Modular Solutions for Compounding Pharmacies & Biosafety Facilities

by Jessica Brown & Allan Swan

A decade after Hurricane Katrina devastated the Gulf Coast region, the effects of underprepared healthcare systems are still apparent. Nearly a year after the first case of Ebola was diagnosed on U.S. soil, the West African nations most affected by the disease remain burdened by insufficient infrastructure to properly isolate and treat patients on a large scale.

Recent disasters in the United States and abroad have illustrated the need for rapid deployment of personnel and facilities to augment challenged healthcare systems. The regulated complexities of modern medicine demand quality, efficient healthcare facilities in which safety is the highest priority. The flexibility, adaptability, and security needed during a disaster response are often incompatible with the stick-built structures of traditional healthcare systems. There is a need for high-quality, rapidly deployable facilities in two particular areas of healthcare – compounding pharmacies and advanced biosafety facilities.

Compounding Pharmacies Compounding” is the creation by a licensed pharmacist of custom prescription medications that meet a patient’s individual needs. Examples of common compounding practices include adapting the form, ingredients, or dosage strength of a drug to accommodate allergies or peculiarities with a patient’s condition. Up to three percent of prescriptions issued in the United States currently are for compounded medications. As personalized medicine grows, so will this total.

The popular image of the compounding pharmacy was tarnished by the October 2012 fungal meningitis outbreak that was traced to several lots of contaminated injectable steroids produced by the New England Compounding Center, setting in motion efforts to better regulate these types of pharmacies. Yet the demand for compounded medications and the pharmacies that make them grows with an aging population and the number of drug shortages fueled by the economics of the pharmaceutical industry.

Drugs that serve a limited population are often discontinued by manufacturers who profit from producing more in-demand drugs. Compounding pharmacies have been filling the associated supply gaps since their inception, which was largely based on the need for injectable drugs. In late 2012, the Food and Drug Administration (FDA) said that approximately 85 percent of the 118 drugs listed in short supply were injectables. High-profile shortages of intravenous fluids in recent years have also raised concern, as these are among the most commonly needed medications in disasters.

Drug shortages and the growth of personalized medicine have not only increased the demand for compounding pharmacies, but also their importance in continuity of care during disasters. Pharmaceutical management in disasters is complex. Unlike other healthcare emergency resources – such as evacuation aids and personal protective equipment – pharmaceuticals typically have relatively short shelf lives that inhibit the ability to maintain adequate stores for emergencies that last longer than 72 hours. As large manufacturers consolidate, there is less redundancy in the supply chain, disruption of which is an obvious threat in most types of disasters. Given these factors, compounding pharmacies have a clear role to play in disaster response, and should be part of local and national preparedness efforts. 

Biosafety Facilities Facilities in which healthcare or public health personnel work with potentially infectious microorganisms and other biological hazards are known as biosafety facilities. These facilities are designated as biosafety level (BSL) 1, 2, 3, or 4 based on the laboratory practices, facility construction, and safety equipment requirements corresponding to the risk level of the microbes to be handled. Microbes that require level 4 biosafety, like Ebola, have a high risk of aerosol transmission and cause diseases that are frequently fatal. BSL 4 microbes demand the most stringent laboratory practice and safety equipment standards, and a separate structure or isolated and restricted area of a building with a specific exhaust system.

Advanced biosafety facilities have extensive application in disasters with capabilities and safety standards that lend them to use for flash laboratory capacity, patient isolation and development and efficacy testing of vaccine and treatment candidates. The need for such facilities was easily seen in West Africa at the height of the 2014 Ebola outbreak. In a region that lacked quick laboratory testing and patient isolation capacity, domestic and international responders struggled to stop the spread of this highly infectious disease. Global health leaders have responded with a search for innovative solutions to thwart such obstacles in future outbreaks. In the fall of 2014, U.S. President Barack Obama challenged the U.S. Agency for International Development to find new tools to help with the crisis.

Required Attributes for Utility in Disaster Response The work performed in sterile compounding pharmacies and biosafety facilities must meet the highest standards for safety, meaning that their construction is traditionally time-consuming, costly, and beholden to multiple regulatory authorities. None of this iseal for a disaster response scenario, in which flexibility, speed, and security are critical.

  • Flexible integration with existing healthcare systems – Healthcare systems operating in disasters need adaptable solutions to facility and equipment shortages in order to maximize agility and cost-effectiveness. Response resources must be quickly integrated into existing health systems with minimal disruption to ongoing operations. The optimal scenario is often a self-contained facility that does not rely on another structure for its utilities or ventilation but can be located in close physical proximity to existing healthcare facilities, with interoperable communications and equipment. As with responders who are trained to be self-sufficient, these facilities must be self-sustaining.

  • Flexibility of purpose – In day-to-day operations, pharmaceutical manufacturers, including compounding pharmacies, need the ability to quickly change the type of product or production capacity to meet market demands. The same is true in a natural disaster when pharmacists are responding to the specific, unpredictable medication needs of patients who likely need immediate replacement of prescriptions. Similarly, a biosafety facility deployed for use in a disaster may be needed for a variety of changing purposes, which means a standardized facility with internal configuration iseal.

  • Safety and security – A team of U.S. Public Health Service pharmacists charged with standing up a fully functional pharmacy to serve a 480-bed federal medical station hospital in Mississippi in the days following Hurricane Katrina cited the need for a secure, lockable space with adequate refrigeration as one of its greatest challenges. This situation highlights the need for a reliable, closed, and solid structure. Along with the similar security considerations, advanced biosafety facilities require sturdy construction to adequately contain pathogens and protect healthcare workers and patients.

  • Speed and longevity – A rapid-onset disaster, from a tornado to an outbreak of a novel pathogen, demands a quick response. Depending on the nature of the emergency, compounding pharmacies and biosafety facilities could both be needed with just days of notice in order to ensure the health and safety of an affected population. In many cases, the organization deploying a facility asset does not know the longevity of need from the outset. It is important to have facilities that can remain in place for extended periods of time and endure harsh weather conditions, where applicable.

Flexible Modular Solutions As modular construction has evolved into a mainstream building solution, many sectors with disaster preparedness responsibilities have explored its use in meeting emergency needs. The Modular Building Institute, an association of manufacturers and dealers of code-compliant relocatable buildings, argued in a 2011 article, “Due to the accelerated, factory-controlled modular construction process, there is simply no better means of providing fast, transitional shelter, schools and medical facilities in times of great need than relocatable buildings.”

In addition to their widely publicized use for temporary housing, there are multiple examples of post-disaster use of modular facilities:

  • Modular units were used as counseling centers in New York following the 9/11 terrorist attacks.

  • After the 2011 Joplin tornadoes, nearly 24,000 square feet of modular space provided rooms for local schools.

  • Mobile kitchen and shower units have supported disaster relief workers, with portability and flexibility of the interior configuration.

Healthcare systems are turning to modular construction even for daily use. Modular units have been used to build on to operating rooms and physician offices, expand diagnostic imaging clinic and dialysis center capacity, and provide temporary emergency departments and pharmacies to avoid business interruption while permanent structures are under construction. Most significantly, the Ebola treatment facilities at Emory and the University of Nebraska Medical Center incorporated elements of modular design – separability and flexibility – to ensure that the presence of the treatment units would not disrupt other operations.

The greatest appeal of modular construction is one of the key features for disaster response: flexibility. Modular units range from functional construction blocks that can be fit into existing facility infrastructure to stand-alone structures or “pods.” Pods are prefabricated boxes designed and built off-site that contain their own air handling and fire suppression systems. This makes them independent from any ductwork and other infrastructure associated with an existing building. The ability to “plug and play,” or select particular elements of a manufacturer’s offerings, allows for the construction of larger, even multi-story, facilities made up of multiple modules. In the fall of 2014, a modular building manufacturer erected a first-of-its-kind 52-bed assisted living and memory care facility in Bradenton, Florida, that was constructed of 40 modular units. The building was completed at least two months faster than a comparable stick-built facility and was the first of 14 such structures planned across the state.

The Ebola crisis in West Africa demonstrated the need for rapid deployment and redeployment of biosafety facilities in an infectious disease outbreak, opening a new door for modular construction in healthcare. In fall 2014, high-containment manufacturing pod facilities that were originally developed with Department of Defense funding for biological and pandemic threat preparedness were being repurposed for use as patient isolation units in response to the Ebola outbreak.

Key attributes for modular health response In addition to the potential for meeting the flexibility, speed, and security requirements, several other factors make modular construction attractive for healthcare emergency response:

  • Portability – A key element to the speed of deployment of modular facilities is their potential for easy transport because of standardized size and construction techniques. Some companies have further enhanced portability by selecting building platforms that lend themselves to international travel, such as standardized intermodal shipping containers.

  • Manageable costs – Traditional pharmaceutical production facilities have been hindered by new regulatory requirements that call for features like unidirectional workflow as well as heating, ventilating, and air conditioning systems that are segregated for different production areas. Manufacturers have touted modular facilities as a cost-effective solution for replacing outdated facilities while acquiring added benefits of flexibility.

  • Localization – Another issue that has made modular construction an attractive option, in particular for drug manufacturers, is the ability to quickly stand up a facility that allows for local production. An interview with Paul Black, chief executive officer of Winston Medical Center, Louisville, Mississippi, on 17 June 2014 provides one example. After a tornado rendered the only hospital in Winston County, Mississippi, uninhabitable in April 2014, its administrators and state health authorities opted to use modular facilities, some provided commercially and others leant from other state emergency management authorities, to serve as temporary replacements for more than a year. The facilities included a trailer with a laminar flow hood for use as a compounding pharmacy. The quick acquisition of these assets allowed local healthcare staff to return to work quickly, heading off concerns about a repeat scenario of Hurricane Katrina, when many healthcare providers left the Mississippi Delta region in order to maintain their livelihoods since their places of work were slow to be replaced.

Remaining Challenges & Opportunities The use of modular facilities in disaster response is not a new concept, and the perception of their utility is bound to negative stereotypes. In the aftermath of Hurricane Katrina, the Federal Emergency Management Administration trailers provided as temporary shelter to thousands exemplified the sluggish recovery of the housing sector and painful insurance claim processes. Structures that appear by nature to be temporary raise questions about whether they can possibly provide the same standard of safety and care as a stick-built permanent building. Yet the opportunity to provide focused, point-of-need, customized, quality healthcare faster, better, and cheaper are evident.

Perhaps the greatest challenge facing the use of modular facilities for compounding pharmacies for disaster response scenarios, particularly within the United States, is the same challenge that continues to complicate their day-to-day use. Although the FDA has authority to regulate drug manufacturing, compounding falls into the gap between state and federal oversight. This regulatory gap continues to evolve and, while some st