New Challenges, Planning for Pandemics Within Specialty Pharmacy

As cases of coronavirus disease 2019 (COVID-19) continue to increase around the world, all industries are acting quickly to help prevent the spread of the disease and ensure continuity of business. Many companies in the United States, especially in areas near significant identified outbreaks, have moved to entirely remote workforce solutions.

In countries where the virus has spread at a near uncontrollable rate, such as Italy, one of the critical businesses continuing to operate with staff onsite are pharmacies that treat patients in need. Specialty pharmacies are an essential subset of this group, which must also adapt to increasing contagion concerns.

These entities frequently provide patients living with chronic and potentially devastating conditions with life-saving treatments. Prescription delays can be a matter of life and death, therefore, operations must continue without disruption.

For specialty pharmacies, contingency plans aren’t as simple as moving a workforce to their remote access solutions. Most specialty pharmacies are implementing their existing plans to prevent disruption of their complex supply chains.

However, many potentially unexpected challenges from drug manufacturing, ancillary supply needs, workforce disruptions, and technological solutions are requiring fast and creative solutions. US officials are currently monitoring 20 drugs that are facing increased shortage risk as a result of the coronavirus and its impact on drug manufacturing.¹

Only 1 drug shortage related to the virus has been reported to date, although details of the specific drug have not been announced by the FDA.² While the impact to the US supply chain is not significant currently, a heavy reliance on API production outside of the United States may lead to new shortages in the near future.

The severity and timing of the impact is currently unclear. A director at the FDA’s Center of Drug Evaluation and Research notes in congressional testimony in 2018, that “We cannot determine with any precision the volume of API that China is actually producing, or the volume…entering the US market.”²

Given that most drug ingredients (APIs) are produced in China, the region originally most heavily impacted by COVID-19, some downstream impacts on the supply chain may occur. Some pharmacies have investigated the chemical makeup of their most important products to understand if they are produced in countries with high levels of infection and potentially halted API production.

Although these shortages would clearly impact specialty pharmacies’ ability to dispense product, there are minimal precautions the industry can take to prepare for unexpected shortages, given that overstocking on a product may lead to shortages for other pharmacies that actually need it. Fortunately, many factories in China have recently resumed production, although the effect from the earlier halts in production and factories in hard hit areas outside of China are still unclear.¹

In addition to actual product shortages, medical supplies and ancillary products that are needed at specialty pharmacies may be limited. Medical supply needs at a specialty pharmacy may evolve in variety and volume needed if COVID-19 continues to spread.

For example, some pharmacies may begin to require highly demanded protective wear to limit the spread between colleagues and to avoid potential contamination of products being packaged and shipped. For example, surgical masks and protective gowns are, in many cases, on back order.

In reaction to potential shortages of medical supplies, US trade officials have granted tariff exemptions for dozens of medical items imported from China, including protective gowns, protective masks, and gloves.³ There have even been instances in which philanthropic organizations in quickly recovering countries, such as China, have sourced and donated protective masks to the United States and other heavily affected countries.⁴

Based on the relatively complex and rare nature of most specialty pharmacy products, treatments are typically stored in a highly limited number of pharmacies and mailed to patients. These products are not readily available for pickup at a retail pharmacy near patients’ homes.

Specialty pharmacies are therefore reliant on national shipping services, such as FedEx and UPS. Many specialty pharmacies also contract with networks of local couriers around the country in the case of localized service interruptions.

If an interruption is expected, specialty pharmacies may send patients larger supplies of treatment to last until the interruption ends. Recently, even pharmacy benefit managers are encouraging increased supplies on-hand for their pharmacy members.

Anthem, Cigna, and UnitedHealth Group have all recommended extending their member prescriptions up to a 90-day supply where possible.⁵ Regulators in some states, such as Kentucky, have even expanded pharmacist prescribing rights, allowing for 30-day prescriptions to be filled in the event that they are unable to reach the patient’s physician.⁶

For cold chain products, sophisticated pharmacies will send coolers with increased insulation to patients to ensure they are able to access viable products during any interruption in the supply chain. Although these practices reduce risk, the US national shipping system is generally expected to remain operable.

If an interruption in our national shipping system were to occur, our nation would likely have even more widely impactful issues; however, this is fortunately considered by many as a highly unlikely scenario.

Most businesses within specialty pharmacy have already limited non-essential business travel. This practice limits the number of individuals traveling, potentially being exposed to COVID-19, and bringing the virus back to the pharmacy where product is being dispensed.

As a result, virtual meetings have increased in popularity. Interviews are also being updated from onsite meetings to online video meetings through platforms such as Skype or Zoom. Many industry conferences have been canceled or delayed, including the industry’s leading conference, the Asembia Summit.

Workforce disruptions are another challenge specialty pharmacies face, which have become increasingly important in recent weeks. Many pharmacies are implementing remote working solutions for non-essential personnel. This practice limits the risk of spreading the disease within the company as a proactive measure.

This solution is also becoming increasingly important for specialty pharmacy employees, as many schools and day cares around the country have announced temporary closures, requiring some employees to stay at home and care for their children.

One proactive practice employed by some specialty pharmacies has been surveying their employee base to understand how much of an impact school closures will have on their onsite staffing. This allows the pharmacy to determine or update reduced onsite staffing models and implement their staffing plans accordingly.

Many specialty pharmacies also are updating their onsite preparation plans if the virus were to spread to the workplace. These instances would of course require intense cleaning and sterilization, over and above the higher level of cleaning likely to have been recently implemented.

Social distancing is also intensified during the outbreak. Common areas will likely be closed, if they haven’t been already, and employees may be asked to work at stations at least 6 feet away from each other.

At this point, only essential personnel that have not been quarantined may be permitted to enter the facility. Some entities may contract with temporary employment agencies or partner organizations if the spread infects too many of the company’s existing employees in a worst-case scenario.

Most leadership teams have updated their lists of essential and non-essential personnel to understand which roles can truly be performed remotely and which individuals must be onsite in order to meet the needs of their patients. Essential personnel would of course include dispensing pharmacists to get products out the door. This may also include a skeleton crew of employees who are able to manage the team and adapt as a situation evolves.

Although some of these roles may be performed at home, some pharmacies may not be fully equipped to operationalize these activities at home. For roles in which employees may be asked to work from home, technology solutions are of course required. Less prepared pharmacies may need to order laptops for their employees.

Even if an underprepared pharmacy is able to purchase additional remote computer equipment (assuming no shortages), remote environments may be overwhelmed by the amount of remote activity. More sophisticated specialty pharmacies regularly test remote environments to ensure servers do not become overwhelmed.

Even well-prepared specialty pharmacies may be reconsidering which roles can truly be completed at home. For example, telephonic solutions are not as simple as forwarding calls to their employees’ home or cell phone numbers, as Health Insurance Portability and Accountability Act rules and regulations require most calls to be recorded.

In many cases, employee-sponsored telephonic solutions may be implemented for remote work. Redundant location plans are also considered in the event of an onsite outbreak of COVID-19; however, this may not be effective if a virus has already spread to employees who are not showing signs of infection.

As cases of COVID-19 continue to spread, the specialty pharmacy industry is quickly adapting to these new and, in some cases, unforeseen challenges from drug manufacturing, ancillary supply needs, workforce disruptions, and reliance on technology. Solutions are quickly being revisited and implemented every day over the past few weeks and months.

Although specialty pharmacies must play an active role in preventing the spread of this pandemic, operations must continue in order to ensure patients who need life-saving therapy the most are receiving their treatments without any disruptions or delays. Although some pharmacies may need to update their contingency plans to account for unforeseen challenges, the COVID-19 pandemic will likely ensure all pharmacies improve their continuity plans for future pandemics or other natural disasters once we are able to get through this challenging time.

About the Author

Gannon Vanscoy is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy hub. Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services. Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles. Gannon earned his Bachelor of Business Administration degree from the University of Miami and is currently pursuing a Master of Pharmacy Business Administration (MPBA) from the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.

References

• Lupkin, Sydney. “How Coronavirus Is Affecting The U.S. Pharmaceutical Supply.” NPR, NPR, 12 Mar. 2020, www.npr.org/sections/health-shots/2020/03/12/814623335/how-coronavirus-is-affecting-the-u-s-pharmaceutical-supply.
• Thomas, Katie. “First Drug Shortage Caused by Coronavirus, F.D.A. Says. But It Won't Disclose What Drug or Where It's Made.” The New York Times, The New York Times, 28 Feb. 2020, www.nytimes.com/2020/02/28/health/drug-coronavirus-shortage.html.
• DeBarros, Anthony, and Josh Zumbrun. “WSJ News Exclusive | U.S. Trade Officials Grant Tariff Relief for Face Masks, Medical Equipment.” The Wall Street Journal, Dow Jones & Company, 7 Mar. 2020, www.wsj.com/articles/u-s-trade-officials-grant-tariff-relief-for-facemasks-medical-equipment-11583516931.
• Hale, Conor. “Alibaba Co-Founder Jack Ma to Ship 500K COVID-19 Test Kits to U.S.” FierceBiotech, 16 Mar. 2020, www.fiercebiotech.com/medtech/alibaba-co-founder-jack-ma-to-ship-500k-covid-19-test-kits-to-u-s.
• Beasley, Deena. “Doctors, and Insurers Too, Urge Patients to Get Medicine on Hand.” Reuters, Thomson Reuters, 14 Mar. 2020, www.reuters.com/article/us-health-coronavirus-prescriptions/doctors-and-insurers-too-urge-patients-to-get-medicine-on-hand-idUSKBN210382.
• Beshear, Andy. Executive Order 2020-224 State of Emergency Relating to the Dispensing of Pharmaceuticals. Published March 10, 2020. https://governor.ky.gov/attachments/20200320_Executive-Order_2020-224.pdf. Accessed March 17, 2020.