New medications and treatment guidelines
Managing asthma is both complicated and costly for patients, so pharmacists play a unique role in helping them navigate how to use their treatments effectively and prevent exacerbations. Keeping up with ever-evolving treatment strategies, guidance, medications, and patient experiences is key.
Guidelines are continually updated to reflect new research, and Cleveland Clinic primary care clinical pharmacist Giavanna Russo-Alvarez, PharmD, BCACP, suggests making it a personal goal to review guidelines annually, and even regularly in between.
“I look for guideline changes,” Russo-Alvarez says. “We as pharmacists can be really helpful in reaching out to practices. We can provide small in-services to keep them informed, as well.”
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Sometimes, changes are frequent and clinicians can’t keep up-even with major changes. Russo-Alvarez notes that some clinicians weren’t even aware of a major recent change that shifted decades of asthma treatment.
This change was the recommendation made in April 2019 by the Global Initiative for Asthma (GINA) to no longer treat teens and adults with asthma with short-acting bronchodilators alone. The recommendation has been hailed as a fundamental change to three decades of asthma management, but was made as a result of concerns over the effects of treating asthma with short-acting Ã2-agonists (SABA) alone.
GINA was established in 1993 by the World Health Organization and the National Heart Lung and Blood Institute to improve global asthma prevention and management, and suggested in its latest annual report that teens and adults with asthma should receive symptom-driven or daily inhaled corticosteroid-containing (ICS) treatments as a way to reduce the risk of serious exacerbations.
SABA risks were first identified in the 1980s and 1990s, according to GINA’s annual report, with evidence supporting an association between over-use of SABA and an increased risk of asthma-related deaths. Randomized controlled trials found no evidence to support the efficacy of regular, compared to as-needed, (PRN) use of SABA. Most guidelines were updated in the 1990s to support PRN rather than regular SABA use as a result of this research.
Trials have also shown that low-dose ICS treatment could reduce exacerbations by up to 50% and help control symptoms, but daily uptake of ICS has been slow-going over physicians concerns about the side effects of corticosteroids, according to the report. The concerns about Ã2-agonists were then shifted to long-acting varieties, and short-acting varieties remained widely used as initial therapy for mild asthma. GINA began looking into the issue more extensively in 2007 and found a host of data to support a link between regular use of SABAs alone, and higher rates of exacerbations and asthma-related deaths.
The paper goes on to list specific treatment recommendations, and Diana M. Sobieraj, PharmD, assistant professor of pharmacy practice at the University of Connecticut, says the new guidelines could result in a shake-up at the pharmacy counter.
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“These guidelines recommend against using a SABA as-needed alone, even in the most mild asthmatics. They recommend ICS be used in all asthmatics, even if on a symptom-driven, as-needed basis,” Sobieraj says. “Pharmacists are more likely to see as-needed dosing of ICS with this recommendation, and fewer patients treated with a SABA PRN only. This is very different than what we have traditionally seen for many decades of asthma management.”
Evolving Treatment Plans
As if changes to fundamental treatments aren’t enough to keep a pharmacist on their toes, immunotherapy and biologics are changing the game when it comes to treating a host of conditions, including asthma.
Immunology is a developing field in asthma care, with researchers recently identifying genetic variants for all types of asthma that could lead to new treatment modalities. Pharmacists may also see more asthmatic patients being prescribed biologics, particularly for specific types of asthma, Sobieraj says.
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“The field of biologics continues to evolve, specifically for patients with what would be considered eosinophilic asthma, which represents a small proportion of asthmatics that are extremely difficult to control,” Sobieraj says. “The most recent FDA-approved therapy is dupilumab, which is also approved for steroid-dependent asthma.”
Dupilumab-marketed as Dupixent-was approved by the FDA in October 2018 as an add-on maintenance treatment for patients age 12 and older with moderate- to severe-asthma with an eosimophilic phenotype or who are dependent on oral corticosteroids. The medication inhibits overactive signaling of interleukin-4 and interleukin-13-both of which are proteins that may contribute to the inflammation that causes moderate- to severe-asthma. Dupilumab comes in two doses-200 mg and 300 mg-in pre-loaded syringes, and is given every other week at rotating injection sites after an initial loading dose. Dupilumab has also been approved to treat eczema, and studies are underway for a number of other uses like various allergies and pediatric asthma.
This newest biologic joins four others already approved for asthma-omalizumab, mepolizumab, reslizumab, and benralizumab-and several more are in development, according to the American Academy of Allergy, Asthma & Immunology (AAAAI). Omalizumab works on the immunoglobulin E (IgE) antibodies that play a role in allergic asthma; and mepolizumab, reslizumab, and benralizumab all target pathways that affect eosinophils-the cell involved in allergic inflammation.
Patient Education, Exacerbation Prevention
Pharmacists are the front line to helping keep patients-particularly in the outpatient setting-compliant with their regimens, or signal to the clinician when a patient’s condition changes.
“I make sure I have a good understanding of what’s been happening recently with patients,” Russo-Alvarez says. She asks about recent changes like hospitalizations and exacerbations to guide her assessment and the questions she asks her patients. Ask about devices-patients may be using them at the wrong time or in the wrong way. Russo-Alvarez suggests asking both new and long-standing patients to demonstrate how to use inhalers, letting them lead the demonstration. It’s surprising what you can learn by watching a patient use a device, and asking the right questions, she says.
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“At a minimum, pharmacists are really well-positioned to teach patients how to use these inhalers,” Russo-Alvarez says, adding that sometimes providers don’t have inhalers on hand to teach patients about their use, or patients become confused on how and when to use different types of inhalers.
She recommends using an inhaler technique training and assessment tool, which can mimic different types of inhalers.
“It can be set to mimic what breathing technique is used in soft mist versus dry powder and metered-dose inhalers,” she says. “You can use it to get feedback on how they are breathing, and the pharmacist can see what works best for the patient and reach out to the provider and maybe recommend an alternative, if needed.”
Pharmacists are also crucial in signaling to clinicians when there may be a change in a patient’s condition. According to Russo-Alvarez, it is a red flag when patients are filling their rescue inhalers frequently, despite using them correctly.