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    Features

    Traveling Toward the Intersection of Drug Development and Delivery

    Overcoming the challenges of delivering drugs to patients.

    Traveling Toward the Intersection of Drug Development and Delivery
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    Louise Righton, Global Marketing Operations Manager, 3M Drug Delivery Systems06.12.18
    How fast are we moving toward patient-centered healthcare? In pharma, we are very cognizant of end-users whether patients or caregivers, and what our products and technologies can do to drive better outcomes for them. From a philosophical standpoint, it is simply the right thing to do. We all want the drugs, and the devices that deliver them, to address patients’ needs and solve their problems, leading to optimal outcomes. From a business standpoint, it makes perfect sense. If a product is effective, safe and also user-friendly, while offering value through better, or more cost-effective, outcomes, providers will prescribe it, payers will fund it, and patients will use it. Trust is established, and long-term value is assured. Of course, it isn’t always as easy as it sounds and a look at pharma industry statistics gives us a startling view of some of the challenges facing our drive for patient-centricity in our industry.

    The Challenges of Delivering Drugs to Patients
    The basic act of drug delivery to the patient can be beset with issues. For example, more than 65 percent of the elderly population suffers from dysphagia1 independent of the presence of any disease or illness that could directly cause the condition. Additionally, it is estimated that 25 percent of elderly people take at least three drugs.2 The majority of elderly people, therefore, may experience some difficulty swallowing, yet may also rely on a number of medications—many of them orally-delivered—to help them manage their health conditions. 

    In a similar vein, consider the case of cancer patients who suffer from nausea and vomiting brought on by chemotherapy treatment. For antiemetic drugs to treat nausea and vomiting following chemotherapy, neither a tablet nor an injectable is ideal given the usage scenario. The last thing patients undergoing chemotherapy want is another needle stick, and a patient experiencing nausea will also likely have problems with swallowing a pill—or keeping it down.

    As the population ages, many elderly patients rely on caregivers which brings its own set of challenges relative to drug delivery. Forty percent of people who enter nursing homes do so in part because they are unable to self-medicate in their own homes, and 23 percent of caregivers report problems with medication management.3 Furthermore, the average nursing home patient swallows 13 pills each day!4 With such a pill burden, alternative solutions are needed to help caregivers more easily manage medication routines, as well as give patients a more user-friendly alterative to the large number of pills they are required to swallow.

    Perhaps dialogue within the pharmaceutical community needs to shift from the perennial “how to change patient behavior,” toward modifying technology to fit the needs, behaviors and lifestyle of the patient. The mindset needs to shift from push to pull: patient education has its place but is not the be-all and end-all, and we must prioritize the pulling in of deep patient insights. An alarming number of patients suffering from asthma and chronic obstructive pulmonary disease (COPD), for example, don’t get the proper dose of their medication due to the simple fact that they are improperly using their inhalers, or not using them at all. One research report suggests that incorrect use is as high as 94 percent,5 while up to 70 percent of patients do not adhere to their prescribed therapy.6 The impact on patient outcomes—not to mention healthcare costs—is unacceptably high with failure rates like these.7 But pharma isn’t helping: there are 14 different form factors of inhalers marketed in the U.S. currently.8 No wonder patients are confused about how to use them when many are prescribed several inhalers to manage their condition. We need technologies that aren’t trying to change patient behavior, but rather are integrating with patient behavior in a more intuitive and value-added fashion. We need to understand needs, barriers, feelings, behaviors and experiences, in order to innovate for better outcomes. Patient education, long relied-upon as a tool to drive compliance, is no longer the holy grail. Striving for deep patient and caregiver insights will enable us to design drugs, delivery technologies and healthcare processes around real patient understanding—this is the new rally cry. 

    Drug Delivery as a Primary Consideration
    As we have seen, pharma has a real opportunity to make a difference, but there is a need to start the drug delivery conversation earlier. The status quo saw pharma pursuing solid-dose oral delivery if it was technically feasible, as the simplest and lowest-cost solution, irrespective of patient and caregiver needs, and practicality of the application in usage.

    When pharmaceutical companies truly examine the usage scenarios for a product and consider how to best match a delivery system with the patient profile, the solution is not always the first (often oral), or even second (injectable), choice. This realization can be daunting for pharma companies that have little to no experience with alternative delivery systems. In these situations, working with a partner that is seasoned in development and manufacturing of niche delivery methods is critical to the success of the project, and it can make the development and regulatory path much smoother. By working in partnership with drug delivery providers, pharmaceutical companies can quickly determine if an alternative delivery form is technically feasible for a drug.

    In light of the crowded and competitive pharma landscape, companies must not only deliver drugs that effectively treat patients’ illnesses but also prioritize patient experience, behavior and preference, thereby addressing compliance. By keeping patient and caregiver understanding top-of-mind during the development process, companies can commercialize delivery methods that better meet patients’ needs.

    Which Way Now?
    Global payers are ever-more demanding, and patient-centricity is one of the keys to unlock value in the future. If a patient is not compliant with prescribed medications, it can be very costly to the payer. New solutions that embrace connected technologies are an exciting recent development in drug delivery. 

    The pharmaceutical companies who embrace the new patient-centric mindset in drug design will reap rewards in the future as they drive better outcomes and establish increased trust with patients, caregivers and ultimately payers. By bringing drug development and drug delivery together early in the process, we will design pharmaceutical solutions that patients can weave naturally into their lives and which are no longer a burden to accommodate. And that’s a win for all involved. 

    References
    1. Mintel: Consumer Trends 2011-2016; Glencoe Family Health Nursing Home VOC, World Journal of Pharmaceutical Research Volume 1, Issue 3, 576-590. Review Article ISSN 2277-7105, 2004 U.S. Bureau of the Census
    2. World Health Organization; World Journal of Pharmaceutical Research Volume 1, Issue 3, 576-590. Review Article ISSN 2277-7105
    3. Cost of Care – Caregiving Facts, Frontline, PBS; Palliative Care for Older People: Better Practices, WHO 2012; China Pharmaceutical Association, 2006
    4. 3M Drug Delivery Systems Voice of Customer Research. Data on File.
    5. Lavorini et al., 2008. Respir. Med. 102(4):593-604
    6. Lindsay et al 2013; 7:329-336. doi:10.2147/PPA.S38208 and Elliott RA 2006;14(4):223-233
    7. Pritchard & Nicholls, 2015. J. Aerosol Med. Pulm. Drug Deliv. 28(2):69-81
    8. Allergy and Asthma Network

    Louise Righton is Global Marketing Operations Manager for 3M Drug Delivery Systems. Louise spent the early part of her career in the over-the-counter healthcare industry developing consumer healthcare brands in the UK, Australia, and Central & Eastern Europe. She then led the brand marketing team for the UK’s leading health and beauty retailer, before joining 3M Drug Delivery Systems in 2004 to develop its global inhaled and transdermal drug delivery technologies businesses.
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