Keith Loria

Keith Loria is a contributing writer to Medical Economics.

The generic pipeline continues to provide significant value to payers and patients as key products in top therapeutic classes lose patent protection.

Matt Gibbs, PharmD, president of commercial markets for Capital Rx, Inc, said although the second generic wave peaked in 2018, many impactful generics entered the market over the past 12 months—most notably, the launch of multiple generics for pregabalin (Lyrica; Pfizer) in July 2019.

“Because there wasn’t a single generic with a 180-day exclusivity period, it resulted in an immediate significant price drop for payers and patients,” he said. “Fourth quarter 2019 also saw the first generic for popular contraceptive NuvaRing enter the market, providing patients who prefer a nonsystemic contraceptive a generic option. This will also benefit payers providing $0 contraceptive coverage to their members under the Affordable Care Act, as brand NuvaRing is a key driver of plan spend in the contraceptive category.”

Early 2020 saw the return of generics to the market for albuterol rescue inhalers ProAir HFA and Ventolin HFA. Generic albuterol inhalers utilizing chlorofluorocarbon propellants existed in the market by the late ’90s, but the requirement to change to alternate propellants shifted these products back to brands.

“The availability of generics in the class will benefit both patients and plans in mitigating spend in the asthma category,” Gibbs said.

He feels the biggest notable generic coming in 2020 is the availability of generic emtricitabine/tenofovir (Tru

vada; Gilead) for use in HIV preexposure prophylaxis (PrEP).

“As plans begin to implement $0 ACA coverage for PrEP, the availability of generic Truvada will significantly decrease overall cost to plans as we see awareness of and access to PrEP improve across the US,” Gibbs said. “This improved awareness and focus on access to PrEP is one step in the global and US goals of getting to zero new HIV transmissions by 2030.”

Ryan Schmidt, associate director of formulary services for Madison, Wisconsin–based Navitus Health Solutions, says that overall, the generic market this past year has been relatively slow.

“There haven’t been many blockbuster generic releases, and the ones that hit the news are generally ‘authorized generics,’ where the manufacturer of the generic product either has an agreement with the brand manufacturer, or in some instances is the brand manufacturer,” he said. “The other thing that limits impact of these releases is a lot of them have come from classes with multiple alternative generic options already, meaning the amount of use in the brand space has been limited.”

Ross Goetz, PharmD, director of business development and national pharmacy compliance administrator for Healthwarehouse.com, noted that digital companies with direct-to-consumer models have increased access to generic medications at an affordable price, making generic drugs more desirable to the consumers opting to manage their own cost portfolio.

Still, when referring to abbreviated new drug application (ANDA) approvals,or first-time approvals of generic drugs, he calls 2020 “a weak year,” citing a few HIV therapies pending generic launch, and the generic for varenicline (Chantix; Pfizer), which has been delayed since the initial date. At press time, the FDA has so far approved 35 first-time generics.

 In 2019, the FDA approved 107 first generic drugs out of a total of 1014 approved or tentatively approved ANDAs, according to the 2019 Office of Generic Drugs annual report.

Shashank Upadhye, JD, a pharmaceutical patent attorney with Chicago, Illinois-based Upadhye Cwik LLP, who has practiced in generic drug law for more than 20 years, said it’s been a tough year for companies that are in just traditional, simple solid oral dosage forms.

An exception, he noted, is Mylan, which obtained recent approval for its biosimilar for insulin glargine— called Semglee, which is a biosimilar to Sanofi’s Lantus insulin.

“Mylan had won some patent litigation and thus had removed the patent obstacle. But it finally won FDA approval for its pen and vial product,” he said. “Mylan [and its production partner Biocon] had some troubles getting approval. It is a complex product, and thus it was not a question of simply copying the Lantus product. Now patients have new options, with hopefully better pricing, now that the FDA has approved more insulins.”

The most notable generic products, Schmidt shared, have not had the major financial impact one would typically expect over the last year.

“Generic insulin products offer significant price decreases for those 

patients without insurance, reducing prices to where they were back in 2012,” he explained. “However, rebates offered on the original brand products still make the brand medications less expensive to plans in most situations, meaning we haven’t seen these have impact on overall spend.”

Similarly, a number of generic inhalers have come to market for common products such as Advair, Symbicort, Proair, and Ventolin. Although the increased competition has had some impact on overall spending, major savings opportunities haven’t risen yet, as the complexity of these devices have prevented a scenario where multiple low-cost generic products are available.

Experts agree that there is an unmet need for more less expensive, generic versions of complex medications in the market.

“Significant savings to payers and the federal government from approving more generic versions of complex medication could be realized,” Bob Lobo, PharmD, director of clinical programs at Vanderbilt University Medical Center, Nashville, Tennessee, told 

 He cited a recent study on the economic burden associated with extended-release (ER) versus immediate-release (IR) formulation among Medicare and Medicaid beneficiaries, in which the findings showed a potential annual cost savings of $2.6 billion by switching certain ER drugs to comparable generic IR formulations.

 The study looked at only 20 ER oral medications, but it suggests that the annual savings from greater access to generic medications are quite significant.

According to Schmidt, the drug with one of the largest effects on spending in the past 12 months has been pregabalin, the generic equivalent to Lyrica.

“There were multiple manufacturers ready to go at launch, meaning costs for the generics were significantly lower than the brand at launch,” he said. “This is important as it helps drive down patient cost, regardless of copay or coinsurance, helping to facili

tate conversion to the generic product, saving both the patient and the plan money right away.”

Conversely, ramelteon, Rozerem’s equivalent, was first released at a similar time, but due to lack of competition in the market, has retained a higher cost relative to other generic medications in the class.

“Pregabalin has dropped in price by over 95% compared with brand Lyrica, [which also took an approximately 5% price increase on January 1, 2020,] and is covered nearly universally,” Schmidt said. “Ramelteon, on the other hand, still costs close to $100 per month.”

Goetz agreed that pregabalin has been the most significant generic over the past year.

“When you look into medications for nerve pain, there is not a great depth of options. Outside of narcotic pain medications, gabapentin stood as the most cost-effective option,” he said. “Although gabapentin comes tied with challenges like a notable [adverse effect] profile, it is often the drug of choice on insurance formularies. For those who rely on their insurance coverage to afford medications, paying for brand name Lyrica was simply not an option. Now available as generic pregabalin, patients can more comfortably elect to switch away from gabapentin without a major cost burden, if any.”

Due to the coronavirus disease 2019 (COVID-19), the FDA has stopped conducting foreign inspections. Given that more than 80% of the generic drugs sold in the United States are made outside the country, the lack of inspections has resulted in delayed or aborted new generic drug launches.

Upadhye said COVID-19 has caused several problems, including decreased profitability for existing generic companies’ products; increased price pressures by the buyers who them- selves are facing business pressures; pressures on existing patent litigation to either do very little to advance the case or to settle the case quickly on whatever terms being offered; and the FDA’s refusal to conduct foreign 

inspections, resulting in delayed or aborted new generic drug product launches or delays in relaunches.

It’s not a surprise that the pandemic is affecting the generic drug market, as when the disease was spreading rapidly in March, there was a major rush to refill medications, leading to a large increase in claims and even shortages. This was immediately followed by a drop-off in overall claims volume, which is now returning closer to normal.

“One major shift is from 30-day claims to more patients getting 90-day supplies via delivery or mail order,” Schmidt said.“The interesting component of this is that maintenance medications seem to have rebounded well, whereas acute medications aren’t rebounding quite as quickly. This isn’t as surprising, as many elective clinical visits are being delayed, and general improved health precautions are likely leading to less non-COVID infections.”

From a new product perspective, the FDA is still in full swing, and the industry has continued to see new approvals of both brand and generic products. The impact of these new releases may be seen a couple of years down the road as some clinical trials have gone on hold or been delayed due to COVID-19.

Goetz believes the market is shifting heavily toward convenience and safety over price alone.

“Utilization of telehealth services reached an all-time high in April 2020, while ambulatory prescriber practices were down roughly 60% in office visits,” he said. “Now that patients are more aware of the options available, it can be expected that they will consider the financial and personal impact of each option as they weigh their plans for their future. As we have seen with many areas of modern commerce, the power is no longer with the large chains with storefronts in every area; it falls with the companies who can provide a service at a fair price, with a larger focus on convenience than ever before.”

1. FDA. First generic drug approvals. Updated July 14, 2020. Accessed August 12, 2020. 

https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals

2. FDA. 2019 Office of Generic Drugs annual report. February 2020. Accessed August 12, 2020. 

https://www.fda.gov/media/135329/download

3. Schieszer J. Barriers coming down for complex generic drug products. 

®. April 14, 2020. Accessed August 12, 2020. 

https://www.drugtopics.com/view/barriers-coming-down-complex-generic-drug-products 

4. Sumarsono A, Sumarsono N, Das SR, et al. ​Economic burden associated with extended-release vs immediate-release drug formulations among Medicare Part D and Medicaid beneficiaries. 

2020;3(2):e200181. doi:10.1001/jamanetworkopen.2020.0181

Articles

A Look at the Year in Generics

Awareness of artificial intelligence (AI) is increasing throughout health care. Relative to pharmacy, the American Society of Health-Systems Pharmacists Foundation’s “Pharmacy Forecast 2020: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems” specifically lists the emergence of AI in its report, inspiring industry discussion and guiding the strategic planning processes of health system pharmacy leadership across the country.

For pharmacy, AI provides information on drug interactions, drug therapy monitoring, formulary selection, costs, usage trends, and more.

“AI is already transforming health care but will become increasingly valuable as investments in systems that can capture and manage data are made and clinical informatics entities work more collaboratively to address current data shortfalls,” said Doug Zurawski, PharmD, senior vice president of clinical strategy at Kit Check, Inc, maker of radio frequency identification (RFID)/AI technology for hospital pharmacies to help with medication management. “It is incumbent upon us, in this industry and in this field, to take the lead and learn more, invest in systems that support AI and machine learning, and prepare for the future with access to artificial intelligence.”

Deborah Sadowski, MHA, RPh, director of pharmacy services at Deborah Heart and Lung Center in Browns Mills, New Jersey, said IBM estimated back in 2011 that there were over 161 billion gigabytes of data in the entire health care arena, which she projects has easily doubled by now.

“We are seeing more and more pharmaceutical companies looking to leverage AI and machine learning solutions to translate their data into therapies that have a better chance of benefiting patients.” 

“It is impossible to manage that much information safely and efficiently with the human mind, so it is essential that we incorporate AI as a tool to help us better care for patients—be it preventing medication errors, managing pharmacogenomics applications for better medication choices, or doing prospective cost analysis for treatment choices—all by processing billions of bits of information efficiently and quickly,” she said. “It is key to remember however that AI is a tool to supplement knowledge and should be used in conjunction with, not a replacement for, the clinical judgment and human experience that the pharmacist or other health care provider brings to the table.”

Vin Singh, MBA, MS, the CEO of Gaithersburg, Maryland–based BullFrog AI Holdings, Inc, a precision pharmaceutical company built around an AI platform, noted that pharmaceutical companies have been plagued for years with vast amounts of data, but most do not have the proper technologies to analyze it all.

“We are seeing more and more pharmaceutical companies looking to leverage AI and machine learning solutions to translate their data into therapies that have a better chance of benefiting patients,” he said. “By combining experts in machine learning and AI with subject matter experts in pharmaceutical and health industries, we can approach it with an open mind and share strategies from a multifunctional perspective.”

Wolf Ruzicka, MBA, chairman and IT innovator for Washington, DC–based EastBanc Technologies, said AI can be used to search for similar chemical molecules to already known drugs in huge existing databases.

A new application is to use AI technologies to analyze large clinical trial data sets to link certain responses and adverse effects to individual genetic markers.

“The goal is to find new drugs with similar treatment properties but less expensive or with less [adverse effects],” he said. “As a result, we can determine which patients could be treated successfully, in some cases lifesaving, while for other patients the drug may not be useful.”

AI represents an innovative way in which entrepreneurs and health care professionals are reinventing the US health care system to better serve patients, which is why many in the pharmacy industry are embracing AI offerings today.

Health care technology company DrFirst recently released its next-generation, patented SmartSig AI technology to improve the quality of patient medication history when it is imported into hospitals’ and health systems’ electronic health records (EHRs).

SmartSig 2.0 accurately translates nearly 93% of incoming prescription information, saving up to 30 seconds of work for each drug entered during the medication reconciliation process.

Rebecca Sulfridge, PharmD, an emergency medicine clinical specialist with Covenant HealthCare in Saginaw, Michigan, credits the new technology with helping to minimize additional patient risks and protecting staff from unnecessary face-to-face exposure during the influx of patients with coronavirus disease 2019 (COVID-19) over the past few months.

“We are spending less time reconciling medication histories manually, and in the first month of use, we recaptured an additional 15% productivity per shift, which represents approximately $650,000 per month, while also improving patient safety and outcomes,” she said. 

Tom Knight, MBA, MS, the CEO of Invistics Corp, a Peachtree Corners, Georgia–based software company working with AI, explained that machine learning is being used to create drug diversion prevention software solutions that are self-learning.

“The goal is to prevent diversion from happening at all, and employing AI-powered technology is a huge step toward this goal—it can catch policy violations and program loopholes before a diversion even occurs.” 

“This is very important to pharmacies and health care facilities as they work to detect and prevent employees from stealing medications, also known as drug diversion,” he said. “Machine learning allows solutions to learn from past diversion incidents, so they become better and better at detecting potential diversion incidents.”

For example, machine learning technology can pick up on isolated incidents that are aligned with known patterns of diversion, such as if a pharmacist is filling prescriptions for oxycodone 3 times more frequently than their colleagues, and synthesize that information with other data, such as reports of suspicious activities from pharmaceutical technicians, and create alerts for managers, or drug diversion specialists. Therefore, drug diversion incidents that might have taken weeks to discover before can be found in hours.

Kara Earle, MBA, MS, senior drug diversion specialist at FairWarning, which works with hospital pharmacies on their drug diversion programs by using AI to help prevent new diversion cases, says she’s seeing a strong push from pharmacies looking to replace older technologies that require manual processes with new, AI-powered technology to streamline workflows.

For example, Mount Sinai in New York, New York, employs FairWarning’s Drug Diversion Intelligence to monitor all daily transactions and detect irregular behavior such as unusual access of controlled substances, medication access after termination, and inventory discrepancies.

“AI has the ability to handle large quantities of data and cross-reference data from multiple systems, so it helps to automate manual steps and increase visibility into the movement of medications to create a broader monitoring picture,” Earle said. “These benefits are big drivers in why today’s pharmacy should be investing in AI-powered technology like drug diversion monitoring.”

Although the impact of AI is growing, Zurawski noted that a lack of standardization in EHRs and regulatory hurdles sometimes hinder access to sufficient volumes of reliable data to effectively inform advanced computing applications.

In the years ahead, he believes clinical informatics, vendor cooperation, and collaboration will help address some of the gaps in data access.

Earle noted AI will continue to evolve, and models will become more effective at identifying diversion before major problems arise.

“The goal is to prevent diversion from happening at all, and employing AI-powered technology is a huge step toward this goal—it can catch policy violations and program loopholes before a diversion even occurs,” she said. “For instance, incorrectly provisioned security settings on dispensing cabinets, users not following proper wasting 

procedures, or nurse managers failing to follow up on open discrepancies are all typical policy violations that may indicate diversion. Identifying those policy gaps early can prevent diversion and save lives.”

During the coronavirus disease 2019 (COVID-19) pandemic, it is very likely that decisions are being driven by vast amounts of data being accessed from around the world. Health care AI gives providers, administrators and others access to data sets of information (eg, patient demographics, length of stay, treatments and outcomes, costs, geography, survival rates).

“Because AI can identify and analyze trends from data and predict, via machine learning from vast amounts of data, it is highly plausible that AI is already being used to strategically plan for redeployment of resources and space—an application of AI extremely useful during crises like the COVID-19 pandemic,” Zurawski said.

Singh noted that the pandemic requires quick solutions that only AI can bring. “AI can help speed up the drug development process without jeopardizing safety and accuracy,” he said. “The benefits that AI can bring to help tackle the COVID pandemic have yet to be fully realized, and it has the potential to serve as a valuable and irreplaceable tool. Global infectious disease challenges will continue to spawn, and having AI tools that can prevent or minimize the damage to public health is essential.”

Additionally, the change in workflows during COVID-19, such as staff assignments and the addition of contract, travel, and float nurses, have made manual monitoring methods almost obsolete.

“Pharmacies need the ability to track medication usage across departments, and even system-wide and near to real time as possible, which AI is capable of accomplishing,” Earle said. “One of our Drug Diversion Intelligence customers was able to identify diversion and medication tampering by a travel nurse who was hired during COVID-19 within 10 days. This allowed the hospital to minimize any impact to patients and fully investigate and remediate the incident in a fraction of the time it would have taken them with manual processes.”

Vermeulen LC, Swarthout MD, Alexander GC, et al. ASHP Foundation Pharmacy Forecast 2020: strategic planning advice for pharmacy departments in hospitals and health systems. 

. 2020;77(2):84-112.doi:10.1093/ajhp/zxz283

An examination of how this innovation is affecting pharmacy.

The Rise of AI

One of the most nerve-racking aspects of any job is a discussion about a raise or better hours or working conditions, as most individuals are shy about advocating for themselves. Still, hardworking pharmacists like you need to ask for what they deserve, whether it be a higher salary, weekends off, or another perk they consider essential.

Here are 5 tips on how pharmacists can get what they want.

“Whether it’s a new position you are seeking or [negotiations about] your current position, remind your employer why you are the right person for the job, what strengths you bring, and how you will make others around you better practitioners,” said Alex Luli, PharmD, BCACP, assistant clinical professor at the University of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences, who also practices in a community pharmacy. Be prepared to show the impact your work has made on the pharmacy. “Besides obtaining feedback from other colleagues, ask the patients or customers,” Luli said. “They can be very powerful advocates when they mention the great care you have given them, and many will be glad to help you out.”

Also remind your employer about a project for which you went above and beyond or a tough situation that you helped resolve, even when it was inconvenient for you or not part of your job responsibilities. If your boss is a stats person, then walk through the door with your figures in hand and show your worth in dollars. If you know what buttons your boss likes pushed, go ahead and push them.

Whether you talk with your fellow pharmacists or look to peers on a message board or in pharmacy group, ask others when they requested a pay raise, what they said, and how they prepared. Take aspects of their winning formula and adopt it to your approach.

Sure, a bigger paycheck is always nice, but consider asking for perks such as better hours and benefits. Luli noted that these negotiations often involve quite a bit of wiggle room. “Many people focus only on salary when negotiating, but there are many other things your employer may be able to provide that are valuable,” he said. “How about discussing increasing your vacation time? Maybe the ability to work remotely 1 or 2 days a week?”

Other options include reimbursement for parking fees, tuition reimbursement, and even moving responsibilities off your plate so you can focus on more rewarding aspects of your job. Discussing these benefits can always be framed as a benefit to not only you but also your employer or team,” Luli added.

Pharmacists are critical health care providers, and you may think you are irreplaceable, but that doesn’t mean you should threaten to quit if you don’t get what you want. Aaron Gilbert, PharmD, a pharmacist in Louisville, Kentucky, noted that today’s employers hold most of the cards because the pharmacy industry is currently a saturated market. “As long as there are enough pharmacists willing to do the unreasonable tasks that are demanded, the employer will have the upper hand,” he said. “I recommend more pharmacists look for employment in places where reasonable expectations are set and hours are more in line with what they desire, even at the expense of higher pay. When there are not enough pharmacists who will do what the [what some of the big chain pharmacies] of the world are demanding, only then will change happen.

Finally, remember to simply ask for what you want—because chances are your boss won’t just hand you raises and benefits. If your employer can’t offer what you’re asking for now, maybe they can in the future. Discuss the key metrics of your evaluation and how you can best fulfill them. That way, when the timing is right and you spark up the conversation again, you will have some leverage in getting what you deserve.

Asking for better pay, hours, or work benefits can be intimidating for pharmacists, but these strategies can help you get the rewards you deserve.

5 Tips for Negotiating Perks

“Pharmacy compounding is the best option for many of our patients who have conditions or needs that are not met with manufactured medication and, in 2020, even more important,” said Almaz Dawit, PharmD, founder of CortexRx Compounding Pharmacy in La Jolla, California. “Compounding pharmacies have stepped up and provided much-needed sanitizer and other supplies that fell short due to COVID-19, highlighting the need for their existence even more.”

Although compounding has experienced a severe and drop in coverage by shortsighted payers

, the events surrounding the COVID-19 pandemic have demonstrated the worth of having ready and capable compounding pharmacies,

 according to Jesse C. Dresser, Esq, partner at Frier Levitt, a pharmacy law group in New York. “From mixing hand sanitizer to ensuring a steady supply of [drugs] for patients in dire need, compounding pharmacies have more than proved their worth in the midst of this crisis,” he said. “But ultimately, the value and importance of pharmacy compounding in 2020 go far beyond safeguarding against medication shortages and continue to play a vital role in fulfilling unmet medication needs for individual patients and health systems alike.”

“Independent ownership is difficult in this time but also has its advantages for those who want to think outside the box.”

From nonsterile to sterile compounding, there has never been a greater need for flexibility while maintaining the highest safety standard, with the most robust policies and standard operating procedures to back it up, said AJ Rivosecchi, PharmD, director of clinical solutions at Kit Check.

“The situation pharmacies find themselves in with unpredictable, ongoing, and pervasive shortages has in many cases taken what may have been a decision on buying finished goods versus compounding based on ability and economics and made it a necessary reality of daily life to maintain standards of care,” Rivosecchi said. “Coupling this increased need with the rising regulatory bandwidth being paid to sterile, nonsterile, and hazardous compounding makes pharmacy compounding a top priority in terms of importance for pharmacies around the country.”

From FDA-enforced current good manufacturing practices at the manufacturer level down to individual state boards, there is no dearth of regulations in the compounding space.

P [United States Pharmacopoeial Convention] chapters 795, 797, and 800 are forefront on the minds of pharmacy leaders,” Rivosecchi said. “[USP general chapter

] 795 covers nonsterile compounding, 797 covers sterile compounding, and 800 covers hazardous drug handling. This trio of regulations, when taken together, has had the biggest impact on the industry.”

Pending revisions to chapters 795 (last updated in 2014) and 797 (last updated in 2008), as well as the official adoption of chapter 800 on December 1, 2019, have guided decisions in the compounding space for the past decade. 

Between the proposed revisions and the official version of USP 800, the industry has never before had so much guidance for ensuring both patient and employee safety. Rivosecchi calls that a “real win” for the industry because it will help standardize best practices and prevent bad actors from skirting more lax regulations. However, these mandates are largely unfunded, and good actors, who aim for compliance and maintenance of best practices, may not have adequate capital to invest to meet new regulations.

“The USP, along with state agencies, regulators, and oversight organizations, [all affect] the industry; the difficulty for pharmacies is that there is no firm consensus of exactly what or when ultimate requirements will be stipulated and/or exactly how they will be enforced,” Rivosecchi said. “There is often significant capital expenditure, in excess of $500,000 even for a midsize hospital pharmacy, which accounts for millions within a health system, that is invested to meet requirements that do not yet exist.”

The biggest challenge the regulations pose to the industry is lack of clarity. For example, although traditional compounding pharmacies are directly regulated by state boards of pharmacy, which inspect, license, and discipline according to state police powers, the FDA retains jurisdiction to regulate the manufacture of new drugs.

“From mixing hand sanitizer to ensuring a steady supply of [drugs] for patients in dire need, compounding pharmacies have more than proved their worth in the midst of this crisis."

“In examining whether a compounding pharmacy is engaged in the improper manufacture of drugs, the FDA’s authority and jurisdiction are often ill defined, and if the FDA determines, in its discretion, that the pharmacy is acting outside the scope of a traditional pharmacy, it may seek to apply higher standards more normally associated with drug manufacturing,” Dresser said. “This could, in turn, lead to additional and unforeseen disciplinary action being taken against the pharmacy.”

In lieu of promulgating formal regulations, the FDA has opted to issue industry guidance on intended regulatory enforcement. It has taken the FDA several years to “finalize” much of this guidance, Dresser said; at press time, the memorandum of understanding addressing the interstate distribution of compounded medications has not yet been finalized and adopted by states and the FDA.

Industry insiders noted that success in compounding involves understanding the landscape and asking key questions: “What does the market need? Where does it need it? How do I meet that need efficiently to allow me to comply with all relevant regulations?”

“To answer those questions, you must consider what’s already commercially available; what the FDA has deemed appropriate for compounding due to shortages; what is the cost of your materials, labor, and maintaining compliance; and, ultimately, where is the balance that makes all these things an attractive target and leads to success,” Rivosecchi said. “The demand is clearly there, so that much is known—the true key to being successful in this space, whether in a hospital or in a commercial application, is identifying what demand you can meet safely and efficiently.”

According to Dawit, success lies in the ability to meet the specific needs of patients who can pay cash for tailored medications and in being innovative and targeted when selecting products. She also noted the importance of visibility to practitioners who support patients whose needs are not met by typical retail pharmacy.

Dresser listed 3 crucial steps toward success: (1) Institute robust procedures that ensure compliance with all applicable forms of regulation. (2) Identify a workable business model in the wake of coverage restrictions. (3) Avoid common legal and regulatory pitfalls.

Pharmacists who want to get involved in compounding should learn from their peers, according to Rivosecchi. “Whatever your focus will be—sterile, nonsterile, or hazardous—go find people who are doing it well and leverage their best practices and learnings,” he said. “No one will have a turnkey solution for you, but everyone in the field is doing something well, and being a true student of the competition can help you identify how to effectively enter this field in a manner that works for your focus.”

Dresser agrees: “There are many experienced consultants—clinical, business, and legal—who can help guide new pharmacies through this industry,” he said. “Taking proactive steps can help mitigate some of the known challenges, such as aggressive and heavy-handed [pharmacy benefit manager] and payer audits.”

Eager pharmacists need to study demographics and be able to educate local practitioners on what compounding involves

, noted Dawit. “Compounding pharmacy allows me to help patients who have specific needs and are overall wanting to improve their health, not just treat a condition,” she said. “I like spending time getting to know my patients, and [it is] rewarding to be able to solve problems that are not addressed by big-box pharmacies. Independent ownership is difficult in this time but also has its advantages for those who want to think outside the box.”

In the era of coronavirus disease 2019 (COVID-19), pharmaceutical compounding is as vital as ever. 

Author | Keith Loria

Articles

A Look at the Year in Generics

The Rise of AI

5 Tips for Negotiating Perks

Health Crisis Highlights Value of Pharmacy Compounding