Kristen Coppock, MA, Managing Editor

Patients with chronic refractory cough (CRC) may benefit from behavioral cough suppression therapy (BCST). In a session of the 2021 American Cough Conference, Laurie Slovarp, PhD, CCC-SLP, associate professor at the University of Montana in Missoula, said increased awareness of BCST is needed for clinicians and patients to know it as a noninvasive, efficacious, and inexpensive form of cough treatment, as well as to understand how this therapy works and how to identify eligible candidates.

According to Slovarp, BCST is known by various names, including speech pathology treatment for chronic cough, respiratory retraining, and cough-suppression physiotherapy.

“Just about every single paper refers to it by a different name,” she said. “If you see ‘speech pathology’ and ‘cough’ together, you can bet that we’re probably talking about the same therapy.”

Prior to using BCST, patients will often see multiple care providers, undergo multiple tests, and try multiple medications, she said.

However, up to 88% of patients with CRC using BCST have shown a reduction in cough severity through published studies. These reductions occurred in cough frequency and sensitivity, while also increasing quality of life for patients.

“These are all patients that have already failed just about every other medical treatment available to them,” Slovarp said.

A survey study published by Slovarp in 2021 investigated the post-BCST satisfaction of 164 patients in the United States and Australia. It found that 58% of patients reported being “quite satisfied” or “completely satisfied” following therapy. The mean change of 6.6 from the Leicester Cough Questionnaire was significant, according to Slovarp.

“There’s pretty reasonable efficacy data on BCST,” she said. “These patients are not just getting better a little bit, many of them have a pretty dramatic improvement.”

According to Slovarp, onset of CRC often occurs with a cough-inducing event, such as a respiratory virus. CRC may present itself in various ways, from a once-a-week coughing fit to a cough that induces gagging or vomiting.

“In my clinic, I see a wide variety of severity,” she said.

BCST is often determined with extensive case history, oral mechanism exam that may find muscle tension or tenderness in the neck, shoulders and suprahyoid, voice evaluation, urge-to-cough testing, and validated patient-report questionnaire.

“The biggest thing for me is the case history,” she said. “Most of the patients we see have been coughing for years.”

Treatment options may be educating patients about coughing including the safety of cough suppression, training patients to suppress coughing; increasing awareness of cough triggers and a pending cough; management of laryngopharyngeal reflux and postnasal drip, voice therapy, and, if needed, a challenge.

Cough-control breathing, relaxation, and swallowing techniques, as well as distractions, and resonant voicing are some of the methods employed in BCST.

“Over time, with suppression, you will feel a reduction in urge to cough,” she said.

Slovarp L. Issues in clinical cough management: Behavioral management of chronic refractory cough. Presented at: American Cough Conference; virtual. June 11, 2021. 

https://app.socio.events/NzMwMw/Agenda/85150/Session/385292

Articles

Noninvasive, efficacious treatment options are available to help patient outcomes and improve quality of life.  

Using Behavioral Management to Control Chronic Refractory Cough

Individuals who are fully vaccinated against COVID-19 can resume activities they were doing prior to the pandemic, according to updated guidance from the CDC. The agency also advised that fully vaccinated individuals can resume many activities without wearing a mask or social distancing.

The CDC considers individuals in the United States to be fully vaccinated 2 weeks after receiving their second of a 2-dose Moderna or Pfizer-BioNTech vaccine series, or 2 weeks after receiving a single-dose Johnson & Johnson vaccine.

According to the CDC, outdoor activities deemed safest for fully vaccinated people, but less safe for unvaccinated individuals, include:

dining with friends from multiple households

attending crowded events, such as a live performance, parade, or sporting event

Some examples of indoor activities considered safest by the CDC for fully vaccinated individuals that are less safe for unvaccinated peers include:

going to an uncrowded shopping center or museum

attending a small gathering of people from multiple households, whether fully vaccinated or not

attending a full-capacity worship service or singing with a chorus

participating in a high-intensity exercise activity

In the updated guidance released today, the CDC cautioned that masks and social distancing may still be required of fully vaccinated individuals in adherence to federal, state, local, tribal, and territorial laws, rules, and regulations, as well as policies put into place by businesses and workplaces.

The agency is advising that all travelers, regardless of vaccination status, will still need to wear a mask when using public forms of transportation, including planes, buses, and trains. They should also continue to practice social distancing and frequent hand washing or use of hand sanitizer while traveling.3 However, fully vaccinated individuals do not need COVID-19 testing before or after traveling, nor do they need to quarantine upon arrival at a destination in the United States.

Individuals who are fully vaccinated should continue paying close attention to policies and COVID-19 situations at international destinations prior to making the trip. International travelers still need to provide a negative test result for COVID-19 or documentation of recovery from the virus prior to boarding international flights, regardless of vaccination status. The CDC also advises international travelers to obtain testing for COVID-19 within 3 days upon return to the United States, but these fully vaccinated individuals do not need to self-quarantine.

CDC guidance advises individuals who are not fully vaccinated to delay taking trips, if possible, until they are fully vaccinated. Those who do travel are advised to take a viral COVID-19 test 1 to 3 days prior to taking the trip and get tested again 3 to 5 days after returning home, as well as self-quarantining for a full 7 days.

When you’ve been fully vaccinated. CDC. Updated May 13, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html

Choosing safer activities. CDC. Updated May 13, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/participate-in-activities.html

Domestic travel during COVID-19. CDC. Updated April 27, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/travelers/travel-during-covid19.html

The CDC considers individuals in the United States to be fully vaccinated 2 weeks after receiving a complete series of COVID-19 vaccine doses.

CDC Says Fully Vaccinated Individuals can Resume Activities Without a Mask

Officials with the FDA have approved an 8 mg dose naloxone hydrochloride nasal spray (Kloxxado; Hikma Pharmaceuticals) for the emergency treatment of known or suspected opioid overdose in adult and pediatric patients.

 This product is a higher dosage of naloxone hydrochloride than the 2 mg and 4 mg dosage products previously approved by the FDA.

Naloxone hydrochloride is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. According to Hikma, the drug has a long history of safe use as the standard of care for reversing opioid overdoses.

Naloxone hydrochloride can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If administered quickly, the drug can counter the opioid overdose effects, usually within minutes. According to the FDA, a higher dose of naloxone provides an additional option in the treatment of opioid overdoses.

According to Hikma, widely prescribing and distributing naloxone may play a vital role in the fight against opioid overdose. With the increasing prevalence of illicitly manufactured synthetic opioids, a higher dose of naloxone may be required to revive a patient

The use of naloxone in patients who are opioid-dependent may result in opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness, or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

According to Hikma, the company expects its naloxone hydrochloride nasal spray 8 mg to be available in the second half of 2021.

Hikma announces US FDA approval of KLOXXADO TM (naloxone hydrochloride) nasal spray 8mg [news release]. April 30, 2021; Hikma Pharmaceuticals. Accessed May 3, 2021. 

https://www.hikma.com/newsroom/article-i5120-hikma-announces-us-fda-approval-of-kloxxado-tm-naloxone-hydrochloride-nasal-spray-8mg/

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose [news release]. April 30, 2021; FDA. Accessed May 3, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose

This product is a higher dosage of naloxone hydrochloride than the 2 mg and 4 mg dosage products previously approved by the FDA.

Higher Dosage of Naloxone Nasal Spray Approved by FDA for Treating Opioid Overdose 

Moderna’s vaccine candidate for the coronavirus disease 2019 (COVID-19) has been 

recommended for Emergency Use Authorization

 (EUA) by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), according to the company.

 This new COVID-19 vaccine (mRNA-1273) candidate was deemed highly effective in a filing released by the VRBPAC on Tuesday.



“We have been working with the [CDC] and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an [EUA]. We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency,”  said Stéphane Bancel, CEO of Moderna, in a prepared statement released Thursday.



On Thursday, 20 VRBPAC members voted in favor of the recommendation with no members voting against it, and 1 member abstained, according to Moderna. Although the VRBPAC’s recommendation is nonbinding, the FDA will take it into consideration in making a final decision on granting an EUA.

The FDA previously approved an EUA application for the first COVID-19 vaccine to be distributed in the United States. The BNT162b2 vaccine was jointly developed by Pfizer and BioNTech.

In addition to announcing the VRBPAC's recommendation, Moderna announced Friday a purchase of additional 80 million doses of mRNA-1273 by the European Commission (EC). The additional doses bring the EC’s confirmed order commitment to 160 million doses, which will commence from the company’s dedicated European supply chain, according to Moderna.

Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States [news release]. Cambridge, MA; December 17, 2020: Moderna. Accessed December 17, 2020. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-advisory-committee-vote-supporting

FDA Briefing Document: Moderna COVID-19 Vaccine. FDA Vaccines and Related Biological Products Advisory Committee. Published December 15, 2020. Accessed December 17, 2020. 

https://www.fda.gov/media/144434/download

Moderna COVID-19 Vaccine Shows High Efficacy, Clearing Path for EUA. 

®. Published December 15, 2020. Accessed December 17, 2020. 

https://www.pharmacytimes.com/news/moderna-covid-19-vaccine-shows-high-efficacy-clearing-path-for-eua

FDA Grants Historic Emergency Use Authorization to COVID-19 Vaccine From Pfizer and BioNTech. 

. Published December 12, 2020. Accessed December 18, 2020. https://www.pharmacytimes.com/news/fda-grants-historic-emergency-use-authorization-to-covid-19-vaccine-from-pfizer-and-biontech

European Commission exercises option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate [news release]. Cambridge, MA; December 18, 2020: Moderna. Accessed December 18, 2020. 

https://investors.modernatx.com/news-releases/news-release-details/european-commission-exercises-option-additional-80-million-doses

This new COVID-19 vaccine (mRNA-1273) candidate was deemed highly effective by an FDA advisory committee. 

Moderna’s COVID-19 Vaccine Receives FDA Committee Recommendation for Emergency Use

The investigational drug remdesivir demonstrated that a 10-day treatment course achieved similar improvement in the clinical status of patients as a 5-day treatment course. Announced today by Gilead Sciences, these topline results were culled from an open-label phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the antiviral in hospitalized patients with severe manifestations of the coronavirus disease 2019 (COVID-19).

No new safety signals were identified with remdesivir across either treatment group, according to Gilead.

Remdesivir is not approved by the FDA nor licensed or approved anywhere in the world. The drug has not yet been demonstrated to be safe or effective for the treatment of COVID-19.

However, remdesivir, a nucleotide analog with broad-spectrum antiviral activity, has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19.

Due to the COVID-19 pandemic, the FDA designated

allowing patients with serious or life-threatening cases of the virus to have access to the drug.

Remdesivir has also been granted the investigational antiviral Orphan Drug status by the FDA.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping to inform whether remdesivir is a safe and effective treatment for COVID-19, and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, in a prepared statement.

A version of this article was originally published by Pharmacy Times. Read the full article at

Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients with Severe COVID-19 [news release]. Foster City, CA; April 29, 2020: Gilead Sciences. [email]. Accessed April 29, 2020.

Coppock K. FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19.

https://www.pharmacytimes.com/news/fda-announces-two-drugs-approved-for-compassionate-use-in-treating-covid-19

Published March 19, 2020. Accessed April 29, 2020.

Hippensteele A. Potential COVID-19 Treatment Granted Orphan Drug Status.

https://www.pharmacytimes.com/news/potential-covid-19-treatment-granted-orphan-drug-status

Published March 25, 2020. Accessed April 29, 2020.

Remdesivir is not approved by the FDA nor licensed or approved anywhere in the world.

Remdesivir Trial Demonstrates Positive Results for Patients with COVID-19

The American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists issued a joint statement Wednesday addressing inappropriate ordering, prescribing, or dispensing of medications for treating the novel coronavirus (COVID-19). The statement also highlights the important roles that pharmacists, physicians, and health systems play in being just stewards of health care resources during times of emergency, and national disaster.

“Physicians’ and pharmacists’ first and foremost ethical obligation in situations of epidemic, disaster, or terrorism is to provide urgent medical care, and ensure availability and appropriate use of necessary medications. This requires close coordination with the entire health care team to help ensure patients receive the testing, treatments, follow-up care, and medications they need,” the statement reads.

According to the statement, these professional organizations are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19, typically for themselves, their families, or their colleagues. These medications include chloroquine or hydroxychloroquine, and azithromycin. In addition, some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment.

“We strongly oppose these actions. We collectively support state and federal requirements that direct a prescription must be written only for a legitimate medical purpose,” the statement reads. “We also strongly support a pharmacist’s professional responsibility to make reasonable inquiries to a prescriber to resolve any questions about a prescription. If a prescription is not for a legitimate medical purpose, it should not be written, and it should not be dispensed."

use in treating COVID-19. Neither of these 2 drugs are approved by the FDA for treating this virus, although chloroquine is approved for other indications, including malaria. The compassionate use authorization allows patients with serious or life-threatening cases of COVID-19 to have access to them as investigational medicinal products, as prescribed therapies.

The organizations’ joint statement emphasized that whether these medications are used to treat COVID-19 is a determination that should be made on a case-by-case basis with physicians, pharmacists, and other members of the health care team working together and resolving questions.

“We applaud the innumerable selfless acts by health care professionals across the nation who are putting themselves in harm’s way to provide care to America’s patients," the organizations said.

However, the statement also cautioned hospitals, health systems, and individual practitioners that, along with lack of FDA approval for treating patients with COVID-19, there is no incontrovertible evidence to support off-label use of medications for this virus. The organizations urged against stockpiling of these medications for COVID-19 with a warning that doing so could have grave consequences for patients with conditions for which these medications are indicated by FDA approval.

“The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential,” the statement reads.

In addition, the organizations addressed confusion possibly resulting from state government agencies and boards that are issuing emergency rules limiting or restricting access to chloroquine, hydroxychloroquine, or other emerging therapies, or requiring new procedures for physicians, other health care professionals, and patients. They urged state government agencies and boards to emphasize professional responsibility, and a need for professional judgement under these new policies.

“In a time of national pandemic, now is not the time for states to issue conflicting guidance, however well-intentioned, that could lead to unintended consequences,” the associations said. “The nation’s physicians and pharmacists continue to demonstrate remarkable leadership on a daily basis. We are confident in physicians’ and pharmacists’ judgment to make the right decisions for their patients, communities and the health care system overall.”

Finally, the statement applauds continuing efforts to conduct clinical trials and generate evidence related to medications that could help mitigate the pandemic. That some pharmaceutical manufacturers are increasing production of high-demand medications, as well as supplying them for use in clinical trials, is encouraging, according to the associations.

Joint Statement of the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists on Inappropriate Ordering, Prescribing or Dispensing of Medications to Treat COVID-19 [news release]. AMA, APhA, ASHP. [email] Issued March 25, 2020. Accessed March 25, 2020.

FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19.

Published March 19, 2020. Accessed March 25, 2020.

According to the statement, these professional organizations are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19.