Category: Uncategorized

Not all specialty pharmacies operate a compounding line of business….. but there are a number of SPs that do. If your pharmacy is into compounding, then you should already be aware of the new standards that are going into effect on November 1^st. If your specialty pharmacy isn’t into compounding, then read on regardless….. and learn something new about your industry.

The new standards are being published by the USP which stands for United States Pharmacopeia, an industry “bible” published annually by this now over 200-year old nonprofit organization. USP is not a regulatory body or an accrediting agency . Rather, USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicine and works to strengthen the global supply chain. USP healthcare standards and solutions are practical tools that healthcare practitioners use to help ensure consistency in operations, foster timely decision making, and quality of patient care. 

As noted in the article, USP standards regularly filter down into regulations that might be federal or state, and/or incorporated by accrediting organizations. As such, it behooves any compounding pharmacy, to get into compliance before an inspection or a reaccreditation. Take special note of the substantive changes to Chapters 787 and 800.

Visit the USP website to learn more.

————————————————————————————-

USP Countdown: Where Are You With Less Than Five Months to Go?

JUNE 21, 2023

With less than five months left before the revised USP compounding-related chapters <795>, <797>, <800> and <825> become compendially applicable on Nov. 1, 2023, experts at the ASHP 2023 Summer Meetings and Exhibition urged hospital pharmacy leaders to complete a gap analysis if they have not done so already, be aware of additional and possibly more stringent requirements that their states may have in place over and above the USP minimum standards, and use the available survey tool from The Joint Commission (if they’re accredited by the organization). 

CLICK HERE to read the full article

Another sonic boom could be heard (well….. at least by dogs) recently when the FDA approved yet another gene therapy! This time the news was truly noteworthy, as the therapy in question has been the aspirational hope of a well known, rare disease population for neigh on three decades. The approved therapy is Roctavian (valoctocogene roxaparvovec-rvox) from BioMarin Pharmaceutical, a gene therapy for the treatment of adults with severe hemophilia-A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.

Roctavian  is a one-time, single-dose infusion and  is the first approved gene therapy for severe hemophilia A in the U.S. 

BioMarin said it estimates only about 2,500 US patients would be eligible for the therapy.  Patients with certain underlying health conditions and problems are excluded from the prescribing information.  The company went on to explain that Roctavian was approved only for patients with severe disease who test negative for an antibody that attacks the virus Roctavian uses to deliver its helpful genetic material into cells. Upwards of 20,000 males in the US have hemophilia-A meaning that about 17,000 people are not candidates for this particular one-and-done therapy. However, this approval only fuels the hopes of the remaining hemophilia-A candidates.

CLICK HERE to access prescribing information

BioMarin claims that Roctavian will come to market at $2.9 million….. which is arguably not expensive when annual costs for traditional blood factors can run as much as $800,000 annually for a typical patient. They also pointed out that the price is less than the $3.5 million for a similar gene therapy for hemophilia-B approved last fall.

BioMarin did not announce details for logistics and distribution.

——————————————————————————————

BioMarin finally secures FDA approval of hemophilia gene therapy

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

June 29, 2023 — The Food and Drug Administration approved on Thursday the first gene therapy for the most common form of hemophilia, clearing the way for what patients, doctors and the medicine’s developer hope could be a one-time treatment for the rare bleeding disorder.

BioMarin Pharmaceutical, the California-based company behind the therapy, plans to sell it under the brand name Roctavian. It’s specifically meant to treat hemophilia A, which is caused by genetic mutations that inhibit the production of a key blood-clotting protein known as Factor VIII.

The company has set a list price of $2.9 million in the U.S., higher than the therapy’s cost in Europe, where it’s priced at about………………article continues

CLICK HERE to access the full article

The FDA recently approved a new infused therapy, Columvi (glofitamab-gxbm) from Genentech, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. Columvi is a T-cell engaging bispecific antibody in non-Hodgkin’s lymphoma, joining recently approved Lunsumio indicated for follicular lymphoma.

DLBCL is considered hard to treat. It is the most common form of non-Hodgkin’s lymphoma. People with DLBCL who relapse and are refractory  progress rapidly and have not been well served by prior therapies. The company pointed out that Columvi is “….an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated.” “Further, Columvi offers “a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”

The fixed-duration for Columvi, as detailed in the package insert, is 12 cycles at 21 day intervals.

Columvi was approved with a black box warning for Cytokine Release Syndrome. 

The company said that the expected cost for Columvi will be about $350,000 for the full course and would be available in the United States in the coming weeks.

Distribution details  were not disclosed. Given its cost and black box warning it is likely that product access will include specialty pharmacy distribution.  

CLICK HERE to access prescribing information

——————————————————————————————–

FDA Approves Genentech’s Columvi for People with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, and a median duration of response of 1.5 years (18.4 months)

Given over a fixed period of time, Columvi provides patients with a treatment end date and potential time off treatment.

South San Francisco, CA — June 15, 2023 –Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the Phase I/II NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Columvi will be available in the United States in the coming weeks. 

Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer ……………… press release continues

CLICK HERE to access the full press release

A boatload of biosimilars are now sitting in the approval circle since the first one was approved in early 2015.  Copies of just four market leaders, including Humira, Neulasta, Herceptin and Remicade, alone account for more than 20 approved biosim follow-ons.  And, the number of FDA biosims in the pipeline is expanding.

The article below details a recent report published by Cardinal Health that bears consideration saying, ”…. the resulting biosimilar versions are poised to change the biosimilar landscape as we know it.”  

The article below is timely as market resistance seems to be softening as payers begin to include more biosims on formulary.  Also, the number of biosims garnering interchangeability status (the holy grail) will allow for substitution where allowed…. four additional adalimumab biosimilar manufacturers are currently pursuing interchangeability.

The article also offers up some interesting prescribing trends within specialties….. with significant upticks in biosim confidence in Rheumatology, Gastroenterology, and Dermatology….. Oncology seems to be a holdout. On the payor front, formulary placement for the foreseeable future is likely to remain sticky due to pre-existing contracts between payers and manufacturers that have built in exclusivity / brand preference clauses that restrict biosims outright or force less preferred formulary placements.

Read on for more insights…..

——————————————————————————————–

Will Humira Biosimilars Entry Cause a Wave or a Ripple?

By Gina Shaw, Pharmacy Practice News

With 2023 poised to be the year of the adalimumab (Humira, AbbVie) biosimilar wave, a new report focuses on the market dynamics that may affect how the new entrants are received by providers and other key stakeholders.

Although the report, issued by Cardinal Health, notes that adalimumab is “arguably the single largest pharmaceutical loss of exclusivity [LOE] event of all time,” and the resulting biosimilar versions are “poised to change the biosimilar landscape as we know it,” interviews with several experts suggest barriers remain. Whether it’s bundled contracts that give exclusivity to the innovator product or other exclusionary tactics, the experts noted that the true market outlook for adalimumab and other biosimilars remain a bit unclear.

One encouraging development, however, is the growing willingness of some providers to consider switching their patients to a biosimilar product, according to the Cardinal Health report. At least 75% of providers in all three relevant specialties surveyed—rheumatology, gastroenterology and dermatology—said they were somewhat comfortable with the prospect of prescribing a Humira biosimilar. Gastroenterologists appeared to be most comfortable, with 93% saying they were at least somewhat comfortable and 50% very comfortable; followed by rheumatologists (86% and 37%, respectively); and dermatologists (75% and 31%). Safety and efficacy as well as overall issues with switching were the most often cited concerns.

“Based on what we’ve observed in the trends within oncology, which had some of the first biosimilars, the differences in comfort level among these three specialties are probably just timeline related,” said Bruce Feinberg, MD, the vice president and chief medical officer of Cardinal Health. “The more exposure specialists have to these agents, [and] the more patients [are] under treatment, the more comfort they will have in prescribing them.”

Where We Are

The first adalimumab biosimilar, adalimumab-atto (Amjevita, Amgen), officially entered……

CLICK HERE to access the full article

Lots of angst between the FEDA and Pharma over drug pricing controls and price negotiations. 

There will be lobbying a’plenty by Pharma to mitigate what is already enacted and stem the tide of further price incursions.  The article below offers a scientifically based premise that there is a major flaw in the current pricing rules.

What is noteworthy is that the premise is based on the simple distinction of small vs. large molecule drugs. As noted, the recently enacted Inflation Reduction Act draws a distinction between large and small molecule medicines setting price control provisions to kick in  for small molecule medicines after 9 years (following FDA approval) vs. 13 years for large molecule biologics. 

Fowl most cruel crieth Pharma!

Why the angst? 

The developers say that they will lose the incentive to invest in post-approval R&D and patients will lose access to potential new treatments. It is here that the FEDS will start to push back saying that post approval R&D is not that costly….. especially if the original approval was for an orphan condition (that incidence is very high) which garnered valuable marketing benefits such as extended exclusivity. The FEDS will also likely push pack on the argument offered below that the developers will likely tend towards large molecule formulae because of the longer 13-year exemption from price controls.

The accountants can do the cost analyses but there is a good  likelihood that a small molecule candidate with a shorter price exemption period will generate more $$s because “patients prefer small molecule medicines that usually come in the form of pills over biologic injections or infusions by a wide margin.” And….. small molecule drugs “are generally easier to make at scale and nearly always less expensive for patients. Importantly, small molecule medicines are more easily genericized than biologics, leading to greater adoption and lower costs.”

So…. On which side of the argument do you lean?

—————————————————————————————

The IRA’s nonsensical distinction between small- and large-molecule drugs

Thanks to advances in science, notably the completion of the Human Genome Project 20 years ago, we are able to treat diseases more effectively than ever before. Researchers have more sophisticated tools not only to identify new drug targets, but also to make drugs to hit those targets. A wide variety of therapeutic agents help make these drugs, including chemically synthesized small molecules; larger molecules made of amino acids like peptides, proteins, and antibodies; and nucleic acids like RNA or DNA. Choosing among these approaches requires looking at the target attributes. Is it inside the cell or outside? Is the target an enzyme, a gene, or a lipid particle? Do we need to block the target or stimulate it? Science is — and should be — the guide to determine the optimal approach for patients.

That’s why, to researchers like me, a provision in the recently enacted Inflation Reduction Act is puzzling. For no clear reason, it draws a distinction between large and small molecule medicines. …………….. continues

CLICK HERE to read the full article

The FDA recently approved a new extended release oral-suspension therapy, Lumryz (sodium oxybate) from Avadel Pharmaceuticals, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Lumryz is taken once daily at bedtime.

Lumryz was approved with a black box warning for Central Nervous System Depression as well as Potential Abuse & Misuse. Lumryz is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and even death. A restrictive REMS has been imposed for the therapy.

CLICK HERE for prescribing information

Avadel confirmed that Lumryz will launch at $64.67 per gram.  Based on the highest daily dosing option (nine grams), the annual cost would top out at $212,440 per year.  This pricing is comparable to that of a competing product, Xywav, from Jazz Pharmaceuticals.

Given its cost and moderately high prevalence of ~140,000 in the USA, is is expected that Lymryz will be available only through specialty pharmacy limited distribution.

——————————————————————————–

Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Adults Living with Narcolepsy

-LUMRYZ is the first and only once-at-bedtime oxybate for people living with narcolepsy

-Once-nightly dosing regimen of LUMRYZ has been found by FDA to provide a major contribution to patient care over all twice-nightly oxybates

DUBLIN, Ireland, June 05, 2023 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZ is now commercially available. LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

“We are proud to announce that LUMRYZ is commercially available through both our RYZUP™ patient support program and our specialty pharmacy network for patients living with narcolepsy who have been waiting for over two decades for a single dose treatment option that provides the opportunity for an uninterrupted night sleep,” said Greg Divis, Chief Executive Officer of Avadel. “LUMRYZ represents a new generation of oxybate treatment the FDA deemed clinically superior to all twice nightly oxybate treatments. The Avadel team is fully prepared to execute our commercial strategy and deliver LUMRYZ to the $3 billion plus once-at-bedtime oxybate market.”

LUMRYZ is the first and only U.S. Food & Drug Administration (FDA) approved once-at-bedtime oxybate for people living with narcolepsy. The commercial strategy for LUMRYZ includes an extensive patient support program, RYZUP, which is designed to provide support and education to patients who have been prescribed LUMRYZ and to assist them in gaining access to their medication. More information about the RYZUP patient support program can be accessed at ryzupsupport.com.

LUMRYZ was granted FDA approval based on positive results from the pivotal Phase 3 REST-ON clinical study completed in March 2020. In the REST-ON Phase 3 trial, once-at-bedtime LUMRYZ demonstrated highly statistically significant (p<0.001) and clinically meaningful improvement compared to placebo across all three co-primary endpoints (Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks) for all three doses evaluated, 6, 7.5 and 9 grams.

LUMRYZ was granted a seven year period of Orphan Drug Exclusivity as a result of the FDA finding LUMRYZ to be clinically superior to all first generation oxybate products. In particular, FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. For more information, please visit www.avadel.com.

And the beat goes on……..

We’ve covered the market moves of both CVS and Walgreens as they transition from a pharmacy centric business model to one of health care provider. The cash flow velocity for each related to multiple acquisitions and some divestitures are all seemingly aimed at carving out a huge niche in controlling…. umm we mean providing…. direct health care services to millions of patients nationally.

Let’s start with a quick recap of how Walgreens’ has recently spent upwards of $16 billion ….

• Acquisition of CareCentrix for $700+ million….. CareCentrix coordinates home care for health plans, patients, and medical providers for 19 million patients in the home setting and approx. 7,400 provider locations.
• Acquisition of specialty pharmacy developer / manager Shields Health Solutions for a $1+ billion.
• Acquisition of primary care network VillageMD for $5.2 billion (majority share). 
• Sold $1.7 billion in shares of Amerisource Bergen to partially fund the $9billion acquisition of Summit Health-CityMD which operates more than 680 provider locations in 26 markets.

Not to be outdone, CVS announced almost $19 billion in deals……

• Acquisition of home care company Signify Health for $8 billion and
• Acquisition of Medicare-focused primary care provider Oak Street Health for $10.6 billion.  

What can one make of all this repositioning?

The legacy pharmacy businesses for each company dovetails well with their healthcare subsidiaries serving as feeders for patient prescriptions….. especially in the specialty medication category.

Second, the market encroachment by hospital / health-system operated retail and specialty pharmacies is mitigated by creating some control over prescribing docs at their subsidiary companies.

And, for CVS, which is also a PBM, the overall environment for PBMs has turned somewhat toxic.

One can only imagine what may be next.

CLICK HERE for full article on Walgreens

CLICK HERE for full article on CVS

The excitement in the air is palpable….  

Yes, another biosimilar to Humira has been approved by the FDA!! Hallelujah!! 

Ummm…..  wait…..  the degree of excitement may be….. exaggerated. 

The FDA did approve yet another biosimilar to Humira but the news wires did not get very hot. Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab). If you are keeping count there are now nine biosimilars to Humira since 2016 with yet a tenth in the wings waiting for approval later in 2023.

It is noteworthy that Celltrion is now seeking to obtain an interchangeability designation for Yuflyma which would give it a valuable marketing edge.

Approval was granted with a black box warning for infections and malignancies.

CLICK HERE to access prescribing information.

Celltrion did not announce pricing for Yuflyma but it is expected to mirror pricing for other adalimumab products now coming onto the US market.

——————————————————————————————-

FDA Approves Celltrion’s Yuflyma, the Ninth Adalimumab Biosimilar

May 24, 2023 — Celltrion Healthcare announced the FDA approval of its adalimumab biosimilar, Yuflyma (adalimumab-aaty), making it the ninth biosimilar referencing Humira (adalimumab) to receive regulatory approval in the United States (Table).

Yuflyma is a high-concentration (100mg/mL), citrate-free adalimumab biosimilar. The biosimilar will be offered to patients in a prefilled syringe and autoinjector administration options.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, a professor of medicine and the associate director of the MD/PhD Program at the University of Massachusetts School of Medicine, in a statement from Celltrion.

The FDA approved the biosimilar for 8 indications:

• rheumatoid arthritis
• juvenile idiopathic arthritis
• psoriatic arthritis
• ankylosing spondylitis
• Crohn disease
• ulcerative colitis
• plaque psoriasis
• hidradenitis suppurativa

Yuflyma is the fifth biosimilar and second anti-tumor necrosis factor biosimilar developed by Celltrion Healthcare to receive FDA approval. Yuflyma is also approved in the European Union and Canada.

“Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice…. As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for U.S. patients,” commented Tom Nusbickel, chief commercial officer at Celltrion USA, in a statement.

Celltrion said that Yuflyma will launch on the US market in July 2023. The company said that it is also seeking an interchangeability designation for the biosimilar, predicting that the extended approval will come in the fourth quarter of 2024.

The news comes after the US welcomed the first adalimumab biosimilar on the market, Amgen’s Amjevita, in January 2023. It will be the only adalimumab biosimilar competing against the originator until July 2023.

In March 2023, the FDA approved the high-concentration, citrate-free formulation of Sandoz’ Hyrimoz (adalimumab-adaz).

Across 2023, an estimated 10 adalimumab biosimilars will enter the US market, with 9 expected to launch in July 2023. In addition to the aforementioned adalimumab biosimilars, the other FDA-approved adalimumab products are Idacio, Abrilada, Yusimry, Hadlima, and Hulio.

The FDA is also reviewing Alvotech’s adalimumab biosimilar, AVT02, which recently received a second complete response letter (CRL) that cited “deficiencies” in the company’s Iceland-based manufacturing facility. The CRL pushed back the FDA’s decision date for approval from April 2023 to later June 2023.

by Skylar Jeremias

A few weeks ago, we sent a Report asking whether value-based (VB) contracting had a heartbeat. Today we have evidence that a meaningful heartbeat has been detected. 

As reported, 12 % of payers have put their toes into the VB pond. The article below offers new evidence that the heartbeat may be getting louder. Kaiser Permanente has cut a multi-billion-dollar deal with Geisinger Health predicated on the VB model.

The deal sets the foundation for a new entity, Risent Health, with plans to expand to as many as five health systems that will generate north of $30 billion in revenue. Those five or so health systems will also represent upwards of 10,000 prescribing physicians…. all of which can be channeled into select pharmacy fulfillment sources.

Their proposed value-based premise takes on a new dimension. The envisioned large scale enables ‘the entity’ to tackle the big obstacles we noted in our earlier Report holding back VB contracting. Key among these is the ability to analyze outcomes across a very large patient population, critical to obtaining a more accurate determination of meeting… vs. not meeting… contractual VB metrics.

None the less, it will take years to determine the ultimate success of the venture.

———————————————————————————

Kaiser to Fold Geisinger into New Value-Based Care Company, Risant Health

The deal creates a new force in the world of value-based health care.

Apr 26, 2023 — Kaiser Permanente and Geisinger Health said they have agreed to create a new company called Risant Health, which plans on making more acquisitions in the years to come.

Under the deal, Geisinger would become a part of Risant and keep its name. The agreement is subject to federal and state regulators.

Like California-based Kaiser and Pennsylvania-based Geisinger, Risant would be a nonprofit; it would be headquartered near Washington, DC.

“In addition to Geisinger, Risant Health will grow its impact by acquiring and connecting a portfolio of like-minded, nonprofit, value-oriented community-based health systems anchored in their respective communities,” according to a statement put out by the companies.

According to The Wall Street Journal, Risant seeks to acquire 4 or 5 more hospital systems and get to total revenue of $30 billion to $35 billion over the next 5 years, and Kaiser is expected to provide about $5 billion in funding to Risant.

Risant Health will operate separately from Kaiser Permanente, while health systems that join the new firm will also retain distinct identities in their communities.

Jaewon Ryu, MD, JD, who became Geisinger’s CEO in 2019, will become the new CEO of Risant Health.

Geisinger includes 10 hospital campuses, a health plan with more than half a million members, and has more than 25,000 employees and more than 1700 employed physicians.

“Through Risant Health, we will make our value-based care expertise, technology and services available to community-based health systems, like Geisinger, to strengthen their ability to provide value-based care models with a focus on high-quality and equitable health outcomes,” said Greg. A. Adams, chair and CEO, Kaiser Permanente, in the statement.

by Allison Inserros, AJMC

From time to time we run across an article that offers more than just recent industry news. Today we stumbled across an article that we suggest be added to your company’s training syllabus. 

The topic has relatively little to do with specialty pharmacy, but it is part of the branch of pharmacy that is above the regular packaged drug dispensed at retail.

The topic of which we speak is Compounding…. a close cousin to specialty poharmacy. There are many similarities between specialty drugs and compounded drugs beyond just cost. As such, all staff working in a specialty pharmacy would benefit from at least a baseline understanding of those similarities and differences to gain as broad an understanding of the segment in which they work.

What follows is a list of key questions that can answer many questions about Compounding.

• How Is a Compounding Pharmacy Different from a Regular Pharmacy?
• What Are the Different Kinds of Compounded Medicines?
• Are There Different Types of Compounding Pharmacies?
• What Governs Compounded Drugs and Compounding Pharmacies?
• Do Compounding Pharmacists Have Education in Making Custom Medicines?
• Why Would I Need to Use a Compounded Drug?
• What Types of Drugs Are Compounded Most Often?
• Why Can Compounding Drugs Be Risky?
• Do Compounded Drugs Cost More Than Manufactured Drugs?
• How Can I Find a Compounding Pharmacy Near Me?

——————————————————————————————–

What Is a Compounding Pharmacy?

When you have to go on a medication, your doctor will probably prescribe a premade one that’s FDA-approved. But sometimes, they may want you to go on a compounded medicine — one specifically made for your needs.

About 1% to 3% of prescriptions in the U.S. are for compounded drugs.

These medicines may be free of certain allergens or have a dosage that’s different than the preset dosages available. They may change the formula for an existing medicine to meet your specific needs.

The risks of compounded medicines are different so the laws that govern compounding pharmacies and compounded drugs differ from a traditional drug manufacturer or pharmacy.

How Is a Compounding Pharmacy Different from a Regular Pharmacy?

Compounding pharmacies sell custom-made medicines. Retail or hospital pharmacies (also known as community pharmacies) sell medicines made by manufacturers, but they can still offer certain compounded drugs. They just may not offer all the exact mixtures you need, especially if what you need must be made in a special setting to ensure safety. In that case, you may need to go to a compounding pharmacy, specifically.

There are about 56,000 community-based pharmacies in the U.S. Of them, about 7,500 pharmacies offer compounding services. Some estimates say that more than 32,000 pharmacies in the country offer some kind of compounding. About 40% of people who can compound drugs work in pharmacies that solely compound drugs.

What Are the Different Kinds of Compounded Medicines?

There are two kinds of medicines made at compounding pharmacies. 

• Sterile compounds are drugs that are injected into your tissue or blood, or put into your eyes. They have a higher risk for contamination than traditional pharmacies.
• Non-sterile compounds come in capsules, creams, and ointments.

Compounding pharmacies have to use pure, pharmaceutical-grade ingredients when they mix up a compounded drug. These must be made at a facility that’s registered with the FDA.

There are differences in how compound and traditional drugs are labeled, too. Compounded medicine labels don’t follow a format like FDA-approved drugs do. They aren’t regulated the same, either.

Are There Different Types of Compounding Pharmacies?

There are two types of compounding pharmacies:

• 503A compounding pharmacies. They can create a medication for you based on your doctor’s prescription. The compounding can’t be done by someone under supervision of a pharmacist. They’re mostly managed by the states.
• 503B compounding pharmacies. These are outsourcing facilities, which can make a medicine based off a prescription. They can also create large amounts of medicines and sell them to medical offices. The FDA manages most of these. They have stricter labeling rules than 503A pharmacies in an effort to avoid confusion.

What Governs Compounded Drugs and Compounding Pharmacies?

Although the FDA has approved the medicines used in a compounding pharmacy, it doesn’t approve compounded drugs like they do with traditional prescription drugs, such as the dosages The FDA can’t confirm if a compounded drug is safe or effective the way that they do with manufactured drugs.

State pharmacy boards manage compounding pharmacies in the U.S. But the FDA can oversee the safety of drugs used in compounding. The Drug Enforcement Administration (DEA) can do the same for controlled substances that are put into compounded drugs. Federal and state authorities can manage the labs and equipment used, too.

Compounded drugs have to follow industry standards, and the United States Pharmacopeia (USP) Convention sets those. If they’re made in an outsourcing facility, they have to follow good manufacturing practice (CGMP) rules that cover how they’re made, processed, and packed. 

In addition to licensed doctors, a licensed pharmacist, or someone supervised by one, can create a compounded drug.

They can be made in a pharmacy or outsourcing facility. The FDA and state pharmacy boards can inspect those facilities.

Do Compounding Pharmacists Have Education in Making Custom Medicines?

Pharmacists learn how to make their own versions of medicines in pharmacy school. Many states test how well they can compound before they get their license.

Many that work in compounding pharmacies have advanced training in compounding. States don’t require specific training, though. There’s no national specialty in drug compounding.

For example, pharmacists can earn a designation as a board-certified sterile compounding pharmacist (BCSCP). This means they meet standards for safety when preparing sterile compounded medications.

Why Would I Need to Use a Compounded Drug? 

If the medicine you need isn’t available in a premade form from a manufacturer, your health care professional might prescribe a compounded drug.

• Pharmacists can mix a drug to:
• Customized dosages
• Add flavor (for a child or pet)
• Change the form (perhaps from pill to liquid)
• Remove allergens or non-essential ingredients

If you’re concerned about taking a compounded drug, talk to your doctor. They may be able to tell if you’re better off on a compounded drug or if a traditional prescription will benefit you. This conversation could be important because a traditional drug may be just as effective — and it’ll probably be cheaper, too.

What Types of Drugs Are Compounded Most Often?

Some drugs are more commonly prescribed in compounded form. These include medicines for:

• Pain: Like baclofen, bupivacaine, cyclobenzaprine, diclofenac, flurbiprofen, gabapentin, ketamine, and lidocaine.
• Hormone replacement: Including, estradiol, estriol, progesterone, and testosterone.
• Dermatology: Doctors often combine different drugs to treat skin-related conditions.
• Animals: It’s common for doctors to prescribe compounded medications for animals and pets.

Compounding pharmacies can be handy when there are drug shortages as well. The pharmacists can essentially make the same formulations as a manufactured drug.

Why Can Compounding Drugs Be Risky?

Some compounding pharmacies and drug preparers may make misleading statements about the safety or efficacy of compounded drugs. They may not follow standards as with traditional, FDA-approved drugs.

If the mixture is contaminated, it can injure or kill people. This happened in 2012 when the New England Compounding Center (NEC) sent out compounded a methylprednisolone acetate solution free of preservatives. It contained fungus that caused 753 infections and 63 deaths.

Be aware about purchasing something from out of state because some states don’t have rules that are as strict as others in terms of quality.

Do Compounded Drugs Cost More Than Manufactured Drugs?

There’s limited data to show price differences between compounded drugs compared to traditional, manufactured drugs.

In 2012, the average cost for an ingredient in a compounded drug was $308.49, while ingredients in non-compounded drugs were $148.75. There was a 130.3% increase in the average ingredient cost for compounded drugs from 2012 to 2013. On the flip side, costs for non-compounded drug ingredients went up 7.7% during that time.

Check with your insurance plan to see how they may cover a compounded drug. They may cover it differently compared to manufactured drug. And you may want to know what they’ll pay before you fill the prescription to avoid any unexpected costs.

by Kristen Fischer