In April 2013, the Food and Drug Administration (FDA) issued draft guidance that could allow new generic quick-relief albuterol inhalers onto pharmacy shelves without dose counters, leaving asthma patients playing a dangerous guessing game.
Allergy & Asthma Network Mothers of Asthmatics (AANMA) believes dose counters should be required on all quick-relief inhalers, given the life-saving role they play in the management of asthma. Without a counter, there is no accurate or convenient way for patients to track the number of doses remaining in an inhaler.
Quick-relief inhalers relax airway muscles to give prompt relief of asthma symptoms; however, they will not work if the inhaler is empty of active ingredients. The problem is that inhalers continue to sound and feel full even when they are not. Inactive gases remain in the canister long after the active ingredients run out and the inhaler will continue to release some spray when activated.
The ideal solution is an integrated dose counter – a device that records and displays the number of “puffs” still remaining in the canister.
In today’s market, 53 percent of prescriptions filled for quick-relief inhalers include a dose counter. This leaves a significant percentage of the population (adults, parents, caregivers and children) at risk and navigating daily without one.
Evidence Is Clear: Dose Counters Save Lives
AANMA believes FDA should close regulatory loopholes that would permit new metered-dose inhalers (MDIs) to enter the market without an integrated dose counter.
Every day in the United States, 30,000 people have an asthma attack and 5,000 people visit an emergency room. Approximately 10 people per day die from asthma. Asthma is the main reason that children go to the emergency room (except for injuries) and treatment exceeds $20 billion in direct costs. Quick-relief inhalers with dose counters can cut respiratory-related emergency room visits by almost half, according to a study of nearly 94,000 patients. The results of the study affirm a clear measurable care benefit and fiscal benefit to requiring dose counters.
What You Can Do?
Speak up. Ask your physician to prescribe an inhaler with a dose counter. Don’t let your pharmacy substitute one without.
Write. AANMA submitted comments on integrated dose counters to FDA and TEVA Respiratory submitted a Citizen Petition. Follow our lead and weigh in! Go to http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-1505 and support TEVA’s petition. Tell the FDA: (1) you are in favor of requiring integrated dose counters on all inhalers; (2) this is the only reliable means for patients to track the number of doses remaining and ensure there is medication available when it is most needed during an asthma attack; (3) dose counters reduce the cost burden of asthma by reducing emergency care.
— By Kimberly Turner, Esq.
Kimberly Turner, Esq., is director of government affairs for Allergy & Asthma Network Mothers of Asthmatics.
Reviewed by Stuart Stoloff, MD
For more information:
1 FDA Docket No.2007-D-0369 Draft Guidance for Industry Describing Product Specific Bioequivalence Recommendations.
2 Dose Counters On Rescue Inhalers Reduce Emergencies. American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting: Abstract 11. Presented November 10, 2013.