The National Headache Foundation (NHF) has issued new migraine care recommendations challenging health insurance payers for uneven treatment of migraine patients.

The “current care models have not kept pace with the many advances in treatment,” NHF said in a statement.

Payers should adopt care models that are patient-centric, in which the clinician—in collaboration with the patient—is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs, NHF said.

“Clinicians and patients are naturally upset that payers are forcing them to use older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist,” said Tom Dabertin, NHF CEO and executive director.

“For too long, migraine patients have been treated differently than others with medical issues as it related to prescription medications,” Dabertin added.

The scientific understanding of migraine has advanced considerably in recent years, bringing better tolerated and better-studied treatments to patients, most notably, anti-calcitonin gene-related petptide (CGRP) monoclonal antibodies (mAbs), oral CGRP antagonists (gepants), and agents targeting serotonin receptors, NHF noted.

“There is also growing awareness among clinicians that what was once thought sufficient efficacy for successful migraine control is, in fact, inadequate,” NHF said. “Unfortunately, the care models set by payers and the consequent treatment paradigms have not kept pace with these advances.”

NHF’s position is that the selection of a migraine therapy:

should ultimately be determined by the clinician, in collaboration with the patient, based on the individual needs of that patient and that patient’s outcomes

should not be determined solely by a step-care model

should not be determined by a one-size-fits-all algorithm, including models focused predominantly on costs instead of outcomes

The organization’s specific recommendations are outlined below.

For patients with a minimum of 8 migraine days per month—a number that constitutes high-frequency or chronic migraine—NHF recommends that the clinician have the ability to select the most suitable preventive therapy, with unfettered access to FDA-approved preventive drugs, for the following reasons:

8 or more migraine days constitutes a significant fraction—25% or more—of the month; 

patients with less time to recover between incidents are more likely to experience a transformation to chronic migraine and more than 15 days per month; and studies suggest patients with 8 to 14 headache days/month have a level of disability similar to those with 15 to 19 headache days/month.

For patients with a 4 to 7 migraine days per month, a modified step-care model is recommended. In this model, patients must first try 1 generic drug for migraine prevention, unless a patient has a contraindication or, per clinician judgment, should not receive it. 

Topiramate, divalproex, sodium valproate, timolol, and propranolol are FDA-approved for migraine prevention. The remaining drugs are commonly used, but not have not been approved for that indication.

“If a drug from this list has failed to provide the patient with benefits in the severity and/or frequency of migraine, or is found to have intolerable side effects, the clinician should be free to select the next most suitable FDA approved preventive therapy, based on the individual patient’s needs and situation,” NHF said.

In the NHF-recommended model for preventive care, a patient is considered to have “tried and been failed by” a given drug if at least 1 of the following applies:

The patient does not experience an adequate treatment response after a 2- to 4-month trial, where response is defined as a 50% reduction in the number migraine days per month during preventive therapy compared with the number of migraine days per month prior to the start of therapy.

The patient cannot tolerate the drug due to its side effects, such as hypotension on beta-blockers, impaired cognition on topiramate, and weight gain on amitriptyline.

At the time of decision, the patient has a previously documented history of having “tried and been failed by” the drug due to intolerability or lack of treatment benefit.

The patient has a comorbidity and/or other contraindications that preclude the clinician from prescribing the drug.

For the treatment of acute migraine, NHF endorses a modified step-care model, in which patients must try 2 generic drugs: first a generic triptan, then any other generic drug, including another triptan or NSAID.

After a patient has “tried and been failed by” 2 of these generic drugs, the clinician can select another suitable therapy based on patient needs. These therapies include FDA-approved acute agents such as lasmiditan (Reyvow) or a gepant (ubrogepant [Ubrelvy], rimegepant [Nurtec ODT]; or atogepant [Qulipta]).

As with the NHF-recommended preventive care model, a patient is considered to have “tried and been failed by” a drug for acute migraine if at least 1 of the following applies:

The patient is not migraine pain-free and functional within 2 hours of treatment after the majority of attacks OR the patient has recurrence of migraine symptoms within 24 hours following treatment.

The patient cannot tolerate the drug due to its adverse effects (eg, tightness in the throat and/or chest with triptans).

The patient has a documented history of the drug having proved either lacking in efficacy or intolerable due to side effects.

The patient has a comorbidity and/or another contraindication that precludes the clinician from prescribing the drug. This list includes uncontrolled hypertension, coronary artery disease and reversible cerebral vasoconstriction syndrome for triptans or gastric ulcer disease and renal insufficiency for NSAIDs.

1. National Headache Foundation position statement on the treatment of migraine. National Headache Foundation. January 19, 2022. Accessed January 20, 2022. 

https://headaches.org/2022/01/19/national-headache-foundation-position-statement-on-the-treatment-of-migraine/

Articles

Current migraine care recommendations do not reflect recent advances in the scientific understanding of migraine disease.  

 Group Calls for New Model of Care for Migraine  

Sara Crystal, MD, is a neurologist and headache specialist currently serving as 

, a digital health program that allows patients to access expert care for migraine.

When considering the general principles of acute treatment, Crystal keeps this in mind: “While not all patients need a prescription migraine preventive treatment, all patients should be offered a migraine-specific acute treatment. By the time someone is seeking care, they no doubt have tried over-the-counter medications and found them ineffective.”

In terms of goals of acute migraine treatment, Crystal aims for:

Crystal noted that triptans are generally considered first-line treatment in patients without contraindications, with the caveat that patients with the following conditions should not take triptans due to their effects on vessel constriction:

Uncontrolled hypertension (blood pressure >140/90)

Use cautiously in patients over 50 years old due to cardiovascular risk factors

Use cautiously in patients with Raynaud phenomenon

There are 7 different oral triptans available:

Patients who experience significant nausea or vomiting, or those who do not respond to oral triptans, may benefit from non-oral triptans, including nasal sprays and injectables. To make this determination, Crystal assesses the patient’s response to the acute medication after 2 different attacks. If the drug is ineffective, she considers another class of medication; another route of delivery can also be considered.

The risk of serotonin syndrome is minimal, said Crystal, referring to this a 2018 study published in JAMA Neurology

. While serotonin syndrome is an important counseling point, the study concluded that “patients with coexisting affective disorders and migraine need not forgo management of one condition to treat the other.”

Other drugs that Crystal considers as part of a patient’s treatment include:

Nonsteroidal anti-inflammatory drugs (NSAIDs), as an add-on treatment to triptans

Anti-nausea medications such as ondansetron or metoclopramide for patients who experience nausea with migraine attacks

According to Crystal, the gepant class of drugs has several advantages over triptans. These small-molecule CGRP receptor antagonists have “better tolerability/side effect profiles, and they do not cause vasoconstriction, so they should be safer in patients with stable cardiovascular disease,” she said, but cautioned that there are drug interactions to consider. 

For the following drugs, always check for drug interactions before filling a prescription:

Gepant: Rimegepant orally disintegrating tablet (Nurtec ODT)

Rimegepant is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. It is also approved for the prevention of episodic migraine.

The dosage of rimegepant for acute treatment is one 75 mg tablet, placed on or under the tongue, for 1 dose as needed. The maximum dose is 75 mg in 24 hours. The safety of using more than 18 doses in 30 days has not been studied. 

The most common side effects of rimegepant are nausea, abdominal pain, and indigestion.

Avoid concomitant administration with strong CYP3A4 inhibitors, strong and moderate CYP3A inducers, and inhibitors of P-gp or BCRP.

Avoid a second dose of rimegepant within 48 hours when taking a moderate CYP3A4 inhibitor (including grapefruit juice).

Counseling note: Allergic reactions may be severe and may occur several days after taking a dose of rimegepant.

Ubrogepant is a CGRP receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.

Dosage is 50 mg or 100 mg by mouth as needed. A second dose can be taken at least 2 hours after the first dose if needed, and the maximum dose is 200 mg in 24 hours.

The most common side effects are nausea, somnolence, and dry mouth.

Avoid concomitant administration with strong CYP3A4 inducers.

See prescribing information for dosage adjustments for other interacting drugs.

Counseling note: The patient should not take a second dose of Ubrelvy within 24 hours after consuming grapefruit or grapefruit juice. 

Serotonin (5-HT) 1F receptor agonist: Lasmiditan (Reyvow)

Lasmiditan is a serotonin (5-HT) 1F receptor agonist. It is indicated for the acute treatment of migraine with or without aura in adults. 

Lasmiditan is a Schedule V controlled substance. Patients should be advised to avoid alcohol when taking lasmiditan, as alcohol increases the risk of CNS and respiratory depression as well as psychomotor impairment.

Lasmiditan dosage is 50 mg, 100 mg, or 200 mg taken by mouth 1 time as needed. No more than 1 dose should be taken in 24 hours. The lasmiditan tablet should be swallowed whole and not split, crushed, or chewed.

The most common side effects are dizziness, sedation, fatigue, paresthesia, nausea and vomiting, muscle weakness, hypersensitivity, increased blood pressure, and decreased heart rate.

Lasmiditan may decrease heart rate and should be used with caution in patients taking medications that lower heart rate, such as propranolol. 

Avoid concomitant use of drugs that are P-gp or BCRP substrates, as lasmiditan can inhibit both.

Counseling note: Lasmiditan should only be taken if the patient has at least 8 hours until they need to drive or operate machinery. A second dose of lasmiditanis not effective for the same migraine attack. 

There are several non-invasive neuromodulation devices on the market, Crystal added. “These offer a non-medication option and can be used in conjunction with medications,” she said, noting that Nerivio—a smartphone-controlled wearable—is approved for the acute treatment of migraine.

Be sure to check out the other three parts of this series: 

Part 1: Non-prescription measures to manage migraine

Part 2: Prescription Preventive Therapies

Orlova Y, Rizzoli P, Loder E. Association of Coprescription of Triptan Antimigraine Drugs and Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor Antidepressants With Serotonin Syndrome. JAMA Neurol. 2018;75(5):566–572. doi:10.1001/jamaneurol.2017.5144

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ef08e09-1098-35cc-e053-2a95a90a3e1d

https://online.epocrates.com/drugs/916710/Nurtec-ODT/Monograph

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd9f9458-fd96-4688-be3f-f77b3d1af6ab

https://online.epocrates.com/drugs/907010/Ubrelvy/Monograph

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aea3358c-ff41-4490-9e6d-c7bf7b3de13f&audience=professional

https://online.epocrates.com/drugs/910910/Reyvow/Monograph

Pharmacists can be a helpful resource in counseling patients about the acute treatment of migraine. Patients often have questions about the best options for treating a migraine attack. 

 

Managing Migraine, Part 4: A Focus on New Drugs for the Acute Treatment of Migraine  

Recognizing knowledge gaps can help address disproportionate treatment that affects patients with skin of color (SOC), according to a speaker at the Winter Clinical Dermatology Conference, held this week in Kauai, Hawaii.1

Susan Taylor, MD, of the University of Pennsylvania’s Perelman School of Medicine, said it is important for dermatologists to understand the different presentations of conditions like atopic dermatitis (AD) and psoriasis in patients with SOC, because correct diagnosis is directly correlated with adequately treating these patients.

“Black children are nearly twice as likely to develop AD compared with White children after controlling for socioeconomic factors, and Asian and Pacific Islanders are 7 times more likely than White [patients] to be diagnosed with AD,” which makes accurate diagnosis all the more important, Taylor said.

She noted 1 of the key differences between diagnosing AD in patients with SOC is erythema.

“We think of inflammation as being red, but not so much in our patients with [SOC],” Taylor said. “That can be a problem because erythema is a significant portion of the EASI and other scoring systems for AD and as such they often underestimate AD prevalence in [SOC].”

Patients with SOC may get hypo-or hyperpigmentation, she said, and follicular morphology is more commonly seen in Black patients compared with White patients. This is key, she said, because follicular prominence in AD may be the only sign in this population.

One pearl she offered for diagnosing this condition in patients with SOC was to: “close your eyes and palpate the skin, using your fingertips may be helpful in identifying a flare.” She also said patients have variability in color in their flares, as the flares could be more brown or grey in appearance, with some scaling.

Keloidal prurigo is sometimes present in Black patients with AD, and Taylor said, Black and Asian patients may present more with lichenification when compared to White patients.

Describing other AD in SOC characteristics, Taylor noted Dennie-Morgan lines, periorbital hyperpigmentation, and palmar hyperlinerarity.

Taylor noted that several studies have also shown that SOC patients are less likely to be correctly diagnosed than white patients with skin diseases. Additionally, some studies have indicated these patients may be less likely to be prescribed proper treatment.

One study by Bell et al, demonstrated that Black patients were less likely to receive topical corticosteroids, topical immunomodulators, crisaborole, or dupilumab despite other data showing good efficacy of these medications in these population for treatment of atopic dermatitis.

This article was originally published on 

Taylor S. Managing challenges in skin of color. Presented at: 2022 Winter Clinical Dermatology Conference; January 14 to 19, 2022; Kauai, Hawaii.

Bell MA, Whang KA, Thomas J, Aguh C, Kwatra SG. Racial and ethnic disparities in access to emerging and frontline therapies in common dermatological conditions: A cross-sectional study. 

One of the key differences between diagnosing AD in patients with skin of color compared to White skin is erythema.

Challenges in Diagnosing Skin of Color: Recognizing Knowledge Gaps

Too often, patients with chronic illnesses can feel like a burden to their clinicians or caregivers.

Chronic illnesses do not take days off — they are called “chronic” for a reason. Since most patients (and clinicians, for that matter) are unable to spend all day, every day, in an exam room, a large portion of day-to-day disease management falls on the patient themselves. This weighty responsibility can take a 

significant toll on a person’s mental health

To put self-management challenges into perspective, this section will focus on a chronic illness that 

 and causes 1.5 million deaths a year: diabetes.

Outside of the clinician’s office, diabetes management is a patient’s round-the-clock responsibility. Patients must watch what they eat, monitor their blood sugar levels, take their medications, maintain a routine of moderate exercise, and some must self-administer insulin injections multiple times a day. They must also know what to do in the case of a health emergency, such as a sudden spike or dip in blood sugar levels, which can lead to dizziness, loss of consciousness, vomiting, and other symptoms ranging from disruptive to life-threatening. And the more complex their diabetes is, the more challenging patient adherence becomes.

If they manage their condition well, people with diabetes can lead relatively normal lives. However, everyone has their own unique set of circumstances influenced by their underlying physical health, personal history, geographic location, economic stability — the list goes on. That said, there are a few issues that stand out as 

consistent barriers to effective diabetes management

Lack of education and understanding of the condition

In order to truly understand how to self-manage, patients with complex diabetes and their families or caregivers require educational support about the effects of disease on the body and how medication, exercise, and lifestyle adjustments can counter those effects. And since most people rely on general practitioners for their primary healthcare, they may be missing crucial, disease-specific education.

A patient’s socioeconomic status, age, cultural beliefs, and additional health factors can inform how they perceive advice for self-management — or make it more difficult to access assistance. Underlying psychological factors including 

anxiety, depression, and eating disorders

 can also compound these issues or act as additional barriers to adherence.

When patients think of their treatment as difficult or complicated, they are less likely to adhere to their self-management as recommended. Clinicians need to ensure that patients are not experiencing adverse effects — both physical and mental — related to using medications or at-home treatments. It is also important for clinicians to understand if patients have any unpleasant feelings associated with medication, such as a fear of injections or difficulty swallowing pills.

In countries without universal healthcare, 

 that out-of-pocket costs are an important determinant of how likely patients are to adhere to their treatment. Patients who have lower incomes are more likely to face economic barriers to consistently taking their prescribed medications. Patients cannot be expected to overcome their own economic barriers, and many general practitioners are ill-equipped to help patients access more affordable treatment.

If unaddressed, these barriers to successful adherence can lead to a decline in the patient’s condition, lower quality of life, development of additional health issues, long-term or repeated hospital admission, or death.

Despite these multifaceted challenges, there are steps clinicians and patients can take to improve patients’ access to and experience of disease management.

How to improve patient care delivery systems

When patients understand and feel engaged with their own care plans, they are much more likely to adhere to clinical recommendations.

The patient’s relationship with their healthcare provider is one of the most important interactions in healthcare, but it is only one part of a larger system of support. Augmenting the patient’s care team with a variety of support specialists — such as health coaches, counselors, care coordinators, and disease educators — can help patients adhere to treatment regimens and experience better health outcomes.

These methods of patient support can vastly improve self-management between office visits and make appointments more efficient and productive.

Approach communication from a patient-centric perspective

Provide multiple communication touchpoints

How to help patients overcome barriers to adherence

Even if it feels counterintuitive to a clinician, the key to overcoming patient non-adherence is this: Healthcare professionals need to position the patient as the primary decision-maker in their own care and actively support the patient’s efforts to achieve their care goals.

Clinicians can embody this approach by asking the patient questions such as:

“What would you like to get from today’s visit?”

“How can I help you reach your goals?”

“What confuses, concerns, or frightens you?”

“Do you need help identifying less complicated treatment options?”

“Do you need help finding less expensive treatment options?”

Integrating activities such as goal setting and problem solving into routine appointments will help facilitate patient and clinician communication that goes beyond mere status updates. Additionally, connecting patients with health coaches gives them an opportunity to easily ask questions and share self-management updates between appointments.

Healthcare professionals need to make patients the primary decision-makers in their own care and actively support their efforts to achieve their care goals.

Improve Patient Care and Chronic Disease Management

Lauren Biscaldi is the Managing Editor of Drug Topics. 

The World Health Organization (WHO) has made an eighth update to their living COVID-19 therapeutics guidelines, according to statement released last week.

Monoclonal antibody sotrovimab has been “conditionally recommended” to treat mild to moderate COVID-19 in those who are at high risk of hospitalization, a list that includes patients who are older, immunocompromised, have underlying conditions, or are unvaccinated.

The treatment joins baricitinib, a current treatment for rheumatoid arthritis, that was recommended by WHO in July 2021.

Two other drugs were also reviewed by WHO experts: ruxolitinib and tofacitinib. However, the effects of these drugs were “uncertain,” leading to a conditional recommendation against their use.

According to the statement, these recommendations are based on data and evidence from 7 clinical trials inclusive of more than 4000 patients with COVID-19 ranging from nonsevere disease to those in severe and critical condition.

Currently, WHO is “in discussions with manufacturers to secure global supply capacity and equitable and sustainable access to the newly recommended therapeutics,” the statement noted, through the Access to COVID-19 Tools Accelerator (ACT-A) Therapeutics pillar, which continues to engage with pharmaceutical companies to create “comprehensive access plans” for low- and middle-income countries.

Baricitinib and sotrovimab are both eligible for WHO Prequalification and assessment of the quality, efficacy, and safety of these products.

WHO recommends two new drugs to treat COVID-19. World Health Organization. January 14, 2022. Accessed January 20, 2022. 

https://www.who.int/news/item/14-01-2022-who-recommends-two-new-drugs-to-treat-covid-19

The monoclonal antibody was conditionally recommended for the treatment of mild to moderate COVID-19 in patients at high risk of hospitalization. 

Sotrovimab Joins the WHO List of Potential COVID-19 Treatments 

Transparency is a buzzword these days. We hear about it on the nightly news in reports about our government, schools, restaurants, and even social media. Transparency in the pharmacy industry is undoubtedly an active discussion topic, and pharmacy owners have been fighting for it for years with little success. Let’s discuss some key areas where a lack of transparency hurts pharmacy owners and, ultimately, patients. 

Because of past situations involving the over-prescribing and over-dispensing of controlled medication, both the Drug Enforcement Agency (DEA) and wholesalers closely monitor pharmacies’ ordering habits. On the surface, this is a good thing: No one is a proponent of pill mills. However, the lack of transparency in this process hurts pharmacy owners and patients.

Pharmacists will regularly turn away legitimate prescriptions from legitimate patients who present with a new controlled prescription. Why? Likely, these pharmacists are worried about going over ambiguous thresholds and ratio limits. The pharmacist is concerned that if they increase their purchases of these controlled substances, they will trigger a controlled medication audit and perhaps prevent the pharmacy from ordering what they need to fill prescriptions. This confusion comes from a lack of transparency from wholesalers and enforcement agencies. 

Many pharmacy owners have heard horror stories of pharmacies forced to close or their ability to order controlled medications taken away. For West Virginia pharmacist Martin Njoku, these horror stories became real life when the DEA raided Oak Hill Hometown Pharmacy and revoked Njoku’s right to dispense controlled substances. The raid, according to previous reporting,

came a few years after Njoku began dispensing buprenorphine to customers, both local to Fayette County, West Virginia, and those displaced by flooding in nearby counties.

Although Martin was cleared of all wrongdoing, the damage was done. He was forced to close his pharmacy and his community lost critical access to the care it needed. 

There is a shroud of secrecy surrounding everyone from the wholesalers to state and federal agencies about what triggers these drastic actions. No one will talk about it and no one will help pharmacy owners and pharmacists on the front line maneuver legally within the system to best help patients. Pharmacists want to help combat the opioid epidemic; we need transparency and collaboration with the key players to do our part while still providing care for our patients. Instead, we feel like we have no choice but to turn patients away.

Another area that lacks transparency is drug pricing. From the patient’s point of view, there has been some significant, positive headway where drug pricing transparency is concerned. However, many pharmacies must still deal with smoke-and-mirrors pricing in the drug acquisition process.

In the traditional wholesaler model, the pharmacy places orders for medication and pays an “invoice cost,” which is an inflated price for its inventory. The pharmacy can earn rebates over the next several months to lower its acquisition cost, but because rebates come in long after the medication is dispensed, pharmacies don’t know the actual cost of a product at the point of sale. They are left to make educated guesses.

Some pharmacies will not bet on getting the total rebate—as it is not guaranteed—so they keep the invoice cost in their pharmacy management system. In contrast, others will accept the theoretical rebate as a given. The ambiguity of each product’s price leads to decisions at the point of care. If the pharmacy assumes it will lose a significant amount of money, it may choose not to dispense the prescription. Conversely, a pharmacist may think they are making a profit on medication—but in reality, their cost is higher than anticipated and they are now losing money. 

These “leaked” dollars add up to significant unrealized revenue for pharmacy owners. For a typical independent retail pharmacy, between 15% and 20% of the prescriptions it dispenses are a negative reimbursement at the point of sale. This loss not only puts a strain on a pharmacy’s ability to stay in business, but it also impacts both clinical decisions and the service offerings provided to their community. The purchasing process needs to be infused with transparency so pharmacy owners can focus on patient care instead of playing purchasing games. 

A lack of transparency around pharmacy payments has the same deleterious effects as pharmacies not knowing drug costs. Frequently, pharmacists are either left guessing how much money they are losing or assuming they are making money only to never see those revenues realized. 

Confusion on the reimbursement side comes in many forms, but the 2 most egregious culprits are effective rate contracts and direct and indirect remuneration (DIR) fees. 

Under an effective rate contract, the pharmacy has a maximum profit percentage cap across an insurance's entire book of business. This cap causes a reimbursement amount at adjudication to become, essentially, a made-up number, with the payment processor guessing at what the rate should be. A “true-up” will happen later, typically resulting in the pharmacy paying back large sums of money to the pharmacy benefit managers. Pharmacy owners are left in limbo for months, wondering what their actual revenues will be. Any business owner can easily empathize with the trouble this unknowing causes.

DIR fees for Medicare claims are the most significant source of concern for pharmacy owners. The lack of transparency comes from several questions: 

How can the pharmacy improve its performance?

While these seem like easy questions to answer, the lack of transparency makes answering nearly impossible. Each Medicare plan has published DIR fee ranges, but these ranges are wide and the difference to a pharmacy’s bottom line is critical if it is, for example, 11% vs 15%. There also never seems to be a straightforward answer for how each pharmacy earns its score and ensures the data are clean. A patient who passes away, for example, counts as missed fills, lowering the pharmacy’s adherence score for many months until the patient drops from its calculation. No one intended for deceased patients to cost pharmacies thousands of dollars. 

Many pharmacy industry organizations and individuals are fighting long, hard battles to improve transparency throughout the industry. It is critically important to talk to your elected representatives at all levels of government and to support organizations like 

Pharmacists United for Truth and Transparency

 in their quest for change. Most importantly, pharmacy owners must understand the impact that a lack of transparency has on their business. Knowing where there are information blind spots may help owners see the bigger picture and make better choices for patients and the pharmacy alike.

Pattani A. DEA takes aggressive stance toward pharmacies trying to dispense addiction medication. NPR. November 8, 2021. Accessed January 3, 2022. 

https://www.npr.org/sections/health-shots/2021/11/08/1053579556/dea-suboxone-subutex-pharmacies-addiction

Without transparency, pharmacy owners must clear numerous hurdles to run an effective business. 

Prescribing Transparency as the Solution to Pharmacy Owner Woes 

Remembering that it is “safe to laze,” and “the redder the better,” can make treating rosacea “as easy as pie,” according to a speaker at the 19th Winter Clinical Dermatology Conference, being held January 14 to 19, in Kauai, Hawaii.

Emmy Graber, MD, board-certified dermatologist and founder of the Dermatology Institute of Boston, and affiliate clinical instructor, Northeastern University, shared these 3 pearls with the dermatologists in attendance, encouraging them that it is, in fact, acceptable to begin pulse dye lasers combined with or immediately after low-dose isotretinoin, a practice once thought incorrect.

She cited 2 different studies by Spring and Ibrahim et al, that showed this practice is safe. One of the papers was a review of 32 publications reporting 1485 procedures, that concluded: “there was insufficient evidence to support delaying manual dermabrasion, superficial chemical peels, cutaneous surgery, laser hair removal, and fractional ablative and nonablative laser procedures for patients currently receiving or having recently completed isotretinoin therapy.”

The second paper, which looked at patients with 46 patients with acne who were divided into 2 groups, 1 of which was treated with just oral isotretinoin (0.5 mg/kg/day), and compared them with a second group treated with oral isotretinoin and 5 sessions of pulse dye laser. In that study, the combined groups showed a statistically significant greater improvement regarding all parameters.

The second pearl Graber shared from her own practice, which is the “redder the better.” She said often patients will tell the physician when their rosacea flares, and a lot of times, it’s after high heat situations, like getting out of the shower or working out. She said she recreates this type of situation by keeping a hairdryer in her office and recreating the flared red appearance, to provide a clearer target for the laser.

Finally, Graber reminded her audience about the “easy as pie” rule, which means treating the post-inflammatory erythema with 3 monthly PDL treatments.

In a separate session at the meeting, Graber told the audience that “several studies have shown that basic skin care alone can improve rosacea symptoms,” and she advised the audience to share some cleansing pearls with patients with rosacea, including moisturizing and washing the face with mild products. She also advises her patients to use sunscreens and avoid alcohol-based products.

“I tell my patients to check all their products for anything on them that says alpha-hydroxy acids,” she said. “These are the things we want our patients to avoid because it exacerbates their rosacea.”

Del Rosso JQ, Bhatia ND, Graber EM, Harper JC. Clinical and therapeutic pearls in acne and rosacea. Presented at: 2022 Winter Clinical Dermatology Conference; January 14 to 19, 2022; Kauai, Hawaii.

Spring LK, Krakowski AC, Alam M, et al. Isotretinoin and timing of procedural interventions: A systematic review with consensus recommendations. 

Ibrahim SM, Farag A, Hegazy R, et al. Combined low-dose isotretinoin and pulsed dye laser versus standard-dose isotretinoin in the treatment of inflammatory acne. 

Graber EM. What’s new and hot in rosacea. Presented at: 2022 Winter Clinical Dermatology Conference; January 14 to 19, 2022; Kauai, Hawaii.

Treating these patients can be a challenge, but it can also be ‘as easy as pie’ if you follow these tips.

Tips for Treating Rosacea Patients

Ruxolitinib cream 1.5% (Opzelura; Incyte) is a first-in-class topical JAK inhibitor for short term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD), which targets the key cytokines believed to contribute to itch and inflammation and offers a newer option for patients whose AD is uncontrolled.

In a non-continuing medical education presentation that was sponsored by Incyte and presented at the Winter Clinical Dermatology Conference this week in Kauai, Hawaii, Alexandra K. Golant, MD, who is medical director of the Dermatology Faculty Practice at the Icahn School of Medicine at Mount Sinai, explained ruxolitinib cream’s role in treating AD. This was a particularly timely talk since the FDA recently approved this product for AD.1

She presented findings from Incyte’s TRuE-AD clinical trial program, which evaluated the topical in over 1,200 patients, ages 12 years and older, who had been diagnosed with AD for at least 2 years and were also candidates for topical therapy. The NDA filing also included safety and efficacy data from a supplemental 44-week, open-label, long-term extension study of both TRuE-AD1 (

, results of TRuE-AD1 showed 50% of the ruxolitinib cream 0.75% group and 53.8% of the ruxolitinib cream 1.5% group achieved the primary end point compared to 15.1% vehicle. Moreover, 56% of the ruxolitinib cream 0.75% group and 62.1% of the ruxolitinib cream 1.5% group achieved the secondary end point of 75% improvement or more in Eczema Area and Severity Index (EASI) score compared to baseline vs 24.6% vehicle.

In TRuE-AD2, 39% of patients treated with ruxolitinib cream 0.75% and 51.3% treated with 1.5% met the primary end point compared to 7.6% of the vehicle group. Also, more than 51% of patients in the 0.75% group and 61.8% of patients in the 1.5% group achieved 75% improvement or more in the EASI score from baseline, vs 14.4% vehicle, according to a press release announcing the study’s results.2

Once the approval was announced, in the release, officials with Incyte advised physicians to 

educate themselves about important safety information regarding ruxolitinib

, including a recently issued boxed warning from the FDA for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, seen with JAK inhibitors for inflammatory conditions.

Fielding a question from an audience member about discussing these warnings with patients, Golant advised the dermatologists in attendance to “be upfront about it,” and advise the patients: “you are going to see a boxed warning when you get this from the pharmacy, and this largely comes from not an AD population,” she said. “I do try to talk to them about the indication I’m prescribing it for, on a limited body surface area in a little period of time.” She said she also discusses the risks of their use as topicals rather than systemic.

Golant AK. Atopic dermatitis: the burden of disease and a novel topical pathway. Presented at: 2022 Winter Clinical Dermatology Conference; January 14 to 19, 2022; Kauai, Hawaii.

Incyte announces acceptance and priority review of nda for ruxolitinib cream for atopic dermatitis. Incyte. Press release. Published February 19, 2021. Accessed March 12, 2021. 

https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-Acceptance-and-Priority-Review-of-NDA-for-Ruxolitinib-Cream-for-Atopic-Dermatitis/default.aspx

The FDA approved the topical JAK1/JAK2 inhibitor ruxolitinib for the treatment of mild to moderate atopic dermatitis in September 2021.

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