Day 1 of the 2011 IPAC-RS conference featured 13 talks and a panel discussion, covering two topics aligned with the conference theme of “Bring Value to the Patient in a Changing World.” The morning focus, “Voice of the Customers,” included presentations by clinicians, a patient education specialist, and the FDA Office of Special Health Issues, in addition to a report on patient-related aspects of the 2010 ISAM/IPAC-RS Equivalence Workshop. The afternoon presentations, on the topic “Patient Interface,” came from representatives of the pharmaceutical industry, the FDA, and a manufacturer of an adherence device.
The first two speakers, William Busse of the University of Wisconsin School of Medicine and Public Health, and Stephen Rennard of the University of Nebraska Medical Center, emphasized the heterogeneity of asthma and COPD. Both encouraged pharmaceutical companies to recognize that one size does not fit all when it comes to treatment of these diseases, in large part because the diseases may take different forms in different patients. Rennard also suggested that COPD patients should be asking not only for improved bronchodilators and easier-to-use devices, but ultimately for a cure for the disease.
Monica Fletcher of the charity Education for Health and Deborah J. Miller of the FDA Office of Special Health Issues described how their organizations meet patient needs, and Søren Pedersen, representing the Aerosol Drug Management Improvement Team (ADMIT) discussed the matching of patients with devices, noting that he as a clinician would like to see more adherence and feedback systems on both MDIs and DPIs in order to improve patient inhaler use. Dennis O’Conner presented a summary of discussion from the 2010 European Workshop on Equivalence Considerations for Orally Inhaled Products for Local Action.
Two of the afternoon talks covered pharmaceutical packaging considerations for improved adherence, though neither addressed OINDPs specifically. Tim Chesworth of AstraZeneca pointed out that with long-term non-adherence to inhaled medications as high as 90%, any improvement created by improved packaging would be a benefit. Joshua Wachman, a former Disney “imagineer” and President of Vitality, described the company’s GlowCaps product and how it improves adherence for patients using medications offered in bottles using the interactive caps.
Another two speakers from the FDA explained how their offices work and how they interface with patients and pharmaceutical companies. William Doub of the Division of Pharmaceutical Analysis explained that his office conducts testing to determine whether patient anecdotes of how their inhalers work match the empirical data. As an example, he cites testing the office has been conducting in response to the more than 400 complaints about a single HFA inhaler received by the FDA between October 15, 2008 and February 26, 2010. The office is also currently assessing the use of spacers and valved holding chambers, the effects of shaking on MDIs, and parameters affecting nasal actuation.
By the time the final presenter Ronald Kaye of the FDA’s Office of Device Evaluation reached the podium, he joked that previous speakers Paul Lucas of Pfizer, Stephen Eason of Vectura, and Julian Dixon of Team Consulting had done such a good job of discussing expectations for the consideration of patient usage of inhalation devices that he would just take questions. Kaye then proceeded to deliver detailed, practical advice for companies who would be submitting products to his office for Human Factors/Usability evaluation.
Although his three-person team has evaluated only one aerosol device to date — as far as combination products go, they so far have dealt mostly with the evaluation of pen- and auto-injectors — they plan to expand and to become more involved with OINDPs. The advice he offered included the observation that “rating scales are not helpful for validation testing; narrative data is expected” because human factors engineering is “a game of words, not a game of numbers,” with numbers potentially giving “a false sense of security.” Kaye also warned that “user preference” and “ease of use” do not necessarily equal optimum design and that “Aspects of use with a low frequency of occurrence can be as important or more than those that tasks that are performed often.”
