, ,

Sven Stegemann, Ph.D., is director of Pharmaceutical Business Development at Capsugel, the world’s leading provider of dosage form solutions to the healthcare industry.

Looking back over the past 20 years, we as pharmaceutical scientists can be proud of the more than 600 new drug therapies that have been brought to the market worldwide to combat major chronic and acute diseases. Thanks to these therapies, life expectancy is continuously increasing, allowing us to reach the 8th decade of life and enjoy our independence for as long as possible. That said, treatment outcomes can, at times, be disappointing for healthcare professionals in the real world as many patients, consciously or unconsciously, do not follow treatment regimens. Nonadherence has been found as a major challenge that negatively impacts therapeutic outcomes. According to a recent report by the World Health Organization, adherence to long-term therapy for chronic illnesses in developed countries averages 50 percent. The report states, “Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments.”

One of the reasons for poor adherence is underestimating the complexity of drug therapy in general, which is especially seen in special patient populations, like the elderly or those in developing countries. First, patients have to experience a health problem and make the decision to see one or more healthcare professionals. From there, they have to understand and accept the diagnosis and treatment protocol and then go to a pharmacy to fill the prescription. While at the pharmacy, patients have to listen to the pharmacist, remember the treatment schedule, and implement it into their daily lives. It is only after they take the first dose that patients can understand their medicine—what it looks like; how it should be taken; and any potential side effects related to it. For very young or very old patients with specific diseases or concurrent chronic conditions as well as impaired functional abilities, the standard drug products may not meet their particular needs. As a result, patients may elect to modify their treatments by splitting or crushing their dosage form, taking the medicine in the wrong way, or omitting or taking the medicine irregularly—all of which lead to nonadherence and poor treatment outcomes.

It is well recognized that in order to achieve efficacy, patients need to be part of the drug development process, starting with drug design. To date, however, the special needs of patients are not well understood and the suitability of dosage forms and other particulars are not tested within the clinical program with the real patient. While pharmaceutical scientists have developed a variety of different dosage forms and drug delivery systems over the past decades, we need to meet today’s challenges by developing innovative medicines tailor-made for certain patient populations in an effort to increase adherence and improve treatment outcomes.

Given the need for a multidisciplinary approach, AAPS has assembled a preconference workshop on October 13 and 14 as part of the 2012 AAPS Annual Meeting and Exposition that will cover the various aspects of patient centric drug products and provide worthy insight into the actual knowledge as well as future perspectives and opportunities of patient centric drug delivery for the pharmaceutical sciences. I look forward to seeing you in Chicago and discussing this emerging area of science.