Ensuring Operational Continuity in a Pandemic for Rare Drug Specialty Pharmacies

The COVID-19 pandemic has upended virtually every aspect of healthcare, creating unimaginable challenges for those who play a role in care delivery. This is particularly true for specialty pharmacies charged with delivering critical, rare disease and oncolytic medications across a distribution system fraught with disruptions. Given these drugs are often intended for very ill patients anxiously waiting for their medications, pharmacies trusted to deliver rare therapies have a high degree of responsibility to be prepared at all times for events that can potentially disrupt service and impact patient care—such as the current pandemic.

While specialty pharmacies cannot control the pandemic, they can effectively manage much of the turmoil and operational uncertainty it brings to their organization by creating a robust, well thought-out Business Continuity Plan (BCP).

Having a plan with pre-defined objectives for different aspects of the operation allows the organization to avoid and minimize disruptions in care.

The COVID-19 pandemic has upended virtually every aspect of healthcare, creating unimaginable challenges for those who play a role in care delivery.

The BCP in use here at Biologics by McKesson—a nationwide, independent specialty pharmacy that is part of McKesson Corporation—has empowered our operational resilience and commitment to excellence during the pandemic. Providing a springboard for our response, the BCP enabled us to circumvent the disruption in service experienced by many organizations. Consequently, we were able to support our biopharma partners, their patients and providers without interruption, delivering our current standards for patient outreach, compliance and outcomes reporting services by:

Successfully filling 100% of patient prescriptions on time since the pandemic began

Supporting the launch of thirteen newly approved FDA therapies, including four exclusive programs

Becoming reaccredited as a URAC 3.1 and ACHC specialty pharmacy *

* A testament to the operational excellence we deliver to our constituents.

Biologics maintains a full Business Continuity Plan, ensuring the resilience of our operations through three critical phases; Response, Recovery and Return to Normal.

Crisis management is implemented in the Response Phase to immediately take control of the situation. An assessment is done, with a focus on safety and staff education, and priorities and strategies are developed for how to best respond to the particular event. It is during this phase that Biologics focused first on ensuring the needs our patients were met quickly, completely and efficiently – and patients could continue to receive their necessary care without disruption.

In the Recovery Phase, the initial response is assessed, and strategies and resource allocations are redefined if needed based on how the response is progressing. Consistent communications is very important throughout this phase to ensure all employees know their role and to facilitate the free flow of information needed to make adjustments.

In the Return to Normal Phase, the recovery effort is closely monitored and a determination is made concerning the feasibility of resuming normal operations. Most importantly, at the end of the event a Post-Incident Review is conducted to assess how well the organization met the challenges it faced, enabling adjustments for the future.

Successfully managing the pandemic obstacles 

There is ample evidence that business continuity plans are highly effective when properly prepared and executed. For example, our BCP provided a strong yet flexible framework for the organization to successfully meet many of the challenges COVID-19 initially presented, such as:

Transitioning key employees to work remotely

To minimize the risk of COVID-19 exposure, many specialty pharmacies found it necessary to deploy their staff to work at home. However, this presented major challenges. Because rare disease and oncolytic medications involve complex therapies, specialty pharmacies need their teams to work closely together at all times. At our company, small teams of specialists are grouped into pods where they sit next to one another, enabling efficient collaboration and communication.

McKesson employee working remotely

As these employees transitioned to home, much effort was focused on ensuring these teams could maintain effective communication despite relocation. Following guidelines in the BCP, equipment, bandwidth and connectivity needs were promptly identified, and resources allocated to enable team members to communicate efficiently from their remote locations. Much effort was also devoted to coaching and mentoring to drive and support teamwork and collaboration.

Much of the success we achieved transitioning to remote work was due to the company’s culture that fostered mutual trust, camaraderie and collaboration. This corporate philosophy energized resiliency across the company, enabling our staff to quickly adjust to remote work without any interruption of operations.

Handling transportation disruptions

When airlines began cancelling flights, coordination of rare drug shipments presented a challenge for all specialty pharmacies for several reasons. Many of these medications are temperature sensitive and need constant refrigeration and monitoring, so it is critical to get them to their destination as soon as possible. There is also a higher sense of urgency with these drugs, as most are needed by very ill patients in the hospital or who are transitioning home and need to ensure they maintain their therapy dosing schedule. Continuity of care is critical for this patient population.

Once again, the BCP came into play, as detailed processes and procedures were already outlined in the plan giving guidance on how to handle these various situations to protect the integrity of the medications. The plan also triggered a heightened level of communication with our main and secondary distribution carriers who assist with the dynamics of deliveries and resolving complexities that may arise.

Our distribution supervisor began working very aggressively with all carriers to ensure efficient and prompt coordination of shipments when flights were cancelled. This high level of communication is still ongoing and will continue for as long as needed to ensure timely delivery for all shipments during the pandemic.

Managing perceived disruption and patient safety concerns

When the pandemic started, there were growing concerns it would impact medication availability and cause supply shortages, creating panic among patients and providers. This concern triggered various challenges for specialty pharmacies. Patients requested quantities above normal amounts to stock up on medications, as they were fearful of not being able to get the drugs they needed.

Biologics Managing Patient Concerns

Our response —and the most important aspect of the plan—was to offer emotional and continuity of care support to patients, their caregivers and providers. This involved enhanced counseling with patients. Our skilled pharmacy and patient support teams are specially trained to understand the higher needs and concerns of rare disease patients, and they succeeded in making patients feel comfortable with ordering normal medication quantities, rather than excessive amounts.

Another issue that quickly materialized in the minds of patients was concern for their safety. Many feared exposure to the virus when considering the source of their needed medications, the health of our employees who processed their orders, and the logistical journey their treatment had to make before it reached their doorstep.

As the pandemic hit, we were very proactive in taking every precaution to ensure employees stayed safe and healthy while dispensing therapies, and these preventative measures are still in effect. Employees’ temperatures are taken upon entering the workplace, access to buildings is restricted to essential personnel only, social distancing is enforced, and gloves and masks are required when appropriate. Additionally, our distribution center has increased sanitation and hygiene measures by doubling cleaning frequency and following the Centers for Disease Control and Prevention environmental cleaning and disinfection guidelines. Our staff calmed the fears of patients by diligently working to communicate this information, as well as the fact that medications are created in a sterile environment and kept that way throughout the distribution channel.

Coordinating deliveries with hospital staff

A major challenge during the initial stages of the pandemic was coordinating delivery of our rare disease drugs with hospital staff. Some rare medications must be received by either the hospital discharge team or the clinical staff for administration to patients in the hospital.

Hospitals, just like all other businesses, were dealing with staffing issues and people working from home, making communications extremely difficult. Our team was persistent in connecting with the proper hospital employees, wherever they were, identifying new avenues for interactions and following protocols in the BCP so critical communications and delivery of medications could occur in a timely manner.

McKesson Delivery Driver

Resources and redundancy empower resiliency

While the pandemic is not yet in the rearview mirror, there are countless other events that can also disrupt operations at a moment’s notice, such as severe weather, floods, power failure, supply-chain issues, computer and network crashes, cyber-attacks1 and even riots, to name only a few.

When these events occur, specialty pharmacies should utilize every available resource to help ensure operational continuity. While our company is an independent pharmacy dedicated to serving biopharma customers, we are part of McKesson Corporation, and as such have access to McKesson’s vast resources and expertise, which were invaluable during the initial stages of the pandemic.

As part of the nation’s largest pharmaceutical distributor, we operated with the proactive measures and safety implementations developed by McKesson. In navigating this challenging climate, McKesson deployed the necessary resources to receive continuous updates from regulatory authorities, identify potential supply/sourcing disruption and ensure complete site redundancy.

By tapping into McKesson’s wide range of assets, we were able to concentrate on our core mission of distributing critical medications efficiently for our biopharma partners, keeping patients as the top priority while ensuring continuity of care.

Success has many components

To effectively implement business continuity and foster resiliency during a disaster or major disruption, a BCP is essential. But other elements also come into play. Strong leadership is required to efficiently execute the plan, and leaders must be vigilant at all times about the welfare of staff, as well as patients.

It is also vital to realize successful performance in any challenging environment is something that cannot be done alone. Collaboration with stakeholders is very important, not only with those internally but also externally, such as distribution partners and others who play a key role in getting rare drugs to patients. Lastly, it is critical to communicate effectively across the entire organization at all levels, enabling the flow of information that empowers employees to keep patient care their top priority.

Specialty pharmacies can better meet the challenges a disaster can present if they proactively prepare by having a BCP that puts patients access to life saving therapies first by creating a response that safeguards the end to end therapy process.  Navigating a global health crisis, while managing a devastating, progressive disease can be overwhelming; patients should be assured that specialized support will simply be a phone call away, with resources available to help them through their treatment journey.

1. https://www.drugpatentwatch.com/blog/business-continuity-and-resiliency-planning-for-biomedical-and-research-organizations/