Take a deep breath: Flu season ahead

Focus on Respiratory Diseases

With influenza season ahead, pharmacists need to prepare for the common respiratory illnesses, such as asthma and chronic obstructive pulmonary disease, and be familiar with how to optimize treatment with all the available medications. An additional challenge is smoking cessation.

Influenza, pneumococcal vaccinations

CDC’s Advisory Committee on Immunization Practices (ACIP) published its recommendations for prevention and control of influenza for the 2014–15 season. The recommendations include intradermal trivalent vaccine (Fluzone Intradermal—Sanofi Pasteur), which uses a much smaller needle than the regular injection; a high-dose trivalent vaccine (Fluzone High-Dose—Sanofi Pasteur) for adults 65 years and older; and an egg-free recombinant trivalent vaccine (FluBlok—Protein Sciences) for people who are allergic to egg protein.

In addition to influenza, pneumococcal vaccination is important for younger children and older adults to avoid pneumococcal infection. Pneumococcal conjugate vaccine ([PCV13] Prevnar 13—Wyeth, Pfizer) can be given to children and older adults with immunocompromised conditions, while pneumococcal polysaccharide vaccine ([PPSV23] Pneumovax 23—Merck) is recommended for adults 65 years and older and for people 2 years and older with a high risk for disease. It is also recommended for adults who smoke cigarettes or have asthma. Pharmacists play a critical role in not only immunizing the public but also clarifying misconceptions people may have this time of year about influenza vaccines. The variety of formulations and delivery methods may help allay their unwarranted concerns.

Asthma: Inhaler use

Management and control of asthma require routine office visits and asthma self-management to keep the disease in check and to avoid emergency department visits, urgent care visits, and missed days of school or work. Plenty of medications manage asthma, including inhaled corticosteroids (e.g., fluticasone, mometasone, beclomethasone, budesonide), inhaled long-acting beta agonists ([LABA] e.g., salmeterol, formoterol), and a short-acting beta agonist (e.g., albuterol) as a rescue medication. There are also a variety of combination products (e.g., fluticasone and salmeterol) and different delivery formulations (e.g., metered dose inhaler [MDI]), dry powder inhaler [DPI]). Although no new molecular entity was approved for asthma treatment this year, fluticasone furoate inhalation powder (Arnuity Ellipta—GlaxoSmithKline) was approved in August to offer a once-daily maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.

Currently, more than 1,000 clinical trials on asthma treatment are ongoing. Having more drugs on the market is not as critical, however, as proper use of inhalation devices when managing asthma. “The drug or the formulation itself will not work if the patient does not use it properly,” said Lucila Garcia-Contreras, PhD, Assistant Professor, Department of Pharmaceutical Sciences at the University of Oklahoma College of Pharmacy, whose research focuses on developing a drug delivery mechanism that directly targets the site of action to decrease the adverse effects of the drugs.

An MDI is the least efficient device to deliver a drug to the lungs because the patient’s inhalation needs to be coordinated with the actuation of the device, and many patients do not use it correctly. Effective treatment requires having the correct device for the drug delivery and adequately training the patient to properly use it, according to Garcia-Contreras.

Patient adherence is a major stumbling block, and the patient’s ability to afford the medication may be part of the problem—potentially resulting in inadequate therapy. “Any time you are using an inhaler, it requires a tremendous amount of education and renewed education,” said Reynold A. Panettieri Jr., MD, Professor of Medicine in the Pulmonary, Allergy, & Critical Care Division and Director of Airway Biology Initiative at University of Pennsylvania Medical Center. “Oral therapies are far greater than inhalers in terms of ease of use without any specific education requirement. However, the systematic absorption of oral medication leads to unwarranted systemic adverse effects, and inhaled therapies can substantially decrease the adverse effects.”

Patients might feel intimidated by a novel and unfamiliar device, so the pharmacist needs to ensure that the patient fully understands how to use the device properly. “Pharmacists play a seminal role because they are the last stop [in] getting the medication to the patient,” Panettieri said.

COPD: DPIs replacing MDIs

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) updated its guideline this year with a few changes to previous recommendations, including an emphasis on the increased risks of complications in chronic obstructive pulmonary disease (COPD) (e.g., deep vein thrombosis and pulmonary embolism in hospitalized COPD patients) and a new section on asthma and COPD overlap syndrome. More than 600 clinical studies on COPD are ongoing worldwide.

Three new drugs have been approved for the treatment of COPD within the past 12 months: umeclidinium inhalation powder (Incruse Ellipta—GlaxoSmithKline), which is a long-acting anticholinergic monotherapy; umeclidinium and vilanterol inhalation powder (Anoro Ellipta—GlaxoSmithKline), which is a combination therapy with a LABA, and olodaterol (Striverdi Respimat—Boehringer Ingelheim), which is a LABA inhalation spray.

Little by little, DPIs are replacing MDIs because they are more efficient, according to Garcia-Contreras. But a major drawback of DPIs is that they depend heavily on the patient’s inspiration to aerosolize the powder properly. If the patient does not breathe properly, then the powder aggregates may be larger than the target drug size, which cannot reach the alveoli and affect the efficacy of the treatment.

Some DPIs have an indicator (e.g., different colored light, the number of inhalations remaining, transparent packaging) for patients to easily determine how much of the drug is left in the device. The goal of optimizing such inhalation devices for treating respiratory diseases is to develop a device that relies less on usability for the patient, said Garcia-Contreras.

E-cigarettes for smoking cessation?

Smoking cessation is quite a challenge for patients and clinicians. An interesting development is that smokers are asking questions about the use of electronic cigarettes (e-cigarettes) as one method for smoking cessation. Their popularity seems to be increasing, especially among teenagers. There is a big concern about e-cigarettes’ safety, lack of regulation, and marketing, according to Devra Dang, PharmD, BCPS, CDE, FNAP, Associate Clinical Professor, University of Connecticut School of Pharmacy.

E-cigarettes may be attractive to young users because they do not produce harmful tar and carbon monoxide, can be recharged, and come in many different flavors, such as menthol, chocolate, and vanilla. The National Youth Tobacco Surveys, sponsored by CDC and performed over 3 years from 2011 to 2013 among students in grades 6–12, revealed that the number of youth who had never smoked but used e-cigarettes increased threefold from 79,000 to more than 263,000. About 44% of the youth who smoked e-cigarettes had the intention of smoking conventional cigarettes. E-cigarette users had higher odds of having the intention to smoke conventional cigarettes than those who had never smoked e-cigarettes.

According to a systematic review in Circulation this year, e-cigarettes may be as effective for smoking cessation as the nicotine patch, with similar adverse event rates. The results were based on seven studies. The authors addressed concerns over variations in regulatory mechanisms governing the sale and distribution as well as ethical issues surrounding the use of e-cigarettes among minors that may undermine efforts to reduce cigarette smoking. A larger and more thorough trial is urgently needed to reveal a reliable outcome regarding e-cigarettes. Now pharmacists are challenged with counseling the young population about the potential negative consequences of using e-cigarettes as well as smoking cessation.

Sharon K. Park, PharmD, BCPS, contributing writer

Enterovirus D68 has providers, parents on alert

State health departments across the country are investigating several reported cases of severe respiratory illness in children, many attributed to enterovirus D68 (EV-D68), a nonpolio enterovirus that can cause mild to severe respiratory illness.

Health officials said they will continue to provide updates that can help providers, patients, and caregivers know how to detect the virus and take action against it.

Although EV-D68 has been reported in small clusters since 1987, CDC said that this year, the number of people reported with confirmed EV-D68 infection is much greater than in previous years. In the United States, people are more likely to get the virus in the summer and fall. CDC said EV-D68 infections are likely to decline later this fall.

Pharmacists are being called upon to provide consistent public health information and public assurance.

In general, infants, children, and teenagers are more likely to get infected with enteroviruses because they lack immunity to them, and children with asthma may have a higher risk for respiratory infection caused by EV-D68.

If a patient presents with acute, unexplained, severe respiratory illness, CDC said health care providers should consider EV-D68 as the cause and proceed with testing. EV-D68 can only be diagnosed with a specific lab test using samples from the patient’s nose and throat, which is typically done at a local or state health department.

CDC said providers should also report any suspected clusters to local and state health departments that may have additional guidance for reporting. Unfortunately, no vaccine nor any antiviral medications are currently available to treat EV-D68. But patients can relieve symptoms with OTC medications for pain and fever. Aspirin should not be given to children, according to CDC guidelines.

CDC guidelines also included certain measures that can go a long way to prevent the spread of EV-D68: washing hands often with soap and water for 20 seconds; avoiding touching eyes, nose, and mouth with unwashed hands; avoiding close contact such as kissing, hugging, and sharing cups or eating utensils while sick or with people who are sick; covering coughs and sneezes with a tissue or shirt sleeve, not hands; cleaning and disinfecting frequently touched surfaces, such as toys and doorknobs, especially if someone is sick; and staying home if sick.

Loren Bonner, MA, Reporter