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.
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:
- Policies don’t necessarily have to be full policies, but they should be written documents and must match your practice.
- 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.
- 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
- 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.
- Placing crash carts in a locked room or in a place with close supervision will solve the challenge of unmonitored access.
- 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?
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.
The 340B Program provides eligible hospitals and health systems resources not associated with federal subsidy, to administer comprehensive healthcare to patients and communities disproportionately affected by social, economic and environmental disparities. The program requires drug manufacturers participating in Medicare and Medicaid to provide outpatient drugs to covered entities at significantly reduced prices.
The last three years have placed extraordinary strains on hospitals, and for many smaller hospitals, the 340B program is critical to survival. Without 340B program savings, many smaller hospitals might need to lay off workers and shutter needed programs, such as those that help to detect and treat patients suffering from chronic conditions. Consequently, underserved populations will need to travel further away to receive care.
For smaller hospitals and those serving rural communities, many of which do not operate their own outpatient pharmacy, the only avenue for patients to access drugs covered under the 340B program is through a contract pharmacy arrangement. However, there are several disadvantages to relying solely on contract pharmacies to meet patients’ specialty medication needs. With a robust in-house specialty pharmacy program utilizing 340B savings, financially challenged hospitals can recover funds quickly while reducing the administrative burden on staff and improving patient outcomes. Could more small and rural hospitals fully utilize the 340B drug pricing program?
Some of the perceived barriers for smaller hospitals to open an outpatient pharmacy and recognize the most benefits out of 340B include:
- The belief that starting their own specialty pharmacy is too expensive, risky or complicated considering the perceived restrictions.
- The myth that there is a threshold of pharmacy spend required.
- The myth that specialty pharmacy programs require a large patient base of specialties such as oncology.
Disadvantages of Contract Pharmacy Reliance
Contract pharmacy restrictions that manufacturers placed on 340B hospitals have limited eligible health systems from reinvesting 340B funding into improving their services and communities. These increasing manufacturer restrictions on specialty medications make owning a specialty pharmacy a critical step toward maximizing savings. When dispensed in-house, the hospital saves money on fees it otherwise would pay to the contracted pharmacies. Community-based health systems, especially those serving rural communities, find it difficult to implement integrated specialty pharmacy programs due to payer or PBM restrictions, drug distribution limitations and absence of the necessary resources and infrastructure.
This results in specialty prescriptions being filled by external pharmacies that are unaffiliated with the health system leading to care fragmentation and inconvenience and frustration for patients. Health systems that do not provide retail or specialty pharmacy services also miss the opportunity to achieve healthy financial margins that are often associated with dispensing specialty medications. The improved margin opportunity for health systems who choose to own their own pharmacy is significant and can allow more hospitals to keep their doors open, while providing an expanded service to patients in a familiar care setting.
Overcoming Barriers with Data
When determining if opening an in-house specialty pharmacy is a good fit, there are many unknowns. It is necessary to understand the landscape of the community, the behaviors and demographics of the patient populations and have a long-range view for the needs of the health system and community. Anticipating industry and pharmaceutical pipeline trends provides an additional advantage in projecting the long-term growth and viability of the program. Executives should have access to their organization’s data and the resources needed to analyze the benefit of this investment. Many hospitals and health systems turn to a specialty pharmacy services company with expertise in these assessments for detailed analyses.
Opening an in-house specialty pharmacy helps hospitals provide superior clinical care, increase revenue and better support vulnerable communities. Incorporating specialty pharmacy services and utilizing the 340B program within the hospital’s clinical programs greatly enhances the patient and provider experience -- delivering an integrated program that drives revenue and reduces the total cost of care.
Craig Wright, Vice President of Pharmacy Services at Advantus Health Partners, says the one of the biggest obstacles our industry faces today is the national drug shortage crisis.
“There’s a lot of disruption that’s happening and it's indiscriminate of the continuum of healthcare,” Wright says. “We've seen shortages in the physician office space, retail pharmacy, specialty pharmacy and home health. There are drug shortages in every therapy class — medications used for anesthesia, oncology and pediatrics, for example.”
What concerns Wright the most is the randomness of it.
“One day, it might be a shortage in one therapy class and another day, it could be another class,” Wright says. “It’s difficult to forecast exactly what shortage is next.”
But even though it seems random, drug shortages are historic, Wright says.
“Shortages were here before the pandemic,” Wright says. “But that has continued, post-pandemic. Add the labor shortage issue to the supply chain disruption — it’s no wonder why drug shortages are at the worst levels we’ve ever seen.”
Biosimilars can provide significant savings and revenue for health systems, but how do you operationalize a streamlined workflow for providers and pharmacy to best support your patients? Baptist Health found success by dedicating a resource to lead a cross-functional workgroup consisting of Providers, Nursing, Data Analysts, Prior-Auth, Patient Assistance, and Pharmacy to build out an automated strategy for biosimilars within their Electronic Medical Record, which is Epic.
While biosimilars are highly similar to their FDA‐approved biologic reference product, there are very few that are considered therapeutically equivalent. Therefore, each biosimilar has its own billing code and reimbursement, which would necessitate a new prior authorization with the patient’s insurance if you want to switch a patient across products. For this reason, the scope of this initiative was limited to new patients initiating therapy.
One of the first challenges you face is insurance dictating what products you can use on a patient. The dedicated resource was able to pull the top 80% of insurance plans for patients that received the biosimilar reference product and identified which biosimilar(s) and/or reference products were covered by each insurance company.
Next a Request-for-Proposal (RFP) went out to manufacturers for sub-340B, sub-WAC, and discounted GPO pricing. Once those were received, a financial evaluation was performed by the data analytics team. The financials will be specific to your institution, since pricing, charging, and reimbursement will vary across health systems. Biosimilars will not always be the most cost advantageous agent and sometimes a reference product makes the most fiscal sense.
Armed with what products are available under each insurance plan, and the profitability of each of those agents, Baptist identified the preferred agents for each insurer. The Epic Beacon team then built the preferred agents as the default in the treatment plan. So, when a provider is initiating therapy the preferred biosimilar or reference product for that insurer will default in the order. The provider can still change the product, if for example a pegfilgrastim patient was more appropriate to receive the Neulasta OnPro onbody device because they have travel concerns, and it will save them a subsequent trip for their second dose. Providers loved this solution, as this required no additional steps to their workflow, and they have the flexibility to change the order to a different agent if they deem appropriate.
While this has been a very effective and efficient solution for Baptist’s providers and patients, this is not a one-time exercise. Reimbursement and pricing changes quarterly, so every quarter a new financial evaluation is performed. Automation is key to continually evaluating the profitability of outpatient therapies, like biosimilars, because of the constant changes and the lack of resources to perform all the necessary financial evaluations. More to come around automating analytics in a future article. Hope you enjoyed and please comment below or reach out directly with any questions.
There is substantial evidence that genotype influences drug safety and effectiveness. Over 300 drugs have pharmacogenetic information in their Food and Drug Administration-approved labeling, and guidelines are available by the Clinical Pharmacogenetics Implementation Consortium (CPIC) to guide the incorporation of pharmacogenetic information into drug prescribing.1,2 However, there remains limited uptake of pharmacogenetic testing in clinical practice. This is in part because of the demand for evidence demonstrating improved patient outcomes with genotype-guided therapy. While randomized controlled trials are the gold standard for establishing the efficacy of an intervention, they are costly and challenging to conduct for pharmacogenetic interventions since only a subset of the population (i.e., those with a variant genotype) are likely to benefit from the intervention. Alternative approaches to evidence generation include use of observational data from patients who received pharmacogenetic testing and pragmatic clinical trials. An example of each is provided below.
CYP2C19 genotyping to predict response to clopidogrel and guide antiplatelet therapy after a percutaneous coronary intervention (PCI) is one of the most common pharmacogenetic implementations.3 Clopidogrel is a prodrug that relies on the CYP2C19 enzyme for bioactivation. Clopidogrel is less effective in patients with a non-functional CYP2C19 allele, who cannot generate sufficient concentrations of the active clopidogrel metabolite to effectively inhibit platelet aggregation.4 On behalf of the NIH-funded Implementing GeNomics In pracTicE (IGNITE) Network, investigators from seven institutions where CYP2C19 testing had been integrated into clinical practice pooled data for over 1,800 patients who had undergone percutaneous coronary intervention to examine outcomes with CYP2C19-guided antiplatelet therapy.5 At each site, alternative therapy (e.g., prasugrel or ticagrelor) was recommended in patients with a non-functional allele in whom clopidogrel was predicted to be ineffective, but the ultimate prescribing decision was left to the provider. The investigators found a significantly lower occurrence of adverse cardiovascular events (i.e., death, myocardial infarction, and stroke) in patients with a non-functional allele treated with alternative therapy versus clopidogrel. These data were consistent with more recent clinical trial data, demonstrating the value of real-world data.6
Pragmatic clinical trial data
Tramadol, hydrocodone, and codeine are dependent on the CYP2D6 enzyme for formation of more potent opioid metabolites. CYP2D6 intermediate and poor metabolizers with very little to no enzyme activity have low concentrations of the more potent opioid metabolites and may not attain sufficient pain relief with these drugs.7 In contrast, ultra-rapid metabolizers, with increased enzyme activity, may generate toxic concentrations of the more active metabolites and are at increased risk for respiratory depression.7 Investigators at the University of Florida conducted a hybrid implementation-effectiveness trial of CYP2D6-guided versus usual post-operative pain management.8 For patients randomized to the genotype-guided arm, recommendations were to avoid tramadol, hydrocodone, and codeine in those with a high risk phenotype (i.e., poor, intermediate, and ultra-rapid metabolizers) and to consider an opioid not metabolized by CYP2D6 (e.g., hydromorphone or morphine). Given the pragmatic nature of the trial, the prescribing decision was left to the provider. The majority of patients (72%) with a high-risk phenotype in the genotype-guided arm, but none of those in the usual care arm, received an opioid other than tramadol, hydrocodone, or codeine.8 There was similar post-operative pain intensity in the genotype-guided and usual care arm, but lower opioid consumption in the genotype-guided arm. A large, multi-site pragmatic trial is currently on-going to further examine outcomes with CYP2D6-guided post-surgical pain management.9
As drug costs continue to rise, pharmacists across the U.S. rise to the challenge of coming up with clinically effective ways to contain costs.
But first, why are costs going up in the first place?
“There’s been a lot of drug innovation and research for the past ten years that has benefitted patients,” says Neal Dave, Executive Director of Pharmacy at Texas Oncology. “Due to these breakthroughs, cancer patients have more treatments available than ever before. But these newer medications have different side effects from traditional chemotherapy. With proper management, patients can stay on therapy longer than before. Even though these treatments are amazing, the cost is going to go up because of the research it took to bring these products to market.”
Texas Oncology has a long history of providing value-based care to patients. Dave works closely with physician leadership, fellow pharmacists and a full care team on an effective drug cost containment strategy. Here are a few strategies the team implemented:
- Dose rounding: A whitepaper examined the dosing of monoclonal antibodies. For example, if a drug vial contains 100 milligrams and a patient’s dose is calculated at 108 milligrams, researchers found these monoclonal antibodies have a wide therapeutic index, which means that eight milligrams won’t make any clinical difference. If a patient had a prescription for 108 milligrams, the pharmacist would use two vials and throw away the rest of the 92 milligrams because it can’t be used on another patient. This created a lot of waste. “After instituting a dose rounding policy, we evaluated how much waste we were avoiding just by rounding down to the nearest vial size,” Dave says. “It is approximately $1 million per month for just our Medicare patients. Texas Oncology uses a dose rounding strategy if the medication has a wide therapeutic index for over five years.”
- Dose banding: Texas Oncology does a similar strategy when the dosing is based on a patient’s weight. Typically, immunotherapy drugs are based on weight, but drug company research showed that you can do a flat dose basis and get the same result for a patient. Although flat dosing is a great idea, patients that have a lower-weight can be given a lower dose based on their weight, as compared to the flat dose. This saves using an additional vial for lower-weight patients, without affecting any clinical outcomes.
- Therapeutic interchange: This is when you can offer a patient an alternative medication that’s just as effective as the original, but at a lower cost. An example is in bone health where two different classes of medications have the same clinical efficacy, except one of them is generic and is 1/10th of the cost compared to the other. Texas Oncology’s protocol, where appropriate, allows pharmacists to substitute for the lower-cost product.
- Biosimilar: Texas Oncology adopted biosimilars early and was able to show a savings of $4 million in one month alone after the adoption of biosimilars, which were originally launched for bevacizumab, trastuzumab and rituximab.
Having a cost containment strategy that your leadership supports is key. Getting the infrastructure of pharmacists, leadership and doctors together is what makes it successful.
“We have a pharmacy and therapeutics committee that meets regularly to discuss value-based care options for patients and discusses where we can have the most impact,” Dave says. “We have a team of pharmacists who are dedicated to cost-saving initiatives.”
For example, Dave says pharmacists can take the lead and build some of these cost-saving ideas into their EMR for dose rounding or therapeutic interchanges.
“A lot of times, providers aren’t aware of how much the drugs costs,” Dave says. “They’ll know they can be expensive, but don’t see the cost-saving differences among drugs in the same class.
Dave wants other pharmacists to know that providing quality care and reducing costs is possible.
“These are areas where we’ve cut down on costs significantly,” Dave says. “If you look for areas where you can make a difference, you’ll find them.”
The University of Florida (UF) Health Precision Medicine Program (PMP) launched in 2012 with an initial focus on pharmacogenetic testing. The first gene-drug pair implemented into practice was CYP2C19-clopidogrel in the setting of percutaneous coronary intervention. Since then, the program has expanded to support implementation of the following gene-drug pairs: TPMT/NUDT15-thiopurines, CYP2D6/CYP2C19-antidepressants, CYP2D6-opioids, CYP2C19-proton pump inhibitors (PPIs), and CYP2C9-nonsteriodal anti-inflammatory drugs. Each implementation occurred in response to a physician request for pharmacogenetic testing to help inform prescribing decisions. Panel-based testing became available in 2019 and covers nine pharmacogenes, including those listed above.
With each implementation, several key best practices are followed. First, it is critical that there is strong evidence to support genetic associations with drug effectiveness and/or safety. Importantly, it is not necessary for there to be evidence of improved clinical outcomes with the use of genotype information in prescribing decisions. Rather, genotype is considered to be another important factor, similar to age or serum creatinine, to consider when optimizing drug therapy for a given patient. The Clinical Pharmacogenetics Implementation Consortium (CPIC) evaluates and summarizes the pharmacogenetic evidence.1 For gene-drug pairs with a high-level of evidence, CPIC provides recommendations for how to integrate genotype results into prescribing decisions. Thus, for institutions newly implementing pharmacogenetic testing, CPIC guidelines are a great resource for evidence evaluation.
Another best practice followed at UF Health is related to the selection of pharmacogenetic variants for testing. There is significant variability in allele frequencies across ancestry groups, and many clinically relevant alleles are common in one ancestry group but rare in others. Our program strives to include any functional variant with appreciable frequency (e.g., ≥1%) in at least one population. For example, for the CYP2D6 gene, the decreased-function *17 and *29 alleles occur frequently in those of African ancestry. Therefore, even though they are uncommon in other populations, *17 and *29 are included on the UF Health CYP2D6 genotype assay. A helpful resource for selecting pharmacogenetic variants for testing comes from the Association of Molecular Pathology, which publishes recommendations for which alleles to include on clinical testing panels.2-4
A third best practice is that genotype results are entered into the electronic health record (EHR) as discrete data. This allows for building automated alerts within the EHR to guide prescribing decisions at the point of care. In the event that a provider orders a drug for a patient, and the patient has a genotype associated with reduced effectiveness or increased risk of adverse effects to the drug ordered, an alert will automatically appear to notify the provider of such. For example, if a provider orders tramadol for a patient with a CYP2D6 genotype associated with reduced tramadol effectiveness, an alert will appear to warn the prescriber that the patient may get little to no pain relief with tramadol.
A final best practice is that clear clinical decision support is provided to assist prescribers with applying genotype results to drug selection and dosing. Genotype-guided recommendations are provided through the automated alerts described above and are consistent with CPIC guideline recommendations. Referring to the example above, the alert would include recommendations to avoid tramadol and either consider a non-opioid analgesic or an opioid that is not affected by CYP2D6 metabolizer status, with specific examples provided. Clinical pharmacists are available for consultation as needed.