2007Commencement Address
College of Pharmacy and Health Sciences

By Roger L. Williams, M.D.
Chief Executive Office and Executive Vice President
United States Pharmacopeia

President Underwood, Dean Matthews, distinguished faculty, family and friends—and last but not least!—the  graduates of the Mercer University College of Pharmacy and Health Sciences class of 2007--I thank you most sincerely for the invitation to speak at your graduation ceremony.  It is a signal honor and opportunity that has great meaning—and, yes, even surprise--for me.  As I listened to the important words and thoughts that opened this ceremony, my thoughts turned back 40 years to my 1967 medical school graduation at the University of Chicago, then to present moment and onward to a future graduation at Mercer in the year 2047, when enthusiastic, bright scholars like you will be sitting in this audience to receive their degrees before a distinguished audience.  A graduation is a moment of pause—an inflection point between the past and the future.  In this context, I offer my sincere congratulations to you, the 2007 graduating class of the Mercer College of Pharmacy and Health Sciences, and to family, friends, and faculty who have worked so hard, as you most assuredly have, to come to this point in time.  The future for you is exciting, challenging, and—for those who are willing to work hard and be engaged—extremely bright.

That our future is challenging goes without question.  Our world, and the world of health care, is getting better, but that doesn’t mean we still don’t have a long way to go.  But this is what makes it exciting!  As the Chinese are often quoted as saying May we live in exciting times.  Well, I can’t imagine times much more exciting than these, not only for a rapidly globalizing world struggling to accommodate a host of other national and international challenges, but also for the life sciences and health care sectors specifically.  You, the graduating class of 2007, are entering these sectors at a time when a consensus has emerged that health care delivery in the US has failed—with the further observation that there is no hope of recovery without radical transformation.  By stating these ominous words, I refer of course to the seminal reports of the Institute of Medicine entitled To Err Is Human, Crossing the Quality Chasm, and Preventing Medication Errors.   I encourage you to read these reports if you have not already done so—they are sound and they are strong in a clarion call for change.  Their findings and the many follow-on studies, publications, public debates, and actions are prompting sea change in how health care will be delivered in the US.  Factors considered in the IOM reported are paralleled by many other factors, not the least of which is that health care in the US is extremely expensive.  We are trending towards a GDP of $21 trillion dollars and about 20% of this will be devoted to health care for a population that is expected to grow (and grow older) to 400 million by mid-21 century.  Many are questioning whether the US is getting the biggest bang for this buck and whether other solutions than those we now employ would serve us better.  I read in the paper recently that the US does not have a health care system, instead it has a system of nonsystematic illness intervention.  And you, newly minted graduates of the College, can be the ones who lead the change to a truly safe and effective patient-centered health care system that is timely, efficient and equitable.  It won’t be me—I’m part of the old system and as a Medicare member, ready to receive every conceivable health care benefit.  I want it all for my aging person—and you and others younger than me will pay for it!  But there is hope that a better system can be achieved, although the enormity of the task is daunting.  Paraphrasing Winston Churchill--Americans generally do the right thing—after they have exhausted all other possibilities!

I would now like to turn to standards, because that is what the United States Pharmacopeia and its primary publication the Pharmacopeia of the United States of America (USP) are all about.  Standards can affect products, processes, and people.  We live in a sea of standards, and standards go a long way back.  I’m reminded of the movie in which Moses comes out of the mist carrying three tablets announcing ‘the 15 commandments, the 15 commandments.’  He then drops one of the tablets and adroitly changes his cry to the ‘ten commandments, the ten commandments.’  More seriously, those ten commandments are standards.  I would call them process standards--ways of behavior--that have stood the test of time, and wouldn’t we all agree that the world would be a better place if we paid more attention to them?  There is another part of standards that speaks to conformity assessments to standards.  A standard has little meaning if it is not accompanied by some type of check to see if the product, process, or person conforms to it.  For the ten commandments, you could say it’s Jiminy Cricket who sits on your shoulder to remind you of how you are doing—or you could imagine someone at the Heavenly Gates doing a conformity assessment on how you have lived your life.  Surely he would check your life’s performance against those commandments.  In today’s world, conformity assessments are and will increasingly become a part of your lives as practicing pharmacists.  Dean Matthews will confront a conformity assessment of the College of Pharmacy and Health Sciences probably in 2008 when the Accrediting Council for Pharmacy Education comes calling to see how the school is doing.  I would call that a site accreditation conformity assessment, where the College will be assessed in terms of compliance with standards that encourage excellence in pharmacy education.  You, the graduating class of 2007, will soon face—if you have not already done so--a NAPLEX examination, offered by the National Association of Boards of Pharmacy.  When you pass the examination, you will be allowed to practice the science and art of pharmacy in the US and its territories.  You will become certified, just as I am a Board certified internist.  These are examples of ‘people’ standards.  And then too, the pharmacies in which you practice must conform to standards that undergo a conformity assessment from the State boards of pharmacy.  Beyond these three areas, you will encounter many other standards that will be important to you.  Standards can be mandatory or voluntary, or they can be required as a provision of reimbursement.  Thus there are many different ways of making you pay attention to standards whether you are particularly interested in them or not.  I see standards for you as becoming not only increasingly important but also increasingly useful.  Remember that standards should be sound and should be useful.  They should provide a method of making or testing something or managing a process or asserting the capability of a person— to promote commerce, save money, and enhance public trust.  But standards should not be confining.  They shouldn’t rob you of your knowledge, skills and abilities in such a way that you fail to exercise your own competence and intelligence.  If you find an inner voice saying ‘I don’t want to do something but the book says to do it that way,’ listen to that inner voice.  It may well be right.  Standards constantly change, and if you don’t listen to your inner voice and take action to identify a standard’s shortcomings, then they won’t change correctly. 

USP’s standards began in 1820 motivated by practitioners such as yourselves who wanted consistency in the medicinal preparations they used in daily life.  And they wanted them to have clear, useful names.  The original USP of 1820 is a fascinating compendium that contains many medicines still in use today, although back then, most of these drugs were crude mixtures compared to their contemporary counterparts—chinchona bark, for example, rather than quinine.  Some articles in the USP of 1820 you would now recognize as dietary supplements.  The original pharmacopeia contained mostly recipes.  This approach has evolved into what we now call compounding.  USP recognizes the right of practitioners to compound medicines in accordance with state and federal laws and is thus supportive of activities that can be part of your practice.  For many reasons, compounding is on the rise, but the practice needs better standards, both in terms of the recipes that are followed, as well as other product, process, and people standards.  And probably most importantly it needs more conformity assessments to these standards.  USP is working in all these areas, and I look forward to hearing from you–the new practitioners– in the ongoing dialogues on pharmaceutical compounding. 

But compounding now yields only a small fraction of the medicines available to practitioners and patients.  Most medicines are manufactured and thus come under the control of the US Food and Drug Administration.  USP evolved in this historic change, which occurred in the latter part of the 19th and early 20th centuries, by becoming more a book of public quality standards—tests, procedures for the tests and acceptance criteria.  In this context, the quality monographs in USP ally with the package insert that provides safety and efficacy information.  I encourage you to treasure USP because without it you wouldn’t be able to see these quality statements that help you assure your patients that they are taking a medicine of known and testable quality.  USP now creates three compendia.  Beyond USP—and working with practitioners such as yourselves—we also publish the National Formulary for excipients and the Food Chemicals Codex for food additives.  The details of how these compendia evolve and how they are used in the US and elsewhere are far beyond what I can talk to you about today, but I can assure you that you read about why they are important in your daily headlines.  When you read about diethylene glycol as a contaminant in medicines killing people in Panama or about melamine in pet food as an adulterant killing pets in the US—you are seeing the great need for public quality standards.  The issues of ensuring the safety and quality of medicines and foods are growing by the day, in part, because medicines are becoming more complex and because we increasingly obtain both medicines and foods from distant lands.  Are you surprised?  I suspect you are not, because the issue of globalization and standards thereto affect every sector of manufacturing, indeed every aspect of our daily lives.

My time is coming to an end, and I sense your ever vigilant Dean’s eyes boring into my back, wondering if I will adhere to the standard he gave me—the time I have to speak.  I will close now and in closing assume briefly the role of a preacher—one that ill suits me to tell you the truth.  Nonetheless, some gentle admonitions as you go forth from this place into the world as scholars and practitioners of the science and art of pharmacy.  First, take care of yourselves.  By virtue of your knowledge, skills, and abilities, plus your place in the community, you will be admired and you will become role models.  I admire you--I may deal with pharmacy technicians at my chain drug store, but I look past the immediate counter with hope and appreciation for the hardworking professional pharmacist who is dispensing--and I wonder how he or she does it?  Calls coming in by the minute asking forever more complicated drug information, OTC questions, refills, billing, and so forth.  I trust that the pharmacist will do everything right!  And when I say take care of yourselves, I’m not talking so much about nutrition and exercise, because I know you are good at that.  I also mean take care of your minds.  You will be very busy, but take some time each week to read a good newspaper and an excellent pharmacy journal or two.  Nourish your brain and stay abreast of what is happening, just as you eat good food and exercise.  I was especially pleased in reading some of the College’s literature before coming here today, which articulated how Dean Matthews and his faculty pay close attention to scholarship and teaching.  They have a Teaching and Learning Committee to help faculty be good teachers and this Committee defines scholarship in terms of accuracy, critical ability, and thoroughness.  Those three words—can there be any more pertinent to practitioners caring for patients?  But don’t think it ends now as you walk out from this beautiful ceremony.  Take teaching, learning, and scholarship with you all your lives to be your guides in a rapidly changing world.  You have my very best wishes and congratulations.  And now I will close with another quote:  "With great power comes great responsibility."  Who said that?  Spiderman’s Uncle Ben.