Lifepoint Health is a leading healthcare provider that serves patients, clinicians, communities, and partner organizations across the healthcare continuum. The company has a growing diversified healthcare delivery network comprised of 60 community hospital campuses, more than 60 rehabilitation and behavioral health hospitals, and 250 additional sites of care, including managed acute rehabilitation units, outpatient centers, and post-acute care facilities.

Historically, the process for managing expired drug waste was not clear for this complex organization, and corporate oversight proved inefficient in providing guidance or standardization across the enterprise. Poor data visibility from the reverse distributor was the primary hurdle to oversight.  Lifepoint Health worked with its reverse distributor to improve data analytics tools to help improve outcomes for its 60 acute care community-based hospitals.

With potentially millions of dollars in annual expired waste costs, enterprise-wide level oversight of expired drug waste is necessary and is dependent on clear visibility into actual expired drug volume and cost data to effect change.

Methods

The first step was to improve the expired drug waste data collection process and data visibility. Lifepoint’s Pharmacy Operations lead worked with the reverse distributor’s team to develop a quarterly report worksheet that provided accurate detailed expired waste data per facility per quarter.  The report consisted of the following information: 

• Division-level aggregated data
• Facility-level totals and line-item data
• Creditworthy Return Benchmarking Data:
  • National
  • Corporate
  • Division
  • Facility
• Non-creditworthy expired returns Reason Codes
• Hazardous waste codes

Secondly, a PowerPoint Summary Report was developed for specific facilities. Due to the considerable number of hospitals, inclusion criteria were developed to determine which hospitals would receive a quarterly PowerPoint Summary Report and which would not.

Summary Reports are described below:

• PowerPoint Content
• Creditworthy returns, non-creditworthy returns, and total expired drug waste cost per facility
• Total expired drug line items and % of Division Total expired waste line items
• Non-creditworthy return totals per reason code
• RCRA U and P listed HD Returns (if applicable)
• Raw return data for non-creditworthy non-controlled drugs for top 150–200-line items.
• Actions to decrease expired drug waste, guidance on what to include in reverse distributor returns and what not to return.

The PowerPoint template was completed with data from the reverse distributor’s quarterly report for each eligible hospital and emailed to the Director of Pharmacy and Division Director of Pharmacy Operations with requests to review the report for opportunities for improvement regarding expired drug waste management.

Results

The reports and recommendations provided to the Directors of Pharmacy resulted in a 4% decrease in expired drug waste volumes, a 9.1% increase in creditworthy returns, and a 16.4% decrease in cost reduction from 2020-2022.

Conclusion

The creation of a reverse distributor quarterly detailed Expired Drug Review Report was key to central oversight of expired drug waste for Lifepoint Health’s acute care hospitals. The reports allowed for timely analytics and process improvement recommendations.

Antimicrobial stewardship programs (ASPs) are critical tools for promoting the safe and effective use of antimicrobial drugs. ASPs are not developed directly for reducing healthcare costs, but good stewardship leads to more cost-effective care. This includes impacting drug expenditures as well as other costs.

Pharmacy expertise is one of the CDC Core Elements of ASPs in hospitals. Regulatory bodies such as The Joint Commission and The Centers for Medicaid and Medicare Services endorse the critical role of pharmacy expertise in ASPs. However, activities of antimicrobial stewardship pharmacists can vary significantly between organizations. Combine this with a general lack of understanding of what ASP pharmacists do and there is no surprise a gap can often be observed between what pharmacy team members think ASP pharmacists should do versus what ASP pharmacists actually can do. Further complicating the issue, variability is a major commonality across ASPs, since each organization has its own specific patient populations, epidemiology, drug use patterns, physical resources, medical services, staff strengths/weaknesses, technology, administrative structure, and organizational priorities.

Even though ASPs are complex, there are many instances where common ground can be observed across sites. For example, programs often need to focus resources on appropriate management of urinary tract infections, respiratory tract infections, and skin and soft tissue infections since they are all common infectious processes. As programs aim to address high-priority items there are also financial targets that may be at play for the department or organization. For the antimicrobial stewardship pharmacist this commonly involves engaging in measures to control drug-related costs while ensuring optimal care. 

Each year the American Journal of Health-System Pharmacy publishes an article about national trends in prescription drug expenditures, including projections for the next year. This is an excellent resource for identifying which drugs should be on your radar for high economic impact potential. In the July 2023 edition of the publication which displays 2022 data with predictions for 2023, HIV medication bictegravir/ emtricitabine/ tenofovir (Biktarvy) ranked 8 in the top 25 drugs by expenditures overall, pneumococcal conjugate vaccine ranked 17 in the top 25 drug expenditures in clinics, and remdesivir (Veklury) was the top drug expenditure in hospitals (for the second year running). By drug category, antivirals ranked third, systemic antiinfectives ranked eighth, and antifungal agents ranked twenty-fourth. It’s likely 2024 will have some of the same high-cost drugs as 2023.

In light of the above information, it may be helpful to discuss antimicrobial drug costs in the context of what antimicrobial stewardship pharmacists can do. That will be the focus of this article. Here I will discuss my top 5 high-cost antimicrobials for hospitals to watch in 2024 and how your antimicrobial stewardship pharmacist can have an impact. Please note that cost-savings/avoidance opportunities can vary by practice setting, some drugs will be discussed by category, and this is by no means an all-inclusive list of high-cost antimicrobials to look out for in 2024.

1. COVID-19 medications: Remdesivir (Veklury^®) and nirmatrelvir/ritonavir (Paxlovid^®)

Although the pandemic is over, COVID-19 is here to stay. With the musical chairs of prevalent SARS-CoV-2 variants and different types of immunity in the community, the rate of severe/critical COVID-19 has thankfully become less frequent while mild-moderate COVID-19 has become relatively more common. There is of course no way to predict the future, but it is highly likely COVID-19 will come in waves as respiratory viruses tend to do each year.

For severe/critical COVID-19, intravenous remdesivir will most likely continue to be a mainstay of therapy. Exceeding $550 per vial, a 5 day course of remdesivir is over $3,300. ASP pharmacists can impact remdesivir use practices by implementing and overseeing criteria for use which are enforced by electronic medical systems and/or pharmacy staff verifying orders. Activities can include ensuring reasonable use as well as avoiding excessively long durations of treatment or delay to discharge. ASP pharmacists can be a critical resource for bridging prescriber awareness to local guidelines, based upon institutional data and trends.

For mild-moderate COVID-19, commercially available oral nirmatrelvir/ ritonavir is the preferred option (except when issues such as drug-drug interactions are a problem). At just under $1500 for a 5 day course, nirmatrelvir/ ritonavir is less expensive than remdesivir, but it is still high cost compared to most antimicrobial drugs on the market. ASP pharmacists can help promote using nirmatrelvir/ ritonavir over remdesivir when both are an option for a hospitalized patient, which supports better treatment and reduced expenditures. Monitoring data, engaging prescriber stakeholders, and providing targeted education may serve to promote optimal use of nirmatrelvir/ ritonavir.

Molnupiravir (Lagevrio^®) approved under an Emergency Use Authorization is another COVID-19 medication to be aware of, but it’s much less likely to be used in the hospital than remdesivir or nirmatrelvir/ ritonavir, since it is third-line for mild-moderate COVID-19 and clinical data supporting it’s efficacy are much less favorable as compared to nirmatrelvir/ ritonavir.

2. Beta-Lactams for drug-resistant gram-negative bacteria

Some of the highest-cost antibacterial drugs fall into this category, and include:

• Sulbactam-durlobactam (Xacduro^®)
• Meropenem-vaborbactam (Vabomere^®)
• Imipenem-cilastatin-relebactam (Recarbrio^®)
• Ceftolozane-tazobactam (Zerbaxa^®)
• Ceftazidime-avibactam (Avycaz^®)
• Cefepime-enmetazobactam (Exblifep^®, not priced yet but expected to be expensive)
• Cefiderocol (Fetroja^®)

Most of these antibiotics fall into the $750-$1300 per day range, but it does depend on renal function, dosing, and contracting. The mix of use on these antibiotics will vary depending on local epidemiology and prescriber preferences. Caring for immunocompromised patients or those from a local nursing facility may be a big driver of drug use for multi-drug resistant organisms, which is where these antibiotics are most commonly employed.

ASP pharmacists and infectious diseases physicians should arguably be involved with every case in which one of these antibiotics is prescribed. ASP pharmacists should work with local stakeholders to steer reasonable selection for initiation, streamlining after 48-72 hours, safety monitoring, and local protocol development with formulary decisions. In addition, ASP pharmacists can work with pharmacy buyers and patient assistance program contacts to control inventories, ensuring the antibiotics that are expected to be needed are available, but while also ensuring excessive stock is avoided and vial replacement programs are leveraged.

3. Intravenous vancomycin

In most hospitals intravenous vancomycin remains the mainstay for empiric treatment of severe infections suspected to involve gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). While vancomycin drug acquisition costs are not near what is seen with the newer beta-lactam/ beta-lactamase inhibitors, the whole price of vancomycin is considerable and may even contribute to longer than necessary lengths of stay. Vancomycin takes up a lot of time for pharmacists, nurses, and labs. Using it smarter or avoiding it all together can yield economic benefits which impact multiple departments and reduce the risk for acute kidney injury.

ASP pharmacists can help promote use of vancomycin alternatives, de-escalation, and discharge facilitation. There are a long list of ways ASP pharmacists can engage with this, which includes but is not limited to:

• Engaging lab on workflows to leverage MRSA nares PCR to de-escalate therapy
• Working with emergency department prescribers to selectively avoid unnecessary initiations for indications such as non-purulent skin infection or urosepsis
• Promoting oral antibiotics (including now inexpensive oral linezolid) to help facilitate discharge
• Early switch to daptomycin for discharge or in patients at high risk for acute kidney injury
• Employing a vancomycin monitor to engage stakeholders in improving practices
• Teaching pharmacy staff how to individualize vancomycin care to optimize workflows which reduce burdens on pharmacists, nurses, and lab staff

A programmatic approach to optimizing vancomycin practices is recommended, rather than attempting to assign the ASP pharmacist to serve as the daily front-line vancomycin dosing and monitoring point-person.

4. Vaccines

Use of vaccinations within the hospital are impacted by patient populations, regulatory requirements, and organizational priorities. Vaccines for influenza, pneumococcus, tetanus, diptheria, hepatitis B, and rabies (including rabies immune globulin) may be of particular note due to volume of use and acquisition cost. Vaccines such as those for RSV, varicella, and SARS-CoV-2 may be less relevant to the hospital setting if more encouraged for outpatient use, but may also be relevant in the hospital. Hospitals should consider their individual historical and expected vaccine use.

ASP pharmacists can assist with developing as well as evolving standardized processes for patient identification and delivery of vaccinations, working with medical, nursing, informatics, and other staff. ASP pharmacists may also lead medication use evaluations while overseeing pharmacy learners (e.g., student interns, residents), which support identifying opportunities to enhance local practices.

Vaccine-related work is not something an ASP pharmacist needs to be deeply engaged in, but they should be involved in the programmatic monitoring of routine practices and engagement for workflow improvements. ASP pharmacists may also be good team players for vaccine inventory control, especially when shortages are expected (e.g., the tetanus vaccine supply issue of 2024).

5. HIV medications

Bictegravir/ emtricitabine/ tenofovir (Biktarvy^®) costs around $140 per pill. It is one of the most important HIV medications today as a well-tolerated single pill regimen recommended by HIV.gov guidelines. Other guideline-recommended antiretrovirals such as rilpivirine (Edurant^®), and emtricitabine/ tenofovir alafenamide (Descovy^®) also carry significant acquisition costs at approximately $50, $75 per pill, respectively.

ASP pharmacists can assist with developing programs focused on antiretroviral stewardship and  formulary management. They can also support inventory control measures, which includes consideration for working with some medications that have short-date expirations after opening. Since many hospitals do not deal with a high volume of patients with HIV, ASP pharmacists can serve as a critical resource to ensure complete regimens, avoiding missed doses, and proper monitoring.

Closing Comments

Institutions can choose to employ their ASP pharmacist as programmatic workflow coordinators, front-line infectious diseases clinical pharmacists, or a mix of the two. How ASP pharmacists are empowered has a great impact on their ability to mitigate costs related to antimicrobial agents such as those discussed here. There can be a great benefit to having ASP pharmacists engaged in pharmacy operations (including inventory control), clinical pharmacy workflow management (including staff interventions), and front-line services (including guiding the use of high-cost beta-lactams).

Several other items of interest not discussed here may include antifungal drugs (e.g., posaconazole [Noxafil^®], isavuconazole [Cresemba^®]), C. difficile therapies for treatment (e.g., fidaxomicin [Fidaxomicin^®]) or prophylaxis (e.g., Vowst^®, Rebyota^®), and long-acting agents primed for outpatient infusion (e.g., dalbavancin [Dalvance^®], oritavancin [Orbactiv, Kimyrsa], rezafungin [Rezzayo^®]).

Find Timothy Gauthier, Pharm.D, BCPS, BCIDP as @IDstewardship on X and Instagram.

The views and opinions expressed in this article are those of the author and do not necessarily reflect the policy or position of any previous, current, or potential future employer. 

The combination of the worsening shortage of primary care physicians (PCPs) and the valuable contributions of pharmacists during the COVID-19 pandemic have bolstered the societal case for pharmacist provider status.

According to the Health Resources & Services Administration (HRSA), there is a current shortage of 17,500 PCPs, and a study commissioned by the Association of American Medical Colleges concluded that the U.S. could experience a shortage of up to 48,000 PCPs by 2034. Moreover, the PCP shortage is even worse based on geographic distribution. Just as there are so-called “food deserts”—areas that have limited access to affordable and nutritious food—there are “PCP deserts”—places where there is one or fewer PCP for every 3,500 people, as defined by HRSA. A staggering 102 million Americans—31% of the total U.S. population—live in primary care Healthcare Professional Shortage Areas (HPSAs), and 65% of these HPSAs are in rural areas.

The Public Health Emergency (PHE) enacted by the federal government in response to the COVID-19 pandemic enabled pharmacists to provide essential services, including testing, vaccination, and treatment initiation. According to The Future of Pharmacy Care Coalition, during the pandemic pharmacists provided 350 million interventions to approximately 150 million people, in large measure due to the excellent accessibility of pharmacies—nine in 10 Americans live within five miles of a pharmacy—and the fact that patients visit their community pharmacist twice as frequently as they visit PCPs.

These two factors have generated greater bipartisan support in Washington, D.C. for pharmacist provider status, with two different legislative approaches emerging. 

One approach is to mandate Medicare reimbursement of pharmacists for a narrow range of services but broadly in terms of geography. H.R. 1770, the Equitable Community Access to Pharmacist Services Act, expands Medicare to permanently include services provided by a pharmacist, including incidental services and supplies, related to testing, vaccines, and treatment for COVID-19, influenza, and certain other illnesses. As of Jan. 10, the bill had 96 cosponsors (49 Republicans, 47 Democrats), and S. 2477 is an identical bill in the Senate that has 14 cosponsors (8 Democrats, 6 Republicans).

The other approach is to mandate Medicare reimbursement of pharmacists for a broad range of services, but only in geographic areas that are underserved by PCPs. S. 1491, the Pharmacy and Medically Underserved Areas Enhancement Act, which has been brought before Congress a number of times in the past, as of Jan. 10 had 12 cosponsors (seven Democrats, four Republicans, and one Independent). As evidence of the bipartisan appeal of the bill, Sen. Tom Cotton (R-Ark.), one of the most conservative senators, and Sen. Raphael Warnock (D-Ga.), one of the most liberal senators, are among its cosponsors. The bill provides for Medicare coverage and payment at the lesser of 80% of the actual charge or 85% of the Physician Fee Schedule amount for certain pharmacist services that are furnished by a pharmacist in a HPSA and would otherwise be covered under Medicare if furnished by a physician.

The former approach as proposed by H.R. 1770/S. 2477 has garnered the most advocacy support, with backing by The Future of Pharmacy Care Coalition, whose members include the leading pharmacist and pharmacy associations, the nation’s three largest drug wholesalers, several of the largest retail pharmacy chains, and 30 hospitals and health systems.

While there was a paucity of legislation passed by Congress in 2023 and partisanship will almost assuredly continue in 2024, an election year, the aforementioned verities of the worsening PCP shortage and the value demonstrated by pharmacists during the PHE offer hope that pharmacist provider status legislation could ultimately be passed as part of a large end-of-year federal spending package.

About the author: Ken Perez, healthcare marketing, strategy and policy consultant and former Vice President of Healthcare Policy and Government Affairs for Omnicell, Inc. 

The responsibility to uphold the sterile compounding standards set forth by The Joint Commission (TJC) and the updated USP Chapter <797> is paramount. The revised guidelines, which came into effect in late 2023, necessitate a proactive approach to ensure compliance and safeguard patient health.

With an eye on the latest pharmacy research and expert guidelines, below are some steps and recommendations to help ensure your hospital pharmacy is up to date on the requirements:

1.) Policy and procedure review

Begin with a thorough review and revision of your current sterile compounding policies and procedures. Ensure they are in strict alignment with the updated USP <797> guidelines. This includes clear definitions and protocols for CSP categorization, beyond-use dating, and personnel qualifications. Emphasize a culture of continuous improvement, encouraging feedback from your team members to help refine these processes.

2.) Empower your team through education and competency

Invest in providing ongoing, comprehensive training programs for your staff. The programs should cover critical aspects, such as aseptic techniques, garbing procedures, and environmental monitoring, and aligning them with the latest standards. Consider utilizing innovative training tools like simulation-based education to enhance and improve learning outcomes. Regular competency assessments are crucial to ensure that all pharmacy personnel are not just trained, but proficient.

3.) Environmental monitoring and control enhancements

Adopt a zero-tolerance policy toward lapses in environmental quality within compounding areas. Implement state-of-the-art environmental monitoring technologies to track air quality, surface cleanliness, and temperature/humidity levels in real-time. These systems can provide actionable data to prevent contamination risks.

4.) Establish a robust quality assurance framework

Quality assurance (QA) is the backbone of sterile compounding compliance. Develop a comprehensive QA program that encompasses all aspects of the compounding process, from material sourcing to final CSP verification. Regular audits, both internal and external, should be part of your QA strategy to identify and rectify compliance gaps promptly.

5.) Advanced garbing and hand hygiene protocols

Reinforce the critical importance of proper garbing and hand hygiene among your team members. Consider implementing interactive training sessions and routine competency checks to ensure adherence. Consider the adoption of newer, more effective garbing materials and hand hygiene products to further reduce contamination risks. 

6.) Documentation

In the world of sterile compounding, we know that documentation is king. Maintain comprehensive, easily accessible records of all training sessions, competency assessments, environmental monitoring results, and QA audits. These records not only demonstrate compliance during TJC surveys, but also provide invaluable data for ongoing process improvements.

7.) Engaging leadership and fostering a safety culture

Active engagement from hospital leadership is essential to drive compliance initiatives and to assess the current plan. Present compelling cases for the resources needed to meet TJC requirements, emphasizing the link between compliance, patient safety, and organizational reputation. Foster a culture of safety and excellence, where every team member feels empowered to contribute to compliance efforts.

8.) Continuous improvement through feedback and innovation

Adopt an open-door policy for feedback on sterile compounding practices from your team. Encourage innovation by staying abreast of advancements in compounding technology and practices. Participate in professional forums and networks to share insights and learn from peers across the industry.

9.) Prepare for TJC surveys with mock inspections

Consider conducting regular mock TJC surveys to prepare your team and identify any potential compliance issues. These simulations should cover all aspects of the survey process, including document review, staff interviews, and direct observation of compounding activities. Use the findings to make immediate corrections and long-term improvements.

By considering and following these recommendations, you can ensure your hospital pharmacy meets the requirements set forth by TJC and USP<797>. This proactive approach to compliance will safeguard patient health, enhance the efficacy of compounded medications, and solidify your pharmacy’s reputations for healthcare excellence.

Achieving and maintaining compliance is a continuous journey that requires dedication, adaptability, and a relentless commitment to excellence. By empowering your team, investing in advanced technologies, and fostering a culture of continuous improvement, you can navigate the complexities of sterile compounding regulations and improve patient care. 

Pharmacy leaders at hospitals and health systems juggle a variety of issues and activities every day. From my decades of experience, I’m familiar with the operational, clinical, financial, and regulatory responsibilities we manage. It’s challenging but rewarding.

While we can’t solve all challenges overnight, we can make progress in one area: regulatory compliance. Let’s start by focusing on accreditation. We’ll look at specific (and perhaps lesser known) standards issues I have seen surveyed, with practical strategies to prepare.

Policies and documents required for compliance

These are items I call “easy A’s,” or foundational policies you should just have in place. While they may seem like you’re just “checking a box,” if you don’t have these, your hospital may be at risk for citation. I recommend three areas to focus on:

• POLICIES: Do you have policies, SOPs, or written processes that address medication shortages, recalls, patient self-administration of drugs, investigational drug continuity, automatic stop orders, and ADRs? These are common policies that get overlooked.
• DOCUMENTS: Do you have criteria for drug selection (formulary), performance improvement plans and data?
• REGULAR REVIEW AND APPROVAL: Do you have processes in place to consistently review your formulary, LASA list, high-alert list, override lists, emergency medication supplies, policies, order sets, and standing orders?

ACTIONS TO CONSIDER:

1. Policies don’t necessarily have to be full policies, but they should be written documents and must match your practice.
2. Formulary demographic sheets or logs should have standardized information for each drug that is proposed for addition, and all should be filled in or marked NA to show they were considered.  Work with your hospital Quality department to ensure there are medication-related PI projects being tracked and reported.
3. Not all reviews are required every year but start by establishing a cadence to keep them current.

Medication security considerations

CMS says medications are secure if they cannot be accessed by unauthorized individuals. Controlled substances must be locked. These considerations are probably compliant in most of your hospital areas, but some might slip by.

• CRASH CARTS: Most of us use the breakaway numbered seals on our carts, but these ensure integrity of the drugs inside, not security. For this reason, controlled substances cannot be stored in them unless the cart is locked with a padlock, which could present a patient safety risk when trying to access emergency drugs.
• NON-CONTROLLED DRUGS: Are your crash carts under constant observation? Are they parked where they cannot be seen (like alcoves or halls)?  If so, you may be at risk for non-compliance, as the seals aren’t locks and they can be opened undetected, which is a security concern.
• UNLICENSED PERSONNEL: Materials Management, EVS, and others may need to handle and/or be around non-controlled medications pursuant to performing their job duties. This is compliant, provided you have a policy that states so.

ACTIONS TO CONSIDER

1. Ensure that no padlocks are used on crash carts. Any controls that might be needed during a code should be kept in separate, locked storage that can be quickly accessed.
2. Placing crash carts in a locked room or in a place with close supervision will solve the challenge of unmonitored access.
3. If any non-licensed individuals enter medication rooms or handle drugs as a regular activity (such as transporting cases of IV fluids), identify them in an approved policy. 

Whether you’re getting ready for an accreditation survey next week or months down the road, you can never be too prepared.  Compliance with the standards of accrediting bodies reduces the risk of patient harm, and isn’t that the ultimate goal?

Save money. Of all the things we can be sure we need to accomplish in our chosen profession, of this we can be sure. We are tasked with saving money. You could say that a seasoned professional would find little that would be surprising about this notion although it has brought me more clarity in how consultants are positioned to make a real difference in the provision of healthcare, in a way that I think is somewhat diminished in the “daily business”.

As we have discussed, contracting and adherence to those contracts can be passively lucrative. Developing habits that combine your distribution and Group Purchasing Organization (GPO) and being mindful of that relationship is one way to assure you keep a firm eye on the bottom line.

In tandem to the points we examined around distribution, the GPO contract itself and value adds the relationship offers is something every hospital/health system should be acutely aware of.

Are you with the right GPO? Do the blend of offerings and financial incentives mesh well with your practice and plans for the future?

There are likely contracts in place that either need to be maximized or re-negotiated. Start with the GPO and build upon the terms and conditions they have already negotiated with the companies they have vetted. This cuts out a lot of background work in that the GPO has done the hard part already.

There are often areas to operationalize group purchasing possibilities to realize shareback (the monies refunded to the I/H/C for performance stop gates) and/or contract compliance thresholds. Have you combined opportunities wherever you can? Have you shifted your clinical activities to reflect a formulary that is therapeutically sound as well as contractually beneficial? This brings more money into the health system, simply by making essential contractual points a reality in practice. This approach takes back the money that many organizations leave on the table simply by how the I/H/C interacts with the GPO.

GPO’s offer quarterly reviews. This may seem like a time suck, one in which you will learn little to effectively change any approach although this review can be invaluable if you operationalize elements of it as it pertains to your individual practice. If you are a large IDN then you have economies of scale to explore, increasing your shareback. This approach also creates a relationship with the GPO such that when it comes time for a contract roll, your representatives know what you are looking for and what you plan to explore moving forward.

The online resources of GPO's can offer an additional lever of opportunity. They can tell you how close to contract compliance you are, where you could shift activity and what that means in the aggregate. What possibilities are you not taking advantage of and how your efforts may combine with Supply Chain to maximize opportunity. Each GPO approaches this a little differently, but the general idea is the same. If you use their analytics with your own, it is possible to create a unique pharmacy program for your operation that speaks exactly to the clinical pathways you wish to explore and/or change.

We have so many obstacles in our way, fire drills every day and constant change to keep up with. Our approach to the distribution and GPO channels can lighten that load so we can turn our attention to creating programming that aligns with prudent financial moves instead of working against us as we attempt to make the most out of our vendor relationships. Bring them in close instead of putting them on the back burner to simmer.

Amidst COVID-19, the U.S. labor market, particularly in healthcare, faced substantial job vacancies (Fontinelle, 2022). The sweeping resignations of 2021 exacerbated these gaps, as competition among employers to attract workers created a cycle prompting people to seek better opportunities, as speculated by Furman (2021). An estimated 60% of healthcare support workers will leave their positions within the next five years (Loria, 2023).

Pharmacies nationwide grappled with a notable shortage of pharmacy technicians. ASHP's 2021 online surveys revealed turnover rates of 21 to 30% among hospital pharmacy technicians. Additionally, 10% of respondents reported losing up to 41% of these technicians. The surveys highlighted that over 97% of participants resorted to overtime pay and utilizing pharmacists to cover vacant technician shifts. In this piece, I will detail my initiative in revamping the pharmacy internship program to combat the technician shortage at my pharmacy, located near three esteemed pharmacy schools within a 50-mile radius.

The primary goal of the revamped program is to foster the development of pharmacy interns within the hospital pharmacy's operations.  Interns primarily check unit dose medication refills in automatic dispensing cabinets while also receiving training in various pharmacy tasks such as sterile and non-sterile compounding, medication history reconciliation, crash cart drawer management, and controlled substance documentation FOR DIVERSION PREVENTION.

The pharmacy interns actively participate in the development of this internship program.  Interns are responsible for compiling and updating the intern manual.  They also develop a competency checklist for each intern task.  A new intern is trained by those who have demonstrated competency in a given task. A new intern needs to demonstrate competency before independently performing the task.

An intern must complete the required USP 797 media-filled tests to be eligible to train in the IV room. IV-trained technicians are responsible for training interns in sterile compounding following the established sterile compounding policies.  The IV room specialist technician or the IV room pharmacy coordinator is responsible for checking an intern's competency in making sterile products. The same training methodology is used for training interns in performing other tasks.

Encouragement is given to interns to undertake technical writing projects to hone their skills. Those inclined towards technology can learn about system integration, while those interested in hospital pharmacy management can engage in workflow and inventory enhancement projects. Two lead pharmacy interns oversee scheduling, training, and competency checks of other interns, as well as organize quarterly intern meetings, thereby refining their leadership skills.

A well-crafted pharmacy internship program not only addresses technician shortages but also equips pharmacy interns for future hospital pharmacy careers.  Over the past three years, our pharmacy intern team has burgeoned from 6 to 18 members, at one point helping cover up to seven open technician positions. Not only do pharmacy interns help maintain a smooth pharmacy operation by filling in open shifts, but they also help reduce overtime pay and burnout among staff.

It's amazing how quickly an industry can change. Thinking back to the early 2000s, hospital pharmacy procurement had successfully transitioned from a break-bulk/surplus purchasing style to just-in-time (JIT) purchasing and maintaining minimum inventory on the shelf.

AmerisourceBergen, McKesson, and Cardinal Health (the "big 3") had consolidated much of the wholesale and distribution industry and made improvements to their operations, largely alleviating the pressure of hospitals to maintain a large stock of medications. Pharmacy buyers, in turn, spent a good part of their day calculating inventory turns and working to get them as high as possible, only ordering what they needed to maintain a 72-96-hour on-hand inventory.

The success and capital efficiency of the JIT model along with continued adoption of pharmacy automation helped to reduce the need for medication storage space in most hospitals — so much so that rooms that had been used for storing medication were repurposed or taken by other departments. Health systems were confident that they could rely upon their pharmacy supply chain to distribute the medications they needed across their system in a timely manner, and central operations were focused on repackaging, IV compounding, and other labor-over-drug-cost initiatives where utilizing technician labor could bring medication costs down.

Forced to Adopt a Hybrid Model

Fast forwarding to today, confidence in JIT purchasing has flagged as medication availability disruptions have increased. Recalls, manufacturer shutdowns, bankruptcies, overseas logistics challenges, and even simple market economics have led to major medication outages and pharmacies simply running out of drugs.

This shift in stability is motivating hospitals and buyers to look for ways to create supply guarantees or reserve stock for vital medications, many times opting for additional on-site physical inventory — the exact opposite direction from JIT models. We're seeing a growing number of hospital systems building their own warehouses and taking on the burden of self-distribution to ensure additional days of drug on hand.

Compounding and repackaging efforts have seen a similar reversal of strategy. Given the severe labor shortages in the hospital pharmacy space, many hospitals are eager for a partnership with a 503B compounding pharmacy to outsource labor-intensive IV admixture processes. Similarly, outsourcing repackaging efforts or simply purchasing higher cost pre-mix products over products that require manual labor for manipulation is almost a foregone conclusion. The additional cost of medications is moot if there is no one available to do the work.

Repackaging and compounding channels have shown their own vulnerabilities as quality, supply, and lead-time issues have plagued the industry. In past years, the decision to "build versus buy" an IV product could be thoughtfully approached, and the transition planned and plotted. These days, this decision to insource or outsource a product is immediate and driven by unpredictable factors in both medication and labor availability alongside recurring 503B facility shutdowns.

One thing that has remained consistent: the mindset of reducing costs by better utilizing people and technology is as salient today as it was 20 years ago. Pressure on hospital pharmacy to "do more with less" has always been there, but the context of "supplying more medications at lower costs" has shifted to "performing more services with fewer available people."

The Greatly Changed — and Expanded — Role of Pharmacy Procurement

With these developments, pharmacy procurement jobs have exploded in complexity. Instead of simply walking the shelves, identifying gaps in inventory, and filling in the blanks, today's pharmacy buyer is burdened with managing questions like: Will this hurt my group purchasing organization compliance? Is this product built in our systems? Does this medication need specific accommodations for 340B issues? Are the correct contracts and prices loaded for our class of trade? Will we meet our committed volumes and achieve tier discounts?

A pharmacy buyer today is not only the inventory manager but an operator with proficiency in regulatory and contractual obligations, dynamic inventory flows, channel relationship management, analytics, and business intelligence. With so many responsibilities, it's become more difficult to track where money is moving, and more challenging to keep up with market dynamics that affect purchasing decisions and acquisition.

For these reasons, the role of buyer is no longer a simple add-on responsibility for a technician or pharmacist to complete in their downtime. Despite the lack of formal training options in the market, procurement has become a specialized position requiring significant investments in training, recruiting, and retention. Centralized purchasing — a model health system pharmacies are largely moving toward as hospitals consolidate — places these duties on dedicated buyers to ensure optimal procurement and distribution of drugs. This model has demonstrated that the appropriate authority and accountability invested in proficient pharmacy buyers can result in ongoing and meaningful outcomes at significant scale.

Achieving An Optimal Balance Between People and Solutions

While pharmacy procurement has become more complex over these last two decades, we are seeing health systems navigate these increased responsibilities successfully leveraging technology and partnerships. By identifying solutions that empower a leaner pharmacy team and help them to prioritize and complete their work efficiently, hospitals can eliminate much of the menial analysis from a buyer's job and help to focus on the 20% that really matters. When considering approaches in this space, there are a few approaches seen most commonly.

The most traditional approach is to use outsourced labor to complete the lower impact work. In the growing field of pharmacy procurement where expertise is hard to come by, there is tremendous value in the perspective gained from working with multiple health systems, but the questions remain: How do you ensure third parties work exclusively in your interest? How fast can you turn around someone else's employee to focus on your highest need in a market where hours matter?

Depending on the firm, there may be inherent conflicts between an outsourcing entity's financial interests and those of the health system. Finding objective and impartial assistance can be difficult, and the higher the degree of dependency on external talent, the higher the chances are that system-specific decisions and safeguards are at risk. Loss of control, lack of accountability, and the inability to shift priorities effectively, especially in a health system pharmacy, can feel like a tremendous disadvantage in a fast-paced market.

On the other end of the spectrum, we hear of "total automation" (i.e., "single pane of glass") solutions touted for so many processes, but more often than not these solutions require tremendous technical resources to implement and maintain. For large teams working in revenue cycle, the ratio of technical resource to claims processors have been advantageous. In pharmacy, we've more often seen these additional technical responsibilities piled onto an already-busy EHR, pharmacy IT, or pharmacy operations teams, and the additional channels needed to push change causes delays in execution. If you perform any critical analysis to select medications for a hospital, someone will have to teach the machine why you choose the way you do and how to handle the many exceptions you consider along the way.

Rather than subsidizing labor with low-accountability outsourcing or attempting to replace it entirely with high-complexity, high-maintenance total automation, the key to making progress while maintaining ownership has been identifying crucial touchpoints that cannot or should not be performed by an external vendor or technology and helping employees execute on these touchpoints rapidly with high-context guidance and oversight.

This is not a new idea - to reduce fraud, the group at PayPal was able to scale using automation to screen billions of dollars in transactions, identify those with the highest likelihood of fraud, and pass those transactions to a team for manual review. More recently, Latent Health advertises using artificial intelligence to identify and automate steps for prior authorization that are trivial or duplicative, leaving just those components that require trusted clinician review. Claims processing automation tools that forward exception cases to specialist teams have made tremendous impacts for health systems and spawned several publicly traded and successful companies in the process.

For all these tools, it's all about getting the information that needs to be "touched" to the people who need to see it, while ensuring those same people don't spend valuable time slogging through things they do not need to see. When done right, this makes the people involved more useful, enables them to use more of their valuable skillset, and gives them ownership of these important processes. For the complex, volatile world of pharmacy purchasing, where flexibility, context, and timeliness are paramount for getting medications safely to your patients, choosing the correct path on your quest to "do more with less" will pay significant dividends.

Drug shortages have existed for many decades but not to the extreme that they are today.  The pandemic (COVID) and how we treated patients, highlighted the extreme vulnerability of the whole drug supply chain in the United States, especially for generic injectable drugs, which are some of the most frequently used drugs in a hospital setting of patient care, from neuromuscular blockers, anti-infectives and oncology drugs.   We rely on some of the cheapest drugs and we count on them to be available, to provide patient care for various diseases and indications and to support patient care service lines, such as oncology and pediatrics.

We need to remember, that the generic drugs that are in short supply, are classified as “small molecule drugs” and not “branded drugs or biosimilars” and some, maybe generic for 25 years or more.  Branded Drug Companies own the API source/supply for their small molecule drugs, if they have the patent/NDA. Generic drug companies don’t have medical science liaisons (MSLs) and normally, don’t do any research to expand the FDA approved indication of a drug or develop a different vial size, when they decide to manufacture the generic (this requires a separate ANDA that can take up to 2 years). Generic Drug Companies file for an ANDA (Abbreviated New Drug Application) with the FDA and have their own professional organization, the Generic Pharmaceutical Association, representing them in Washington DC and with the FDA.

As we enter 2024, there are still no solutions that have been implemented policy wise, by the FDA and legislatively, to address the Drug Shortage issue, and the same questions.  There have been many meetings and hearings in Washington DC being held with the FDA and Committees, such as Energy and Commerce, with representatives from many different professional organizations, clinicians who treat patients, and even patients and their families, impacted by drug shortages, but still no actions, policies, or legislation being presented for review and approval, to solve the drug shortage crisis.  There are discussions about the role of the FDA in the approval process of generic drugs, as well as the role of each generic manufacturer and their professional organization, the Generic Pharmaceutical Association.  Drug shortages have been blamed on drug costs being too low for generic drug companies to sustain a profit (race to the bottom), to API shortages and country of API origin, to lack of quality in manufacturing (cGMP), geographical location of manufacturing facilities and exposure to natural disasters, lack of FDA inspections or timely inspections, lack of communication to the FDA on a drug shortage by generic companies and the reason for the drug shortage and the supply chain.  Generic drugs are not only purchased and distributed to hospitals, but physician practices (e.g. oncology), 503Bs for compounding (sterile to sterile), private payer infusion companies and various home infusion companies. Sometimes generic drugs end up in what we call the grey market.  A more recent concern that has arisen, is the impact of geo-political issues on the global supply chain of drugs.

To develop long-term solutions, there needs to be an understanding of the whole process/steps in developing a generic drug and address each step accordingly with a solution, until it gets to the end user to administer to a patient.  Some of the legislation and changes being recommended as solutions, regarding generic drugs, can and will impact the drug supply chain, availability of generic drugs and ability to order drugs to treat patients.  

One program being established by the Center for Drug Evaluation and Research (CDER) is the Quality Management Maturity (QMM) Program.  The Goals of QMM are 1. Foster a strong quality culture mindset. 2. Recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practices. 3. Identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities. 4. Minimize risks to product availability to assure reliable market supply.

A second program is Senate Bill S.2510, the RAPID Reserve Act (Rolling Active Pharmaceutical Ingredient and Drug Reserve Act”, which addresses building and maintaining reserves of critical medications and their key ingredients, including API (active pharmaceutical ingredients), and reducing reliance on foreign drug manufacturers.

The Pediatric Cancer Drug Supply Act of 2024 was recently proposed and directs the U.S. Department of Health and Human Services (HHS) to establish a program to create a reserve supply of essential pediatric cancer drugs.  HHS would contract with eligible drug manufacturers to produce a stockpile of the most essential pediatric cancer drugs. As part of the contract, drug manufacturers would receive payments from HHS based on the quantity and cost of pediatric cancer drugs held in reserve. HHS would have authority to order manufacturers to distribute drugs from the buffer stocks into the commercial market to alleviate or prevent drug shortages.

As we continue into 2024 my thought is that there will be some reasonable discussion, decisions and appropriate solutions being approved by the FDA and legislatively, so we can get back to delivering patient care, sooner, rather than later.  If there is no drug, there is no Value!