The Impact of COVID-19 on Pharmacy Management and Compliance

The coronavirus disease 2019 (COVID-19) pandemic not only introduced rapid-fire changes to care delivery, but it also exposed the health care system’s weak links. We learned just how fragile the current health care infrastructure is as frontline pharmacy staff and leaders were forced to navigate new medication and supply shortages as well as rapidly adapt to this once-in-a-century global public health emergency.

COVID-19 Presents Additional Challenges for Pharmacists

While pharmacists have expanded their clinical scope and become increasingly resilient amid a multitude of regulatory storms over the last decade, COVID-19 has served as a major tipping point. The virus hit the pharmaceutical supply chain, intensifying existing drug shortages, complicating inventory management, and presenting new considerations for USP compliance. Pharmacy leaders have leveraged their experience, their role in interdisciplinary teams, and technology to quickly reinvent approaches to manage long-standing issues exacerbated by the pandemic. 

Annie Lambert, PharmD, BCSCP, clinical program manager of Simplifi 797 at Wolters Kluwer Health

Addressing Inventory Management and Drug Shortages During Disruption 

Challenges in medication inventory management and drug shortages are not new, and in fact the pandemic in some cases offered an unusual opportunity for pharmacists to proactively prepare as the initial case surge was not widespread. However, weaknesses in the supply chain are raising concern that the next drug or supply shortage could become a daily event. 

Fortunately, there are proven strategies hospital pharmacists can consider employing when facing a shortage:

Make a list of critical drugs and supplies and take inventory regularly. Understand baseline usage rates and re-assess when changes in practices or acuity occur. Using technology, like inventory management systems or shared databases, can help increase visibility into what is available across multiple locations and create opportunities for consolidation.

Identify available drug alternatives. Initiate approvals for clinical substitutes and research/line up alternate vendors proactively. Based on the list of critical drugs, prepare alternative therapies and get approval for bi-directional interchanges based on the products available. 

Consider operational impact of changes on the interdisciplinary team. Sometimes a change to benefit pharmacy may have an offset on nursing or vice versa. There is not always a choice when making changes but if a choice is presented, consider the ripple effects and communicate the rationale behind the decision whenever possible. 

In-house Compounding

Traditionally, when certain medications are cost prohibitive or otherwise not available, pharmacists look to compounding to prepare those medications, either through a 503B outsourcing vendor or internally. Throughout the pandemic, health system pharmacies have had to balance the increased need for compounded products with the decrease in drug and equipment supplies. But outsourced vendors are increasingly unavailable, either due to their own COVID-related closures or because they are already at capacity. In these cases, in-house compounding may be the only option, but the following should always remain priorities:

Know the vendors. Have regular conversations with 503B outsourcing facilities and take inventory of what products they have available as well as their criteria for adding new items to a contract. Also be wary of alternative vendors and new entries to the market – use only trusted sources for compounded medications.

Assess alternative dosage formulations. When insourcing compounding during drug shortages, be mindful of products that may be different from standards. Mix-ups in strengths and concentrations can have serious impacts to patient safety.

COVID-19 workflow changes can impact compounding. Adjustments in workflow, such as changing medication administration times to reduce exposure time for nursing, may cause a shift in demand for compounded preparations and pharmacy workload. Adapt by assessing staffing levels and non-essential work in the IV room during these peak times. 

Ensuring Compliance in 2021

There is no higher priority for hospitals and health care workers than to engage in care delivery that promotes the highest level of safety for patients and maintains the health of the workforce. The United States Pharmacopeial Convention (USP) compounding chapters serve as the guardrails for patient and worker safety. While anticipated revisions were put on hold in 2020, the pandemic forced regulatory bodies such as the FDA and USP to issue interim guidance to address compounding amid COVID-19.

The pharmacy department’s responsibility is to understand which versions and standards apply to their operations. Regulatory bodies will be looking for how hospital pharmacies responded to the challenges as well as how they implemented interim practices – applicable to their facility – from a compliance perspective.

As the COVID-19 vaccine rolls out and facilities continue to navigate USP compliance in 2021, hospital pharmacists should work within the ebbs and flows of the “new normal” and consider the following:

Focus on what is controllable and unchanging. Ensure compliance with the current and official chapters of USP 795 (2014) and USP 797 (2008), with temporary adjustments in line with the interim guidance. Continue to work towards compliance with USP <800> which has not changed since published in 2016 and is the best practice for worker safety. 

Document practice changes due to the pandemic. Regulatory bodies will be looking for evidence of how facilities adopted interim guidance including assessment criteria for returning to standard operating procedures and communication to staff.

Data, data, data. Review documentation for routine compounding tasks, competencies, and certification. Identify any gaps, initiate corrective action plans, and prepare to explain the cause if related to interim practices. 

Central to regulatory compliance and reducing risk is arming the pharmacy with the tools to develop standard operating procedures, building pharmacy staff competency and expertise, and adopting workflow technologies that help ensure accuracy in the compounding of CSPs. A comprehensive compliance management system is invaluable to establish the training, risk management, and quality assurance practices necessary for a safe and efficient sterile compounding environment.

Looking Forward

When it comes to medication safety and ensuring compliance over sterile compounding, there is no one more knowledgeable than a pharmacist. In the face of increased pressure due to the COVID-19 pandemic and rapidly evolving shortages, new technology and interdisciplinary work teams can ensure patient care and employee satisfaction do not suffer. Pharmacists certainly have the strength and adaptability needed to meet existing — and as of yet unforeseen — challenges and can do so with the right tools to support evolving patient care initiatives.