When it comes to helping patients with respiratory disorders, 2014 promises to be a year of change and challenges for pharmacists. Nasacort Allergy 24HR should hit the retail market just in time for next year’s spring pollen season. New drugs—and better delivery devices—are on the way for patients with chronic obstructive pulmonary disorder (COPD). More difficult is achieving cessation in the shrinking but still sizable sliver of smokers, most of whom are hard-core nicotine addicts.
In Pharmacy Today’s annual respiratory update, we provide the latest information on OTC options for allergies, patients with COPD, and smoking cessation—including the popular e-cigarettes that are increasingly common in public spaces.
Like Rudolph in April, patients with spring allergies can be spotted as soon as they enter community pharmacies. The nose red from rubbing and the watery eyes give them away as they head to the cough-and-cold aisle. In the past, patients would stop first at the antihistamines, but this spring, Nasacort Allergy 24HR (triamcinolone acetonide nasal spray, Sanofi/Chattem) could be what they’re looking for.
“I think it will be a nice addition to have an intranasal steroid for over-the-counter use,” said Dennis Williams, Vice Chair for Professional Education and Practice, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. “For upper airway allergies, intranasal steroids are actually the most effective therapy overall. With some of the issues with seasonal allergies, including congestion, even decongestants don’t work well in some cases.”
Pharmacists will need to help patients with dosing, as Nasacort Allergy 24HR has different instructions for its three approved age groups: adults and children 12 years or older, children 6 to under 12 years, and children 2 to under 6 years. Additional information included in the labeling informs consumers that when using this product, the growth rate of some children might be slightly slower. The labeling also states that if a child needs to use the spray for longer than 2 months a year, parents should talk with the child’s physician about long-term use of the product.
Lori Wilken, PharmD, Clinical Pharmacist and Assistant Professor at the College of Pharmacy, University of Illinois at Chicago, worries about the impact of the OTC steroid on patient adherence. “In my practice, I see that patients’ adherence with the use of nasal steroids is already low because many dislike the intranasal delivery system,” Wilken said. If patients have to pay out of pocket for these medications, their adherence will decrease even further.” When one agent in a class goes OTC, most insurers stop paying for it, and some will end coverage of other agents in the class, she explained.
Williams’s concerns tilt toward the clinical concerns. “Maybe Nasacort isn’t considered by some the best intranasal corticosteroid, but it’s a good starting point,” he said. “To have something like that available for over-the-counter use creates a big role for pharmacists in terms of talking to patients about its use and correct administration.”
Where will Nasacort Allergy 24HR on OTC shelves fit into therapy? “The basic approach would be the same as it is now,” Williams said. “Get some idea about the patient’s symptoms and their severity. For the mildest form of the disease, an oral antihistamine is still the first choice. But if people continue to have symptoms, or the severity of the symptoms cannot be controlled with an oral antihistamine, or if congestion plays a big role, that’s a place for an intranasal corticosteroid.”
“The medications we currently have for COPD slightly improve the lung function for our patients, but this does not always translate into quality patient care,” Wilken said when asked about the pharmacotherapy of COPD. “We are looking now at decreasing hospitalizations, decreasing mortality, and improving patient quality of life. We know that if a patient gets admitted to the hospital with a COPD exacerbation, their lung function never goes back to what it was before the admission. ... New studies need to show not just the change in lung function, but the impact on hospital admissions and quality of life.”
“We’ve seen that the device makes about as much difference as the molecule,” Williams said. “These new products are going to be challenging for patients to use. Counseling by pharmacists is going to be critical to achieving proper use of these new products for COPD.”
Wilken agrees. “Pharmacists should assemble the inhalers before dispensing them and have the patient demonstrate use, even if this is not the first fill.”A combination of the ICS fluticasone and the LABA vilanterol, the inhalation powder Breo Ellipta (GlaxoSmithKline/Theravance) was approved by FDA in May of this year. In September, an FDA advisory panel recommended approval of a second vilanterol-based combination from GlaxoSmithKline and Theravance, one containing the LAMA umeclidium.
The process of incorporating these new agents into the clinical approach to COPD will be interesting to watch. LABAs in particular have a bad reputation, owing to the unexplained mortality problems seen in patients with asthma—a condition the new products are not approved to treat.
“I don’t see physicians using a LABA without an ICS,” Wilken said. “I see them using a LAMA as first-line and then adding on an inhaled corticosteroid/LABA combination. The risk of mortality [with LABAs] hasn’t been shown in patients with COPD [as it has in those with asthma], but you still see the reluctance because of safety concerns.”
Products containing ICSs are also of concern. “Doctors are really pulling back with using [these agents] because of an increased risk of pneumonia,” Wilken said.
In the half century since the U.S. Surgeon General reported a definitive link between smoking and lung cancer, public health efforts have succeeded in driving down the number of smokers. Those who still use tobacco consist chiefly of youthful experimenters and a hard-core older group whose nicotine addiction is very difficult to break.
For patients with COPD, there’s only one way to stop the decline in lung function: stop smoking. Nothing else works, Wilken said.
E-cigarettes are showing up in more and more public places, and e-cig advocates are pushing these devices as a “safer” way to get nicotine on board (see page 34). Might they be the magic solution we’ve sought?
Not likely, Wilken said. In fact, she said, “I think in a couple years, I’m going to be running an e-cigarette clinic.” She has heard smoking compared to jumping off a 50-story building, while using e-cigarettes is like jumping off a 5-story building—safer, yes, but you get the same result.
“We’re seeing decline in lung function” in people using e-cigarettes, Wilken said. “At this point they’re not regulated, so you don’t know what’s in them.”
In fact, Wilken said, nicotine replacement in general is not the best way to get people off tobacco. “We need to be using the products that we have available that have been shown to be efficacious,” Wilken said. “Varenicline, for example, has been shown to be the most effective agent out there. The fear of suicidality and depression [is keeping people from using this agent]. I’m hoping a new BMJ study will show that that is really not the case.” That study, released on the journal’s website in early October, used nationwide data from Denmark on use of varenicline or bupropion for smoking cessation. The researchers found no increased risk of cardiovascular events among those using varenicline in 2007 through 2010.
Progress in medicine often is glacial in pace, and that has been true for respiratory disorders. Today, though, the progress in this field is palpable. Having an OTC intranasal steroid will add much to what pharmacists can offer patients starting in the spring, drugs and administration devices are becoming more refined for patients with COPD, and everyone can be proud of the progress made over the past 50 years in smoking cessation.