By: Jesse Goodman, M.D., M.P.H.
Graduate students who won a faculty-judged “America’s Got Regulatory Science Talent” competition at the University of Maryland recently filled my office with some of their ideas and energy.
Their winning ideas, and their commitment and excitement, bode well for the future of the sciences involved in ensuring that medical products are safe and effective. Perhaps above all, the problems that inspired their ideas provided powerful reminders that consumers should be engaged by health professionals and involved in their own care, including understanding the names and purposes of any medicines they are taking.
Jane Kalinina and Neha Patel, who are both pursuing degrees in law and pharmacy, saw the need for better patient awareness and understanding while working in pharmacies.
“Patients regularly called and asked, ‘What am I taking this for?’” said Kalinina. Citing a typical example, she described a patient who had been confusing her hypertension and diabetes medicines, and thus had been taking the wrong amount of each.
Such problems, they noted, are particularly problematic among the elderly, who often take multiple medicines and may see multiple doctors who may not always be aware what their colleagues have already prescribed.
Kalinina and Patel’s idea to help potentially better inform patients include the name of the condition a prescription medicine treats right on the bottle. In researching this idea, they learned that the State of California recently implemented just such an approach, with plans to evaluate potential benefits due in 2014. Kalinina and Patel plan to track this program and its evaluation and, if benefits are confirmed, hope to see the approach adopted nationally. Their idea won third place in the competition sponsored by the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI).
Second place was awarded to five doctoral students in Pharmaceutical Health Services Research: Patience Moyo, Mehmet Burcu, Sarah Dutcher, Xinyi Ng and Dinci Pennap. Their proposal was aimed at reducing the risk of harmful drug interactions through enhancing links among doctors, health systems and pharmacists, so that pharmacists have access to complete records of medicines being prescribed.
First place went to Curtis Gallagher, a doctoral student in molecular medicine at the University of Maryland, Baltimore, who researched “untapped opportunities” to facilitate reporting and monitoring of potential drug side effects and other unanticipated problems.
He noted that about 150 million Americans take at least one prescription. Based on personal experience and a 100-person survey, he found most people did not know about MedWatch, the FDA program where negative events can be reported and are tracked for trends, or found reporting too time consuming. His suggestion was for FDA to develop easier-to-use pull down menus of potential side effects, based on a drug’s FDA labeling, and allow consumers to file through FDA or through other websites consumers typically find when doing a computer search for information on a drug or condition. His ideas are being discussed at FDA.
As our health care system works to develop and refine many new approaches to enhancing the safe use of medications, this advice to consumers remains critical: know what you are taking, and why.
Jesse L. Goodman, M.D., M.P.H., is FDA’s chief scientist. In addition to being responsible for FDA’s cross-cutting scientific and public health efforts, he also provides strategic leadership for FDA’s regulatory science and innovation initiatives.