is compliant with maintaining product integrity and chain of custody throughout the non-acute continuum.
Managing pharmaceuticals across the vast and diverse network of care settings outside of the hospital can present several new challenges for supply chain leaders. As the use of vaccines and expensive specialty pharmaceuticals continues to grow, so does the need for a highly efficient and reliable supply chain. Many of these drugs have special handling requirements that can be burdensome on the infrastructure and staff that manage these drugs.
For example, flu vaccines need to be stored in a refrigerator until use. Vaccines that are left at room temperature could result in decreased potency.1 However, within many non-acute facilities, refrigerated storage space can be limited so they cannot receive large orders. These facilities need a low unit of measure (LUM) and just-in-time service model to maintain the product quality and avoid waste. To help your facilities better manage the products upon arrival, the CDC recommends that every medical practice has written protocols in place for storing and maintaining the vaccines to preserve product integrity.1
Some health systems will turn to self-distribution of pharmaceuticals as a means of addressing the need to purchase in large quantities to reduce service costs. In doing so, the health system is also taking on the regulatory requirements and risk associated with transporting these products.
It is important to maintain the product temperature during transport, particularly if pharmaceuticals are moving between the central pharmacy or warehouse to the point-of-use care setting. During transportation the products should be packaged with temperature monitoring devices to ensure integrity. “Temperature sensors placed on the tote or on the box allow the person receiving the product to read the sensor and know that the products have been maintained within the manufacturer’s recommended temperature guidelines,” said Patrick Baranek, Director of Pharmaceutical Sales, Rx Marketing and Services at McKesson Medical-Surgical. “This will help validate that they can trust the products that have arrived at the provider’s practice.”
A distributor who specializes in servicing pharmaceuticals to non-acute facilities can help you design a service model that not only helps with temperature monitoring, but also with safely storing vaccines and delivering them on a just-in-time basis, saving space at the non-acute clinical facility. “We can hold inventory and deliver the products at precisely the time it’s needed most for that particular site,” said Darrell Rawlings, Vice President, Pharmaceutical Products and Services.
The operational model for pharmaceuticals must also comply with the chain-of-custody requirements as defined by the federal Drug Supply Chain Security Act (DSCSA) regulation requiring the tracking and handling of certain pharmaceuticals to be identified, verified and traced. Distributors are required to be licensed and to comply with federal reporting requirements.2 Health systems, including non-acute sites, that dispense prescriptions may also need to be in compliance with the DSCSA.
“It is so important that health systems have the right paperwork, particularly when distributing the drugs between a central pharmacy and a non-acute location. Having a chain of custody policy in place prevents potential drug diversion,” said Jody Dobson, Vice President, Business Development for McKesson. “Working with your non-acute distributor as an extension to your health system helps maintain the integrity of your pharmaceutical supply chain,” said Dobson.
A distributor who specializes in servicing pharmaceuticals to non-acute facilities can help you design a service model that not only helps with temperature monitoring, but also with safely storing vaccines and delivering them on a just-in-time basis, saving space at the non-acute clinical facility.
The use and abuse of controlled substances is a top-of-mind issue for all healthcare organizations. Historically, to order Class II controlled substances the process required filling out paper triplicate 222 forms. This process is fraught with inefficiencies and the opportunity for diversion. This issue is particularly acute in surgery centers that rely on these drugs arriving on time to perform procedures. A single error on one of these forms can result in the shipment being delayed for weeks.
Utilizing the DEA-administered Controlled Substance Ordering System (CSOS) eliminates the manual processes.3 The CSOS program generates a unique identifier for each provider to limit and validate authorization of those placing a CII order. The CSOS ordering system is integrated into the distributor platform to provide more security, reduce the order to procurement timeline and provide better tracking. Leveraging CSOS can be a means of helping reduce risk and improve operational performance.
Finally, health systems should also be preparing for USP General Chapter <800>, a regulation that goes into effect December 1, 2019. USP General Chapter <800> provides standards for the safe handling of hazardous drugs to minimize the risk of exposure to healthcare providers, patients, and the environment.4
This regulation not only impacts pharmacies that mix or provide hazardous drugs, but also clinicians and supply chain teams that administer or come into contact with the hazardous drugs. Surprisingly, several non-acute care settings administer pharmaceuticals that fall into the hazardous drugs category, such as hormones. Supply chain teams should review its personal protection equipment (PPE) products to ensure that the PPE items meet the USP General Chapter <800> standards. For health systems, implementing a medical-surgical formulary of USP General Chapter <800> compliant products can help bring their non-acute facilities into compliance.
As your supply chain looks to improve the management of pharmaceuticals, a distributor who specializes in servicing the non-acute continuum can be a real strategic asset in helping drive operational efficiency and reducing risk through a distribution model designed for low-unit-of-measure, cold chain and next-day delivery. “McKesson’s ability to customize a pharmaceutical supply chain tailored to each health system and each care setting, coupled with providing medical surgical and laboratory supplies on the same order delivers a lot of value to our customers,” concludes Baranek. “Giving them the tools to take control of their non-acute supply chain is invaluable.”
Finally, learn how to develop and execute strategy, resources and a communication plan that align stakeholders across functional areas in the non-acute space.