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Click the title above for a link to open the Pharmaceutical Commerce October 2024 issue in an interactive PDF format.

Pharmaceutical Commerce - October 2024 Issue (PDF)

 marks the second to last one of 2024. To help keep the momentum going through the end of the year, it’s only fitting that this edition is headlined by a cold chain topic, one of the publication’s “bread and butters.”

We wanted to focus on exploring the technological advances in this space, and although that can be a tall task, SpotSee’s Billy Sanez articulates the concept well in a 

 on keeping often-critical "do-not-freeze" injectable drugs safe through to the "last mile" of their delivery. “Cold chain logistics managers must use the right solutions for the product being shipped at every stage of the supply chain,” he notes. “Single-use indicators are most valuable during the last mile, as they are more easily read by distribution staff and end users. Conversely, devices with minute-by-minute connected alerts and robust analytics capabilities are preferable for continuously monitoring the entire supply chain. In addition, everyone involved in last-mile distribution should understand their respective job and its far-reaching consequences.”

Contributing Editor Suzanne Shelley touches on temperature management as well in her 

 into the trends and strategies shaping the practices of specialty pharmacies and their partners. She also explores the complex commercialization and access aspects associated with specialty therapies, noting there are three primary objectives that efforts focus in on: ensuring swift drug access for patients, minimizing out-of-pocket (OOP) expenses, and promoting sustained adherence to therapy. The goal for today’s specialty pharmacies is to anticipate and then address all the needs that individual healthcare providers and patients may have.

 of his “Who Moved My Prescription?” series, Bill Roth of IntegriChain details a major complaint issued by manufacturers—the fact that branded prescriptions are increasingly being turned away by retail pharmacies of all kinds, an extension of the issues faced by specialty-lite products nearly a decade ago. Meanwhile, in her latest 

, Amy Niles of the PAN Foundation examines a pair of provisions from the Inflation Reduction Act that will go into effect on Jan. 1 of next year, including a $2,000 cap on OOP drug spending for all individuals with a Medicare Part D plan. The concern lies in the unintended consequences these could have on patients, she points out, particularly the threat of rising Part D premiums.

All this and more highlight our October offerings. We hope you enjoy, and thanks for reading.

— Mike Hennessy Jr., President and CEO, MJH Life Sciences

Headlining our October issue of Pharmaceutical Commerce is a look inside an emerging key component of cold chain transport and management—ensuring the safety and control of novel injectable drugs through to their "last mile."

Strengthening the Chain 

Aaron Rodgers—the star NFL quarterback who was playing for the Green Bay Packers at the time—made headlines in 2014 when he told fans to “r-e-l-a-x” following the team’s slow 1-2 start that season.

It’s clear that the power of acronyms truly resonated with me, being that I’m sharing this blast from the past a decade later; so I’d like you all to indulge me for a moment while I share an acronym of my own: D-S-C-S-A.

The DSCSA, or Drug Supply Chain Security Act, was signed into law by Congress in November 2013 as part of the Drug Quality and Security Act and in a nutshell, aims to tackle the challenges presented when contaminated, counterfeit, or stolen drugs enter the supply chain. As you all will read in this issue’s 

, FDA has made several rulings over the past 11 years in order to ensure successful compliance with the Act, including last year, when the agency announced a one-year stabilization period that would delay enforcement of certain DSCSA requirements (including implementing electronic tracing at the package level) until Nov. 27, 2024.

This and more were discussed at the Healthcare Distribution Alliance’s 2024 Traceability Seminar in August. During the meeting, in 

an installment for Pharma Commerce’s conference video content

, I sat down with Ilisa B.G. Bernstein, president of Bernstein Rx Solutions, LLC, and a former FDA employee—and asked her point-blank about what level she felt pharma's overall preparedness in adhering to the DSCSA compliance deadline was at.

“We’re in a good place," she told me, roughly about three months out at the time. "It’s not ready 100%, but FDA implemented this one-year stabilization period, which allowed the supply chain to mature, and the connections really helped. We’re at a much better place than we were last year, and we’re closer to really being where we need to be, but there are still connections between trading partners where the data quality is poor, where there’s discrepancies in information that’s provided, and those need to be cleaned up.”

So with a mix of optimism and urgency, it should be an interesting countdown to compliance for the pharmaceutical supply chain.

Nicholas Saraceno is Pharmaceutical Commerce's Editor. He can be reached at nsaraceno@mjhlifesciences.com.

Getting a handle on level of compliance-readiness for the Drug Supply Chain Security Act deadline—now just weeks away.

A Sense of Urgency

In August, supply chain leaders within the industry gathered at Washington, DC’s Marriott Marquis for the Healthcare Distribution Alliance’s (HDA) 2024 Traceability Seminar, perhaps with a greater sense of urgency than 
years past.

The goal of the conference was to “learn more about upcoming Drug Supply Chain Security Act (DSCSA) implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers, and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.”

Industry members recalled last year's event, when in what felt like only several minutes before FDA was set to hit the stage to discuss the DSCSA, the agency announced two compliance policy guidelines that established a one-year stabilization period until Nov. 27, 2024—thereby choosing to delay enforcement of Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.

The decision provided those companies working in the pharma supply chain with more time to implement and troubleshoot their systems and processes.

The FDA had held firm in stating that this extra time does not mean that trading partners should delay preparation to comply with 582(g)(1); instead, they should take advantage of the extension by “building and validating” their systems.

These issues were reiterated at the 2024 event's “State of Implementation: FDA’s Perspective” session, in a presentation led by both Leigh Verbois, director of the office of drug security, integrity, and response within FDA's Center for Drug Evaluation and Research office of compliance, and Abha Kundi, JD, MPH, team lead. Their objective was to “review DSCSA implementation and trading partners’ feedback on progress and to achieve interoperable, electronic tracing of products at the package level,” while also examining FDA activities that are in the works.

The agency has also stated the stabilization period will not be extended any longer. However, per Section 582, FDA can issue exemptions, and has done so with small dispensers (less than 25 employees) until Nov. 27, 2026. Other stakeholders can file for a waiver, exception, or exemption (WEE) request, which will be evaluated by the FDA on a case-by-case basis.

At the same time, the agency did express where its priorities lie, which is in providing patients access to their medications in a secure manner. In that light, it decided to reopen its request for information on “implementing interoperable systems and processes for enhanced drug distribution security requirements under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.”

Other noteworthy sessions at the HDA event included “Filing WEEs: Lessons Learned and HDA Perspectives on DSCSA Implementation and Readiness,” and “Legal Perspectives for DSCSA Compliance Legal Teams.”

Will industry be ready to comply? We’ll have to wait and see, but in the meantime, to read and view all our coverage from the 2024 Traceability Seminar— along with past shows—including behind-the scenes video interviews, please visit 

pharmaceuticalcommerce.com/latest-conference

The Healthcare Distribution Alliance's latest seminar was as timely as ever, with the end of the stabilization period for DSCSA implementation drawing closer. 

Conference Connect: The Twists and Turns in Pharma Traceability

Sustainability has become a real necessity and the pursuit of organizations across the globe, as many now throw down the scientific gauntlet.

It is important for companies, including those in the life sciences industry, to proactively set targets and focus on long-term initiatives that will provide value realization and business transformation toward creating a more sustainable and resilient future. Indeed, within our own business, our adherence to the Science-Based Targets initiative through our strategic partnership with EY Parthenon

 un- derscores our commitment to conscientious corporate stewardship.

At the time of the announcement, I had noted that our alliance with EY Parthenon marks a pivotal advancement in our sustainability pursuit and that by leveraging its expertise in industrial decarbonization, we are poised to expedite our net zero objectives. Our hope, as a result, is effectuating a meaningful reduction in our carbon emissions. Keeping that in mind, when it comes to net zero objectives, I am referring to “we” as large-scale manufacturers.

Overall, embarking on the journey toward decarbonizing entire processes will undoubtedly prove overwhelming for many. Still, if we want to restrict global temperature fluctuations, then it is one that we must all embrace.

Ultimately, it’s about looking toward the future and trying to understand wide-ranging stakeholder needs to create long-term and effective solutions. When it comes to addressing environmental schemes and proposals, every part of the manufacturing process needs to be considered. Organizations could look at a number of measures to reduce their carbon footprint, which could include:

Implementing an energy management system and increasing the usage of renewable energy sources, includ- ing solar power. This is something we do, with the aim of reducing fossil fuel consumption by 20% to 25%.

Improving overall equipment effectiveness by addressing machine time hours to reduce energy consumption.

Looking at how and which devices can be used with the internet of things, in order to continually monitor energy consumption, as well as to create energy-efficient designs.

Reducing waste generation within premises and upcycling where possible.

Promoting the use of electric vehicles and making the move toward hybrid models.

Undertaking sustainable practice through the use of zero liquid discharge, which can enable plants to save power and generate daily energy.

Creating biodegradable and compostable barrier films and coatings, promoting the use of single polymer plastics when it comes to packaging materials, while also working with companies to reduce overall packaging size. 

The mission to reduce the overall carbon footprint remains a driving principle for the pharmaceutical sector, with a focus on making manufacturing “contained, continuous, and connected,” while optimizing raw material use and reducing waste. We must continue to work collectively to achieve this goal, ensuring clear communication and complete transparency. We are moving in the right direction and already we’re seeing visible gains. 

S.R. Shivshankar is CEO at ACG Packaging Materials.

1. Kulkarni, M. ACG Joins Forces with EY-Parthenon For Strategic Partnership. Pharma Now. June 13, 2024. 

https://www.pharmanow.live/latest-news/ acg-joins-forces-with-ey-parthenon-for-strategic-partnership

Why it's critical for companies to set long-term, strategic goals in their journeys toward decarbonization. 

Tapping the Value of Conscientious Stewardship

Ongoing innovation in drug development is allowing patients managing one or more comorbidities to live longer and have an improved quality of life. Pacing much of that innovation are specialty medications, which are high-cost, complex therapies approved to treat a growing array of chronic conditions, rare diseases, and life-threatening illnesses. This includes cancer; HIV/AIDS; hepatitis C virus; rheumatoid arthritis and other immunology conditions; respiratory illnesses; multiple sclerosis; cystic fibrosis; hemophilia; and more.

What makes specialty medications so special? Such therapies typically have complicated dosing and administration requirements (often requiring self-administration of an injectable therapy at home or regular infusions in a clinical setting). They may engender unpleasant or debilitating side effects, and they often have premium prices that result in high out-of-pocket (OOP) costs for patients. Meanwhile, many require biomarker profiling or other types of genetic testing prior to initiation, along with ongoing lab testing over time.

Meanwhile, most specialty therapies must clear strict prior authorization (PA) requirements prior to prescribing. And many of these high-value drugs are temperature-sensitive, so they typically require complex cold-chain requirements and sophisticated chain-of-custody processes to ensure their stability throughout all stages of storage, distribution, and dispensing. With all of these factors at work, an array of wraparound services for both healthcare providers (HCPs) and patients is critical to ensure the most successful use of these therapies.

Commercialization efforts for all specialty therapies focus on three primary objectives: to ensure swift access to the drug for patients, to minimize OOP expenses, and to promote sustained adherence to therapy. The goal for today’s specialty pharmacies is to anticipate and then address all of the needs that individual HCPs and patients may have.

Specialty pharmacies play a direct role in helping HCPs and patients to manage many barriers that can undermine these critical objectives. They will also use data analytics to tailor the support as much as possible for both stakeholder groups while enabling ongoing improvement of the program offerings over time.

Steady growth in the number and volume of specialty medications in recent years has drastically changed the healthcare and pharma/life sciences landscape. In 2023, 55 novel drugs received FDA approval

—with 80% of those the specialty variety. Meanwhile, the pace continues; as of late August 2024, FDA has already approved 29 novel drugs.

Over the past decade, the specialty drug portion of total prescription dispensing in the US (by revenue) has also grown significantly—from 24% in 2013 to nearly 40% in 2023, according to a recent analysis by the Drug Channels Institute (DCI).

 In 2023, US Rx dispensing revenues from specialty pharmaceuticals reached $243 billion, DCI finds.

The institute also notes that the largest six specialty pharmacies in the US (based on 2023 prescription revenues) are:

CVS Specialty (owned by CVS Health): $73.3 billion

Accredo/Freedom Fertility (owned by Cigna/Evernorth/ExpressScripts): $59.5 billion

Optum Specialty Pharmacy (owned by United Health Group): $32.3 billion

AllianceRx /Walgreens Pharmacy (owned by Walgreens/Boots Alliance):$8.4 billion

CenterWell Specialty Pharmacy (owned by Humana): $6.2 billion

Onco360 Oncology Pharmacy/CareMed Specialty Pharmacy (owned by BrightSpring Health Services): $4.6 billion

“One of the most important attributes for a brand team to consider is whether the potential specialty pharmacy partner has the experience and expertise that is needed to reach the target patient population, and whether they have the desired payer contracts in place to ensure the broadest possible market access at launch,” says Dave MacLeod, managing director, consulting, Syneos Health. The types of enhanced services offered by today’s specialty pharmacies—beyond traditional pick-pack-and-ship capabilities—are discussed ahead.

Addressing HCP needs to streamline patient access to therapy

With the rapid pace of innovation in specialty medications and their inherent complexity, physicians face challenges staying up to date on the latest approved options and associated evidence and guidelines. “The types of logistical and administrative barriers physicians face when considering prescribing a specialty drug are very real and brand teams need to think about all aspects of that,” says Lindsay Reel, PharmD, vice president, pharmacy practice and specialty solutions, EVERSANA.

Tailored educational outreach and training goes beyond just sharing clinical evidence related to safety and efficacy and comparative effectiveness. It also involves helping prescribers to understand the critical role that biomarkers and other types of genetic testing may play to inform proper diagnosis.

Managing the PA process is always arduous and creates delays (and frustration) for HCPs and patients, especially when a denial requires an appeals process.

“Many prescribers give up after a PA is denied because they do not have the time and resources to spend appealing the decision,” adds Reel. “When the specialty pharmacy designs a system to automate and streamline the PA process and provides trained clinicians to guide the HCP through the appeals process, the physician is more likely to prescribe the therapy.”

Creating a support ecosystem that enables different types of automated and personal communication options is critical to maximize HCP engagement, notes Meghan Pasicznyk, vice president, product, Accredo by Evernorth. Such options include a centralized message center that coordinates outgoing notifications, announcements, and pending actions (such as PA status), two-way chat that allows registered HCPs to contact clinical representatives when necessary, and e-prescribing/renewable capabilities that function seamlessly with multiple electronic health record systems.

Addressing issues patients face to ensure affordability and adherence

Given the niche treatment that specialty therapies provide, patients are often left to combat high OOP payments that go beyond their deductibles. Those costs can sometimes be in the hundreds of thousands or even millions. Many specialty pharmacies provide "patient advocates" to help individuals navigate their own insurance coverage and explore other options that may be available for financial support.

“The ability to centralize access to the various copay and charitable foundation options for patients, while providing clinical specialists who may be able to help the physician to find an alternative therapy option, is an essential value-added aspect of any specialty pharmacy offering,” says Renee St. Jean, senior director of pharmacy services, Innomar Strategies (part of Cencora, formerly AmerisourceBergen). “It takes a lot of hand holding to plot the next steps to ensure that patients are able to receive the specialty medications that are prescribed for them.”

And such effort pays dividends. Consider, for instance, that in 2023, Accredo helped to coordinate $3 billion in copay assistance on behalf of its enrolled patients, according to Pasicznyk.

As for adherence challenges, the stakes are higher than ever when it comes to treatments for rare, chronic, and often life-threatening conditions. “The goal is to meet patients where they are, and provide personalized support to help them get on and stay on their prescribed therapy regimens,” adds MacLeod.

This includes helping patients and their caregivers to understand the disease; how the therapy works; how it is administered; what potential side effects they may experience and how to manage them; and what is needed to coordinate regular lab testing. St. Jean explains: “When trained personnel—who have deep clinical knowledge about the rare condition and the therapy in question—can be accessed through a centralized platform, it provides invaluable knowledge and reassurance to both patients and HCPs.”

Incorporating real-world evidence can also benefit specialty pharmacies. Gathering and analyzing such data helps identify patterns of non-adherence. This enables potential delivery of personalized interventions, such as, for example, condition-specific outreach by a clinical coach, notes Pasicznyk. She adds that in a recent pilot program to test such interventions related to chronic inflammatory conditions, “patients receiving at least one targeted outreach had up to 9% higher adherence rates.”

Despite ongoing advances in automation and digital efficiency, individual patients will need to speak with a person (i.e., nurse, pharmacist, benefits specialist) at certain points in their journey. “It’s about leveraging all of your data-driven insights and then deciding where to leverage technology versus the human touch,” says MacLeod. “This is something that the best specialty pharmacies are doing very well—truly understanding individual behaviors and preferences down to the patient level and then meeting them where they are.”

Hallmarks of a world-class specialty pharmacy offering

Specialty pharmacies play an integral role in bridging the gap between clinical trial data and real-world practice. To that end, data analytics is a differentiator. “By collecting longitudinal information on medication adherence, disease progression, side effects, clinical outcomes, and quality of life, the specialty pharmacy can help the brand team to assess the real-world effectiveness, value, and impact of their therapies over time and evaluate the effectiveness of the program offerings,” says Reel.

According to MacLeod, the best specialty pharmacies are those that build out their data-analytics capabilities to address three key objectives:

This includes specific metrics that track the time required for each service that is provided.

This includes tracking start/conversion rates, days to first fill, days on therapy, refill rates, etc.

Optimizing the experience for stakeholders: 

For medications that must go through several steps (and, hence, delays between prescribing and initiation on therapy), the specialty pharmacy should not only track each step of the process but should create protocols to communicate clearly along the way.

“Increasingly, specialty pharmacies are using their own integrated data to predict patients who face a greater risk of non-adherence so that brand team resources can then be focused in the most efficient way to help patients overcome the barriers they face,” adds St. Jean.

Advanced data analytics can help to segment patients according to specific attributes of their patient experience, for instance, recognizing those who are experiencing cost challenges versus those who are experiencing side effects or struggling with other social determinants of health. “This helps the specialty pharmacy to direct targeted messaging or support options that resonate much more directly,” says MacLeod. "Such targeted outreach helps to improve outcomes and reduce frustration for patients."

Patient engagement and support efforts aside, having strong cold-chain capabilities in place during product transport, is, of course, paramount in the handoff to pharmacies. In managing temperature-sensitive specialty therapies, the need to ensure failsafe door-to-door distribution is a top priority. “It’s important to choose a specialty pharmacy partner with extensive cold chain infrastructure and expertise,” says Reel. She adds that brand teams should verify that the pharmacies and distribution facilities they are partnering with have an up-to-date and comprehensive business continuity planthat will prevent any drug loss or delays.

“Sophisticated processes are needed to safeguard today’s high-value, temperature-sensitive therapies so they can remain stable and not jeopardize the potency and purity of the therapy throughout all stages of storage, distribution, and delivery,” says St. Jean. “Specialty pharmacies that developed a robust infrastructure during the height of the COVID-19 pandemic will benefit as a higher volume of specialty therapies continues to come to market.”

According to MacLeod, delivering specialty products to HCPs on a "near-real-time basis" helps to reduce risk for HCPs, who often don't have the infrastructure in place to guarantee maintaining the exact temperature specifications for storing high-value, fragile immunotherapies and cell and gene therapies onsite.

As for Accredo, the pharmacy believes in widespread testing of the temperature-sensitive products it handles, with SOPs to accommodate specific therapies.

“To support the unique requirements of specific ultra-low-temperature products, we customize our clinical and fulfillment models and establish drug-specific processes,” says Pasicznyk. “As part of our implementation process for new therapies, we also conduct extensive testing of ultra-cold-chain products. Test shipments are sent to multiple locations so that temperatures can be monitored, and appropriate packaging and overall product integrity can be validated.”

For specialty pharmacies and their distribution partners, the goal is to anticipate and address every issue that may arise for HCPs and patients—and then make the experience for both as seamless and as transparent as possible.

1. Advancing Health Through Innovation: New Drug Therapy Approvals 2023. FDA’s Center for Drug Evaluation and Research. 

https://www.fda.gov/media/175253/download?attachment

2. The Top 15 Specialty Pharmacies of 2023: Market Shares and Revenues at the Biggest PBMs, Health Plans, and Independents. Drug Channels Institute. April 16, 2024. 

https://www.drugchannels.net/2024/04/the-top-15-specialty-pharmacies-of-2023.html

3. How to Improve Specialty Drug Adherence for Patients with Inflammatory Conditions. Evernorth Health Services. November 3, 2023. 

https://www.evernorth.com/articles/improving-medication-adherence-inflammatory-conditions

When it comes to navigating the complex clinical and commercial landscape for specialty drugs—including hurdles in access to these critical but costly therapies—today’s specialty pharmacies are bringing more skills and services to the table.

Specialty Pharmacy: The Trends Shaping Best Practices

While it might not be as high profile as the consumer goods or food/beverage supply chains, the pharmaceutical supply chain is just as important—if not more so—and faces many of the same logistical challenges. Changing demand, evolving regulations, and general industry trends are forcing pharmaceutical logistics professionals to re-examine tried-and-true strategies through the lens of new technologies.

In particular, I see three challenges remaining top-of-mind for the pharma supply chain in the short, medium, and long-terms:

Short-term: Enforcement of the Drug Supply Chain Security Act

While it has been more than a decade in the making, the FDA appears to be on track to begin full enforcement of the Drug Supply Chain Security Act (DSCSA) come this November.

The DSCSA, designed to reduce the amount of counterfeit product reaching consumers, requires a multi-step verification process at each node along the supply chain. Manufacturers assign each prescription drug package a series of five serial numbers. Distribution facilities must be able to integrate their systems with the pharmaceutical manufacturer to ensure each package stored and shipped is consistent with the manufacturer’s serial numbers. And once the package reaches the pharmacy, the pharmacist must verify each packages’ serial numbers with the manufacturer’s serial numbers before filling any individual prescription.

The DSCSA’s thoroughness will certainly help provide peace of mind for patients, and it can help the pharmaceutical supply chain catch counterfeit drugs before they cause costly investigations and lawsuits. However, not everyone is ready for full enforcement. While pharma manufacturers and major drug store chains have the resources needed to obtain DSCSA-compliant serialization and electronic data interchange technology, smaller pharmacies may not be able to afford the upgrade.

The FDA has yet to offer a solution for these pharmacies. A January-February 2024 survey conducted by the American Pharmacists Association found only 14% of dispensaries were fully outfitted for compliance—and many of their respondents were independent pharmacies.

However, in a newer development, the FDA did issue an exemption until Nov. 27, 2026 for dispensers with 25 or fewer full-time employees that are licensed as pharmacists or qualified technicians.

Although the Healthcare Distribution Alliance has questions out to the FDA about how to help these pharmacies, there’s no solution in place yet. Logistics professionals should track FDA guidance in the coming months, including any delays of DSCSA enforcement.

Medium-term: Applying data to minimize supply chain disruptions

If there’s any message this decade has offered pharmaceutical supply chains, it’s “expect the unexpected.” COVID-19 interrupted manufacturing, then less than a year later tested Pfizer and Moderna as they worked to meet unprecedented demand for the COVID vaccine. More recently, the unexpected collapse of the Francis Scott Key Bridge forced immediate overhauls to traffic patterns, and increasingly intense weather could set production and delivery back weeks.

While logistics professionals may not be able to control the weather, they can leverage data to be better prepared for these events. Over the next few years, there will be a greater focus on building “control towers” within pharmaceutical supply chains, integrating both internal and external data to outmaneuver rapidly changing conditions.

For example, understanding which facilities are experiencing labor shortages can help pharma manufacturers prepare for product shortages and shift production if necessary. Monitoring the path of a hurricane can help manufacturers avoid shipping out time-sensitive product from an impacted distribution center.

Thinking globally, manufacturers are also likely to leverage external data to understand shipping patterns and requirements across countries. Tracking this information can help manufacturers understand when their product is likely to go through customs, while timing the shipment to avoid letting their product spoil because it arrived over the weekend.

Long-term: The logistical implications of more personalized medicine

As our understanding of disease has evolved, so has the pharma industry’s approach to treating patients. Drug manufacturers are moving away from one-size-fits-all medicines and toward treatments, such as injectables, engineered for specific patients. In fact, research suggests the market for injectable drug delivery is likely to grow at a compound annual growth rate of 8.6% through 2029.

But with the greater focus on more personalized medicine come new complications in how treatments are transported. Injectables require continual temperature control, so third-party logistics providers that are storing it need both extensive refrigeration space and monitoring technology to ensure the temperature never reaches unsafe levels—both expensive propositions. Shippers will need to invest in packaging that can keep injectables in safe conditions for long-distance travel.

In addition, delivery of more personalized medicine will require a strong chain of custody. In metropolitan areas, pharma manufacturers can tap delivery infrastructures through Amazon and similar companies to deliver sensitive medicines for the last mile. But in rural areas, where access to medical care can be more difficult to obtain, delivery is often outsourced to independent contractors, and there’s no guarantee their vehicles are equipped to deliver injectables safely. Chain-of-custody technology helps hold the entire supply chain accountable, and, in the event a medicine spoils, pinpoints where the lapse in safety occurred.

As the injectable drug delivery market continues to grow, pharmaceutical logistics professionals will turn their attention to how best to leverage these technologies—refrigeration, environmental monitoring, and chain-of-custody—while keeping their supply chain viable for more personalized medicine.

Challenges for a changing pharmaceutical industry

Moving medicines through the supply chain has always been a complex process, requiring added levels of security and environmental monitoring. But with the rollout of new regulations, and the shift to more personalized medicine, old strategies of shipping treatments simply won’t hold up to the scrutiny now placed on pharma logistics. In the short-, medium-, and long-terms, the onus will be on improved technologies—including serialization, refrigeration, and data control towers—to keep goods flowing smoothly and in line with stringent protocols. 

Tim McClatchy is Vice President of Life Sciences at Kenco.

1. APhA Survey Shows Dispenser DSCSA Implementation Slow, but Encouraging. American Pharmacists Association. February 23, 2024. 

https://www.pharmacist.com/APhA-Press-Releases/apha-survey-shows-dispenser-dscsa-implementation-slow-but-encouraging

Waivers and Exemptions Beyond the Stabilization Period

https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

3. Injectable Drug Delivery Market Size, Share, & Trends Trends by Type (Device, Formulation), Therapeutic (Infectious Diseases, Cancer), Usage Pattern (Immunization), Administration (Skin, Musculoskeltal), Distribution Channel, Patient Care Setting, & Region – Global Forecast to 2029. 

https://www.marketsandmarkets.com/Market-Reports/injectable-drug-delivery-market-150.html

Various forms of technology—including in the serialization and refrigeration spaces—are necessary in order to keep goods flowing smoothly through the supply chain. 

Three Key Pharmaceutical Logistics Challenges to Monitor 

Precision and reliability are paramount in the pharmaceutical industry. Every production aspect must be meticulously controlled to ensure the efficacy and safety of medications and vaccines. This level of control extends to distribution, where cold chain logistics are crucial to maintaining product integrity.

Do-not-freeze injectable drugs, including biologics (such as insulin) and GLP-1 class drugs, must be transported and stored under the right conditions to maintain their potency and quality. However, determining whether unacceptably low temperatures had occurred during transit can be challenging, as freezing isn’t always evident. Continuous monitoring is needed to comply with regulations, detect temperature deviations, take corrective measures, and deliver safe products.

When do-not-freeze injectable drugs are exposed to temperatures outside the ranges prescribed for storage and transport, their chemical and physical properties become altered. As a result, the drugs are less effective, potentially harmful to patients, and must be discarded.

Even the slightest temperature variation in the last mile of distribution can wreak havoc, spoiling entire batches of medicine. As you can imagine, such events create significant financial losses for pharma companies. IQVIA's Institute for Human Data Science estimates the biopharma industry loses about $35 billion annually due to cold chain logistics and temperature control issues.

The good news is that these losses are avoidable, provided you become more agile and adapt digital technologies for supply chain control and visibility.

Making last-mile distribution less daunting

Ensuring every batch of do-not-freeze injectable drugs is safe and high-quality doesn’t have to be daunting. Continuous monitoring lets you catch temperature excursions early and mitigate them before they become problematic.

You can track temperature fluctuations using two modern technologies:

 These cost-effective stickers change color to alert you when do-not-freeze injectable drugs are exposed to potentially damaging temperature levels. That way, you’ll know whether the drug has frozen and thawed during transit, even when it has no visible signs of having been frozen.

These cutting-edge devices continuously measure critical environmental profiles of pharmaceuticals and provide a full view of their journeys through the supply chain.

Temperature stability during transportation and storage

Real-time temperature monitoring and evaluation ensure that do-not-freeze injectable drugs are within the proper range in the last miles of their journeys, which is essential. Deviations must be reported and inspected immediately when they occur.

Cold chain logistics managers must use the right solutions for the product being shipped at every stage of the supply chain. Single-use indicators are most valuable during the last mile, as they are more easily read by distribution staff and end users. Conversely, devices with minute-by-minute connected alerts and robust analytics capabilities are preferable for continuously monitoring the entire supply chain.

In addition, everyone involved in last-mile distribution should understand their respective job and its far-reaching consequences. This can be achieved through regular, comprehensive training programs that cover the procedures for handling temperature-sensitive drugs and when there is an alert of a temperature excursion.

The training should be tailored to each personnel’s role and give them a thorough understanding of temperature control best practices and the effect of excursions on drug quality and safety. Evaluation should be done at the end of the training to guarantee adequate learning.

Efforts should also be made to keep workers updated with relevant regulatory compliance and industry standards.

The regulatory landscape governing drug distribution

Maintaining a secure and safe cold chain is critical to the safety of pharmaceutical supply. For this reason, the distribution of healthcare-related products is highly regulated.

As the quantity of temperature-sensitive drugs increases, there’s a shift toward standardizing pharmaceutical distribution regulations. In the US, the FDA outlines its standards for distributing healthcare-related products within its current good manufacturing practices. The document stipulates best practices for transport, packaging, labeling, record-keeping and personnel training.

Similarly, the EU’s Good Distribution Practice of Medicinal Products for Human Use requires cold chain logistics stakeholders to ensure the integrity and quality of medicines by adhering to the storage conditions prescribed by manufacturers.

Understanding the regulatory and logistical requirements for do-not-freeze injectable drugs and implementing cold chain management best practices in the last mile helps prevent product degradation, ensuring products reach end users safely.

There’s no doubt that keeping do-not-freeze injectable drugs stable from manufacturing to the last miles of their journeys is essential. Combined with the right techniques and employee training, modern temperature monitoring devices can help ensure success in last-mile distribution—and provide an edge in cold chain logistics.

Bill Sanez is Director of Global Marketing at SpotSee.

Alongside the proper temperature-monitoring technology, optimal production control is necessary for success in cold chain drug delivery. 

Keeping Do-Not-Freeze Injectable Drugs Safe Through the Last Mile 

In some industries, mergers and acquisitions (M&A) are relatively infrequent, single events. Not so in the pharmaceutical world, however. The relationship between Big Pharma and the smaller companies that populate the pharma ecosystem is synergistic. With the pace of technological development increasing and the need for new products a constant driver of investment, M&A in the sector is a routine and essential part of the business.

Smaller pharma companies have an outsized impact on drug development, reportedly accounting for 63% of all new prescription drug approvals over the past five years. These nimbler companies bring and shape the seminal concept and conduct early-stage R&D, but lack the resources to take their products further in the drug development/regulatory process. Typically, these organizations partner with Big Pharma companies that benefit from de-risked technologies, and which have the deep pockets and global presence to effectively market the end product.

Still, many ventures are unsuccessful, and a lot of money, resources, and potential health benefits are on the line. It’s critical that buyers take a disciplined approach to M&A integration that sets the stage for maximizing the value of every acquisition.

Ahead, we will discuss the key elements of successful M&As.

For a deal to be done well, buyers need to understand the value of the asset in question and have a broad vision of how the asset integrates into their operation. Once the transaction is completed, buyers must build out the larger, market-based vision of why they are making the purchase, how the new operation will fit into the current organization, and what that will mean for other parts of the business. This vision should include not only the financial or operational benefits, but also how the acquisition will strategically position the company in the market, enhance its product portfolio, and address unmet customer needs.

Once senior management has aligned on what the vision is, they need to put to paper the elements of their plan for integration by communicating both the vision and the plan to the organization in a way that creates excitement and enthusiasm. What’s critical here is building a value narrative and having key leaders talk about the acquisition transparently—a subject that, up to the signing of the deal, was off-limits. Targeted communications to different levels of the organization can help ensure everyone is on the same page. Clear communication should also extend to external stakeholders, including customers, partners, investors, and regulators, who may need reassurance about the cost and value of the acquisition.

Identifying best-in-class leadership and process

Along with articulating and disseminating the narrative behind the acquisition and the plan for bringing that vision to life, a key element for success involves identifying best-in-class individuals and processes that were part of the acquired organization. While most acquiring companies make an effort to identify people in the acquired organization that are key to realizing the new asset’s potential, it’s rare that a determined effort to identify individuals who really are standouts in their area of responsibility takes place—and it’s even more unusual for acquirers to evaluate key processes evolved by the acquired organization. Too often, the assumption is made that “big is better,” which short circuits any idea of finding individuals and practices that could offer competitive advantage. But if maximum value is to be realized from an acquisition, this step should be part of your plan.

Making changes in structure and reporting relationships

In bringing together two separate companies, M&A usually results in a changed organizational structure. This can involve merging departments, eliminating redundancies, moving teams and restructuring manager/employee relationships. Leadership must decide how value and efficiency can be maximized. Here, too, forthright communication is key. This helps avoid confusion, maintains productivity, and ensures everyone knows who they report to, who their new team consists of, and how decisions will be made moving forward.

Aligning the processes and ways of working between the two companies is essential to minimize friction in operations. This involves assessing existing workflows, identifying overlaps or inefficiencies, and establishing new processes that incorporate the strengths of both organizations. Teams may need to adopt new methods of decision-making, internal processing, collaboration methods, or project management approaches. This often includes integrating technical systems, such as internal communication tools, tracking software, data platforms, etc. Ongoing communication and support strategies that reinforce new procedures help make these changes stick.

Cultural alignment is an essential and challenging part of M&A. Merging companies often have different approaches to communication, decision-making, process, and a myriad of other things. Leaders must articulate the desired culture, model it themselves, and put in place mechanisms that integrate the new culture at all levels. This might involve taking the best of what worked at both companies to create something new or transitioning the new acquisition into the culture of the purchasing company.

The size of an acquisition often determines how challenging its integration will be and what strategies a company should employ. A smaller acquisition might be absorbed easily, without significant restructuring. A larger deal, on the other hand, may require months of careful planning and significant changes to processes, protocols, and organizational structures. Larger acquisitions tend to involve more people, making alignment across teams more of a challenge and maintaining consistent communication even more critical to success. Whatever the size of an M&A deal, having a clear strategy and staying flexible in execution are key to ensuring long-term value and a smooth transition.

M&As are essential components of the pharmaceutical market. Long-term success as a business in this sector often means effectively navigating these changes. Successful M&A operations depend on strong leadership, disciplined planning, and clear communication. By aligning vision, culture, and processes across both organizations, companies can maximize their acquisitions, bringing value to company personnel, shareholders, and ultimately, customers. 

Michael Abrams is a managing partner at Numerof & Associates.

How can buyers maximize the value of their acquisitions?

Key Elements for Success in Pharma M&A Integration

To lower out-of-pocket (OOP) costs of prescription medications for people enrolled in Medicare and to reduce drug spending by the federal government, several key changes to the Medicare Part D benefit were made possible with the passage of the Inflation Reduction Act (IRA) in 2022. Two of the IRA’s most important provisions will go into effect on Jan. 1, 2025—a $2,000 cap on OOP drug spending for all individuals with a Part D plan, and the opportunity to opt-in to the Medicare Prescription Payment Plan and spread costs throughout the year. This program is being offered by Part D plan sponsors.

As a result of these Part D benefit changes and the increased financial burden on Part D plans, many are concerned about the unintended consequences on patients, such as the potential for increased Part D premiums. The IRA does address this concern by implementing a premium stabilization program, beginning this year through 2029, limiting increases in the Part D base beneficiary premium to 6% growth each year. For 2025, the base premium is $36.78, an increase of $2.08 or 6% over the 2024 base premium. It is important to note, however, that this 6% cap does not apply to individual premiums that plans charge. In fact, a recent analysis by Avalere illustrates that Part D Plan premiums are increasing by double digits.

An increase in Part D plan premiums of double digits has been reported by Medicare beneficiaries themselves. A recent national poll from the PAN Foundation’s Center for Patient Research finds that nearly one in three (28%) Medicare beneficiaries enrolled in Part D plans say the cost of the monthly premium for their prescription drug plan is higher in 2024 than it was in 2023.

Among those who reported an increase, 11% say their premiums increased 16% to 20%, while 10% say their premiums increased by more than 20%. Unfortunately, two in five (40%) of Medicare beneficiaries enrolled in Part D plans say they have financial difficulty affording the monthly premium for their prescription drug plan.

What can be done to stabilize premium growth and make costs more affordable for patients?

The annual open enrollment period (Oct. 15 – Dec. 7) presents an opportunity for Part D enrollees to compare plans for lower-priced coverage that meets their needs. According to the Kaiser Family Foundation,Medicare Advantage drug plans are anticipated to have lower monthly premiums than stand-alone drug plans.

The variability in monthly premium costs was a driving factor behind a new voluntary premium stabilization demonstration program announced in July by the Centers for Medicare & Medicaid Services (CMS) for stand-alone Part D plans. The demonstration program has three components for the plans that choose to participate:

It lowers the base beneficiary premium by $15 (or less if a $15 reduction would result in a plan premium of less than $0).

It limits total Part D premium increases to $35 between 2024 and 2025 (applied after considering the $15 reduction).

It offers enhanced protection by the federal government against the risk of losses for stand-alone plans.

Overall, this demonstration program hopes to stabilize the Part D plan market in the initial transition years of the IRA’s Part D benefit changes and to test whether the premium changes improve the efficiency and overall economics of the Part D benefit changes.

Finally, charitable foundations such as the PAN Foundation offer financial assistance to eligible individuals to help cover their insurance premium costs. As OOP costs for prescription medications start to decrease, but other costs, such as Part D plan premiums, continue to be a burden on Medicare beneficiaries, this kind of assistance will become even more important.

We all look forward to monitoring the implementation of CMS’s demonstration project and hopefully see that over time, premiums for stand-alone plans begin to stabilize, because swapping one high healthcare related cost for another won’t end up helping patients in the long run. 

Amy Niles is chief mission officer at PAN Foundation.

1. Part D Premiums Increasing Despite Stabilization Program. Avalere. October 17, 2023. 

https://avalere.com/insights/part-d-premiums-increasing-despite-stabilization-program#:~:text=In%20a%20recent%20analysis%2C%20however,for%20the%202024%20plan%20year

2. National Polling: Medicare Patients Seeing Premium Costs Increase in 2024. PAN Foundation. March 29, 2024. 

Why looming benefit changes—and the resulting unintended consequences—are a concern for patients.

Pharmaceutical Commerce - October 2024