Mari Edlin

Although the number of new drug shortages in the United States has declined to 186 in 2018 since a high of 267 in 2011, there have been 80 for the first half of 2019, according to the University of Utah Drug Information service.

“Shortages continue to be on the rise and in talking with our customers, we’ve discovered the problem continues to get worse. More medications are going on allocation or unavailable and what used to be short, periodic shortages have become long and drawn out, making it a continuous challenge for clinical leaders,” says Patrick Yoder, PharmD, CEO, LogicStream Health, a Minneapolis-based clinical process improvement and control software provider. 

“Some medication shortages have been going on for years with no real sign of recovery,” he says.

“While the number of drug shortages has declined substantially in recent years, any drug shortage places substantial burdens on healthcare, providers who may have to ration medicines or identify alternative treatments,” says Andrew Powaleny, director, public affairs for Pharmaceutical Research and Manufacturers of America (PhRMA).

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“The issue of drug shortages demands attention and collaboration from all stakeholders involved in providing life-saving medicines to patients. This includes the biopharmaceutical companies producing brand-name medications, as well as generic drug and biosimilar manufacturers, wholesalers, distributors, pharmacies, and healthcare providers,” he says. 

 conducted between March 6 and April 4, 2019 of 365 acute and non-acute care facilities across the country-members of Vizient, a healthcare performance improvement company headquartered in Irving, Texas-confirms the ever-present problem of drug shortages and their ramifications. 

Nearly two-thirds of respondents report they managed at least 20 shortages from July through December 2018; 64%, more than 21; 33%, six to 20; and 3%, up to five. Thirty- eight percent report one or more medication errors directly related to a drug shortage in that same time period.

The most commonly reported items facing shortages, according to the survey, are controlled substances, local anesthetics, antibiotics, electrolytes, and emergency injectables such as “crash cart” drugs, many of which are low-cost generics. 

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Injectables comprise 39% of drug shortages in 2019, according to the University of Utah Drug Information Service.

The FDA primarily attributes shortages to quality/manufacturing issues but also points to production delays, some caused by not receiving raw materials and components from suppliers, and drug discontinuations. An estimated 70% of shortages are caused by manufacturing and quality problems, according to the Healthcare Supply Chain Association. 

“The FDA can’t require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs,” says Charlie Kohler, spokesperson for the FDA. “With fewer firms making older, sterile injectable drugs, there is a limited number of production lines that can make these drugs. Raw material suppliers also are limited in the amount they can make due to capacity issues at their facilities.”

Kohler says that these limitations, along with long lead times and the complexity of the manufacturing process for injectable drugs, result in shortage vulnerabilities. “When one company has a problem or discontinues, it is difficult for remaining manufacturers to increase production quickly, and a shortage occurs,” he says.

Dan Kistner, PharmD, senior vice president, pharmacy solutions for Vizient, outlines the causes of drug shortages:

 Too many lines offered, making it difficult to maintain capacity

 Aggregate product quota preventing other manufacturers who might enter the space from making more product

 Low ROI. If a product is not profitable, manufacturers might switch to other drugs 

Powaleny attributes drug shortages to shifts in clinical practices; wholesaler and pharmacy inventory operations; changes in hospital and pharmacy contractual relationships with suppliers and wholesalers; and manufacturing issues, such as an unforeseen breakdown in manufacturing equipment that disrupts production.

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“The difficulty is identifying what medications will be impacted by any of these things and how that will affect care delivery and patient safety, along with understanding when any particular shortage will occur,” Yoder says.

“The biggest risk is patient safety and potential harm to patients when clinicians cannot deliver appropriate care because of a medication shortage. Deferring procedures, adverse drug events, medication errors, cost of alternatives, and the time clinical teams spend managing shortages are all results of shortages,” Yoder says.

The Vizient survey focuses on the impact of drug shortages on U.S. hospital labor forces. Responses indicate that shortages are costing these institutions $359 million a year in labor expenses, or about 8.6 million hours of additional labor, to seek supply, update technology, and implement mitigation strategies that enable continuity of care. Survey participants attributed labor costs to triaging patients and making changes in the ordering system.

The repercussions of drug shortages not only impinge on financial resources but also on patient care, from delay or cancellation of a medication or treatment to medication errors. The Institute for Safe Medication Practices conducted a survey primarily of hospital-based pharmacy directors and managers, purchasing agents, and technicians from August through October 2017. It found that the majority (71%) were unable to provide patients with a recommended drug or treatment, and 47% thought this resulted in patients receiving a less effective drug. In addition, 75% stated that patient treatments had been delayed because of drug shortages. 

Kistner recommends some strategies for mitigating drug shortages: increase competition; ramp up supply and capacity; reward quality in generics; expedite manufacturer approval processes; provide real-time analytics about what is purchased and which supplies are dwindling; and apprise hospitals of potential drug shortages so that they do not become a repeat problem.

Among Vizient’s solutions are Novaplus, which provides access to 15,000 individual, high-demand line items encompassing a broad range of categories.

Respondents to the Vizient survey had a say in what they believe to be effective solutions to the drug shortage problem: implementing processes to restrict duration of therapy; increasing stock of medications that were anticipated to be limited in supply; utilizing unit dosing to prevent waste; using alternative ways of administering a drug; and implementing one or more taskforces or committees dedicated to addressing drug shortages and allocations.

LogicStream has introduced the Drug Shortage App that identifies shortages and their impact on hospitals and automates the entire life cycle of managing a shortage. It provides clinical information that allows teams to understand and mitigate the ramifications for shorted medications. Yoder says that although most hospitals have a drug shortage management process, they tend to be manual, time-consuming, and costly. 

“FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. It determines how best to address each shortage situation based on its cause and public health risk,” Kohler says.

To address manufacturing/quality problems, FDA works with manufacturers to resolve issues, from an incorrect expiration date on a package to finding a particulate in a product. “Regulatory discretion may be employed to address shortages to mitigate any significant risk to patients,” he says.

The agency also assists manufacturers with drug shortages in ramping up production if they are willing to do so. Kohler says this often necessitates approval of new production lines and raw material sources to help increase supplies. FDA expedites review of these to help resolve shortages of medically necessary drugs; however, the agency can’t require companies to increase production.

If a manufacturer has data to support extension of an expiration date for inventory that is close to expiration or has already expired, FDA is able to review this information and approve the extension, helping to increase supplies until new production is available.

In addition, FDA could turn to other manufacturers that are willing and able to redirect product to the U.S. market if a shortage involves critical drugs needed for U.S. patients. This requires an evaluation of a product to ensure efficacy and safety, including the formulation and other attributes of a drug and the quality of the manufacturing site where a drug is made.

Kohler says that while the FDA looks for ways to mitigate drug shortages, there are a number of factors that can cause or contribute to the problem that are outside of the FDA’s control.

The agency issued a long-term, strategic plan to outline its priority actions and efforts drug manufacturers and others can take to prevent drug shortages by promoting and sustaining quality manufacturing, along with launching the Drug Shortages Task Force July 2018, to study reasons why shortages continue.  

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Drug shortages might be decreasing, but their continued existence is urging the pharmacy industry to maintain its vigilance.

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Despite the passage of the Biologics Price Competition and Innovation Act of 2009, which provided a regulatory pathway for biosimilars, only 20 have been approved, and seven marketed, in the United States. The most recent was Kanjinti (trastuzumab-anns) for Herceptin (trastuzumab).

IQVIA expects biosimilars to lower overall spending on biologic medicines by $153 billion from 2019 to 2023 as a result of competition. 

A study conducted by Avalere Health found that the availability of biosimilars could increase overall access to biologic medicines by an additional 1.2 million patients. 

“Developing and marketing biosimilars is an expensive proposition. It takes a significant investment in manufacturing expertise and a capacity to create these types of drugs,” says 

, vice president of pharmacy solutions for Vizient Inc.

“In addition, the biosimilar approval process has taken some time for the FDA to build. Therefore, manufacturers have had to work on various aspects of development while FDA was making final decisions,” he says. “Now that the FDA and manufacturers have worked through 20 approvals, there is a greater level of awareness of what is required to be successful with this type of drug development.” 

, a partner within the Generic and Biosimilar Pharmaceuticals Practice Group at Schiff Hardin in Chicago, attributes slow development in part to companies’ initial wariness of proceeding down the biosimilar pathway due to the amount of uncertainty associated with the process. He is optimistic, however, that application approvals are rising due to more guidance on the technical front, a better understanding of the considerations related to biosimilar litigation, and higher acceptance in the marketplace.

“The FDA does a good job with guidance; but, from a regulatory perspective, not many [biosimilars] have been approved or launched. The marketplace for biosimilars is not where it is expected to be by 2019,” says Juliana Reed, vice president of corporate affairs for Pfizer.

The Biosimilars Forum-an organization based in Washington, D.C.-has developed three proposals for promoting the use of biosimilars and for counteracting misaligned incentives and unfair reimbursement:

1.) Lower costs by eliminating a copayment for Medicare beneficiaries who choose a biosimilar. 

The Forum estimates that would save patients $3.3 billion dollars in out-of-pocket costs over 10 years and save taxpayers $5.2 billion.

2.) Develop a physician-focused, shared savings program in which Medicare savings associated with prescribing a biosimilar is shared with providers.  

Not only would that provide an incentive for providers but it could save as much as $3 billion in tax dollars over 10 years.

3.) Increase add-on payments for prescribers of biosimilars to incentivize their use by increasing the amount doctors in Part B are reimbursed for administering them.   

The Forum estimates the United States could realize a savings of as much as $8.2 in health costs over the next decade.

Avalere has calculated that biosimilars could reach between 26% and 46% in market share if Medicare paid for beneficiaries’ out-of-pocket costs and could save billions by adding a payment bonus for providers for prescribing biosimilars.

Patent walls are one of the greatest barriers preventing biosimilars from entering the marketplace. Drug companies could create patent walls around their products by changing manufacturing processes, finding new indications for an approval, or by changing a drug’s dosage-all extending protection over a long period of time.

, chairman of the board and chief medical officer for BioFactura in Frederic, Maryland, says that although the goal of a biosimilar is to produce a drug identical to its reference, interchangeability is considered bumping up against a patent if both products are exactly the same. 

Hausfeld says AbbVie holds about 136 patents for Humira (adalimumab), while the first biosimilar alternative isn’t due to hit the U.S. market until 2023.

“The whole concept of biosimilars is completely new to providers. As a result, pharmacists, as drug information experts, have had to invest a lot of time to learn the nuances of the FDA’s approval process in order to educate prescribers, who are still becoming familiar with biosimilars and developing the necessary level of comfort to prescribe them to patients,” Lucio says.

Another challenge for providers, he says, is when a doctor selects a product (i.e., a biosimilar) different from what a payer chooses (i.e., the reference product or another biosimilar).

“When this happens, both parties have to do more work to manage the information exchange regarding which product will be used and reimbursed. For providers, the need to respond to various decisions across a range of payers could mean they have to carry multiple products (the brand and several biosimilars),” he says.

Lucio says the willingness of physicians to use biosimilars varies by agent. For example, physicians have been less reticent to prescribe Zarxio (filgrastim-sndz)-biosimilar to Neupogen (filgrastim)-because it is easy to monitor, is administered daily, and presents immediate outcomes.

On the other hand, Lucio says biosimilar competitors, such as Inflectra (infliximab-dyyb) for Remicade (infliximab) are facing less uptake because their effect is harder to assess and reimbursement is more difficult to align. 

, vice president of policy, medical and external engagement at Sandoz Inc., says the U.S. healthcare system saved about $500 million in less than two years through the adoption of its biosimilar Zarxio. The product has become the first of its kind to surpass its reference biologic in market share. According to real-world data from Sandoz, patient costs for Zarxio were 9% lower than those for its reference biologic.

In May, the FDA published its Guidance for Industry entitled, “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance describes the regulatory pathway for biosimilars that can be substituted, without the involvement of a prescriber, for branded biologics. It assists in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application.

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Without the option of interchangeability, biosimilar manufacturers are forced to compete with established products, which can add costs that are borne ultimately by the consumers,” Nelson says.

“Because there are no approved interchangeable biosimilar products on the market, patients will not receive an approved biosimilar if they are currently on therapy. There is no mandatory substitution at the pharmacy level as there is with small molecule products,” Nelson says.

He advocates for investigating a statutory change that requires treatment-naÃ¯ve patients-those that have never received the particular biologic product in any form-to receive an approved biosimilar or the lowest-cost option of the prescribed product. Other proposals include creating a separate tier exclusively for generics and biosimilars, and for a cost-sharing program.

Lucio doesn’t find interchangeability to be a real issue because the majority of competitive products are administered by a provider or through specialty pharmacy and not filled by a patient; thus, the pharmacy is not making a decision on which product to use. However, in the case of insulin, patients pick up their prescriptions at a pharmacy, making the choice of a biosimilar more relevant.

Naming biosimilars-the branded drug’s name and a unique, four-letter suffix-is a bone of contention among biosimilar advocates. The Biosimilars Council has urged the FDA to reverse course on its current proposal and rescind the suffix-based naming policy that serves as a barrier to biosimilar access for America’s patients.

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The Council asserts that suffixes could create a perception that there are meaningful differences between reference products and their biosimilars, along with patient and provider confusion because reference products don’t require a suffix. It also contends that suffixes could undermine interchangeability and fail to signify any safety benefits. A final ruling has not yet been issued.

More than 90% of employer-sponsored plans covered a biosimilar of filgrastim in 2017, and more than 40% placed it on a preferred tier, according to the Institute for Patient Access; however, only about 7% had a biosimilar for infliximab on a preferred tier, according to Avalere.

“The issue is paying for them: the complex reimbursement process for biologics and biosimilars often disincentivizes the prescribing and use of biosimilars,” Nelson says.

“Biosimilars certainly have not achieved the tiered formulary status that is seen by generic drugs in the small molecule space. Due to the pricing and reimbursement system, a provider is sometimes reimbursed at a lower rate for using a biosimilar than for using the reference biologic-a disincentive to prescribing a biosimilar,” Nelson says.

“In the private sector, payers will reimburse based on a percent mark-up of the ASP of the drug that is actually administered. Because the ASP for a biosimilar is lower than that of the reference product, purchasers would prefer to use the more expensive reference biologic for which they could make more money on the mark-up,” Nelson says. 

Pharma companies are in litigation due to insurer-directed biosimilar exclusion contracts which opponents argue  the practice is restricting entry and competition.

UnitedHealthCare covers Neulasta (pegfilgrastim) first, and if it proves ineffective, then the insurer will cover its biosimilar, Udenyca (pegfilgrastim-cbqv). That is opposite of how it works for traditional generics in which a patient must fail on a generic before being given a brand name drug.

“It’s not medically sound to fail first with a reference drug before being able to access a less expensive biosimilar,” Reed says.

“If the reference product doesn’t work, the biosimilar probably won’t either,” Lucio says. 

“Biosimilars create a more competitive pricing environment among drug manufacturers that can help drive down drug costs. UnitedHealthcare evaluates each brand-name biologic and its biosimilar one-by-one and makes a coverage decision based on the lowest cost product in order to deliver lower costs to our members, clients and consumers,” says the insurer.

Biologic medicines could lower spending by $153 billion by 2023.

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The 2012 nationwide fungal meningitis outbreak resulting from contaminated steroid injections from the New England Compounding Center in Framingham, MA, is still reverberating throughout the industry. The FDA and compounding pharmacy stakeholders are still wrestling with many unresolved issues from the tragedy, but there are ongoing discussions and a proposed piece of legislation to reach a resolution.

After the tragedy, Congress passed the Drug Quality and Security Act (DQSA) in 2013, which authorized FDA to create a memorandum of understanding (MOU) with states to address some interstate distribution of compounded drugs by traditional compounders-called 503A facilities in the law, after the section of the Federal Food, Drug, and Cosmetic Act (FD&C). 

The agency plans to finalize the MOU in 2019. 

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FDA issued a draft MOU in 2015, but withdrew it after strong pushback from pharmacist, physician, and patient groups. The agency released a revised draft in September 2018 that outlines the allowable level of out-of-state distribution of compounded drugs in states that enter into the MOU. The revised version also allows for a greater percentage of total prescriptions for compounded drugs-50%-before becoming what the FDA considers an “inordinate amount,” which would require additional reporting by and inspection of compounding pharmacies. 

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If state pharmacy boards choose not to sign the MOU, only 5% of total prescription orders dispensed or distributed by a 503A compounder in that state can be shipped out of state. 

Reed Smith LLP, a law firm based in Pittsburgh, directed a letter to the FDA last December, targeting the threshold change and other issues. Although the threshold has increased, Rachael Pontikes, a partner with Reed Smith, says the firm believes the boost does not solve the concerns raised by the 2015 draft. The new threshold “has also narrowed what is included in that threshold to compounded products,” she says.

, PharmD, president and CEO of Innovation Compounding, a 503A pharmacy in Kennesaw, GA, is concerned about the potential 5% cap if Georgia’s pharmacy board decides not to sign the MOU. His pharmacy, like others, compounds products in a specific therapeutic area-in his case, compounded products for allergy immunotherapy-which might not be available from pharmacies in other states.

“We are concerned about patient access. It’s difficult to tell a doctor ‘no’ when a drug is allowed clinically, but not by federal law,” Hodges says. 

“The proposed 5% cap creates the potential that patients won’t be able to access compounded medications,” says Scott Brunner, executive vice president, International Academy of Compounding Pharmacists (IACP).

Hodges says the MOU puts pressure on state boards, which may be hesitant to sign the MOU in its present form.

“It’s an unfunded mandate for states,” Brunner adds. “The FDA is, in effect, commandeering a state agency to take enforcement actions that the state legislature hasn’t necessarily funded. That creates ambiguity over whether state boards even have the legal authority to sign the MOU.”

“There is no incentive to sign,” says 

, PharmD, of Koshland Pharm: Custom Compounding Pharmacy, a 503A pharmacy in San Francisco. “Signing the MOU will present even more work even if it increases the percentage of products sold across state lines.”

Brunner adds another caveat to the MOU-stakeholders do not have enough time to respond to the terms.

The 2018 draft MOU also revisits the definitions of “dispense” and “distribute” that had traditionally been distinct. Currently, they are the same in the MOU draft. Public comment swayed the agency to make more of a distinction, says Ilisa Bernstein, PharmD, JD, deputy director of the Office of Compliance, Center for Drug Evaluation and Research at FDA.

The definitions are consistent with previous law she says. “We are getting closer, but because the MOU is not yet operational, no one has signed it yet. We have spent many years trying to make the MOU acceptable.”

No other organizations consider “dispense” and “distribute” to be the same thing. “The difference is not clear,” says Erik Tosh, RPh, chairman of the IACP Board.

Brunner says the FDA conflates the definitions in a way that runs contrary to how they are defined in state and national laws, and even in the National Association of Boards of Pharmacy (NABP) Model State Pharmacy Act.

“The FDA’s proposed MOU redefines the two terms in a way that Congress did not intend and which stands to limit patient access to compounded medications,” Brunner says.

Another disputed issue is the FDA’s refusal to allow 503A pharmacies to compound for office use, that is, supplying a small quantity for physicians to keep on hand in their offices to use when needed by their patients. 

 “Compounders provide access to medications that are not commercially available, but that prescribers believe are necessary for adequate treatment. Doctors should be able to order them. We want to do the right thing but need guidance on what is expected,” Koshland says.

“Some state laws allow 503A pharmacies to compound for office use, but FDA’s interpretation is that office use is not allowed due to the requirement that there be a prescription,” Brunner says. “Pharmacists can compound a 30-day supply prior to receipt of prescription, but the FDA says it can’t leave the pharmacy until the prescription is received. It can’t be stored by the physician without a patient-specific prescription, so it’s largely a dispute about which highly trained, highly regulated healthcare professional’s shelf it sits on.”

Outsourcing facilities, or 503B compounding pharmacies, created under DQSA that do not require a patient-specific prescription under Section 503B of FD&C. These facilities are subject to increased quality standards, such as compliance with Current Good Manufacturing Practice (cGMP), and enhanced reporting. 

The FDA says its new draft is based on feedback from stakeholders and comments received on the initial draft guidance and is being revised, in part, to reflect further consideration of how cGMP requirements should be applied.

Bernstein says that due to the stricter requirements for these pharmacies, they “provide a higher level of patient protection.” 

Tosh is concerned, however, that the cGMP standards often require testing and are not always cost efficient.

For many 503A pharmacies, the requirement that only 503B pharmacies can compound without a patient-specific prescription stands in the way of patient access. The physician’s only option is to write a prescription for the compounded substance, send a patient to the pharmacy to pick it up, and then return to the physician’s office for a subsequent visit-for which the patient will be charged-to have the medication applied, Tosh says. 

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Jennifer Burch, PharmD, president of IACP and owner of Central Compounding Center South, a 503A pharmacy in Durham, NC, knows the burden this places on a patient who might not have immediate access to a medication. 

Although only 503B pharmacies may compound for office use, Burch says it is usually too small a quantity to make it economically viable for them. 

During a public hearing on drugs compounded for office use, cGMP, and an overview of the revised draft guidance, David Glasser, MD, secretary for federal affairs, American Academy of Ophthalmology, questioned the ability of 503B pharmacies to meet patient needs when medications, such as antibiotics, are required immediately and sometimes unexpectedly. 

“It becomes a financial situation for 503B pharmacies because there isn’t enough demand,” he says. He would like the FDA to approve low-volume orders for office use-quantity limits for emergencies. “The risk of not having a drug outweighs the harm,” he says.

Another concern is FDA’s reliance on guidance documents to regulate compounding, says Tosh. “There is a statutory process by which agencies must issue regulations, he notes. “When it is announced-having followed that proper statutory process-stakeholders must then abide by it in their operations. 

“Unfortunately, FDA has been skirting the proper rule-making process, issuing Guidance for Industry (GFI) documents. Those GFI’s do not have the force of formal regulation, but the FDA is holding compounding pharmacies accountable to GFI as if they were proper rules,” he says. “They do not create or confer any rights for or on any person and do not operate to bind FDA or the public for enforcement purposes.”

But CDER’s Bernstein says the FDA uses guidance to interpret the law and that it enables stakeholders-not just compounders-to provide input that is reflected in guidance documents. 

“We need to exercise oversight to prevent another 2012 outbreak that wasn’t an isolated incident and ensure regulatory oversight as Congress had intended,” Bernstein says. “Compounding can be an important component of care, but products aren’t reviewed for quality and safety which can cause health risks. Promoting access to quality compounded drugs requires that compounders follow the law.”

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The good news for the industry is a new bill-HR 1959, Preserving Access to Compounded Medications Act of 2019 by Congressmen H. Morgan Griffith (R-VA) and Henry Cueller (D-TX).

An IACP statement emphasizes the need for clarification of the MOU and for new legislation: “The FDA has misinterpreted congressional intent, overstepped its regulatory authority, and is jeopardizing patient access to compounded medications as a result,” IACP’s Scott Brunner says. “This legislation, which has broad support both in Congress and from an impressive coalition of groups representing pharmacists, physicians, and patients, seeks to assure that FDA’s role and actions in regulating compounding pharmacies are in line with Congress’ stated aims when it passed DQSA in 2013.”

Authorize “office-use” compounding by 503A pharmacies where permitted by state law.

Define the terms “distribute” and “dispense” consistent with the NABP model pharmacy act and other state and federal law definitions.

Clarify that compounding pharmacies are retail pharmacies for purposes of FDA inspection authority.

Require FDA to go through the formal rulemaking process for establishing DQSA policies rather than issuing “guidance documents” that circumvent requirements for public notice and input.

Formally recognize state boards of pharmacy as the primary regulators of pharmacy compounding.

FDA plans to finalize the draft in 2019. 

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Pharmacists have come a long way since the days when their only responsibility was dispensing drugs. 

Starting in the 1980s, pharmacists were urged to take on a vital role by providing medication expertise to ensure patients properly and safely use their medications. The 2003 Medicare Prescription Drug Improvement and Modernization Act fueled the change.

“The changing healthcare environment has required pharmacists to assume advanced roles. They now must focus not only on how to improve healthcare quality, but also on driving down healthcare costs, of which medications comprise a significant proportion, for organizations and patients,” says 

, PharmD, practice coordinator at Northwestern Specialty Pharmacy in Chicago.

“The increase in the number of specialty therapies has  . . . promoted integration of pharmacists into clinics to ensure appropriate initial and continued education, as well as timely follow-up and medication management,” she adds.

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As a practice coordinator and clinical pharmacist, Man supervises clinical pharmacists within specialty pharmacy, assumes administrative/management-oriented decision-making responsibilities, serves as the point person for electronic medical record issues, handles human resources-related activities and time cards, precepts pharmacy residents and students, and helps patients navigate their insurance benefits.

Pharmacists at Northwestern Specialty Pharmacy also recommend adjunct medications as necessary, perform interventions such as dose adjustments, clinically monitor patients after starting therapy, and counsel patients. 

, PharmD, MPH, wears a lot of hats as a pharmacist. She is not only editor-in-chief of the Journal of Managed Care and Specialty Pharmacy, but is also an associate professor in population health at Wingate University, Charlotte, NC; an adjunct associate professor at the University of Florida at Gainesville; and an author.

Happe warns, however, that multiple gigs like hers should be complementary and not in conflict. “In a gig economy, it is necessary to establish synergy between what I do, making logistics easier, and creating a better product,” she says.

As the journal’s editor-in-chief for the past six years, she sets the publication’s strategic agenda, makes final decisions about which articles to print, and oversees the peer review process.

In her role at Wingate, Happe teaches population and public health across interdisciplinary departments, providing an interprofessional educational experience for pharmacy students.

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At the University of Florida, she is director of the managed care pharmacy track in a master of science pharmacy outcomes program designed for working professionals and post-PharmDs.

 (Morgan James Publishing), is due out in November and is geared toward teenagers  to use in conversation with their parents and teachers about opioids. She wrote it after she saw some disappointing statistics about the low rate of discussions between parents and their children on the subject of prescription drug abuse.

“I’ve never served in a retail setting because I have always been interested in nontraditional pharmacist roles,” Happe says. She notes an oversupply of pharmacists and insufficient roles in traditional retail and hospital settings, leading to shorter hours and less pay. “But there are a plethora of opportunities-research, consulting, analytics, technology, and writing-for specialized pharmacists with a secondary degree or additional experience,” she adds. 

“I don’t let walls or silos become a constraint,” she says. Physicians recognize that pharmacists can help with diagnoses and medication therapy, and with quality measures tied to medication in value-based programs, and contribute to the financial success of a team.

“I also have an opportunity to practice at the top of my license, pursue things about which I am passionate, and make a difference,” she says.

On the other hand, Happe faces a few challenges as a pharmacist with many roles: 

 Difficulty being reimbursed for service.

 Lack of collaborative practice agreements in many states.

 The logistics of management, accounts, and calendars.

, PharmD, co-owner of Towncrest Pharmacy in Iowa City, IA, says his pharmacy has been evolving since its inception and is integrated into healthcare teams with which it works.

Towncrest encompasses five areas, McDonough says:

Traditional dispensing. McDonough says Towncrest has become more efficient in dispensing drugs by using automation-the pharmacy has three robots and an automatic pill counter-and by optimizing the use of technicians who conduct medication verification. 

Clinical responsibilities. Medication therapy management, transitions of care, and medication optimization and synchronization-enabling consumers to fill all of their prescriptions on the same day and receive compliance packaging to spur adherence-are key clinical roles. McDonough says that the pharmacy makes recommendations to physicians, 50% of whom accept them.

Durable medical equipment. Pharmacists fit customers for CPAP masks  diabetic shoes, and compression stockings, and assist with ostomy bags and wound care. 

Compounding. Pharmacists work with prescribers to establish proper dosage  and products for patients with special needs.

Long-term care. Pharmacists provide medication management, make home visits, evaluate and optimize medications, and share information with prescribers. Between 500 and 600 of Towncrest’s patients are in a nursing facility.

McDonough says the changing roles of pharmacists align with the dynamic healthcare industry and could also be attributed to pharmacists gaining additional education and training. 

“You can no longer make money just from dispensing, but have to be diversified, so we work closely with accountable care organizations (ACOs), payers and physicians to develop new reimbursement models,” he says.

Towncrest has conducted a variety of pilot programs, including one that indicated a $300 per member per month savings due to medication management.  

, PharmD, clinical pharmacy manager, infectious diseases, at Montefiore Health System in New York City, agrees with Happe that more education and training have opened up opportunities for pharmacists to move from the retail setting and into clinical roles in the inpatient setting.

“The pharmacist’s role [has] become a bridge in a clinical setting, aiding physicians with the ever-changing and expanding realm of pharmaceuticals,” says Dale Shaw, PharmD, based in Tucson, AZ. Shaw has served in a hospital setting, as an entrepreneur, and a consultant for a digital pharmacy company. During a stint at the Naval Medical Center San Diego, he went on rounds with the intensive care unit, pathology, and medical teams, and became the link between nursing and physicians. Nursing relies on pharmacists for information, such as on which medications can safely be delivered in the same IV or administered simultaneously, he noted.

At Montefiore, Saraiya meets daily with an infectious disease team to assist with dosing, choosing the most effective drugs for specific diseases, and minimizing adverse effects. She also serves as a precept for students and residents, lectures on infectious disease, attends antimicrobial meetings, and is responsible for the hospital’s antimicrobial stewardship program, which has been in place for 10 years. 

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Some of Saraiya’s colleagues are specializing in statistics, population health, public health, ambulatory care for patients with chronic diseases, managing readmissions programs; and serving on transplant teams as required by CMS. 

Saraiya says that pharmacists with enhanced training are no longer uncommon. “However, that’s not the public perception. We need to change that; the public is not aware of our training and background,” she says.

But physicians are clamoring for assistance with medication and appreciate pharmacists’ new roles. Shaw agrees that physicians have offered little resistance. “Although economics has played an important role over the last few decades to reshape healthcare, the exponential advancement in medicine has created a necessity to work as a team to provide seamless care,” he says.

Changes fueled by the 2003 Medicare Prescription Drug Improvement and Modernization Act.

Changing Healthcare Environment Prompts New Roles for Pharmacists

Discount drug cards appear to be the product du jour in healthcare, from those marketed by pharmacy benefit managers (PBMs) and retailers to those from drug manufacturers and membership organizations, such as 

The main motivation behind more cards and agreements to increase patient savings is the revocation of gag clauses that censored what pharmacists could tell their patients. 

Some cards have a track record, while others have just entered the market. 

 has offered a discount card since 2009, 

 since 2018.  Many cards have an app that offers information and help to users. 

Maximizing Medication Therapy Management Services

Last December, CVS Caremark partnered with 

, an Atlanta-based digital health company, to launch a digital pharmacy savings card targeting the uninsured, the underinsured, and those with a high deductible. The PBM administers the program and provides medications through 68,000 pharmacies in its network.

Some skeptics question whether these cards really save customers money, but those who offer them are confident about their value, transparency, and ability to improve adherence-an important issue. According to a Kaiser Family Foundation survey, among those currently taking prescription drugs, 24% of all adults and 23% of seniors say it is “difficult” to afford their prescription drugs, including about one in 10 (overall and among seniors) who said it is “very difficult.” 

In 2017, the Annals of Internal Medicine estimated that a lack of adherence causes nearly 125,000 deaths and 10% of hospitalizations a year, while potentially costing the healthcare system as much as $289 billion a year. As many as one-third of prescriptions are never filled.

, vice president for product communications for Sharecare, says the company’s new card is part of a larger product vision that offers tools and features to overcome adherence barriers. “The first fill is the most important in terms of helping patients remain compliant,” she says.

, PharmD, chief pharmacy officer for FamilyWize, based in Bethlehem, PA, agrees with Byrne. “The impact of a discount card is on first fill. If consumers don’t get a discount, they might not fill their prescriptions, affecting adherence. However, it is difficult to measure the effect of a card on adherence,” he says. 

“Our strategy follows a completely different model than traditional discount drug cards by including our consumer platform, which also provides content, education, safety, and messaging to address the most prevalent barriers to adherence and compliance,” says 

, executive vice president of enterprise at Sharecare. “It will be important to study and validate the impact cards make in improving adherence across populations.” 

One of the primary features of the Sharecare Rx card is the Discover section on the Sharecare app that includes helpful search features for members, including medication prices, finding a doctor, and other tools. 

With the app, users may opt to get notifications and reminders to refill their prescriptions, as well as information on how to take their medications as directed; drug-specific information on safety and side effects; alerts about interactions; and can track their medications.

Cardholders can create a profile on Sharecare’s stand-alone platform so data reside in one place. “Patients’ medical information typically lives in many different systems so that having a complete list of medications ensures members have easy and convenient access to the information no matter where they are,” Byrne says. Cardholders also may search for a specific medication, filtering results by price, pharmacy location and hours, and availability.

The company is working with its health plan and employer partners to integrate their formulary coverage and pricing into Sharecare, providing seamless access to prescription benefits and information. 

Gruverman says users could save up to 80% on generics and take advantage of a wide variety of discounted brands. “This alleviates a major cost burden for people who manage chronic conditions and lack adequate insurance or the resources to purchase these medications,” he says.

The downside is that discount drug card expenses do not count toward a patient’s deductible or out-of-pocket maximums and cannot be combined with insurance; however, some of Gruverman’s peers recommend that consumers submit receipts to their insurers for potential credit.

He sees the development of innovative drug pricing models as more consumers use smartphones and digital tools to manage parts of their everyday lives, and as additional players across the healthcare landscape, such as payers, PBMs, and employers deploy tools to make medications more affordable and accessible.

, a nonprofit resource helping people afford their medications, has saved consumers $275 million since its card’s inception. The company claims 40,000 transactions take place per month with its card, which covers more than 6,000 drugs. 

, says that since the gag rule was lifted last October, which prohibited pharmacists from proactively telling consumers when prescriptions would cost less when paid for out-of-pocket rather than using their insurance plan, discount drug cards offer even more value. 

The financial path all discount cards take could have fees that end up coming out of consumers’ pockets, Sagall has noted on the NeedyMeds blog. 

These fees include negotiated discounted price by PBMs, transaction fees by pharmacies each time a card is used, PBM transaction fees to cover costs of setting up and running a pharmacy network and processing claims, and marketer fees that go toward card promotion and distribution.

Sagall questions why pharmacies would accept a drug card when it could seem to be in their best interest to charge customers a nondiscounted price, but he also notes five reasons why they would:

They can discount a drug just enough to make some profit.

Programs increasingly cater to the uninsured and underinsured