Pharmaceutical Supply Chain

One lesson that COVID19 has taught us all, is the importance and crucial advantages of having a reliable supply chain and distribution model. Simply put: resiliency and efficiency are the names of the game going into 2021. Apotheca Wholesale Pharmaceuticals has a well-established base as a pharmaceutical distributor to create efficient, transparent systems of ordering medicines and maintaining supplies for pharmacies, medical practices, and specialty facilities.

The Department of Homeland Security released a report on “Threats to Pharmaceutical Supply Chains” in 2018. In the several hypothetical scenarios proposed, a global pandemic wasn’t mentioned once. However, the recommendations they drew were still very prescient and likely to see implementation (if not already enacted)

DHS Recommendations:

“• Encouraging more transparency from manufacturers, requiring them to disclose the reason behind a supply chain or manufacturing disruption, and their expected timeline for resolution.

• Providing accessible education for manufacturers on their responsibilities to report disruptions to the FDA and the importance of complete and accurate information linked to the shortage.
• Changing the requirement for manufacturers to notify the FDA five business days after experiencing an interruption in manufacturing to immediate notification upon discovery of disruption, especially if the drug affected is “critical” or “life-saving” in nature.
• Developing a list or more specific criteria defining what the FDA considers “life-saving” drugs, as a first step in determining whether adequate emergency stockpiles should be maintained.
• Incentivizing manufacturers to produce “life-saving critical” drugs facing an impending shortage or disruption by requiring Group Purchasing Organizations to retain exclusive contracts or guaranteed-volume contracts.
• Prioritizing and streamlining ANDA approvals and technology transfers for manufacturers of drugs that the FDA deems to be lifesaving and critical to patient care. The effectiveness of this solution would increase if manufacturers notified the FDA of potential shortages as early as possible and did not wait until five business days after disruption to production has already occurred.
• Fostering further public-private partnerships and information sharing under the PCII Program, which protects information related to critical infrastructure,
• Allocating resources into departments or third-party organizations dedicated to assessing the threats and vulnerabilities facing the industry, in a similar fashion to how the FAA designates airline safety teams that analyze risks that the industry faces as a whole.
• Issue guidance and incentives for pharmaceutical supply chain entities to conduct self-audits and regular reporting regarding the state of business/manufacturing continuity preparedness.
• Establish a standard for new pharmaceutical manufacturing and storage site selections, taking into account necessary infrastructure, the redundancy of such infrastructure, or alternative sources.”

Apotheca Was Already Acting

Through building and nurturing long-term relationships with manufacturers Apotheca has cultivated the tools, interoperability, and business connectivity to assist customers quickly and avoid time-consuming and therefore: costly negotiating mistakes. By the very way we do business every day, we were already preparing for a crisis that few foresaw.

It no is no longer a question of “if” another wave of COVID19 will strike. In fact, it is less a matter of waves and more a matter of waxing and waning as new strains develop and new vaccinations or countermeasures are adopted.

Here are a few points on navigating the currents:

• Decentralized, Digital record-keeping- Paper records are a key weakness in a world where contactless deliveries and real-time tracking are becoming more and more commonplace.
  • The potential for disruption of manufacturing and transportation of temperature-sensitive materials makes this all the more critical.
  • In-person presence to physically interact with shipments may not always be possible, this can cause supply-chain to collapse if digital tracking is not precise.
• Managing Costs- There is so much uncertainty right now in the wake of a tumultuous Presidential election with regard to freight and fuel costs, labor rates, technology costs, and regulatory changes that every step must be taken to manage costs. Through platforms like TMS (Transportation Management Systems) and YMS (Yard Management Systems), professionals gain the necessary transparency into the shipping process to enable them to streamline procedures and keep costs low.
• Advance Supply Chain Management- The regulatory landscape that protects pharmaceutical distributors and patients is vast and complex. The regulatory powers of the Drug Supply Chain Security Act (DSCSA) is exercised by authorities to target-controlled medicines as they travel the supply chain and provides traceability through electronic means to eliminate illegal transactions. Also the Controlled Substance Suspicious Order Monitoring (SOM) programs protect patients, distributors and practices alike by requiring mandatory reporting of suspicious activities.
• Leveraging Relationships for Our Clients – Apotheca possesses the history and relationships to help you navigate successfully. Since its’ founding in 1876 the HDA or Healthcare Distribution Alliance “has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. HDA’s members include 36 national, regional and specialty primary distribution companies who are not just distributors but are technology innovators, information management experts, security specialists, and efficiency professionals. Their expertise streamlines the supply chain to ensure safety and efficiency, while also achieving cost savings for our nation’s healthcare system.”

Final Thoughts

Medical practices and pharmacies that can successfully pivot from the previous “everyday” business to the new regulatory environment imposed by COVID19 will succeed, those who cannot either fail and collapse or require massive government subsidy to survive (barely, if at all.) The true winners will be our patients and our partners when we work together smoothly, efficiently, and reliably to close supply gaps by managing both demand and customer expectations. Our role is to facilitate your success providing the framework within which supply and demand find one another and business is safely, legally, and regularly conducted in a world that is becoming increasingly physically hazardous, legally unpredictable and costly in terms of finances and lives.

Apotheca Wholesale Pharmaceuticals is well equipped and ideally suited to help your business wade through the uncertain changes that 2021 will bring.

Contact us today at Customerservice@apothecainc.com or call us at 602-252-5244.