Giving Patients a Breath of Fresh Air
Respiratory market player Dey LP responds quickly to regulatory developments.
Vice President of Operations
The respiratory products market has seen some new challenges in the past year. FDA has questioned the barrier of semipermeable packaging for inhalation drugs, has suggested that all drug unit doses carry bar codes, and has joined the EPA by removing the essential-use designation for chlorofluorocarbon (CFC) propellant use in metered-dose inhalers for certain products. Such actions have required respiratory products firms to reconsider packaging and labeling.
Instead of just reacting to these developments, Dey LP is putting them to use. Not waiting around for FDA mandates, the respiratory products manufacturer is already taking steps to redesign its packaging and labeling and to bring new products to market.
In this exclusive interview, Gary Michaud, Dey's vice president of operations, and Raymond Joske, vice president of marketing and business development, share their plans with PMP News editor Daphne Allen.
Describe your respiratory products.
Joske: We split our products into two groups: products for treating asthma and products for treating chronic obstructive pulmonary disease (COPD). Dey has always been known as a manufacturer of products that bring value to the patient. Everything is clearly marked. What differentiates Dey in terms of its competition is manufacturing and a patient-friendly focus that we maintain with such products as Albuterol, Ipratropium, and Cromolyn. A new product we are actively promoting is AccuNeb, a child-strength dose of Albuterol for children ages 2 through 12 with childhood-onset asthma. Another product is DuoNeb, a combination product of Ipratropium and Albuterol for patients with COPD. We have a nebulized DuoNeb, nebulized AccuNeb, and Albuterol in a metered-dose inhaler (MDI) and in a nebulized version.
Are you looking for MDIs that do not use ozone-depleting substances?
Vice President, Marketing and Business Development
Michaud: We are concerned that FDA is talking earnestly about phasing out CFCs for Albuterol products. The agency may phase out CFCs in MDIs in favor of hydrofluoroalkane (HFA), so we're looking to HFAs in the future. It hasn't been stipulated by FDA yet, but I think it is safe to say in the next couple of years MDIs with CFC for Albuterol will be gone.
Are you looking at other advancements, like dose counters?
Joske: With our focus on patient- friendly packaging, we're always looking for such features.
Michaud: Counters are getting very sophisticated, so the device part of an MDI will show doctors whether patients are compliant, and that can help improve treatment and outcomes.
What changes are in store for your nebulized-product packaging?
Michaud: We were the inventors of unit-dose respiratory product packaging in the late 1970s and early 1980s. We put saline into 3-ml and 5-ml polypropylene containers and sterilized them. As technology changed by about 1987, we were one of the first respiratory companies to get into large-scale production using Rommelag form-fill-seal (FFS) machines.
How has FFS evolved?
Michaud: The electronic side of it has gone from relay logic circuit controls to sophisticated computer controls. The machines themselves have evolved from manually cleaned machines to clean-in-place (CIP) technology, which is much more sanitary and designed with what they call light side, dark side technology. Particle-generating motors and hydraulic systems are on the dark side, and product on the light side is never exposed to them. You can depend on uniform cleaning and not depend on testing to show whether systems were properly cleaned.
Have you changed package design?
Michaud: No. We were lucky in that we chose a user-friendly design. Our vials are flatter than competitors' vials, so they are user friendly--users can completely squeeze product out.
How have you handled FDA's concern that semipermeable packaging for respiratory products may not keep out external contaminants?
Michaud: We are in the process of changing our packaging. We will be putting a foil overwrap on all our products. It will start phasing in during the second quarter of 2003 and should be completed in the first quarter of 2004. Another way we are adding value is through bar coding. We also have plans over the next year and a half to begin providing customers who require it and request it individually overwrapped vials with bar codes. These codes will have not only National Drug Codes, but also lot numbers and expiration dates. We are currently polling our customers right now about symbology. Reduced Space Symbology (RSS) looks like it may be adopted by the industry, so we will have that available. In the beginning, though, most of our customers won't be able to read it, so we may first use Code 128. Then, as the industry adopts RSS, we'll switch over to it.
We are concerned about reducing medical errors. This is a strong effort to reduce such errors. In addition, it should help hospitals with billing and inventory control. Overwrapping and bar coding is quite an undertaking for us, when you consider that we make more than 850 million vials a year.
Joske: Our former CEO, Charles Rice, has established this platform of excellence in manufacturing that benefits patients. Our new CEO, Mel Engle, is doing everything possible to maintain that excellence as we move forward with these plans.